Trumm Drug

November Drug News

FDA board split in keeping Avandia in the market
The FDA drug-safety oversight board earlier this month voted 8-7 in favor of keeping Avandia, a diabetes drug found to increase the risk of heart attacks, in the U.S. market, according to a Senate Finance Committee currently investigating how the agency handles drug safety issues. Committee member Sen. Charles Grassley, R-Iowa, criticized the FDA for concealing the details of the oversight board’s meeting. The Wall Street Journal (subscription required) (10/30)

VA imposes restrictions on Avandia use
The Department of Veterans Affairs is implementing limits on the use of GlaxoSmithKline’s diabetes drug Avandia, after concluding that “for some patients, rosiglitazone may not afford the same margin of safety as alternative drug therapies,” according to a statement issued Wednesday. The agency said it will only provide Avandia to patients already taking the drug, a move GSK says is not “in the best interest of patients.” The New York Times (10/18)

Experts warn advisory panel on OTC cough, cold drugs
Over-the-counter cold and cough medicines are not safe and effective for babies and toddlers and should not be given to children under 6 years old, doctors told FDA advisers on Thursday. The recommendation was given during a two-day meeting on the sales of nonprescription drugs to children, which was held in response to last week’s reports that such drugs can be dangerous to children younger than 2. The Washington Post/Associated Press (10/19)

Commentary: OTC cold drug ban is not the answer
The FDA panel’s decision to recommend banning the sale of over-the-counter cold and cough drugs for children under 6 years old does not necessarily protect the young from ineffective medications, pediatric cardiologist and author Darshak Sanghavi writes in The Boston Globe. The drugs can be safe for children when used properly, and an outright ban, particularly on prescription cold medications, may cause even more harm to children, Sanghavi asserts. The Boston Globe (10/30)

Pfizer announces end of inhaled insulin drug
Pfizer has decided to stop production of its inhaled insulin drug Exubera, citing the drug’s failure “to gain the acceptance of patients and physicians,” chief executive Jeffrey Kindler said in a statement. Pfizer will face a $2.8 billion pretax charge because of its decision to drop the biotech drug, which it had originally expected to be a blockbuster. The Wall Street Journal (free content) (10/19) , Forbes (10/18)

New labels to warn about hearing loss from ED drugs
The FDA said it is adding a warning about the risk of hearing loss to labels of erectile dysfunction drugs Viagra, Cialis and Levitra, after confirming 29 reports of hearing loss among users of these drugs since 1996. The drug regulator will also impose the new warnings on Revatio, a pulmonary hypertension drug containing an ingredient similar to Viagra. Yahoo!/Associated Press (10/18)

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