FDA Study Reveals Clot Risk Increases with Use of Yaz, Yasmin and Others


The U.S. Food and Drug Administration has released an updated safety communication regarding drospirenone-containing birth control pills, following its review of the results from an agency-funded study. According to the FDA, Bayer Pharmaceutical’s widely-used birth control pills, Yaz and Yasmin, are 75 percent more likely to cause blood clots in women than older-generation pills. The [...]

Risk of Birth Defects Increase With Use of Two Epilepsy Medications


Unfortunately, the use of certain prescription drugs during pregnancy can greatly increase the risk of birth defects in newborns. In fact, two FDA-approved epilepsy medications, Keppra and Lamictal, are examples of the type of prescription medications that could cause harm when taken in pregnancy. Currently, both Lamictal and Keppra are listed as Category C drugs, [...]

GSK Receives FDA Warning Over Manufacturing Violations


Earlier this week, the U.S. Food and Drug Administration issued a warning letter to drug-maker, GlaxoSmithKline, citing several manufacturing violations found during a March 2011 inspection of the company’s drug-manufacturing plant in the United Kingdom. More specifically, federal regulators say the company failed to establish proper procedures that would prevent the microbiological contamination of their [...]

Avastin Label Now Reflects Risk of Ovarian Failure

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According to the results of a new study, use of the popular cancer drug, Avastin, could potentially affect fertility in some women. Based on the data, the U.S. Food and Drug Administration ordered the drug’s label be updated to reflect the risk for ovarian failure, as well as the risk for additional adverse events, such [...]

Stronger Caution Lables Recommended for Bone-Building Drugs

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The U.S. Food and Drug Administration recently convened two advisory panels in order to conduct a broad safety review of bone-building drugs, which are currently being used by approximately five million women in the United States alone. The two groups ultimately concluded that stronger cautionary language should be added to these bone-building drugs, which include [...]

Prescription Drug Ads Often Skirt FDA Regs

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New research recently reported in MedPage Today suggests that only a limited number of advertisements for prescription drugs are actually in compliance with FDA regulations on marketing to doctors. The research, which was conducted by Dr. Deborah Korenstein of Mount Sinai School of Medicine in New York, revealed that during a one month period, almost [...]

Multaq Makes Fifth Appearance on FDA Watch List


Each quarter, the U.S. Food and Drug Administration releases an updated list of drugs to watch for potential signs of serious side effects or safety issues. For the fifth consecutive time, Sanofi-Aventis’ Multaq (dronedarone) is included. The FDA’s most recent watch list covers the first three months of 2011. During this span of time, the [...]