FDA orders suicidal action warning on epilepsy drugs
December 16th, 2008
HONG KONG (Reuters) - Access to maternal healthcare in eastern Myanmar is inadequate and most expectant mothers suffer from poor nutrition, anemia and malaria, raising the risk of pregnancy complications, researchers said. In an article in the medical journal PLoS Medicine, they said forced relocation doubled the risk of women developing anemia and greatly decreased their
Full Post: Myanmar mothers have poor access to healthcare
WASHINGTON (Reuters) - Makers of epilepsy drugs must add a warning that the medicines carry a risk of suicidal thoughts or actions, U.S. health officials said on Tuesday.
“The risk of suicidal thoughts or behavior was generally consistent among the eleven drugs analyzed and was observed in patients who were treated for epilepsy, psychiatric disorders, and other conditions,” the Food and Drug Administration said in a statement on its website.
Epilepsy drugs include Pfizer Inc’s Lyrica and Neurontin, GlaxoSmithKline PLC’s Lamictal and Johnson & Johnson’s Topamax.
(Reporting by Lisa Richwine; editing by Maureen Bavdek)
--------------------------------------------------------------------------------------------Related Posts:
WASHINGTON (Reuters) - A review of clinical trial data from four drugmakers shows no overall risk of heart problems in patients taking drugs to treat osteoporosis, the U.S. Food and Drug Administration said on Wednesday. The agency reviewed studies on Merck & Co’s Fosamax, Roche’s Boniva, Novartis AG’s Reclast and Procter and Gamble Co’s Actonel and
Full Post: Studies do not link heart risk to bone drugs: FDA
--------------------------------------------------------------------------------------------
WASHINGTON (Reuters) - U.S. regulators have approved Epix Pharmaceuticals Inc’s Vasovist imaging agent to help detect blood vessel problems, the U.S. Food and Drug Administration said on Wednesday. Epix, which announced the approval on Monday, has said the injectable product can help doctors better track the flow of blood seen in scans and find blockages or
Full Post: U.S. FDA says Epix’s Vasovist cleared for sale
--------------------------------------------------------------------------------------------
WASHINGTON (Reuters) - Data on Pfizer Inc’s smoking cessation drug Chantix continue to back the product’s safety, the company said on Wednesday after a watchdog group called for stronger warnings about risks. Based on all data including clinical trials, “we stand by the efficacy and safety profile of Chantix when used as directed, an important treatment
Full Post: Pfizer says data support quit-smoking drug’s safety
--------------------------------------------------------------------------------------------
By Ransdell Pierson NEW YORK (Reuters) - U.S. regulators on Tuesday said their review of clinical trials does not suggest Merck & Co’s Singulair asthma drug or similar medicines cause suicide or suicidal thought, although the data were inadequate to draw a firm conclusion. However, the U.S. Food and Drug Administration said it was continuing to review
Full Post: FDA says Singulair data do not suggest suicide link
--------------------------------------------------------------------------------------------
WASHINGTON (Reuters) - The U.S. Food and Drug Administration, hampered by increasing globalization and a rise in complex products, may not be able to adequately protect the public’s health, the watchdog arm of Congress said in new findings released on Thursday. “As a result, the American consumer may not be adequately protected from unsafe and ineffective
Full Post: Report cites FDA’s weaknesses over drugs, devices
Posted in Health News

