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The Latest on Pain Relievers: Answers from the FDA

Here, a Q & A with Sharon Hertz, Deputy Director of FDA’s Division of Anesthesia, Analgesia, and Rheumatology Products, who has been with FDA for 15 years. Dr. Hertz graduated from SUNY Upstate Medical Center in Syracuse, N.Y., and completed her residency in neurology at SUNY Health Sciences Center at Brooklyn. This Q&A reflects the latest FDA Drug Safety Communication.

Q. What are non-steroidal anti-inflammatory drugs (NSAIDs)?

A. NSAIDs are a group of drugs used to temporarily relieve pain and inflammation. They work by blocking the production of prostaglandins, or chemicals believed to be associated with pain and inflammation.

Q. What conditions do NSAIDs treat?

A. Prescription NSAIDs are important to help manage many debilitating conditions such as osteoarthritis and rheumatoid arthritis. Some prescription NSAIDs also are used to treat pain. Over-the-counter versions of some NSAIDs are used to treat pain associated with dental problems, tendonitis, strains, sprains and other injuries. NSAIDs are also commonly used to treat fever and to reduce pain associated with menstrual cramps.

Q. What are non-selective NSAIDs and COX-2 selective NSAIDs?

A. Non-selective NSAIDs work by inhibiting two enzymes that are involved with inflammation—cyclooxygenase-1 and cyclooxygenase-2 (COX-1 and COX-2).

There are several non-selective NSAIDs on the market, including diclofenac, ibuprofen, ketoprofen, meloxicam, naproxen, and oxaprozin. Ibuprofen and naproxen are available in both prescription and over-the-counter (OTC) versions. The doses in OTC NSAIDs are lower than the doses of prescription versions and should only be used for up to 10 days without seeing a doctor. So, if you take OTC ibuprofen (Advil and Motrin) or naproxen (Aleve), the doses are about half the doses of prescription versions.

COX-2 selective inhibitors are a newer type of medicine that block the COX-2 enzyme more than the COX-1 enzyme. The only COX-2 selective inhibitor currently on the market in the United States is the prescription drug Celebrex (celecoxib), which is marketed by Pfizer. It was believed that COX-2 inhibitors may be less likely to cause the stomach problems associated with the older NSAIDs, but all NSAIDs carry the risk of stomach problems.

Q. What are the risks of taking NSAIDs?

A. As with all drugs, there is the potential for an allergic reaction to NSAIDs. Symptoms might include hives, facial swelling, wheezing and skin rash.

There is the potential for gastrointestinal bleeding (bleeding in the stomach or elsewhere in the digestive tract) associated with all NSAIDs. The risk of bleeding is low for people who use NSAIDs intermittently. The risk of stomach problems goes up for people who take them every day or regularly, especially for people who are older than 65, people with a history of stomach ulcers, and people who take blood thinners or corticosteroids (prednisone). Alcohol use can also increase the risk of stomach problems.


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