FDA scales up CV warnings on NSAIDs

The FDA already had a warning out about the cardiovascular safety of nonsteroidal anti-inflammatory drugs, or NSAIDs. But on Thursday, it strengthened that warning for both prescription and OTC meds.

The agency is requiring prescription drugmakers to update their drugs' labels to include more specific information about their heart attack and stroke risks, and it's requesting that OTC drug manufacturers do the same in their Drug Facts labels, it said.

According to the FDA, the therapies--which include prescription meds Celebrex from Pfizer ($PFE), as well as popular consumer health treatments Advil from Pfizer and Motrin from Johnson & Johnson ($JNJ)--increase risk of heart attack or stroke, and those side effects can manifest as early as the first few weeks of NSAID use. The longer people take the drugs, the higher the risk might become, it noted.

"There is no period of use shown to be without risk," Judy Racoosin, deputy director of the FDA's Division of Anesthesia, Analgesia, and Addiction Products, said in a statement, adding that all users--even those without an underlying risk for cardiovascular disease--are susceptible.

NSAIDs, among the most commonly used drugs in the world, have been the subject of safety speculation for years. In 2005, U.S. regulators added a boxed warning to prescription NSAIDs like Celebrex and asked Pfizer to pull its Bextra from the market. The year before, Merck ($MRK) discontinued its Vioxx--another NSAID--also over cardio concerns.

Last year, the FDA revisited its warning on the drugs, taking a look at Bayer's OTC Aleve in particular. In February 2014, an advisory committee panel met to weigh evidence on the group and decide whether a warning was still necessary for the German pharma's contender. But ultimately they voted against removing the tag, citing insufficient evidence that Aleve should escape the warning.

- see the FDA's announcement

Special Reports: Pharma's Top 11 Marketing Settlements - Merck - Vioxx | Top 10 Drug Advertising Spends -- Q1 2012 - Celebrex

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