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 'depakote'. Sat, 03 Sep 2011 02:17:21 +0100 http://www.medworm.com/index.php?rid=4992997&cid=t_102922_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FlsjDsYTX5tA%2F For the second time in less than two years, the FDA has issued a sobering warning about the Depakote epilepsy med sold by Abbott Laboratories. This time, the agency says that children born to mothers who take the anti-seizure drug or related products during pregnancy have an increased risk of lower cognitive test scores than children exposed to other such drugs (read here). The conclusion was reached after the agency reviewed epidemiologic studies. In the primary study upon which the FDA based its conclusion, cognitive tests were performed at age three; in other studies, testing was done on children 5 to 16 years old. The problem, the FDA says, is that long-term effects on cognitive development are unknown and it remains unclear whether the effects occur when fetal exposure is limited to l... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4992997 Thu, 30 Jun 2011 21:19:37 +0100 4992997 http://www.medworm.com/index.php?rid=4436941&cid=t_102922_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FpgW5SMkd_Ws%2F The US Department of Justice has decided to intervene - or join - a whistleblower lawsuit that was filed in late 2008 by three former Abbott Laboratories sales reps, who accused the drugmaker of concocting an illegal scheme to promote its Depakote seizure med. The charges include paying kickbacks to docs to boost prescriptions and, subsequently, defrauding Medicare and Medicaid. The fact that the feds are interested is not a surprise. In late 2009, Abbott disclosed in a Securities and Exchange Commission filed that the Justice Department ws investigating Abbott’s sales and marketing activities of the pill, which is used to treat bipolar disorder, seizures and migraines. The probe centers on possible violations of the Federal False Claims Act, the Food and Drug Cosmetic Act and the Anti-K... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4436941 Fri, 04 Feb 2011 13:35:45 +0100 4436941 http://www.medworm.com/index.php?rid=3618089&cid=t_102922_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FJPHebsNnizk%2F Three months ago, some enterprising thieves staged a daring theft by cutting a hole in the roof of an Eli Lilly warehouse and making off with all sorts of medicines (background). The made-for-TV moment focused attention on supply chain security and so here is another episode: 10 days ago, a trailer containing 15 pallets of Lupin Pharmaceuticals generic drugs was stolen in Memphis, Tenn. Lupin never bothered to put an announcement on its website, but we have a copy of the letter sent to its wholesalers (see this). The heist yielded a slew of generic cholesterol-lowering pills, namely generic Zocor and Mevacor, as well as generic Depakote, which is taken by epileptics and is sensitive to temperature, and the Cefadroxil antibiotic. There is nothing sensational about a stolen trailer, of cour... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3618089 Tue, 01 Jun 2010 13:16:56 +0100 3618089 http://www.medworm.com/index.php?rid=3463858&cid=t_102922_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FJPDzW8C-sqc%2F A federal judge ordered Abbott Laboratories to give prosecutors some of ceo Miles White’s emails as part of a federal probe into whether the drugmaker improperly marketed its Depakote pill, which is used to treat bipolar disorder, seizures and migraines. Emails sent or received between 1996 and 2008 by two other execs - William Dempsey and Jeff Leiden - must also be turned over. The US Attorney for the Western District of Virginia is investigating Abbott for “potential federal violations arising out of Abbott’s impermissible off-label marketing of Depakote as a treatment for agitation and aggression in the elderly, and health-care fraud arising out of that allegedly improper use,” US District Judge Samuel Wilson wrote in a recent opinion (see here). Abbott allegedl... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3463858 Tue, 13 Apr 2010 12:19:31 +0100 3463858 http://www.medworm.com/index.php?rid=3056884&cid=t_102922_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FjpT-v-IGEXs%2F The agency says the epilepsy can cause an increased risk of neural tube defects and other major birth defects, such as craniofacial defects and cardiovascular malformations, in babies. And the FDA warns that women of childbearing potential should only use valproate if it is essential to manage their medical condition (here is the FDA statement). The drug has a sordid profile: it already carries a strong “black box” warning that it may cause birth defects (prescribing info) and a study in The New England Journal of Medicine linked it to lower IQs in the children of women who took the drug. In June, the FDA recommended added study of delayed development reported in children whose moms took Depakote. The warning comes just one month after Abbott Labs disclosed the US Department ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3056884 Thu, 03 Dec 2009 23:38:26 +0100 3056884 http://www.medworm.com/index.php?rid=2970418&cid=t_102922_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FH3evCBwKRAw%2F As they say: another day, another probe into a drugmaker. The latest - the US Department of Justice is investigating Abbott’s sales and marketing activities of the pill, which is used to treat bipolar disorder, seizures and migraines, according to its quarterly filing with the US Securities and Exchange Commission for Depakote. The government wants to know whether the drugmaker violated civil and/or criminal laws, including the Federal False Claims Act, the Food and Drug Cosmetic Act, and the Anti-Kickback Statute in connection with Medicare and/or Medicaid reimbursement to third parties. An Abbott spokeswoman tells Dow Jones that the drugmaker is cooperating, but declined further comment. And a spokesman for the US Attorney in the Western District of Virginia, which is handling the prob... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2970418 Fri, 06 Nov 2009 19:58:32 +0100 2970418 http://www.medworm.com/index.php?rid=2039942&cid=t_102922_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2008%2F12%2F16%2Ffda-issues-alert-for-epilepsy-drugs-despite-controversy%2F Back in January, the U.S. Food and Drug Administration (FDA) warned doctors that drugs used to treat epilepsy (also called antiepileptic drugs or AEDs) may raise the risk of suicidal thoughts or actions (according to a USA Today story). It came to this conclusion after examining 199 studies that looked at 11 different anti-seizure medications, such as Neurontin, Tegretol and Depakote. Earlier this month, a panel at the American Epilepsy Society 62 Annual Meeting (as reported by Medscape) disputed the FDA’s findings and suggested that the methodology that the FDA used was severely flawed, resulting in a recommendation that was also flawed: After crunching the numbers, Drs. Hesdorffer and Berg told meeting attendees that the study findings are inconsistent across the 11 drugs. The ... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=2039942 Tue, 16 Dec 2008 21:12:51 +0100 2039942 http://www.medworm.com/index.php?rid=1664627&cid=t_102922_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F350398994%2F Time to bring out the old trueism from the Morning Mayor: Every brand new day should be unwrapped like a precious gift. So unwrap yours and set aside those concerns about deadlines, meeting and what-not. Meanwhile, we will tend to the official Pharmalot mascot and grab our favorite cup of stimulation. Here goes… Dingell & Grassley Try To Overhaul The FDA (The Wall Street Journal) EU OKs Schering-Plough Anethesia Drug (Yahoo/Reuters) FDA Panel Recommends Roche Arthritis Drug (Yahoo/Reuters) FDA Approves Generic Versions Of Abbott Epilepsy Drug (Bloomberg News) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1664627 Wed, 30 Jul 2008 11:22:31 +0100 1664627 http://www.medworm.com/index.php?rid=1494562&cid=t_102922_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F304501987%2F Drugmakers are scrambling to convince the FDA not to add warnings for suicidal behavior risks to a large class of epilepsy drugs also used widely for a variety of other conditions, The Wall Street Journal reports. On Monday, at a closed meeting of epilepsy researchers and industry reps in New York, the FDA presented data that agency officials said show a statistically significant difference in suicidal tendencies for patients who have taken one of 11 epilepsy drugs that are on the market. However, the difference is quite small; the risk for patients on a placebo was 0.23 percent and for those taking one of the 11 drugs it was 0.37 percent, the Journal writes. Several drugmakers at the forum held by the Epilepsy Study Consortium told the FDA that its analysis is flawed because it grouped th... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1494562 Wed, 04 Jun 2008 12:12:29 +0100 1494562 http://www.medworm.com/index.php?rid=1035616&cid=t_102922_122_f&fid=35055&url=http%3A%2F%2Fsarasotaneurology.com%2F2007%2F11%2F19%2Fseizures-medication-treatment-offers-hope-for-a-normal-lifestyle%2F Seizures are the manifestation of uncontrolled electrical activity in the brain. Affected individuals show clinical symptoms of seizures with twitching or jerking of one side or their entire body. With this they can make gasping noises, turn blue in the face, bite their tongue or lose control of their bladder. These symptoms are charateristic of a grand mal seizure. During an epileptic attacks, the person is not responsive or aware of what is going on around them. Fortunately there is excellent treatment available to control seizures and in many cases, keep patients seizure free. It is estimated that there are 2-3 million individuals in the United States who suffer from recurrent seizures (epilepsy.) Many of these people are neurologically intact with the cause of their seizures being unkn... Sarasota Neurology blogs http://www.medworm.com/rss/comments.php?id=1035616 Mon, 19 Nov 2007 11:32:22 +0100 1035616 http://www.medworm.com/index.php?rid=777620&cid=t_102922_140_f&fid=34838&url=http%3A%2F%2Fbipolarmale.blogspot.com%2F2007%2F07%2Fmrs-mo-is-having-hard-time-at-work-just.html (Source: Bipolar Mo) Bipolar Mo blogs http://www.medworm.com/rss/comments.php?id=777620 Fri, 27 Jul 2007 12:17:00 +0100 777620 http://www.medworm.com/index.php?rid=718810&cid=t_102922_109_f&fid=34788&url=http%3A%2F%2Firvingpsychiatrist.blogspot.com%2F2007%2F07%2Fdepakote-in-hiv-often-presenting-in.html Neurology. 2006 Mar 28;66(6):919-21.Valproic acid adjunctive therapy for HIV-associated cognitive impairment: a first report.Schifitto G, Peterson DR, Zhong J, Ni H, Cruttenden K, Gaugh M, Gendelman HE, Boska M, Gelbard H.Department of Neurology, University of Rochester Medical Center, Rochester, NY, USA.In vitro and animal model data demonstrate that valproic acid (VPA) can ameliorate HIV-associated neurotoxicity. The authors conducted a pilot 10-week placebo-controlled study of VPA 250 mg twice daily in 22 HIV-infected individuals with (n = 16) and without (n = 6) cognitive impairment. VPA was safe and well tolerated, with trends toward improved neuropsychological performance and brain metabolism in the impaired subjects.PMID: 16510768 [PubMed - indexed ] (Source: a psychiatrist who lear... a psychiatrist who learned from veterans blogs http://www.medworm.com/rss/comments.php?id=718810 Fri, 06 Jul 2007 22:03:00 +0100 718810 http://www.medworm.com/index.php?rid=698173&cid=t_102922_140_f&fid=35439&url=http%3A%2F%2Fbipolarsoupkitchen-stephany.blogspot.com%2F2007%2F06%2F1999-2007-ocd-adhd-childhood-bipolar_26.html Faraone&Biederman Letter to Editor, 2002 APAAm J Psychiatry 159:496-497, March 2002© 2002 American Psychiatric Association Letter to the EditorDrs. Faraone and Biederman Reply STEPHEN V. FARAONE, PH.D. and JOSEPH BIEDERMAN, M.D.Boston, Mass."3. The claim that a meta-analysis of studies of ADHD and the D4 receptor gene must include all other genes tested makes no sense. Studies of different genes test different hypotheses.Mixing apples and oranges does not clarify any statistical analysis." (Source: soulful sepulcher) soulful sepulcher blogs http://www.medworm.com/rss/comments.php?id=698173 Wed, 27 Jun 2007 04:25:00 +0100 698173 http://www.medworm.com/index.php?rid=683514&cid=t_102922_140_f&fid=35439&url=http%3A%2F%2Fbipolarsoupkitchen-stephany.blogspot.com%2F2007%2F06%2Fmonitoring-depakote-blood-levels.html I have had some searches hit my blog for a few things that I can elaborate on, due to the post the search hit wasn't what the person was looking for, and I can actually help expand the information.DepakoteThis medication is not monitored by dosage, it is monitored by blood levels. It is not about the milligrams a patient is taking it is based on how a patient feels, and most of the time it is at a blood level of 100-125.The blood work needs to be done before the morning dose, and 12-14 hours after the last dose. If levels are lower than 100, then that can give room for increase of dosage of Depakote until the patient feels better and/or is at the 100-125 blood level.Depakote causes weight gain[it did for my daughter] and there is a black box warning for Pancreatitus as well as Polycystic O... soulful sepulcher blogs http://www.medworm.com/rss/comments.php?id=683514 Mon, 18 Jun 2007 22:57:00 +0100 683514 http://www.medworm.com/index.php?rid=777629&cid=t_102922_140_f&fid=34838&url=http%3A%2F%2Fbipolarmale.blogspot.com%2F2007%2F05%2Flife-is-pretty-unremarkable-for-me-at.html (Source: Bipolar Mo) Bipolar Mo blogs http://www.medworm.com/rss/comments.php?id=777629 Sat, 19 May 2007 12:53:00 +0100 777629 http://www.medworm.com/index.php?rid=601210&cid=t_102922_109_f&fid=34800&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FClinicalPsychologyAndPsychiatryACloserLook%2F%7E3%2F115053184%2Fdepakote-in-pregnancy.html Even when controlling for the IQ of the mother, children of moms who took anticonvulsant/mood stabilizer Depakote were turning up mentally retarded at a 24% clip. This was much higher than the other medications to which it was compared. This is based on a presentation at the American Academy of Neurology and I've not seen the actual study design and stats, so I can't say this was a great study or not. The fact that they tested IQ of 2-year-old kids, which is fairly unreliable, is probably a weakness, though the authors say they'll follow these kids for a few more years. In any case, it does seem like this could be big news if it is a consistent finding. Link to quick press release. Hat Tip (and an extended writeup): AHRP. (Source: Clinical Psychology and Psychiatry: A Closer Look) Clinical Psychology and Psychiatry: A Closer Look blogs http://www.medworm.com/rss/comments.php?id=601210 Tue, 08 May 2007 12:55:00 +0100 601210 http://www.medworm.com/index.php?rid=590562&cid=t_102922_140_f&fid=35439&url=http%3A%2F%2Fbipolarsoupkitchen-stephany.blogspot.com%2F2007%2F05%2Fmedication-vs-discipline-vs-adhd-vs.html "Give him Ritalin""I tried that, he “came down” from that med each afternoon and cried uncontrollably for two hours. That was not my son. His behavior did not change. I stopped giving him the Ritalin. I lied about giving him the meds. “From now on,” I told him, “you are responsible for how you behave."The Bipolar Chicks Blogging have taken on the Childhood Bipolar Disorder Paradigm, with one personal story regarding medications and discipline, and what one person did, when medication wasn't the answer or choice for this mom.Bring on the Hate Mail-I’ve Spanked my 4 Year Old, Instead of Drugging Him.There's also a new read at Philip Dawdy's Furious Seasons with a link to CBS' "The Early Show" The Bipolar Children Are Killing My Back discussing Childhood Bipolar in kids. Which quo... soulful sepulcher blogs http://www.medworm.com/rss/comments.php?id=590562 Sat, 05 May 2007 03:39:00 +0100 590562 http://www.medworm.com/index.php?rid=574550&cid=t_102922_140_f&fid=35439&url=http%3A%2F%2Fbipolarsoupkitchen-stephany.blogspot.com%2F2007%2F04%2Fif-you-knew-you-only-had-17-years-how_27.html When Lindsay was inpatient at all of the hospitals; her clothes and belongings were constantly stolen.Some items made it home. Some did not.There is one shirt that made it the entire absurd trip from hell; and she wears it every single day. When it is being laundered, she waits for it to be washed and dried. It is a victory shirt. Just like her, she made it out. Worn, and faded.Still here.During those days, and months, I basically lived in my car. I had scissors, sharpies, notepads, files and poster boards of photos of Lindsay.I replaced lost and stolen clothing so many times, that by the time she came home, she had no clothes in her possession. I had to replace it all. But there was that shirt.I was tired of her things being stolen. Her dignity was already removed, and her youth stolen, a... soulful sepulcher blogs http://www.medworm.com/rss/comments.php?id=574550 Sat, 28 Apr 2007 01:52:00 +0100 574550 http://www.medworm.com/index.php?rid=552129&cid=t_102922_140_f&fid=35439&url=http%3A%2F%2Fbipolarsoupkitchen-stephany.blogspot.com%2F2007%2F04%2Fmri-of-brain-and-spine-complete-and-she.html More later, but she did the MRI on her own, no medication, no IV.I wore earplugs and held her legs and stood there for 45 minutes. Watching this young woman show me the true definition of courage. She cried. She did it.We walked to the gift shop, and she picked out a plush kitty that looks like our tabby cat.I reside under her shadow. (Source: soulful sepulcher) soulful sepulcher blogs http://www.medworm.com/rss/comments.php?id=552129 Tue, 17 Apr 2007 01:41:00 +0100 552129 http://www.medworm.com/index.php?rid=552132&cid=t_102922_140_f&fid=35439&url=http%3A%2F%2Fbipolarsoupkitchen-stephany.blogspot.com%2F2007%2F04%2Fcome-back-road-is-this-way.html "In the quiet afternoon you left and went down into townAnd I just watched the empty road behind youWhere the fog lies kissing the mountainsideYou want to lie sleeping, deep inside.."heart, "how deep it goes" (Source: soulful sepulcher) soulful sepulcher blogs http://www.medworm.com/rss/comments.php?id=552132 Sun, 15 Apr 2007 00:26:00 +0100 552132 http://www.medworm.com/index.php?rid=483640&cid=t_102922_140_f&fid=34838&url=http%3A%2F%2Fbipolarmale.blogspot.com%2F2007%2F03%2Fwind-is-in-from-africa-last-night-i.html "The wind is in from AfricaLast night I couldn’t sleep"(Mitchell)Last night I couldn’t sleep but I think the wind here was coming in from the Arctic and blowing snow with it. The house is cold and I am huddled up in front of a blank screen with a fleece and only coffee and the voice of Joni Mitchell to warm me up. Mrs Mo confiscated the diazepam after my night of abuse but has since returned it in a vain attempt to get me to sleep. I’ve not really bothered with it as I think it only starts to have a hypnotic effect on me when I’ve taken enough to start shutting down my respiratory centre. I think the lack of sleep is starting to catch up with me, I’m no longer buzzing, just quietly driven (like Lady Penelope by Parker) and burning out. However, I’m still infused with ideas of m... Bipolar Mo blogs http://www.medworm.com/rss/comments.php?id=483640 Tue, 20 Mar 2007 05:26:00 +0100 483640 http://www.medworm.com/index.php?rid=478970&cid=t_102922_140_f&fid=34838&url=http%3A%2F%2Fbipolarmale.blogspot.com%2F2007%2F03%2Fi-saw-portillo-this-morning-and-he-read.html I saw Portillo this morning and he read my letter. He said he viewed bipolar and schizophrenia as very much overlapping entities, almost part of a continuum, and didn't want to get wrapped up in DSM diagnostic pedantics. I thought that was a wierd thing to say. I confirmed my decision not to see any more psychiatrists which he grudgingly accepted. Anyway he commented on my restlessness and foot tapping and noted the largactil (Thorazine to the yanks) wasn't doing much for me. He said he'd spoke to a couple of shrinks (one was Dr Elton) about me and both felt largactil was appropriate but my choice of 25mgs was too low a dose "for a man of my weight"... indeed! They suggested I up it to at least 50mg 2-3 times daily. Both shrinks also felt I should try depakote and Portillo wanted me to sta... Bipolar Mo blogs http://www.medworm.com/rss/comments.php?id=478970 Fri, 09 Mar 2007 20:58:00 +0100 478970