NSAID Warning Labels Revised
In April 2005, the FDA asked drug manufacturers of prescription NSAIDs to include with their products a “black box” warning -- the strictest type -- that emphasizes an increased risk for cardiovascular events and gastrointestinal bleeding in patient's who use the drugs. The FDA also requested manufacturers of OTC NSAIDs to revise their labels to include more specific language concerning potential cardiovascular and gastrointestinal risks. Due to its proven cardiovascular benefits, aspirin was excluded from these labeling revisions.
COX-2 Inhibitors
COX-2s are a class of prescription drugs that have the anti-inflammatory effects of NSAIDs, but do not upset most people's stomachs. However, some of these drugs have been withdrawn from the U.S. market due to increased risk for heart attack and stroke. Celecoxib (Celebrex) is currently the only available COX-2, and it has a strong warning label alerting users of the potential for heart attack, stroke, and serious gastrointestinal problems. (The warning is the same one the FDA recommended for the labels of prescription NSAIDs in 2005.)
Triptans
Triptans (also referred to as serotonin agonists) were the first drugs specifically developed for use against migraine. They are the most important migraine drugs currently available. They help maintain serotonin levels in the brain, and so specifically target one of the major components in the migraine process. Triptans are now recommended as first-line drugs for many adult patients with moderate to severe migraines when NSAIDs are not effective. Patient satisfaction is high with these drugs, and they have the following benefits:
- Effective for most patients with migraine
- Beneficial for patients with combination tension and migraine headaches
- May be effective for preventing menstrual migraines
- Do not have the sedative effect of other migraine drugs
- Withdrawal after overuse appears to be of shorter duration and is less severe than with other migraine medications
Sumatriptan. Sumatriptan (Imitrex) has the longest track record and is the most studied of all triptans. It is available as a fast-dissolving pill, nasal spray, or injection. Injected sumatriptan works the fastest of all the triptans and is the most effective, but it can cause pain at the injection site. The nasal spray form bypasses the stomach and is absorbed more quickly than the oral form. Some patients report relief as soon as 15 minutes after administration. The spray tends to work less well when a person has nasal congestion from cold or allergy. It may also leave a bad taste. Sumatriptan is effective for many patients, but 20 – 40% of people experience a headache recurrence within 24 hours after taking the drug.
Previous Section
