OTC Pain Relievers Get FDA Review for Heart Risks

The common wisdom is that all drugs deliver a side effect as they deliver relief. The assumption has been that over-the-counter medications (OTC), used by millions of Americans, deliver fewer side effects – but that may not be true.

Medications such as Aleve and Advil are getting a second review by the Food and Drug Administration (FDA) over concerns of a cardiac risk.

The FDA recently held a two-day look at NSAIDS, non-steroidal anti-inflammatory medications used to treat arthritis, headaches and everyday aches and pains.

Bayer’s Aleve (naproxen), an anti-inflammatory drug, will be the focus of an advisory committee of experts because it may carry a lower risk of stroke and heart attack than competitors Celebrex (Advil) made by Pfizer, and ibuprofen (Motrin) made by Johnson & Johnson.

Generic ibuprofen.

Oxford University researchers last year suggested 700 naproxen studies on 350,000 patients showed there was less risk with Aleve (naproxen). If those indications prove true, the OTC drug could be relabeled giving sales a multi-billion dollar boost.

NSAID sales were $1.7 billion last year, according to ABC News. Prescription Celebrex topped the group with sales of $2.9 billion.

Since these drugs are taken so regularly the meeting is an attempt to answer the lingering questions. Prescription NSAIDS will make up the bulk of the discussion. Prescription pain relievers are taken usually at a higher dose and for a longer time than over-the-counter medications but the recommendations may be extended to OTC as well.

NSAIDs carry a warning about heart dangers which were added in 2005.  Labeling was added to OTC Aleve, Motrin and Advil suggesting users take the lowest amount possible and for no more than a few days to avoid adverse events.

The panel will consider whether short-term risks should be added to the label of OTC NSAIDS.

Major manufacturers such as Pfizer and Johnson & Johnson want to leave the labeling alone.

The impetus for the review is the legacy of the NSAID Vioxx, which was pulled from the market in 2004 due to an increase in heart attack and stroke. Among the new kind of NSAIDS, Celebrex is the only one that remains on the market.