Drs. Mehmet Oz and Dr. Mike Roizen
Dr. Mehmet Oz is host of the popular TV show “The Dr. Oz Show.” He is a professor in the Department of Surgery at Columbia University and directs the Cardiovascular Institute and Complementary Medicine Program and New York-Presbyterian Hospital.

Dr. Mike Roizen is chief medical officer at the Cleveland Clinic Wellness Institute, an award-winning author, and has been the doctor to eight Nobel Prize winners and more than 100 Fortune 500 CEOs.

Dr. Mehmet Oz,Dr. Mike Roizen

Tags: off | label | drug | use | FDA | medications | migraines

Is 'Off-Label' Drug Use Safe?

Friday, 18 January 2013 09:09 AM EST

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 United States, 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. In fact, 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 or have their reps suggest to doctors that their medications are effective for off-label use. This is true even if the off-label 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. For example, one super-large pharma company was recently fined $700 million for advocating that their drug - approved only for use during chemo - be used by cancer patients who were not on chemo. They'd been warned not to do that by the FDA, because the pharma company's own study had found generalized use increased serious risks and other drugs worked just as well for patients not on chemo.

The not-so-good news: There's no fast-track for FDA-approved drugs to get a thumbs up for alternate uses. That means people who could be helped by a novel application may not be.

But that may be changing: The Second Circuit court overturned the conviction of a pharmaceutical representative for advocating off-label use of a drug, saying the conviction violated the defendant's right of free speech, and the government sought to prosecute the defendant solely on the basis of his speech.

However this shakes out, when you get a prescription from any doctor, ask if it's being prescribed for the approved use. If it's not, ask how long it has been used for your particular off-label application; if any studies testing its safety and effectiveness for that application have been done; and what the potential side effects are when used to treat your condition.

In your case, anti-seizure medications are used often to treat migraine when other medications have not provided relief. And stay tuned; there's a new nerve-stimulation treatment that looks like it might prevent and stop migraine attacks.

Q: I went through menopause about two years ago, and I've put on 15 pounds since then. Help! Is this inevitable? - Stephanie P., Waterbury, Ct.

A: Good news! Weight gain and menopause don't have to go hand in hand. Yes, your body has changed. Estrogen and progesterone production have pretty much shut down. Yes, as you age your metabolism may slow. Yes, this combo can make you put on extra weight and a roll (or more) of belly fat. And yes, that's risky: Belly fat's not an inert lump; it cranks out proteins and other agents that amp up your risk of diabetes, heart disease and cancer. But don't blame menopause. Eating the wrong food is probably what's filling out your omentum - the pouch that holds your belly fat. And you can change that and your body!

Worry more about what you're eating. Eat lean proteins, fresh veggies and fruit, and 100 percent whole grains, and you'll lose weight. Lean protein protects muscle mass. Fiber and phytonutrients keep your RealAge younger. And a 900 milligram daily omega-3 DHA supplement fights food cravings, lowers inflammation and protects your brain and eyes.

Try going vegetarian/vegan. That'll eliminate most or all saturated fat and cholesterol (bye-bye belly roll).

Start strength training. After 50, everyone loses muscle mass, but weight training with hand weights or stretch bands three times a week tones and builds muscles and protects your bones.

Get moving. Walking (it's our favorite - we walk 10,000 steps a day), bicycling and/or an aerobics class will help you keep your metabolism revved and your heart strong.

© 2013 Michael Roizen, M.D. and Mehmet Oz, M.D.
Distributed by King Features Syndicate, Inc.

© HealthDay

Is off label drug use safe?
Friday, 18 January 2013 09:09 AM
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