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Archive for September, 2007

Medical Letter review: Pregabalin for fibromyalgia

Wednesday, September 26th, 2007

The Medical Letter, the US equivalent publication to the Drug & Therapeutics Bulletin, has recently published an appraisal of pregabalin (Lyrica®) for fibromyalgia. Pregabalin has recently been licensed in the US for treatment of fibromyalgia, and it is the first drug approved in the US for this condition. It is not currently licensed for this indication in the EU. The Medical Letter review briefly discusses fibromyalgia and pregabalin’s pharmacology, then summarises the major published clinical trials. It concludes that pregabalin may be modestly, and sometimes transiently, effective in reducing pain in people with fibromyalgia. Adverse effects are frequent, including dizziness, somnolence, headache, and weight gain, and peripheral oedema may be a problem. Angioedema, which may…

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U.S. FDA Holds up Approval of Lamotrigine

Monday, September 24th, 2007

U.S. health regulators stopped short of approving a new long-acting version of the widely used epilepsy drug lamotrigine (Lamictal) until certain concerns are addressed, GlaxoSmithKline Plc said Friday. Reuters Health Information (Source: Medscape Business of Medicine Headlines)

Court Rules for Pfizer in Patent Infringement Case on Neurontin

Friday, September 21st, 2007

NEW YORK–(HSMN NewsFeed)–Pfizer Inc said today that an appeals court has overturned a lower court ruling that several generic manufacturers did not infringe the company’s patent for stabilized formulations of gabapentin, the active ingredient in Neuronti… Biopharmaceuticals, Generics, LitigationPfizer, Neurontin, gabapentin (Source: HSMN NewsFeed)

Provigil(Modafinil) Tablet [Cephalon, Inc.]

Friday, September 21st, 2007

Updated Date: Sep 21, 2007 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

Drug safety news letter from the FDA

Thursday, September 20th, 2007

The US FDA has launched the first issue of its new Drug Safety Newsletter this week. It will be published quarterly with the goal of keeping “our medical community posted … about selected postmarketing drug safety reviews, important emerging drug safety issues, and recently approved pharmaceutical products.”The first issue covers postmarketing surveillance data on:- rituximab (Rituxan), an immunosuppressant used primarily to treat non-Hodgkin’s lymphoma or rheumatoid arthritis: reports of progressive multifocal leukoencephalopathy associated with this agent (“rare fatal demyelinating disease that is caused by a viral infection of the brain following reactivation of the JC or BK polyomavirus (also known as papovavirus) present in about 80 percent of adults”)- modafinil (Provigil), a CNS s…

Mirena: the other side of the story.

Thursday, September 20th, 2007

Authors: Ewies AA PMID: 17877694 [PubMed - in process] (Source: BJOG : An International Journal of Obstetrics and Gynaecology)

FDA Safety Changes: Pulmicort Respules, Lexiva, Pegasys

Wednesday, September 19th, 2007

The FDA has issued safety labeling changes for budesonide inhalation suspension, fosamprenavir calcium tablets and oral solution, and peginterferon alfa-2a subcutaneous injection. Medscape Medical News (Source: Medscape Pathology Headlines)

Managing Bipolar Disorder

Wednesday, September 19th, 2007

  Pages: 1 2 | Next »     Print Article Twenty-five or so years ago, most people diagnosed with bipolar disorder were middle-age adults who had distinct euphoric episodes. Today most people identified with manic-depression present a remarkably different picture of the condition: Not only is depression the most pervasive feature of the illness, the manic phase is usually a mix of irritability, anger and depression, with or without euphoria. In fact, euphoric mania is the exception, not the rule. Today the average age of onset of bipolar disorder is 19. It’s not clear whether there is a rising incidence of the disorder in younger people or it is just being recognized more in children and adolescents. But now as then, bipolar disorder most often remains undi…

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FDA Approves LEVAQUIN(R) Short Course Therapy For Treatment Of Complicated Urinary Tract Infections And Acute Pyelonephritis

Tuesday, September 18th, 2007

The U.S. Food and Drug Administration (FDA) has approved use of the five-day, once-daily regimen of LEVAQUIN(R) (levofloxacin) 750 mg I.V. and oral, for the treatment of complicated urinary tract infections (cUTI) and acute pyelonephritis (AP). [click link for full article] (Source: Health News from Medical News Today)

Topiramate (Topamax) reduces conditioned abstinence behaviours and handling-induced convulsions (HIC) after chronic administration of alcohol in Swiss-Webster MICE

Tuesday, September 18th, 2007

Conclusion: These findings suggest that topiramate reduces HICs during alcohol withdrawal and alcohol-conditioned behaviours during conditioned abstinence in Swiss-Webster mice. (Source: Alcohol and Alcoholism)

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