FDA Tightens Warnings On Popular Painkillers Over Heart Attack, Stroke Risks
The drugs, known as NSAIDs -- nonsteroidal anti-inflammatory drugs -- already carried a warning that they "may cause" increased risk of heart attack and stroke. But federal officials say that link is now confirmed.
The New York Times:
F.D.A. Is Set To Toughen Nonaspirin Warnings
The Food and Drug Administration is strengthening warnings on painkillers like ibuprofen to say that they cause an increased risk of heart attack and stroke. The over-the-counter forms include Advil, Motrin IB and Aleve. The distinction was subtle: The labels already say such drugs “may cause” increased risk of heart attack and stroke. But the agency said that new data from a recent analysis provided stronger evidence of the increased risk of heart failure from such drugs. (Tavernise, 7/9)
The Wall Street Journal:
FDA Strengthens Warnings On Class Of Popular Painkillers
The FDA said new data have caused it to conclude that the medicines—called NSAIDs, for nonsteroidal anti-inflammatory drugs—definitely cause an increased risk of heart attack and stroke. It long has required a warning on the class of drugs, saying they “may cause” an increased risk. The agency will require that makers of prescription versions of the medications change their labels. The change will include the statement that the risk may be present throughout the entire course of NSAID use, even within the first weeks of treatment. (Burton, 7/9)
The Associated Press:
FDA Strengthens Heart Risk Warning In Popular Pain Relievers
Federal health regulators are bolstering warning labels for popular pain relievers, adding information about the risk of heart attack and stroke in the short term. The changes announced Thursday apply to prescription non-steroidal anti-inflammatory drugs, or NSAIDs, including arthritis treatments like Celebrex. The agency said it plans similar changes to over-the-counter drugs in the same class, such as Advil and Motrin. (Perrone, 7/9)
Los Angeles Times:
FDA Strengthens Warning On Prescription Anti-Inflammatory Medications
A decade's worth of research on nonsteroidal anti-inflammatory drugs, or NSAIDs, has prompted the Food and Drug Administration to demand stiffer warnings on the labels of such prescription medications as celecoxib (marketed commercially as Celebrex) and diclofenac (Voltaren) about the increased risk of heart attacks and strokes in those taking the drugs. ... Those warnings come a decade after the FDA issued a public health advisory on the use of rofecoxib, better known as Vioxx, after it was found that those taking the medication had higher rates of heart attack and stroke. The pharmaceutical giant Merck subsequently pulled Vioxx from the market. (Healy, 7/9)
And on another safety issue -
The Wall Street Journal:
FDA Should Withdraw Sanofi Device Over Safety Concerns: Advocacy Group
A consumer group is asking the FDA to remove a Sanofi device used in stomach and pelvic surgeries over concerns the product is neither safe nor effective, and has also been associated with deaths and injuries. In a petition filed with the agency, Public Citizen maintains that Seprafilm, which is marketed by the Genzyme unit at Sanofi, should never have been approved. Why? The advocacy group alleges that clinical studies the FDA relied on for approval were “plagued with problems,” including the failure of one researcher to follow the study protocol or report adverse event data. ... [A] Sanofi spokeswoman adds that “we stand behind the clinical trial results and nearly 15 years of post-marketing surveillance data reported to the FDA for Seprafilm… and have been reviewing safety data on an ongoing basis since the product was first introduced in the clinical trial setting.” (Silverman, 7/9)
