FDA & Prescription Drugs | InjuryBoard Montgomery

Vytorin, manufactured by Merck & Co. and Schering-Plough was introduced as the newest weapon in the fight against “bad” cholesterol. But last week the U.S. Food and Drug Administration dealt...

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Attorneys who take on the pharmaceutical industry as a voice for consumers injured by medications found an unlikely ally this week, in doctors. Noting that the U.S. Food & Drug Administration is often "overwhelmed" by drug safety problems ranging from serious side effects to unsafe manufacturing facilities, editors of the New England Journal of Medicine said patients benefit from information uncovered by attorneys during liability investigations, according to an Associated Press report released Friday.

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A new study just released has confirmed that Vytorin does not lower the risk of heart disease. Vytorin is a combination of a statin and a cholesterol lowering drug. The Enhance study showed that while Vytorin lowered cholesterol, it did not reduce plaque in arteries.Doctors had embraced the drug because it does such a great job of lowering low-density lipoprotein, or LDL, the so-called bad...

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Medtronic warned doctors in January of an increase in inflammatory masses around their implantable infusion pumps. The warnings involved the SynchroMed and IsoMed infusion pumps. They deliver medications to patients. The FDA has now said that makes it a Class I recall. The Food and Drug Administration defines a Class I recall as a situation in which there is a reasonable probability that use...

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Researchers have found a contaminent in samples of recalled Heparin that are chemically similar to the drug but may explain the adverse reactions that have been reported. The FDA is unsure how the contaminant got into the Heparin. Initial testing did not reveal the contamination due to the similarity. High-tech testing by Baxter and other groups uncovered a heparin-like compound in batches of...

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The agency responsible for drug safety in China has stated that it is the responsiblity of importing countries and companies to inspect and certify drugs are safe. The statement follows a recall by Baxter for the blood-thinning drug heparin. Four people have died and there have been hundreds of reports of adverse reactions following the use of the drug. "We attach high importance to this,"...

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Pfizer made the decision today to pull drug ads for Lipitor with Dr. Robert Jarvik. Dr. Jarvik does not hold a medical license and there was some controversy over his use in the Lipitor drug ad. The ads have appeared on tv and in print since 2006. Dr. Jarvik invented the artificial heart. He does have a medical degree but is not licensed to practice medicine. But House Democrats said the...

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The Congressional subcommitte Oversight and Investigations will be issuing subpoenas to FDA investigators over the antibiotic Ketek. They are looking for more information into fraudulant clinical data that was used to gain approval for the drug. Last year the FDA issued a black box warning label for Ketek, the highest safety warning. The subcommittee is investigating drug safety and whether...

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A study performed by Merck & Co. over two years ago showed that Vytorin, a cholesterol lowering and statin drug did not effectively reduce the amount of fatty deposits in arteries. Vytorin is a combination of Zetia, a cholesterol lowering drug, and Zocor, a statin. The study concluded that Zocor and Vytorin had the same affect on fatty deposits. There has been confusion over what that means...

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Test strips used by diabetics to test their blood sugar levels have been recalled after it was discovered they were giving false readings. The recalled test strips were manufactured by Bayer and are used with the Contour TS blood glucose meter. The test strips in question are sold predominately through mail order to be used only with the Contour TS meter. The recall covers seven countries --...

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It was announced today that Merck is recalling 1.2 Million doses of its HIB and Comvax vaccine. The recalled vaccines are used to prevent pnuemonia, meningitis, and hepatitis B and are generally injected into children under the age of five. The plant were the vaccines are manufactured is contaminated, although Merck has not said with what. The recall involves 11 lots of a Hib vaccine,...

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It's all over the news lately, and yesterday there was a staph infection death in Kern County, Virginia, prompting the entire school district to close. A student reportedly died from a staph infection that proved resistant to antibiotic treatments. The story on MSNBC.com reports that more than a third of the population may carry staphylococcus infection. MRSA is the deadliest variety of staph...

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The FDA has reviewed 30 cases of acute pancreatitis in patients taking Byetta, a drug used to treat type II diabetes. The agency suspects a link between Byetta and pancreatitis in some of these cases.Amylin Pharmaceuticals will be updating the information about acute pancreatitis in the PRECAUTIONS section of the Byetta label. Patients on Byetta should be alert for any signs of pancreatitis,...

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Major consumer manufacturers of over-the-counter infant cough and cold medications recalled fourteen different infant cold meds yesterday because of the danger of overdose of these medicines in young children.Consumer groups have long advocated changes in administering cough syrup to young children, especially two and younger. In this age group the risk of toxicity and overdose is much higher...

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Eli Lilly & Company, at long last, has stepped up the Zyprexa warning label on its flagship treatment for schizophrenia and bipolar disorder. The warning label for olanzapine, the generic name for Zyprexa, now will read that Zyprexa has a greater propensity to cause weight gain and high blood sugar than other atypical antipsychotics.Physicians have noticed for several years the alarming side...

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