Q: My doctor suggested I take anti-seizure medication for my migraines, but it’s not approved for that. He says it’s safe and effective. What’s your take?
EVELYN P., COUNCIL BLUFFS, IOWA
A: In the U.S., 4.02 billion prescriptions are written annually and more than 20 percent are to treat diseases or conditions for which the drugs are not specifically Food and Drug Administration-approved. That’s called off-label use and it is perfectly legal. More than half of all uses of cancer drugs are prescribed off-label — and that’s even OK with health insurance companies.
But pharmaceutical companies can’t advertise and their reps can’t suggest to doctors that their medications are effective for off-label use. This is true even if the benefits have been demonstrated in peer-reviewed, scientific studies.
The good news: This keeps companies from pushing medications for uses that have not been verified as safe and it protects you. One drug company was fined $700 million for advocating that their drug — approved only for use during chemo — be used by cancer patients not on chemo. The FDA warned them not to do this because the pharma company’s own study found that use increased serious risks and that other drugs worked just as well.
When you get an off-label prescription, ask how long it has been used for your condition, if any studies testing its safety and effectiveness for that application have been done and what the potential side effects are. In your case, anti-seizure medications are used often to treat migraines when other medications have failed. There’s a new nerve-stimulation treatment that might prevent and stop migraines.
The You Docs — Mehmet Oz, host of “The Dr. Oz Show” and Mike Roizen of Cleveland Clinic — are authors of “YOU: Losing Weight.” To submit questions, go to www.RealAge.com. A King Features syndicate.
