Are NSAIDs safe? Five facts you should know

Nonsteroidal anti-inflammatory drugs (NSAIDs) are used by millions of people for pain relief from arthritis, headaches, muscle aches and other similar conditions.

Some NSAIDs such as celecoxib (Celebrex) are available by prescription only. Other NSAIDS, such as ibuprofen (available as generic, also sold as Motrin or Advil) and naproxen (available as generic, also sold as Aleve) are available by prescription and over-the-counter(OTC), depending upon dosage strength. Prescription NSAIDs are generally used for long-term chronic pain conditions like arthritis.

Over the years, the safety of NSAIDs has received considerable attention. You might remember that two prescription-only NSAIDs—Vioxx and Bextra—were taken off the market in 2004 after reports of increased risk of heart attacks. Celebrex is the only drug from the same COX-2 selective class as Vioxx that remains on the market. Earlier this week, the U.S. FDA convened a scientific panel (which I happened to participate in) to review the safety of NSAIDs, with particular attention on whether some are safer for the heart.

Here are five things you should know about the safety of NSAIDs.

All NSAIDs can increase the risk of heart attack and other life-threatening cardiovascular events. In 2005, the FDA added warnings about the risk of heart attack and stroke to all prescription NSAIDs. That year FDA also strengthened labeling on lower-dose, OTCNSAIDs, warning patients to take the lowest dose possible for only a few days at a time to avoid the same risks as prescription NSAIDs. While heart attack and stroke are rare, a study by Danish researchers reported that they can occur with even short-term use of NSAIDs. FDA panelists recommended revising the label to warn of this short-term risk.

Newer studies suggest that naproxen may be safer on the heart than other NSAIDs, but the data are not conclusive. Among the published studies reviewed this week was one comprehensive study that suggested fewer heart problems with naproxen. But this new research was not deemed strong enough to conclude that there are fewer heart problems with the use of naproxen than other NSAIDs.

All NSAIDs can cause gastrointestinal discomfort and, rarely, serious gastrointestinal bleeding and ulcers. NSAIDs increase the risk of serious gastrointestinal adverse events, including bleeding and ulcers. This risk is highest among people who have a prior history of peptic ulcer disease and/or gastrointestinal bleeding, concurrent use of drugs such as oral steroids or blood thinners, longer use of NSAIDs, smoking, use of alcohol, older age, and poor general health.

While the evidence is somewhat controversial, studies show that NSAIDs belonging to the so-called COX-2 selective class (which includes celecoxib) have fewer gastrointestinal side-effects than other NSAIDs.

Prescription NSAID medicines should only be used as prescribed. Also, they should be used at the lowest dose possible for your treatment and for the shortest time needed. OTC NSAIDs should not be taken for pain for more than 10 days or for fever for more than3 days unless directed by a doctor. If pain or fever persists or gets worse, if new symptoms occur, or if the painful area is red or swollen, talk to a doctor, as these could be signs of serious illness.

Tell your healthcare provider about all of your medical conditions and medicines you take. When taking any medication, always read and follow the label carefully. Give your doctor and pharmacist a complete list of your medicines, including over-the-counter and herbal products; this allows them to check for any potential drug interactions. Ask a doctor or pharmacist before use if you're taking aspirin for heart attack or stroke, because NSAIDs may decrease this benefit of aspirin. And stick with one pharmacy if possible this way your pharmacist can check for drug interactions when filling your prescription.

Be well, stay well ~

Andy Stergachis, Ph.D., R.Ph. is the Director of the Global Medicines Program at the University of Washington in Seattle and a subject expert on public health and pharmacy-related topics.