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 'black box warning'. Sat, 03 Sep 2011 02:28:21 +0100 http://www.medworm.com/index.php?rid=3008397&cid=t_103914_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F11%2Fis-google-new-fda.html At the recent FDA public hearing, Google presented its "ideas" for standard paid search ads for Rx products. The following, for example, shows its "proposal" for "Black Box Sponsored Links:"According to Klick Pharma's "Applying FDA Regulations to Online Marketing" guide, "Products with boxed warnings do not have the same flexibility in terms of creating reminder ads, as this form of ad is not permitted by the FDA for such drugs. While many boxed warning drugs have and continue to use branded reminder ads for search, it is not advisable given the current environment."Bayer has chosen not to heed this warning and decided to use Google's new "proposed" format for its  YAZ search campaign, as shown in this screen shot below (the ad I am referring to is the one on top, :-):YAZ is a special... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3008397 Thu, 19 Nov 2009 13:15:00 +0100 3008397 http://www.medworm.com/index.php?rid=1883570&cid=t_103914_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F421456941%2F Three years ago, the FDA required makers of antidepressants to supply Med Guides along with their pills. That wasn’t good enough for a couple of New Jersey moms, who have been pushing their state legislature to go further - a bill requiring a doctor or nurse to obtain informed consent from a minor’s parent before writing a prescription for any psychotropic that already carries a Black Box warning. In fact, thanks to their urgings, a bill has been kicking around the state legislature for nearly two years and passed the assembly. However, the state senator who heads the Senate health committee, Joe Vitale, has repeatedly failed to schedule the bill for a vote (here’s the bill and the assembly version). Last fall, he told us the bill would move forward, but it never did. And Vitale ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1883570 Wed, 15 Oct 2008 10:49:50 +0100 1883570 http://www.medworm.com/index.php?rid=1625797&cid=t_103914_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F336156450%2F Last week, an FDA advisory committee voted that 11 epilepsy meds can increase the risk of suicide, but voted 14-4 against adding a Black Box about those risks on the drug labeling, something the agency itself suggested several times in the weeks leading to the meeting. The episode followed a spate of new or revised Black Box warnings - the most serious warning the FDA can recommend a drugmaker place on product labeling - for a host of drugs over the past few years. These include antidepressants, antipsychotics, antibiotics, anemia treatments, ultrasound meds, asthma drugs and diabetes pills (have we forgotten anything? Send us a note). The recent vote over epilepsy meds prompted speculation that, perhaps, the FDA has become so painfully aware of safety concerns that the Black Box warning i... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1625797 Tue, 15 Jul 2008 14:43:15 +0100 1625797 http://www.medworm.com/index.php?rid=1526301&cid=t_103914_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F313904319%2Ffda_adds_black_box_warning_to_1.html The U.S. Food and Drug Administration announced that it now requires the manufacturers of "conventional" antipsychotic drugs to include a black box warning on the labeling and prescribing information of this class of drugs.The changes are to warn about an increased risk of death associated with the off-label use of these antipsychotics to treat behavioural problems in older patients with demntia. Off-label treatments are those uses that are not FDA or manufacturer approved. (Source: PharmaGazette) PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1526301 Tue, 17 Jun 2008 16:00:06 +0100 1526301 http://www.medworm.com/index.php?rid=1488221&cid=t_103914_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2008%2F06%2Fevista-nobody-is-pointing-gun-at-us.html According to an IndyStar.com article, the new Evista ads "are raising a new round of criticism from some women's health groups" (see "A new pitch for an old pill"). Lilly markets Evista.The issue is whether or not Evista's breast cancer prevention benefit is worth the risk."Evista," says the article, "has been shown to raise the risk of blood clots and fatal strokes. In one clinical trial of 10,000 patients with coronary problems and other health issues, women who took Evista had a 49 percent higher risk of dying if they suffered a stroke than those who took a placebo."The drug's packaging insert even carries a black-box warning about those risks -- the strongest warning required by the Food and Drug Administration."The article seems to be a "fair and balanced" critique and quotes a few di... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=1488221 Mon, 02 Jun 2008 18:03:00 +0100 1488221 http://www.medworm.com/index.php?rid=1356373&cid=t_103914_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F266288921%2F This is certain to cause a ruckus. Two years after Health Canada warned about prescribing antidepressants to children, a new study reports that the number of children and teens who died by suicide increased 25 per cent after years of steady decline, The Vancouver Sun writes. At the same time, the increased suicide rate coincided with a 10 percent drop in the rate of visits to docs for treating depression in children. The researchers tracked health records of more than 265,000 Manitoba children per year between 1995 and March 2006. Health Canada warned in 2004 that antidepressants may be associated with an increased risk of suicide-related events in patients under 18. They found the warning was followed by a 14 percent drop in antidepressant use among children and teens, fewer visits to doc... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1356373 Tue, 08 Apr 2008 11:11:17 +0100 1356373 http://www.medworm.com/index.php?rid=1268595&cid=t_103914_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F243395476%2F Three years ago, the FDA required makers of antidepressants to supply Med Guides along with their pills. That wasn’t good enough for a couple of New Jersey moms, who have been pushing their state legislature to go even further - a bill requiring a doctor or nurse to obtain informed consent from a minor’s parent before writing a prescription for any psychotropic that already carries a Black Box warning. Last November, however, it looked like the bill, which had been kicking around a year, was dead after making it to the New Jersey assembly and senate. The state senator who heads the health committee, Joe Vitale, failed to schedule the bill for a vote, citing procedural issues and the need for further study. At the time, he told us the bill would still move forward, but it never did. He ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1268595 Fri, 29 Feb 2008 16:22:22 +0100 1268595 http://www.medworm.com/index.php?rid=1134002&cid=t_103914_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F212804601%2F Those FDA warnings about the risk of suicidal thoughts and behaviors in children and adolescents taking those meds appear to have had “modest and targeted effects on the intended populations,” according to a study in Archives of General Psychiatry (subscription may be required). Relying on data from the Medco pharmacy benefits manager, the researchers analyzed trends in antidepressant use for three age groups - kids between 6 and 17 years old; adults aged 18 to 64, and those 65 and older. And they examined the usage over three time periods - May 1, 2002 to June 19, 2003, before any warnings were issued; June 20, 2003 to Oct. 15, 2004, when a warning was issued on Glaxo’s Paxil, and from Oct. 16, 2004 to Dec. 31, 2005, during which time Black Box warnings were issued and s... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1134002 Mon, 07 Jan 2008 21:23:25 +0100 1134002 http://www.medworm.com/index.php?rid=1147418&cid=t_103914_107_f&fid=36698&url=http%3A%2F%2Fminingdrugs.blogspot.com%2F2008%2F01%2Fboutique-drugs-splitting-mass-market.html "Recently, the term boutique has started being applied to normally-mass-market items that are either niche or produced in intentionally small numbers at very high prices. For example, before the release of the Wii, a Time Magazine article suggested that Nintendo could become a boutique video-game company, producing games for niche audiences, rather than trying to compete directly with Microsoft and Sony [1]" [Boutique@WP]"articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals and articles (other than food) intended to affect the structure or any function of the body of man or other animals." [FDA definition]As found via Bio-IT/drug discovery expect analysts in the future more boutique drugs. Two main causes are mentioned.Fi... Mining Drug Space blogs http://www.medworm.com/rss/comments.php?id=1147418 Sat, 05 Jan 2008 21:15:00 +0100 1147418 http://www.medworm.com/index.php?rid=1030257&cid=t_103914_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F185452818%2F It would only be surprising if Takeda Pharmaceuticals didn’t make such a move. The drugmaker plans to roll out ads touting the safety of its own Actos diabetes pills tomorrow - just two days after Glaxo acquiesced to the FDA and agreed to place yet another Black Box warning on Avandia product labeling. The new warning carries info about heart attack risks; an earlier Black Box mentions heart failure. Although the latest Avandia warning says that evidence is “inconclusive” about the increased risk of heart attacks, Wall Street expects the language to further dampen sales of the drug, which have plummeted since safety concerns arose in May, the Associated Press notes. And this gives Actos an advantage, because its the only diabetes drug in the same class as Avandia. Takeda ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1030257 Thu, 15 Nov 2007 23:26:40 +0100 1030257 http://www.medworm.com/index.php?rid=1027238&cid=t_103914_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F184761620%2F This was expected, but now it’s official. The agency acted after a recent panel voted to recommend the Glaxo diabetes pill remain on the market, but with stiffer warnings about heart attack risks. The debate followed a controversy that erupted last May, when The New England Journal of Medicine published a meta-analysis showing Avandia increased the risk of heart attacks by 43 percent. Last week, Health Canada severely restricted usage. “FDA has moved expeditiously to review the cardiovascular risks of this drug so that we could inform patients and doctors at the earliest possible time of our findings,” says Janet Woodcock, FDA’s deputy commishr for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research, in ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1027238 Wed, 14 Nov 2007 17:23:20 +0100 1027238 http://www.medworm.com/index.php?rid=974715&cid=t_103914_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F174274876%2F Glaxo’s diabetes pill already has such a warning about heart failure, but apparently the FDA wants to add one about the risk of heart attacks, according to The Wall Street Journal. Talks are still under way, the paper writes, but if agency officials succeed, the move would make it still more difficult for sales to rebound. Ever since the New England Journal of Medicine published a study last May that Avandia raised the risk of heart attacks by 43 percent, the drugmaker has insisted evidence is lacking that the diabetes pill is more dangerous than rival meds. Avandia scrips, meanwhile, have continued to plunge and sales were down 38 percent in the third quarter. As the paper notes, Takeda’s Actos also carries a warning about the risk of heart failure, but not heart attack. An F... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=974715 Wed, 24 Oct 2007 11:30:48 +0100 974715 http://www.medworm.com/index.php?rid=880357&cid=t_103914_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F158052073%2F Two weeks ago, the controversy over antidepressants and Black Box warnings for suicides re-emerged after yet another study in the American Journal of Psychiatry suggested that prescriptions fells due to the publicity given the issue three years ago. Then, CDC data was released showing a rise in suicide among youngsters in 2004 - before the warnings actually showed up on labeling. The American Psychiatric Association complains the warnings are scaring away docs and patients, some of whom may benefit from the meds. So what affect did those Black Box warnings have on antidepressant usage? We asked Medco, the big pharmacy benefits manager, to share annual scrip data and the trend is interesting… Scrips for male and female youngsters between 10 and 19 years old were rising between 2001 an... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=880357 Tue, 18 Sep 2007 12:47:02 +0100 880357 http://www.medworm.com/index.php?rid=862234&cid=t_103914_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F155020316%2F There was an outburst of news last week concerning antidepressants and whether Black Box warnings placed on product labeling was responsible for an increase in suicides. The link between the meds and suicide was already controversial, but the latest study fanned the debate because the increased suicide rate took place during the same year that there was significant publicity about the links. Yet, this was before the warnings were actually issued. Moreover, the new study was based on just one year of data. So we asked you whether the Black Box should stay, given that the FDA is on record saying the warnings could be revoked, depending upon additional info. One caveat - this is not a scientific poll. However, the results clearly suggest that there is support for the warnings. Our thanks to t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=862234 Tue, 11 Sep 2007 11:26:13 +0100 862234 http://www.medworm.com/index.php?rid=850662&cid=t_103914_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F153453025%2F In the explosion of information yesterday surrounding the use of antidepressants, suicides and Black Box warnings, there was a little noticed item. The study in the American Journal of Psychiatry was authored by eight people, two of whom have rather noticeable conflicts of interest. The study, which received front-page treatment in The Washington Post, was co-authored by Robert Gibbons, a professor of biostatistics and psychiatry at the University of Illinois at Chicago, who has served as an expert witness for Wyeth, the company that sells Effexor. And J. John Mann, a psychiatry professor at Columbia University, has received research support from Glaxo, which sells Paxil, and served as an adviser to Eli Lilly, which peddles Prozac and Cymbalta. How do we know? These competing interests wer... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=850662 Fri, 07 Sep 2007 13:42:19 +0100 850662 http://www.medworm.com/index.php?rid=847519&cid=t_103914_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F153058952%2F That’s the conclusion of yet another study in the American Journal of Psychiatry, which finds that teenage suicides rose 14 percent from 2003 to 2004, a year in which the debate that antidepressants actually cause suicide gained widespread publicity. (Here is the abstract). The data suggest that for every 20 percent decline in antidepressant use among patients of all ages in the United States, an additional 3,040 suicides per year would occur, Robert Gibbons, a professor of biostatistics and psychiatry at the University of Illinois at Chicago, who did the study, tells The Washington Post. Meanwhile, the CDC today released new data showing the suicide rate for 10- to-24-year-olds increased by 8 percent in 2004, the largest single-year rise in 15 years. The decline took place from 1990... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=847519 Thu, 06 Sep 2007 17:16:12 +0100 847519 http://www.medworm.com/index.php?rid=828076&cid=t_103914_87_f&fid=34867&url=http%3A%2F%2Fwww.thediabetesblog.com%2F2007%2F08%2F28%2Fcnn-coverage-of-diabulemia-is-bananas%2F Filed under: Type 1, Childhood, Opinion, Allie Beatty, Support, PersonalitiesI'm outraged at the coverage CNN provided on diabulemia. They accuse diabetics who suffer with the condition of doing the wrong thing. CNN neglected to address the cause of diabulemia. The drug all insulin dependent diabetics must use is a synthetic hormone that has been genetically modified. It is nothing like human insulin or any natural vertebrate insulin, for that matter. The fact that 1 in 3 diabetics choose to take less insulin is not because they wish to eat more food. It is a reaction provoked by an inadequate and dangerous genetically modified drug. The reason a diabetic would take less insulin is to avoid experiencing the unnatural side effects the insulin is causing. CNN sensationalized diabulemia and ... The Diabetes Blog blogs http://www.medworm.com/rss/comments.php?id=828076 Tue, 28 Aug 2007 04:00:00 +0100 828076 http://www.medworm.com/index.php?rid=773341&cid=t_103914_87_f&fid=34867&url=http%3A%2F%2Fwww.thediabetesblog.com%2F2007%2F08%2F01%2Fso-avandia-stays-but-will-doctors-prescribe-it%2F Filed under: Type 2, Childhood, Adult Onset, Drugs, ComplicationsIt was plastered all over the news earlier this week. The committee of advisors to the U.S. Food and Drug Administration voted 22-1 to keep GlaxoSmithKline's Avandia on the market. They also voted 20-3 the evidence reveals Avandia increases risk of heart attack. Comforting, isn't it? Avandia, used to treat type 2 diabetes, has been under attack for cardiovascular risks since a late May study showed a 43 percent higher risk of heart attack. Okay, so Avandia will likely get a black box warning from the FDA, its sternest alert to doctors. Pascale Boyer Barresi, an analyst at Bordier & Cie in Geneva stated the black box is likely and Avandia sales will probably not recover to previous levels. They might gain 10 to 15 percent... The Diabetes Blog blogs http://www.medworm.com/rss/comments.php?id=773341 Wed, 01 Aug 2007 04:00:00 +0100 773341 http://www.medworm.com/index.php?rid=748911&cid=t_103914_87_f&fid=34867&url=http%3A%2F%2Fwww.thediabetesblog.com%2F2007%2F07%2F21%2Fless-insulin-longer-life%2F Filed under: Type 1, Type 2, Childhood, Adult Onset, Diet, ResearchHoward Hughs Medical Experts have discovered the key to a longer life is lower insulin levels. Less insulin helps cells fend off diseases that lead to early death like heart disease, cancer and diabetes. So how does one lower their insulin levels? Caloric restriction by way of eating less carbohydrates. Caloric restriction postpones the onset of life-threatening conditions like cancer, diabetes, and heart disease. It may still happen, but at a later age. Scientists manipulated genes in mice to produce 50% less insulin and saw the mice live 18% longer. While lowering insulin throughout the body can lead to a diabetic state, scientists found that allowing insulin levels to be high throughout most of the body, and lowering the... The Diabetes Blog blogs http://www.medworm.com/rss/comments.php?id=748911 Sat, 21 Jul 2007 04:00:00 +0100 748911 http://www.medworm.com/index.php?rid=682755&cid=t_103914_87_f&fid=34867&url=http%3A%2F%2Fwww.thediabetesblog.com%2F2007%2F06%2F18%2Fprescribers-letter-offers-practitioners-unbiased-avandia-advice%2F Filed under: Type 2, Adult Onset, Drugs, ResearchAvandia is out of the top headlines lately, but I am sure the controversial drug remains top-of-mind for type 2 diabetics carrying a prescription. I fumbled upon Prescriber's Letter recently, an independent service providing information about meds to paid subscribers. They claim their research reports are unbiased, the website does not accept advertising (a plus) and overviews are written by editors advised by experts, government agencies and national organizations. The June edition of Prescriber's Letter offers a synopsis on Avandia. It might be worth a read. In a nutshell, Prescriber's acknowledges Dr. Nissen's meta-analysis which points to higher heart attack risk for Avandia versus different meds or placebos. They also acknowledge expe... The Diabetes Blog blogs http://www.medworm.com/rss/comments.php?id=682755 Mon, 18 Jun 2007 04:00:00 +0100 682755