Pharmaceutical Lawsuit and Recall Information
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The FDA (Food and Drug Administration) “stands accused of being little more than a rubber-stamping agency for Big Pharma.” “The FDA has progressively morphed into a mere pawn and instrument of the drug industry, which has little to do with drug safety, and everything to do with maximizing profits.” writes Dr. Mercola in an article, [...]
New Law Could Allow FDA To Approve Medical Devices Without Going Through Approval Process A new law on the books could allow the “FDA to approve a new medical device if it is similar to an existing, previously approved device, even if that older device has been recalled because of safety problems. This means that [...]
Pradaxa Side Effects The FDA is evaluating reports of serious bleeding in Pradaxa patients. Pradaxa is a blood thinner used tho help prevent stroke in heart patients. Bleeding may lead to serious consequences while on Pradaxa. The label contains a warning about “significant and sometimes fatal bleeds”. As of now, FDA advices patients to continue [...]
CNBC (2/25) reported that in a television interview, “FDA’s Margaret Hamburg” addressed the “backlog of generic drug applications at the Food & Drug Administration.” She said, “We frankly are taking too long to review important applications, and we want to help get those products out.” Hamburg aims “to bring the median review time of generic [...]
Defective Medical Devices Recalled Too Slowly Bloomberg News (2/15, Cortez) reports, “St. Jude Medical Inc. (STJ)’s Riata, a cable used in heart defibrillators, is the latest example of a defective medical device that wasn’t spotted quickly enough because US surveillance systems are lacking,” according to an article published in the New England Journal of Medicine. “St. [...]
FDA Reports Are Slow to Effect Prescribing Behaviors Medscape (2/15, Hitt) reports, “Many US Food and Drug Administration (FDA) drug-risk communications have a delayed effect, or no effect on drug monitoring or prescribing behaviors, according to the findings of a new report” published online Jan. 18 in the journal Medical Care. After analyzing data from 49 studies [...]
HIV Drugs Side Effects HealthDay (1/31, Dallas) reports, “– Although there remains a possibility that some of these medications might cause birth defects, such as cleft lip and palate,” according to a study published in the January issue of Cleft Palate–Craniofacial Journal. To analyze the possible association between antiretroviral drugs and birth defects,Vassiliki Cartsos, an associate [...]
FDA Needs Clear Guidelines Pharmaceutical companies might stop developing treatments for diseases like diabetes or obesity if clearer guidelines are not given from the FDA said Christopher Viehbacher – chairman of the board of Pharmaceutical Research and Manufacturers of America. Pharmaceutical companies are having a difficult time predicting how the Food and Drug Administration weighs [...]
FDA Warning For Transvaginal Surgical Mesh The U.S. Food and Drug Administration has issued a warning regarding the post-surgical risks associated with transvaginal surgical mesh, which is often implanted in women to repair weakened or damaged tissue, as well as to provide support in cases of pelvic organ prolapse (POP). This type of surgical mesh [...]
The U.S. Food and Drug Administration has ordered drug maker, Sanofi-Aventis, to update the label for its anti-arrhythmic medication, Multaq, in order to inform users of the increased risk for death or serious cardiovascular events when taken by patients with permanent atrial fibrillation. The FDA has approved Multaq (dronedarone) to treat atrial flutter and paroxysmal [...]
