FDA Panel Loosens Avandia Safety Restrictions
Despite some concern over whether the diabetes drug Avandia can increase heart problems, an FDA panel Thursday loosened restrictions on how doctors can prescribe the drug.
The New York Times: FDA Vote Is Minor Victory For Troubled Diabetes Drug
A panel of experts voted Thursday to loosen restrictions on a controversial diabetes drug, saying doctors should have more freedom to prescribe it to patients. But the decision was unlikely to improve prospects for the drug; sales have sagged since a highly publicized episode in 2007, when a doctor showed evidence that it increased the risk of heart problems (Tavernise and Thomas, 6/6).
The Associated Press/USA Today: FDA Panel Favors Easing Safety Limits On Avandia
Federal health experts are recommending changes to safety restrictions on former blockbuster diabetes pill Avandia, in light of a new analysis suggesting that the drug may not increase the risk of heart attack as much as previously thought (6/6).
Medpage Today: FDA Panel Loosens Noose On Avandia
A panel of FDA advisers thinks it is time to ease restrictions on access to Avandia (rosiglitazone), a onetime multimillion dollar blockbuster drug brought low by reports that it increased the risk of heart attacks. In a combined meeting of separate FDA advisory committees, 20 of 26 panelists voted Thursday to recommend removing or modifying rosiglitazone's highly restrictive label and distribution system. Five voted to keep the product's risk evaluation and mitigation strategy (REMS) as it is now. One panelist voted to remove the product from the market. Of the 20 panelists who voted to remove or modify the labeling and distribution system, 13 voted to modify it and seven voted to remove the REMS entirely (Pittman, 6/6).
Medpage Today: Law Weakens FDA Conflict-Of-Interest Regs
More drugs with dangerous side effects could get onto the market as the result of recent legislation that loosens conflicts of interest restrictions on experts serving on panels that advise the FDA, according to a new analysis. The analysis, published in the journal Science, reviewed a 2007 law that placed caps on the number of waivers that could be granted allowing experts with conflicts of interest and a 2012 law that removed those safeguards (Fauber, 6/6).