New drug approved for migraine headaches - sumatriptan succinate

Nutrition Health Review, Summer, 1993

The Food and Drug Administration has approved a new injectable drug, sumatriptan succinate, for the acute treatment of migraine attacks. The drug (Imitrex Injection) should not be used to treat hemiplegic or basilar migraine.

Because of the drug's potential to cause coronary artery construction, it is contraindicated in patients with ischemic heart disease. Also, because treatment with sumatriptan may result in rises in blood pressure, patients with uncontrolled hypertension should not take it.

Clinical studies have shown that doses as low as one milligram have been shown to be effective in some patients. The maximum single recommended dose is six milligrams injected subcutaneously. an auto-injecting device is available for patients who need the maximum dose.

The agency recommends that physicians give the first dose of the drug in their offices. This would allow them to monitor patients for adverse reactions and ensure that the auto-injector will be used properly.

The manufacturer of the drug, Glaxo, Inc., Research Triangle Park, North Carolina, is planning to provide educational information, which includes a videotape and a patient brochure.

In clinical trials involving more than 1,000 patients with acute migraine attacks, approximately 80 percent of patients improved within two hours of treatment, and 65 percent of all patients were pain-free.

The most common side effects associated with sumatriptan are pain and redness at the injection site. Common neurological side effects include dizziness, drowsiness, anxiety, and malaise. Patients may also complain of atypical sensations, such as tingling, feelings of tightness, heaviness, hot or cold, or pressure sensations. Less often, patients may complain of musculoskeletal, ear, nose, and throat symptoms.

Adverse effects are usually transient and without long-term complications.

Use of ergot-containing drugs should be avoided within 24 hours of taking sumatriptan.