MedWorm provides a medical RSS filtering service. Over 6000 RSS medical sources are combined and output via different filters. This feed contains the latest medical blog items that have been tagged with 'fda warning'. Sat, 03 Sep 2011 02:16:55 +0100 http://www.medworm.com/index.php?rid=5069824&cid=t_96262_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F5ktd4wPgYzs%2F Valeant Pharmaceuticals has been on an acquisition spree, but perhaps the Canadian drugmaker may want to conduct a bit more due diligence before its next purchase. One of its recent deals was for Sanitas, which is based in Lithuania and controls Jelfa, another drugmaker based in Poland and that actually produces much of the Sanitas portfolio (read this). Valeant is paying about $455 million in cash (see here and here). However, a July 14 warning letter issued by the FDA to Jelfa notes that the Polish drugmaker has some basic problems with quality control. During an October 2010 inspection, the FDA found Jelfa did not thoroughly investigate the failure of a batch or any of its components to meet specifications, which the agency called an unacceptable practice. The FDA then offered a tutoria... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5069824 Tue, 26 Jul 2011 15:35:11 +0100 5069824 http://www.medworm.com/index.php?rid=4953360&cid=t_96262_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FJ_ALGGujptA%2F If at first you don’t succeed, try, try again? Last year at this time, the FDA chastised CSL, a big maker of flu vaccines based in Australia, for flunking an inspection that found several manufacturing deficiencies and, in addition to demanding a summary of corrective actions, agency officials took the unusual step of demanding a meeting with senior execs to review their plan (back story). Apparently, such meetings have absolutely no impact. The FDA has just issued a warning letter as a follow up to a March 2011 inspection, which generated a 483 report showing that CSL has no idea how to properly conduct an investigation to determine why fevers and convulsions were reported after children were given its products. Just the same, the FDA wants another meeting. But how bad was the effo... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4953360 Tue, 21 Jun 2011 14:09:08 +0100 4953360 http://www.medworm.com/index.php?rid=4848152&cid=t_96262_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FIJJqdimReMk%2F Two years after the FDA warned Apotex about severe manufacturing problems at one of its plants, the agency has issued a so-called close out letter that, essentially, gives the drugmaker a green light to resume shipments to the US. However, the FDA notice did not mention problems cited with another plant that were noted in a separate warning letter issued to Apotex last year (read the close out letter). The move may largely end a difficult episode for had been one of the biggest providers of generic drugs to the US. A June 2009 warning letter detailed numerous lapses, notably failing to fully investigate why batches of various products did not meet specifications. Three months later, the FDA issued an import alert for all meds made at this facility and the other plant, which was the subject... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4848152 Fri, 20 May 2011 11:43:34 +0100 4848152 http://www.medworm.com/index.php?rid=4813675&cid=t_96262_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FMOvCGSP2Uq4%2F Timing, as they say, is everything. On April 14, Octapharma announced that the European Medicine Agency’s Committee for Medicinal Products for Human Use had recommended lifting a six-month-long, EU-wide suspension of its Octagam biologics, which are used for treating primary humoral immunodeficiency, myeloma or chronic lymphatic leukaemia. Why was there a suspension in the first place? Last September, regulators noticed an unexpectedly high number of reports of thromboembolic events in patients using the meds (see here). But last month, Octopharma announced the CHMP had decided the Swedish drugmaker had taken “appropriate corrective measures” at its manufacturing sites (read here). However, on April 15, the FDA issued a warning letter as a follow-up to inspections that to... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4813675 Tue, 10 May 2011 15:38:29 +0100 4813675 http://www.medworm.com/index.php?rid=4768112&cid=t_96262_117_f&fid=37824&url=http%3A%2F%2Fwww.doctorkalitenko.com%2Fblog%2Flate-warnings-prescription-drugs%2F It takes quite a while for drugs to be approved by FDA. We are made to feel safe with years of clinical trials and information being published. Even safer when we watch TV ads which loudly proclaim all of the side effects of the medication we are about to be prescribed. But the truth is, that most testing is done by the manufacturers of the drugs and so most information is published by them. There is, however a rising number of cases where discovered negative effects were kept quiet and unpublished for consumers. The most recent FDA warning about a drug called Lamictal came last week. While used to treat seizures in kids, it can cause aseptic meningitis, a possibly fatal condition. This is a terribly sad state of affairs, for sure, but it reiterates a bigger point: the more natural we liv... Doctor Kalitenko antiaging blog blogs http://www.medworm.com/rss/comments.php?id=4768112 Fri, 29 Apr 2011 20:39:10 +0100 4768112 http://www.medworm.com/index.php?rid=4753970&cid=t_96262_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FN7yYPeyVrt4%2F During a lengthy inspection last fall of a supplier of active pharmaceutical ingredients, the FDA found something curious. The Baltimore facility run by ChemPacific, which also has operations in China, was failing to complete batch records for various lots of Norepinephrine Bitartrate. Entries were incomplete or missing, records were backdated and the in-house quality unit failed to detect the problems. In other words, ChemPacific was cited for playing fast and loose with its paperwork. In one specific example, the FDA noted that Chinese characters signifying a “need to change” were written on different batch records. And someone at the supplier told FDA investigators that the characters indicated these marked pages were to be replaced with a corrected batch record page. Interestingly... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4753970 Tue, 26 Apr 2011 15:00:24 +0100 4753970 http://www.medworm.com/index.php?rid=4627022&cid=t_96262_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fzsc31rHAVPw%2F A South Carolina state court jury decided late yesterday that a Johnson & Johnson unit violated consumer protection laws by sending doctors a misleading letter in 2003 about the safety and effectiveness of the Risperdal antipsychotic. The jurors also found warning label info was deceptive. And so a judge will now decide whether $360 million in penalties will be paid, Bloomberg News writes. South Carolina argued J&J’s Ortho-McNeil-Janssen Pharmaceuticals unit engaged in “unfair and deceptive acts” by claiming Risperdal was better than competing drugs in the letter, which was sent to some 700,000 doctors nationwide, including 7,200 in the state. The FDA issued J&J a warning letter about false and misleading claims that minimized risks, such as diabetes, and o... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4627022 Wed, 23 Mar 2011 12:05:21 +0100 4627022 http://www.medworm.com/index.php?rid=4622503&cid=t_96262_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F_nQ1_zS9Qoc%2F As we know, doctors who sign up as clinical trial investigators have certain responsbilities. These include, but are not limited to, protecting the rights, safety and welfare of participants; ensuring the control of drugs used in the trial, personally conducting the trial and supervising other activities. However, while certain tasks can be delegated, general responsibilities may not. But one doctor failed to follow through. To wit, he relied on a research nurse to carry out all sorts of things back in 2007. Such as? The nurse signed his name on protocol documents, including a financial disclosure form and two serious adverse event reports. Meanwhile, two of four subjects did not meet eligibility criteria. Yet, the doctor was apparently unaware until another research nurse told him. As the... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4622503 Tue, 22 Mar 2011 21:12:28 +0100 4622503 http://www.medworm.com/index.php?rid=4610994&cid=t_96262_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F03%2Ftaro-pharmaceuticals-bag-o-glass-moment.html I don't know who's "stupider" -- Taro Pharmaceutical, which published an OVIDE lotion branded comic book for kids without including warnings or the FDA, which sent the company a notice of violation letter because it did not include warnings such as "OVIDE Lotion is flammable?!"Holy cow! Flammable?! Even with the warning, Taro should never promote this product in a  comic book aimed at kids!It sort if reminds me of the Saturday Night Live "Bag O' Glass" skit featuring toy manufacturer Irwin Mainway, played byDan Aykroyd and Consumer Reporter played by Candice Bergen. Consumer Reporter: So, you don't feel that this product is dangerous?Irwin Mainway: No! Look, we put a label on every bag that says, "Kid! Be careful - broken glass!" I mean, we sell a lot of products in the "Bag O'" line.... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=4610994 Fri, 18 Mar 2011 18:20:00 +0100 4610994 http://www.medworm.com/index.php?rid=4610999&cid=t_96262_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FBdZ5Bc9I_LI%2F There are oversights… and then there are oversights. Somehow, though, Taro Pharmaceuticals forgot to include all of the warnings about its Ovide lotion for treating lice in a promotional children’s book distributed at the 2010 American Academy of Physician Assistants conference in Atlanta, and in material submitted to the FDA. What kind of warnings? Well, Ovide is not the sort of item you would want to simply hand a child. For instance, the lotion should only be used with adult supervision; the lotion is flammable, so its best to stay away from hair dryers if the child has wet hair; never use Ovide with anyone who is sensitive to the active ingredient, and if swallowed - well, you know - seek immediate medical attention. But not one word of these cautionary messages shows up in... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4610999 Fri, 18 Mar 2011 16:41:59 +0100 4610999 http://www.medworm.com/index.php?rid=4600797&cid=t_96262_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FjAzjWgOAy2w%2F Some of the employees at the CIBA Vision facility in Cidra, Puerto Rico, appear to have trouble seeing straight. The FDA recently sent a warning letter to the unit, which makes contact lenses, for failing to notice inconsistent product labeling. Moreover, the short-sighted staff also continued to use two contract labs even after determinng the companies were responsible for earlier sterility failures. “During the period of March through May 2010 your firm opened three CAPAs (corrective and preventive actions) to address issues related to distributed products which had labeling inconsistencies. These deficiencies were not detected by your quality inspectors even though your procedures require that quality assurance inspectors verify if the label rolls have the correct expiration date,... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4600797 Wed, 16 Mar 2011 12:31:56 +0100 4600797 http://www.medworm.com/index.php?rid=4507579&cid=t_96262_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FVDH6IuJdeJY%2F You read it here first. In a harsh warning letter, the FDA has reprimanded Sanofi-Aventis for failing to meet regulatory deadlines for reporting serious side effects with many of its drugs, including the Lovenox blood thinner, the Multaq heart drug and the Allegra D allergy pill, and also did not report post-marketing studies or completed, unpublished clinical trials in NDA annual reports. The seven-page missive, which was dated January 28, comes after the agency reviewed Sanofi paperwork last May. And a separate letter dated February 9 notes that a Sanofi plant in Germany has problems with contamination. When it came to reporting adverse events, however, some reporting delays stretched back as far as 2007 - there was a delay of 896 days in reporting side effects associated with the Glybur... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4507579 Tue, 22 Feb 2011 15:42:33 +0100 4507579 http://www.medworm.com/index.php?rid=4478161&cid=t_96262_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FE4YxlSrSI60%2F The use of language is a subtle art. Ask any regulator. And the regulators at the FDA have determined that Novartis was a bit too subtle, perhaps, in trying to promote its Fluvirin vaccine for the flu. The agency recently issued a warning letter that chastised the drugmaker for distributing a sales aid and print advertisement that were deemed misleading. Specifically, the promotional materials incorrectly characterized a published recommendation by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices and implied the Novartis vaccine can be used in all age ranges covered by the ACIP recommendations, according to the FDA letter, which was issued on February 4. For the current flu season, the ACIP recommended annual vaccination including infants who ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4478161 Mon, 14 Feb 2011 13:22:30 +0100 4478161 http://www.medworm.com/index.php?rid=4450520&cid=t_96262_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FkraFUdPQ2ig%2F Two weeks ago, Baxter Healthcare ceo Bob Parkinson disclosed to analysts that he received a warning letter from the FDA concerning problems at two plants in Puerto Rico. This is an embarassment and then some for Baxter, which was at the center of the contaminated Heparin scandal nearly three years ago that led to deaths and intense scrutiny of FDA oversight (back story). And so Parkinson made a point of mentioning the January 20 letter since it had not yet been disclosed publicly. Not surprisingly, he chose not to dwell on the contents, but did acknowledge the agency took issue with the way Baxter investigated unspecified “issues,” conveyed post-marketing reports and other “relevant information.” However, he stressed there were “no reported patient adverse eve... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4450520 Tue, 08 Feb 2011 15:23:22 +0100 4450520 http://www.medworm.com/index.php?rid=4168208&cid=t_96262_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FWoFKcVzc854%2F Mention the phrase ‘white paper’ and an authoritative guide to a particular policy issue may spring to mind. Of course, white papers may also be nothing more than promotional thoughts dressed up as think pieces. And that’s what the FDA has decided the Ipsen Group did in creating and distributing a paper about Insulin-like Growth Factor Deficiency, an affliction in which growth is inhibited. In a recently disclosed warning letter, the agency took Ipsen to task for omitting important risk info and broadenening the indication for its Increlex treatment. But the underlying issue was that the white paper wasn’t really a white paper and there were several tell-tale signs that offer some interesting insight into agency thinking on such situations. To wit, the FDA noted the... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4168208 Mon, 15 Nov 2010 17:13:53 +0100 4168208 http://www.medworm.com/index.php?rid=4018445&cid=t_96262_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FtabhHuqmFnw%2F Gilead Sciences just can’t get it right. Earlier this year, the FDA inspected its San Dimas, California, facility, which yielded a so-called 483 inspectional report citing various problems with the agency’s Good Manufacturing Practices. The biotech responded but to no avail. The FDA has now issued a warning letter and Gilead may be forced to curtail exports of the AmBisome antifungal treatment. The problems, which were noted in a filing with the US Securities and Exchange Commission, include control systems and monitoring, procedures to prevent microbiological contamination and preventative cleaning and equipment maintenance. Quality procedures and controls were also noted for certain lots of the Viread AIDS med and the overall “effectiveness” of the plant in carryi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4018445 Thu, 30 Sep 2010 12:15:50 +0100 4018445 http://www.medworm.com/index.php?rid=3999298&cid=t_96262_150_f&fid=38374&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FePharmaSummit%2F%7E3%2FFZ0JwxcX8g4%2Fcan-fda-keep-up-with-pharma-advertising.html AccessRx.com looks at the current balancing act Pharma companies are playing with the FDA while advertising to consumers. The USA and New Zealand are the only two countries in the world that allow Pharma companies to advertise to their consumers. The Pharma companies spend over $4.8 billion every year. The FDA regulates these ads, but is often far behind in monitoring and enforcing their policies on the ads.What do you think the FDA can do to better patrol Pharma Marketing? While the number of warning letters from the FDA has increased from 21 in 2008 to 45 as of August this year, the FDA is having trouble with the volume of advertising and reviewing campaigns. (Source: ePharma Summit) ePharma Summit blogs http://www.medworm.com/rss/comments.php?id=3999298 Fri, 24 Sep 2010 13:12:00 +0100 3999298 http://www.medworm.com/index.php?rid=3973114&cid=t_96262_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F2VKEYVGzqQs%2F Just as Allergan pleads guilty to a misdemeanor for misbranding in relation to off-label promotion of its widely used Botox (see this), the drugmaker was also tagged by the FDA for running an ad for its Acuvail anti-inflammatory that the agency deemed misleading for overstating efficacy and omitting risk information. Acuvail is an non-steroidal anti-inflammatory drug, or NSAID, that is used Acuvail is used to treat pain and inflammation after cataract surgery. But a recent two-page ad - which features a row of four diamonds that range from small and dull to large and sparkly - suggests the drug has “enhanced” and is superior to other ocular NSAIDs. The FDA, however, says this isn’t so, and goes on to spank Allergan for implying Acuvail improves outcomes and patient comfort, a... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3973114 Wed, 15 Sep 2010 12:30:23 +0100 3973114 http://www.medworm.com/index.php?rid=3921072&cid=t_96262_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F4G-9Di_UofA%2F File this under three strikes and you’re out: Baxter Healthcare was dinged by the FDA for circulating a brochure for its Aralast NP emphysema treatment that contains misleading efficacy claims. As many of you know, this sort of overstatement is not all that unusual, but in Baxter’s case, well, the FDA has about had it. In its Aug. 3, warning letter, the agency points out that Baxter is a corporate recidivist. “We are very concerned by your continued violative promotion of your products,” the agency writes. “Baxter was cited for similar violations (overstatement of efficacy and unsubstantiated claims of superiority) in an April 14, 2009, Warning Letter and a July 7, 2008, Untitled Letter from OCBQ (the Office of Compliance and Biologics Quality).” And so... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3921072 Tue, 31 Aug 2010 19:28:36 +0100 3921072 http://www.medworm.com/index.php?rid=3903129&cid=t_96262_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FTnk_tZYOS78%2F Two years after the FDA came down hard on Ranbaxy Laboratories, the generic drugmaker is reportedly offering to make a sweeping, one-time penalty payment in hopes of convincing the agency to allow shipments of various drugs to the US to resume. Such a payment, which is usually tied to a consent decree, may constitute as much as 20 percent of revenue over the past three years. The news was reported on MoneyControl and Ranbaxy officials refused to comment, but did not deny the report (watch the video here). We await a reply from the FDA. You may recall that, two years ago, federal prosecutors cited the Indian drugmaker for allegedly falsifying records that resulted in the production and sale of meds failing to meet FDA standards. The allegations included fabricating bioequivalence and stabil... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3903129 Wed, 25 Aug 2010 13:39:56 +0100 3903129 http://www.medworm.com/index.php?rid=3749856&cid=t_96262_146_f&fid=38266&url=http%3A%2F%2Fsleepeducation.blogspot.com%2F2010%2F07%2Ffda-warns-against-nighttime-cramp-cure.html (Source: Sleep Education) Sleep Education blogs http://www.medworm.com/rss/comments.php?id=3749856 Tue, 13 Jul 2010 16:39:00 +0100 3749856 http://www.medworm.com/index.php?rid=3511776&cid=t_96262_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FiKJQxS2m-mc%2F Earlier this month, the FDA sent Pfizer a warning letter for failing to properly monitor pediatric clinical trials in which at least 13 children with bipolar disorder experienced overdosing that led to restless legs, tremors, involuntary facial movements and a serious skin disorder. This is a big problem for the drugmaker, since Pfizer hopes to receive an extra six months of marketing exclusivity in return for having conducted the pediatric trials. But the dosing scandal could prompt the FDA to request further trials, which would require so much additional time that exclusivity would likely be lost, since the basic Geodon patent expires in 2012. This would also delay pediatric approval, which would expand the possibilities for a drug that generated $1.1 billion in sales last year. But who ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3511776 Wed, 28 Apr 2010 13:58:00 +0100 3511776 http://www.medworm.com/index.php?rid=3483120&cid=t_96262_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FYtTuaEgi9dM%2F For those tracking the missives sent by the agency to drugmakers, here is a quick round-up of letters that were posted late last week on the FDA web site. Interestingly, two of the violations involve a web page and an email. GlaxoSmithKline was tagged for placing an ad in the Dec. 1, 2009, issue of the Journal of Clinical Oncology that was cited for being false and misleading for omitting safety and effectiveness info about Arzerra (here’s the letter and here’s the ad). In another letter, sent to Astallas Pharma and Glaxo, which have a partnership to promote the Vesicare bladder control drug, the FDA charged that a web site promotion is “false or misleading because it presents unsubstantiated superiority claims and overstates efficacy” (here’s the letter and the w... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3483120 Mon, 19 Apr 2010 11:51:35 +0100 3483120 http://www.medworm.com/index.php?rid=2719764&cid=t_96262_111_f&fid=36048&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FAHeartyLife%2F%7E3%2FZGZcwKYooPs%2F Ibuprofen (Advil, for example), is a commonly used pain medication that is taken by mouth. However, some unscrupulous people have been selling topical ibuprofen over-the-counter, meaning ibuprofen in a cream or ointment. What concerns the FDA is that there is no proof that ibuprofen in a topical form in any over-the-counter products. They’ve sent warning letters to eight companies who are selling the products. According to the FDA press release: The names of the products and manufacturers that received warning letters are: Emuprofen (Progressive Emu, Inc.) BioEntopic 15% Ibuprofen Crème (BioCentric Laboratories, Inc.) Ibunex Topical Ibuprofen (Core Products International, Inc.) LoPain AF 15% Ibuprofen Crème (Geromatrix Health Products) IB-RELIEF (MEKT LLC) Profen HP (Ridge Medical ... A Hearty Life blogs http://www.medworm.com/rss/comments.php?id=2719764 Fri, 21 Aug 2009 00:25:51 +0100 2719764 http://www.medworm.com/index.php?rid=2702362&cid=t_96262_111_f&fid=36048&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FAHeartyLife%2F%7E3%2FpkbwwwAtu0c%2F Here is an FDA press release warning the public about certain glucose testing strips that are used by people with diabetes: FDA Issues Public Health Notification on Glucose Monitoring Technology The U.S. Food and Drug Administration (FDA) today advised health care practitioners and patients against using certain glucose monitoring technology that employs a specific test strip when the patients are also receiving therapeutic products containing non-glucose sugars. Non-glucose sugars contained in some therapeutic products such as peritoneal dialysis solutions and certain immunoglobulins can falsely elevate glucose results, which may prompt excessive insulin administration. These therapeutic products, which are labeled to indicate that they may interfere with this particular glucose monitori... A Hearty Life blogs http://www.medworm.com/rss/comments.php?id=2702362 Fri, 14 Aug 2009 20:06:46 +0100 2702362 http://www.medworm.com/index.php?rid=2637865&cid=t_96262_111_f&fid=36048&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FAHeartyLife%2F%7E3%2FIPCAVFv_wRw%2F If you’ve been considering switching to the so-called electronic cigarettes to keep your smoking habit but lower your health risk, save your money. Electronic cigarettes, or e-cigarettes are no safer than the traditional tobacco ones, says the FDA. According to the website E-Cigarettes Choice , While cigarettes emit about 4,000 identifiable chemicals as they are smoked and 69 are known to cause cancer, e-cigarettes contain less than 10 to 20 chemicals on average, depending on the brand or strength purchased.  No more tar blackening your lungs and no more carcinogens. But the FDA says: The FDA’s Division of Pharmaceutical Analysis analyzed the ingredients in a small sample of cartridges from two leading brands of electronic cigarettes. In one sample, the FDA’s analyses detected d... A Hearty Life blogs http://www.medworm.com/rss/comments.php?id=2637865 Sat, 25 Jul 2009 12:00:17 +0100 2637865 http://www.medworm.com/index.php?rid=2580269&cid=t_96262_111_f&fid=36048&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FAHeartyLife%2F%7E3%2Fi849o-HOqKU%2F This article appears on FDA’s Consumer Updates page , which features the latest on all FDA-regulated products. ~~~~~ Image: Newscom.com Share and Enjoy: Post from: Blisstree FDA Warning: Two Liquid “Energy” Products (Source: A Hearty Life) A Hearty Life blogs http://www.medworm.com/rss/comments.php?id=2580269 Wed, 08 Jul 2009 01:30:11 +0100 2580269 http://www.medworm.com/index.php?rid=1924714&cid=t_96262_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F436851712%2F The agency sent the biotech a warning letter for using what it called a ‘false and misleading’ consumer brochure to promote its Sensipar kidney med to patients. The problem? The brochure “omits and minimizes the risks associated with the use of Sensipar and broadens the indication for Sensipar,” according to the letter. For instance, Amgen failed to note that Sensipar, which is used to treat patients undergoing dialysis for chronic kidney disease, is associated with the risk of adynamic bone disease and poses a risk to patients with hepatic impairment, the FDA letter states. And these are serious risks (here is the brochure). For its part, Amgen says it will address FDA concerns. “We immediately ceased distribution of the brochure. Amgen is committed to respon... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1924714 Thu, 30 Oct 2008 12:05:49 +0100 1924714 http://www.medworm.com/index.php?rid=1860605&cid=t_96262_136_f&fid=37846&url=http%3A%2F%2Fhealthinfoispower.wordpress.com%2F2008%2F10%2F08%2Ffda-issues-a-warning-letter-to-labcorp-regarding-the-illegal-marketing-of-the-ovasure%25e2%2584%25a2-test%2F On September 29, 2008, the U.S. Food and Drug Administration (FDA) Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), Center for Devices and Radiological Health, issued a warning letter (FDA Warning Letter) to the Chief Executive Officer of the Laboratory Corporation of America (LabCorp) regarding the illegal marketing of the OvaSure™ ovarian cancer [...] (Source: Libby's H*O*P*E*) Libby's H*O*P*E* blogs http://www.medworm.com/rss/comments.php?id=1860605 Wed, 08 Oct 2008 19:39:45 +0100 1860605 http://www.medworm.com/index.php?rid=1782899&cid=t_96262_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F387607769%2F The FDA sent a warning letter last month to the drugmaker for promoting its Bystolic high blood pressure med to docs without properly noting the medication’s risk. An 8-page ad, which ran in various medical journals, also implied the drug is better than rival meds even though there is no substantial evidence to prove such claims. “Although the journal ad does include important safety information on its second page, it omits and minimizes certain risks,” wrote Thomas Abrams, head of the FDA’s Division of Drug Marketing, Advertising and Communications in the August 28 letter, which noted the ad specifically left off a warning about the drug’s use in patients with congestive heart failure. The FDA also noted the ad claimed that the beta-blocker works better for p... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1782899 Tue, 09 Sep 2008 12:19:00 +0100 1782899 http://www.medworm.com/index.php?rid=1734253&cid=t_96262_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F375315658%2F The FDA sent a warning letter on August 12 to the drugmaker’s Sandoz generic unit about a failure to properly validate the manufacturing process for a copycat version of AstraZeneca’s Toprol XL, a blood pressure medication, which it makes a North Carolina plant. “We question the continued distribution of this product until better process controls are implemented and process validation is completed,” the FDA wrote to Sandoz ceo Bernard Hampl. “We are also concerned that the problems noted in the metoprolol validations could be indicative of problems and poor decisions made with other product validations.” A Novartis spokesman tells Reuters the FDA’s concerns were “primarily about documentation and validation. We are working together with the F... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1734253 Tue, 26 Aug 2008 15:39:50 +0100 1734253 http://www.medworm.com/index.php?rid=1603098&cid=t_96262_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F331021305%2Ffluroquinolone_antimicrobial_d.html The U.S Food and Drug Administration has notified the manufacturers of fluroquinolone antimicrobial drugs that a "boxed warning" in the label of the product is required to inform patients of the increased risk of tendonitis and tendon rupture.Aside from the boxed warning the FDA also decided that manufactures provide a Medication Guide to patients warning of the possible side effects. The drugs already carry a warning of an increased risk of tendon ruptures but an increased number of adverse event reports prompted the increased visibility of that warning.The class of antimicrobial drugs known as fluroquinolones, such as Cipro, have been approved to treat or prevent bacterial infections such as sinusitus, urinary tract infections, cystitis and lower respiratory tract infections.Th... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1603098 Wed, 09 Jul 2008 19:00:33 +0100 1603098 http://www.medworm.com/index.php?rid=1543342&cid=t_96262_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F319901960%2Fdoj_investigation_of_paxil_widens.html The U.S. Department of Justice confirmed that its investigation into whether GlaxoSmithKline withheld data concerning adverse risk associated with Paxil has been expanded to include the U.S. attorney's office in Boston and is being coordinated in Washington.Paxil, an antidepressant drug manufactured by GSK, was issued a warning letter by the U.S. Food and Drug Administration in 2006 stating that there were potential suicide risks among young adults taking the medication. (Source: PharmaGazette) PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1543342 Wed, 25 Jun 2008 16:00:51 +0100 1543342 http://www.medworm.com/index.php?rid=1500280&cid=t_96262_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F306362658%2F Over the past 10 years, there was a drop by about half, in fact, Dow Jones reports. A big falloff began in 2002, when the agency began requiring all warnings go through its chief counsel office, which was supposedly designed to make the letters legally consistent and credible, the wire notes. The year before this change took effect, in fiscal year 2001, the FDA issued 1,032 warning letters. In 2006, the FDA sent 538 letters, and in 2007 it sent 471, FDA data show. Some members of Congress, FDA staffers and former FDA officials have criticized the change, suggesting it favored industry. “The number of warning letters has always been one of the surrogate measures of FDA’s enforcement performance,” David Kessler, who was FDA commish from 1990 to 1997, tells Dow Jones. &#822... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1500280 Fri, 06 Jun 2008 21:57:30 +0100 1500280 http://www.medworm.com/index.php?rid=1469738&cid=t_96262_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F298484956%2Fnipple_cream_gets_fda_warning.html The U.S. Food and Drug Administration has issued a warning to all nursing mothers that the use of Mommy's Bliss Nipple Cream may be harmful to their nursing babies.The nipple cream sold to help nursing mother soothe dry or cracked nipples contains the potentially harmful ingredients chlorphenesin and phenoxyethanol. The product label states that there is no need to wash off the cream prior to nursing however, the ingredients could possibly cause respiratory distress, vomiting and diarrhea in babies.The ingredient chlorphenesin can also cause dermatitis which can worsen the drying and cracking of the nipples."FDA is particularly concerned that nursing infants are being unwittingly exposed by their mothers to this product with dangerous side effects," said Janet Woodcock, direc... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1469738 Mon, 26 May 2008 15:00:39 +0100 1469738 http://www.medworm.com/index.php?rid=1467088&cid=t_96262_87_f&fid=36050&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FBreastfeeding123%2F%7E3%2F297436393%2F Yesterday the U.S. Food and Drug Administration issued a warning against the use of Mommy’s Bliss Nipple Cream, marketed by MOM Enterprises, Inc. to nursing mothers for treatment of cracked and sore nipples. The packaging specifically states that it is not necessary to remove the cream before nursing, but two ingredients in the cream may be harmful to nursing infants. The FDA describes the dangers of chlorphenesin and phenoxyethanol: Chlorphenesin relaxes skeletal muscle and can depress the central nervous system and cause respiratory depression (slow or shallow breathing) in infants. Phenoxyethanol is a preservative that is primarily used in cosmetics and medications. It also can depress the central nervous system and may cause vomiting and diarrhea, which can lead to dehydration in... Breastfeeding 1-2-3 blogs http://www.medworm.com/rss/comments.php?id=1467088 Sat, 24 May 2008 22:54:17 +0100 1467088 http://www.medworm.com/index.php?rid=1332530&cid=t_96262_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F259314716%2Fjj_foot_gel_regranex_may_incre.html The U.S. Food and Drug Administration announced that a Johnson and Johnson foot gel that is used by diabetics may increase the risk of cancer.The gel, Regranex, was found to increase the number of cancer deaths of people who had previously been prescribed the gel 3 or more times."At this time, FDA believes that there may be some evidence for an increased risk of death from cancer in patients who had repeated treatments with Regranex," the FDA said in a statement. "Because there are known risks associated with diabetic foot and leg ulcers that do not heal, the potential risk of using Regranex should be weighed against the benefit for each individual patient."[Source: YahooNews] (Source: PharmaGazette) PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1332530 Thu, 27 Mar 2008 22:00:50 +0100 1332530 http://www.medworm.com/index.php?rid=1329095&cid=t_96262_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F258594981%2Fcolonoscopy_prep_solution_may.html New research at Scott & White Clinic at in Temple, Texas suggests that the solution used in preparation for a patient to undergo a colonoscopy can cause acute kidney failure and long-term kidney damage.The research suggests that while the risks of oral sodium phosphate solution are rare, they do exist especially for older patients."People should be very cautious in the use of these agents because of their potential of causing kidney damage," said study author Dr. Anand Khurana.The oral sodium phosphate solution already has a U.S. Food and Drug Administration black box warning. The FDA recommended that the solution be used cautiously among patients with impaired kidney function. The new study shows that the solution can affect even those with no previous kidney problems.The co... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1329095 Wed, 26 Mar 2008 20:00:19 +0100 1329095 http://www.medworm.com/index.php?rid=1204680&cid=t_96262_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F229163269%2Fchantix_early_communication_be.html In November the U.S. Food and Drug Administration issued an Early Communication warning that Pfizer's anti-smoking drug Chantrix may be associated with increased suicidal thoughts and aggressive behavior.On Friday the FDA issued a Public Health Advisory announcing that it has asked Pfizer to include the warning to the label of Chantrix.The FDA stated that after reviewing adverse event reports that it appeared that it was increasingly likely that there may be "an association between Chantix and serious neuropsychiatric symptoms." The FDA has therefore asked Pfizer to increase the prominence of the label warning and in the prescribing section of the drug. The FDA also stated that it is working with Pfizer to finalize a Medication guide for patients."Chantix has p... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1204680 Mon, 04 Feb 2008 20:00:37 +0100 1204680 http://www.medworm.com/index.php?rid=1139826&cid=t_96262_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F213998995%2Fcompounded_menopause_hormone_t.html The U.S Food and Drug Administration announced that it sent out warning letters to seven pharmacy operations that had made claims about the safety and effectiveness of their "bio-identical hormone replacement therapy" (BRHT) products which were unsupported by medical evidence.The FDA considers the claims to be false and misleading and is concerned that the unfounded claims are misleading to women and health care professionals. The pharmacy operations' claims include that their drug, which contains hormones such as estrogen, progesterone and estriol (which has not been proven safe by the FDA) are better than FDA approved hormone replacement therapies and that the drug also treat diseases such as Alzheimer's disease, stroke and different types of cancers."We want ... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1139826 Wed, 09 Jan 2008 18:00:22 +0100 1139826 http://www.medworm.com/index.php?rid=1079764&cid=t_96262_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F196793368%2Fbedwetting_drug_gets_fda_warni.html Desmopressin, a drug that limits the amount of water that is eliminated in the urine and also is used to prevent and control excessive thirst, urination and dehydration due to injury, surgery and certain medical conditions has received a U.S. Food and Drug warning update request.The FDA has requested that the manufactures of desmopressin update the prescribing information to include new information about severe hyponatremia, dangerously low levels of sodium in the body, and seizures. Children treated with desmopressin nasal spray for primary nocturnal enuresis (PNE/ bed wetting) are particularly susceptible and the drug is no longer indicated for the treatment of PNE.According to the FDA 61 reports of seizures, 36 associated with the nasal spray form of the drug were reported. There w... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1079764 Fri, 07 Dec 2007 16:00:51 +0100 1079764 http://www.medworm.com/index.php?rid=1072405&cid=t_96262_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F195737938%2Fdrug_warnings_and_withdrawls_f_1.html FiercePharma has compiled a list of the top 10 drugs to have who have had approval either withdrawn or been forced to add stronger warning labels, by the FDA, with respect to their pharmaceutical products.  The list is based on 2006 worldwide sales so ranking does not necessarily include the big new makers.1. Antidepressants - Various companies - "Black" box warning regarding increased risk of suicidal thoughts.2. Epogen/Aranesp - Amgen - "Black" box warning of heart and vascular risk at higher doses3. Zyprexa - Lilly - Warning of weight gain and metabolic problems4. Avandia - Glaxo - "Black" box warning of heart failure and heart attack5. Actos - Takeda - "Black" box warning of heart failure6. Provigil - Cephalon - Waning of Stevens-J... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1072405 Wed, 05 Dec 2007 20:00:41 +0100 1072405 http://www.medworm.com/index.php?rid=1072407&cid=t_96262_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F195660439%2Fblackbox_warning_for_genetechs.html Proposed in February and approved in July, Xolair (omalizumab) will be sporting a new, upgraded black box warning as per U.S. Food and Drug Administration recommendation. The warning will emphasize that Xolair, an injectable, used to treat patients with asthma related to allergies, may cause anaphylaxis. Anaphylaxis may cause chest tightness, dizziness, fainting, trouble breathing, itching and hives and swelling of the mouth and/or throat.  The FDA has also asked Genetech to revise the Xolair label and provide patients with an updated medication guide with the strengthened warning.Xolair is indicated for the treatment of asthma patients, over the age of 12, who have severe persistent asthma and who have tested positive for a perennial aerial allergen such as polled, grass or dust... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1072407 Wed, 05 Dec 2007 18:00:20 +0100 1072407 http://www.medworm.com/index.php?rid=1072409&cid=t_96262_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F195622211%2Ftakeda_pharmaceuticals_actos_g.html In June 2007, during congressional hearings, the U.S. Food and Drug Administration revealed that it has called for the strongest black box warning possible on Actos.After reviewing postmarketing adverse event reports, the FDA that Actos (pioglitazone), approved to treat Type 2 diabetes, required a black box warning emphasizing that the drug may cause or worsen heart failure in certain patients. The warning covers all thiazolidinedone class drugs including Avandia, Actos, Avandaryl, Avandamet and Duetact."Under FDA's postmarketing surveillance program, we carefully monitor new safety information for marketed drugs and take appropriate action when necessary to inform patients and health care providers of new information," said Steven Galson, M.D., M.P.H., director of FDA&#... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1072409 Wed, 05 Dec 2007 16:00:21 +0100 1072409 http://www.medworm.com/index.php?rid=1057350&cid=t_96262_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F191855328%2Fglaxosmithkline_gets_warned_by.html The U.S Food and Drug Administration has warned GlaxoSmithKline plc (NYSE:GSK) over misleading letters the company sent to health professionals promoting its breast cancer drug, Tykerb.The FDA found that the letters sent out by Glaxo "are misleading in that they omit and minimize the most serious and important risk information" and "selectively present efficacy information for Tykerb, thereby overstating the efficacy of the drug. Most important, the letters minimize the important risk of decreased left ventricular ejection fraction," a measure of the amount of blood pumped out of one section of the heart, the FDA said in a letter to Glaxo.The FDA letter, six pages in all, also states that the information contained in Glaxo's promotional letters is misleading be... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1057350 Wed, 28 Nov 2007 14:00:59 +0100 1057350 http://www.medworm.com/index.php?rid=1052570&cid=t_96262_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F191229872%2F The agency sent a warning letter to the drugmaker for omitting and minimizing the most serious risks, and selectively stating efficacy info, in letters that were sent to docs as part of a promotional campaign. The campaign began shortly after the FDA approved Tykerb as a treatment for certain patients with advanced breast cancer. (Here’s the evidence). In its Nov. 21 letter (which you can read here), the FDA notes the promo letters “minimize the important risk of decreased left ventricular ejection fraction,” which measures of the amount of blood pumped out of one section of the heart. The Glaxo letter also failed “to present the most serious and important risk information,” including warnings about pregnancy, patients with liver impairment and diarrhea. &#822... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1052570 Tue, 27 Nov 2007 11:59:44 +0100 1052570 http://www.medworm.com/index.php?rid=1047608&cid=t_96262_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F189440696%2Fpossible_fda_warning_on_two_fl.html A U.S Food and Drug Administration panel will review recommendations that  psychiatric warnings be added to the labels of Roche Holding AG's Tamiflu and GlaxoSmithKline's Relenza.The recommendation includes adding label warnings be increased on Tamiflu to include "in some cases, these behaviors resulted in serious injuries, including death, in adult and pediatric patients." FDA staff would also like the Relenxa box label to include:"reports of hallucinations, delirium and abnormal behavior" seen in some patients taking the drug.At this point FDA staff is unsure whether it is the drugs causing the adverse events or if they are a manifestation of a disease or a combination of the two. Roche has stated that there is no causal relations... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1047608 Fri, 23 Nov 2007 18:00:53 +0100 1047608 http://www.medworm.com/index.php?rid=1014988&cid=t_96262_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F181758597%2Fepogen_procrit_and_aranesp_get_fda_labeling_changes.html "The U.S. Food and Drug Administration today approved revised boxed warnings and other safety-related product labeling changes for erythropoiesis-stimulating agents (ESAs), which treat certain types of anemia. These new statements address the risks that the drugs Aranesp, Epogen and Procrit pose to patients with cancer and patients with chronic kidney failure."For patients with cancer the box warning now includes that ESAs caused tumor growth and shortened survival time in patients with advance breast, head and neck, lumphoid and non-small cell lung cancer.For patients with chronic kidney failure the new box warning states the ESAs should be used to maintain a hemoglobin level between 10 g/dl to 12 g/dl. Higher levels increase the risk for death and serious cardiovascular occurre... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1014988 Thu, 08 Nov 2007 18:00:10 +0100 1014988 http://www.medworm.com/index.php?rid=989734&cid=t_96262_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F177174812%2Ffda_says_roches_cellcept_raise.html Roche Holding AG (OTC:RHHBY) organ rejection drug, CellCept, increase the risk of miscarriage and birth defects according to the U.S. Food and Drug Administration. There is also the possibility of congenital malformations.The FDA has added a new black box warning to CellCept's label about the increased risk of facial and ear deformities and problems in limbs, heart and other organs. The FDA relied on date collected from postmarketing data collected from 1995 to 2007 that found of the 77 women exposed to the drug, 25 had a spontaneous abortion and 14 had a deformed fetus or infant.CellCept is given to prevent kidney, liver and heart transplant rejection and should not be given to a woman until a pregnancy test is given, and confirmed negative, within one week of the commencement of... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=989734 Tue, 30 Oct 2007 13:35:03 +0100 989734 http://www.medworm.com/index.php?rid=979218&cid=t_96262_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F174962703%2Fsanofiaventis_receives_warning.html The FDA sent a warning letter to Sanofi's CEO Gregory Irace accusing the company of knowingly having submitted clinical data had "multiple and significant violations of FDA regulations… that affected the integrity of data submitted".After the FDA required more information on Ketek following fears that it could cause liver damage, data obtained as part of a postmarketing study by Pharmaceutical Product Development was submitted on behalf of Aventis prior to its merge with Sanofi-Synthelabo.At the heart of the matter is Dr Anne Kirkman-Campbell who in 2004 was convicted of fraud regarding patient enrollment and fake consent forms during the Ketek study. The issue also raised concerns in Congress and a former Pharmaceutical Product Development employee testified that... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=979218 Thu, 25 Oct 2007 18:15:14 +0100 979218 http://www.medworm.com/index.php?rid=903791&cid=t_96262_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F161314401%2F Apologies for signing off so late tonight. We were gainfully occupied with sundry tasks and time slipped away. Nonetheless, here we are with a few items to help you sleep better. We wish you sweet dreams… Chinese Drugmaker And API Supplier Gets FDA Warning Letter (FDA Warning Letter) Crucell Denies Blame For Merck’s HIV Vaccine Flop (Yahoo/Reuters) India Tells Pfizer To Drop Prices Of Two OTC Drugs (The Business Standard) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=903791 Wed, 26 Sep 2007 00:58:33 +0100 903791 http://www.medworm.com/index.php?rid=800177&cid=t_96262_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F144373788%2F The drugmaker received a warning letter that a professional file card, which is basically promotional material, overestimated the effectiveness of its Alzheimer’s med, contained misleading info concerning risks and unsubstantiated superiority claims, and recommended an unapproved combo with another drug. You can look at the file card here. “These violations are concerning from a public health perspective because they suggest that Exelon is safer or more effective than has been demonstrated, and they encourage the use of Exelon in circumstances other than those for which the drug has been shown to be safe and effective,” wrote Tom Abrams, who heads the FDA’s Division of Drug Marketing, Advertising and Communications, in the letter to Alex Gorsky, who heads Novartis p... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=800177 Wed, 15 Aug 2007 12:06:26 +0100 800177 http://www.medworm.com/index.php?rid=797221&cid=t_96262_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F143781157%2F The drugmaker omitted important risk info and made unsubstantiated claims that Geodon is better than another drug, according to a July 16 warning letter posted on the FDA web site. And the agency asked Pfizer to stop running the ad, which appeared in an unnamed medical journal. The FDA wrote that the ad, which you can see by clicking on this link, included some info about potential side effects from the injectable version of Geodon, but didn’t mention “other serious warnings and precautions,” such as the possibility of neuroleptic malignant syndrome, tardive dyskinesia, hyperglycemia and diabetes. The ad also suggested Geodon was more effective than a generic drug, haloperidol, “when this has not been demonstrated by substantial evidence or substantial clinical expe... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=797221 Mon, 13 Aug 2007 20:45:05 +0100 797221