Joint FDA advisory committee weighs in on fate of Avandia
PHILADELPHIA A joint advisory committee of the Food and Drug Administration has voted to recommend allowing a diabetes drug made by GlaxoSmithKline to remain on the market, though it still has to undergo the agency’s scrutiny.
Twenty of the combined 33 members of the FDA’s Endocrinologic and Metabolic Drugs advisory committee and Drug Safety and Risk Management advisory committee voted to recommend allowing Avandia (rosiglitazone) to remain on the market, though 17 of them recommended restricting its sales or enhancing its warning labels, while three voted to allow it to remain on the market with no labeling changes; another 12 recommended withdrawing it from the market, and one member abstained.
The drug had become controversial after a 2007 clinical study found that it increased the risk of heart attacks. Nevertheless, an earlier FDA advisory committee recommended that it remain on the market at the time.
Final authority on the fate of Avandia rests with the FDA, which is not bound by advisory committees’ votes but will take them into account when making a final decision.
Former CVS Caremark chairman announces healthcare venture with WL Ross
NEW YORK Former CVS Caremark chairman Edwin “Mac” Crawford has joined forces with WL Ross CEO Wilbur Ross, to co-invest in and restructure healthcare companies.
Crawford said, “My team and I are excited to join forces with such a distinguished private equity firm at this pivotal time for the healthcare industry. The pending structural changes to the industry will create new winners and losers, and I am eager to play a major role in adapting to this challenging environment.”
Crawford was named chairman of the board at CVS Caremark after the two entities merged in 2006. In his roll at Caremark, Crawford lead one of the nation’s leading pharmaceutical services companies, which shifted its services’ focus to the consumer during his reign, thus “[addressing] the needs of both payers and consumers by providing high-quality, cost-effective services in a manner that is convenient, flexible and easy for the consumer to navigate and understand,” he said at the time.
FDA: Qualaquin has serious side effects
SILVER SPRING, Md. Unapproved use of a drug used to treat malaria can cause serious side effects, prompting the drug’s manufacturer to develop a risk management plan, the Food and Drug Administration said.
The FDA said that use of Philadelphia-based AR Scientific’s drug Qualaquin (quinine sulfate) to treat nighttime leg cramps had caused serious and life-threatening bad reactions in 24 patients, including permanent kidney damage and two deaths, as well as reduction in blood platelet levels and internal blood clots.
The reports have prompted AR Scientific to develop a risk evaluation and mitigation strategy, or REMS, requiring that patients receiving Qualaquin be given a medication guide explaining how to use the drug and potential side effects.
“Healthcare professionals and patients should be aware that FDA has not approved the use of Qualaquin for the treatment or prevention of nighttime leg cramps,” FDA Center for Drug Evaluation and Research Office of Antimicrobial Products director Edward Cox said. “FDA has received reports that some patients have developed serious side effects when taking quinine for nighttime leg cramps.”