Diabetes Recall

By Christine Gorman

I often think of the first couple of years after a drug has been approved as its guinea-pig period. After all, even the most careful clinical trials of a new medication usually involve just a few thousand patients. So, in the beginning, only a drug's most common side effects are known. But once a pharmaceutical clears the Food and Drug Administration's review process, hundreds of thousands, if not millions, of people start taking it. That's when you get a better idea of the true rate of complications, as well as any untoward interactions with other drugs.

Consider what happened with Rezulin, the diabetes drug that was taken off the market last week. The FDA approved the medication in 1997 after tests on 3,000 people showed that it could help control Type 2 (formerly adult-onset) diabetes, which affects 15 million Americans. Although some test subjects developed abnormal liver reactions, no one suffered permanent damage, and no one died. Now that millions have taken Rezulin, however, it has been linked to at least 90 cases of liver failure, 63 of which resulted in death.

When serious complications first started showing up, the FDA strengthened the warning labels on Rezulin and recommended regular liver tests for all patients using it. But not everyone got tested, and it was impossible to predict who would suffer a bad reaction. Then last year the FDA approved two new drugs (Actos and Avandia) that are chemically related to Rezulin but appear to be safer. Rezulin began looking like more trouble than it was worth.

All three drugs work by boosting the body's response to insulin. Unlike folks with Type 1 diabetes, those with Type 2 usually produce their own insulin. "Type 2 is more of a supply-and-demand problem," says Dr. David Nathan, a diabetes expert at Massachusetts General Hospital in Boston. The body can't keep up with its elevated need for insulin, and it becomes more and more resistant to the insulin it does make. Rezulin was the first drug that directly lowered insulin resistance.

Some critics have argued that the FDA waited too long to ask Warner-Lambert, Rezulin's manufacturer, to issue a recall. The pharmaceutical company still believes Rezulin is a good drug and blames the media for sensationalizing its risks. But if you're one of the 500,000 Americans currently taking Rezulin, what you need to know right now is how to get off the drug without jeopardizing your health.

Don't go cold turkey on your own; your diabetes could slip out of control. And if you rely on supplemental insulin, your doctor may need to adjust your dose. Don't be surprised if you're not put on one of the new alternatives. There are several older medications that doctors rely on to treat Type 2 diabetes. "I personally have been very cautious about prescribing the new drugs," Nathan says. Besides, Actos and Avandia also require precautionary liver tests.

It may be possible for you to beat insulin resistance through lifestyle changes. Losing weight, if you're overweight, is a start. But even if you have trouble dropping pounds, getting more exercise and adding whole grains to your diet can lower your resistance and decrease your need for medication. No one ever said treating diabetes is easy, but there's a lot you can do to keep it from controlling your life.

For more information on Rezulin or diabetes, visit time.com/personal You can e-mail Christine at gorman@time.com