Alabama updates in category: FDA & Prescription Drugs

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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Botox has been linked to serious adverse reactions leading to hospitalization and death. The FDA requests that patients report adverse reactions to its MedWatch program.

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Health Care Cost in the United States is out of control. Are we getting our money’s worth? Cost of health insurance for family of four exceeded gross earnings for a minimum wage full-time worker. Over 47 million Americans remain uninsured.

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In recent years, the use of oral sodium phosphate solution (Fleet Phospho-Soda) as a bowel preparation for colonoscopy or surgery has become more and more common. The U.S. Food and Drug...

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Desipramine is a dangerous drug which has been associated with sudden deaths in children and adolescents.

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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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On Monday, Baxter announced they are temporarily suspending the production of the drug Heprin, after 350 negative reactions have been reported in conjunction with the drug. The active ingredient in Heprin, a blood-thinning medication, was reportedly made at a Chinese facility that the U.S. Food and Drug Administration (FDA) failed to inspect, according to a report in the Wall Street...

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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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The U.S. Food and Drug Administration (FDA) has approved revisions to the current Ortho Evra Contraceptive Patch label. The updated labels will reflect results from a new study that found users of the patch were at an increased risk of developing serious blood clots (also known as (VTE - venous thromboembolism), than those women who use birth control pills.The study was conducted by Boston...

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