FDA & Prescription Drugs

• Doctor Says Drug Maker Tried to Quash His Criticism of Avandia

  Jeremy Thurman | June 04, 2007 2:50 PM | 0 CommentsOklahoma City, OK

  The New York Times just had an article about the Drug Avandia. It states that a Congressional committee hearing next Wednesday will try to determine whether federal regulators paid sufficient attention to potential risks of the diabetes drug Avandia. One witness, scheduled to appear at the hearing, claims that Avandia's maker, GlaxoSmithKline, attempted to silence his criticism of the drug....

• Avandia linked to Heart Attacks

  Jeremy Thurman | May 22, 2007 10:46 AM | 0 CommentsOklahoma City, OK

  The widely prescribed diabetes drug Avandia is linked to a greater risk of heart attack and possibly death, a new scientific analysis revealed, and the U.S. government issued a safety alert Monday. The Food and Drug Administration urged diabetics taking the pill to talk to their doctors, but stopped short of forcing a sharper warning label on the drug sold by GlaxoSmithKline PLC of LondonMore...

• GLAXO SMITH KLINE DATA LINKS PAXIL TO INCREASED RISK OF BIRTH DEFECTS

  Jeremy Thurman | May 03, 2007 9:03 AM | 0 CommentsOklahoma City, OK

  On December 13, 2005, Glaxo Smith Kline released a follow up to a prior study comparing the effects of bupropion to other antidepressants. The preliminary study and it follow up are available on the GSK website [insert link to study]. Though not specifically powered to study the effects of Paxil (paroxetine), GSK concluded "In this study, the use of paroxetine in the first trimester of...

• Increase in risk of Thromobembolism among ortho evra users

  Jeremy Thurman | May 02, 2007 10:10 AM | 0 CommentsOklahoma City, OK

  STUDY FUNDED BY JOHNSON & JOHNSON FINDS A TWO-FOLD INCREASE IN THE RISK OF THROMBOEMBOLISM AMONG ORTHO EVRA USERSIn a study prepared by I3 Drug Safety, a service company for the pharmaceutical industry, the authors found that women using the Ortho Evra birth control were more than twice as likely to suffer venous thromboembolisms than woman using oral birth control. There was not sufficient...

• FDA - MedWatch - Permax (pergolide)- Product Market Withdrawal -

  Jacob Diesselhorst | March 30, 2007 10:31 AM | 0 CommentsOklahoma City, OK

  FDA notified healthcare professionals and patients that companies that> manufacture and distribute pergolide have agreed to withdraw the drug> from the market. Pergolide is a dopamine agonist (DA) used with> levodopa and carbidopa to manage the signs and symptoms of Parkinson's> disease. Results of two new studies showed that some patients with> Parkinson's disease treated with pergolide had...

• Paxil Birth Defects

  Jeremy Thurman | March 22, 2007 1:46 PM | 0 CommentsOklahoma City, OK

  In December, 2005 the U.S. Food & Drug Administration (FDA) issued a Public Health Advisory regarding Paxil, which was based upon two separate studies done by U.S. and Swedish researchers. The FDA warned doctors and patients that exposure to Paxil during pregnancy posed a serious risk to the fetus and was linked to an increased risk of Congenital Heart Defects. If you or loved one have been...

• Lupron Litigation

  Jacob Diesselhorst | March 22, 2007 9:50 AM | 0 CommentsOklahoma City, OK

  Five women who claim to have suffered harm from injections of Lupron for treatment of endometriosis are suing the drug's manufacturer, Tap Pharmaceuticals, in U.S. federal court. Samuel Bearman of Pensacola, Florida, one of two attorneys for the plaintiffs, told Redflagsdaily.com that the pre-trial discovery process is expected to begin shortly. The five women claim, for example, that Tap...

• Nuvaring

  Jacob Diesselhorst | March 22, 2007 9:42 AM | 0 CommentsOklahoma City, OK

  The NuvaRing® is a hormonal contraceptive that works in a similar way to the oral birth control pill and the Ortho Evra birth control patch. The NuvaRing, however, is a flexible, soft, two-inch ring that is worn in the vagina for three weeks and removed for one week.During the fourth week, which is NuvaRing-free, the woman will have a menstrual period--like those using the pill or the patch....

• House Passes Historic Whistleblower Bill Protecting Federal Scientists

  Jeremy Thurman | March 16, 2007 11:30 AM | 0 CommentsOklahoma City, OK

  In an effort to end corruption on the Federal level for Scientists who expose political interference in their research, the house overwhelmingly passed the Whistleblower Protection Enhancement Act. This is important especially in light of drug litigation where federal scientist often fear political ramifications for expousing dangerous drugs such as Vioxx, Ortho Evra et al. Hopefully this will...

• FDA Requests Label Change for All Sleep Disorder Drug Products

  Jacob Diesselhorst | March 15, 2007 10:00 AM | 0 CommentsOklahoma City, OK

  The U.S. Food and Drug Administration (FDA) has requested that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labeling to include stronger language concerning potential risks. These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving. Sleep driving is...