Are Your Drugs Safe?

Shoddy and fraudulent pharmacy products pose a growing threat.

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Like Soclof, customers are at a disadvantage when it comes to figuring out if the medications they get from their pharmacist or mail-order benefit plan are fakes. In many cases, counterfeiters imitate packaging of the legitimate company, as in the case of the fake OneTouch test strips. The fraud was discovered only because alert users clued in LifeScan Inc. of Milpitas, Calif., the company selling the strips, that they were getting odd results. At other times, counterfeiters mix real pills with fake (as in the case of the counterfeit Lipitor) or "uplabel," substituting 10-mg pills, say, for 40-mg ones.

Experts in counterfeiting suggest that patients examine pills and packaging when they get a new prescription and note if the medicine tastes different, dissolves differently, or appears to have different effects. "We're big advocates of going back to the pharmacy" where the prescription was filled if something looks off, says Ilisa Bernstein, director of pharmacy affairs for the FDA. A pharmacist can help answer questions: Often a pharmacy will switch a patient from one generic to another, and the difference in the pills' appearance can spark needless worry. If in doubt, Bernstein says, take the medicine back to the pharmacy, or call the manufacturer.

For years, federal agencies have warned Internet shoppers of the risks of getting bogus or substandard medication. Yet the Internet drug trade is still booming. In May, the FDA announced that patients who had bought Xenical, a weight-loss drug, over the Internet received pills that looked identical to the Roche product but contained talc and starch. Other pills contained Meridia, a different weight-loss drug. In a June survey by MarkMonitor, a San Francisco-based firm that keeps tabs on online sales and marketing abuses, 38 percent of spam E-mail hawking Internet drugs came from China; 24 percent came from the Russian Federation; and just 2 percent came from sites actually in Canada, though many others claimed to be based there. An online pharmacy that falsely claimed to be in Canada sold the tainted drugs that killed Marcia Bergeron, the Vancouver Island woman. The MarkMonitor survey found that just four of the 3,160 pharmacies surveyed were certified by the National Association of Boards of Pharmacy, which vets online drugstores.

Suspect supplements. If there are troubling gaps in the regulation of imported pharmaceuticals, the oversight of nutritional supplements has yawning cavities. More than 150 million Americans take vitamin and mineral supplements regularly, but those tablets don't always contain all of the active ingredient claimed. In June, the FDA issued rules defining good manufacturing practices for supplements. But manufacturers still aren't required to prove dietary supplements are safe and effective by testing them before they enter the marketplace, as they are with prescription drugs.

Thus consumers tend to learn of safety and quality issues only after supplements are on the market. In August, for instance, the FDA warned people not to take red yeast rice supplements sold by Swanson Healthcare Products Inc. or Sunburst Biorganics because they contained lovastatin, a prescription drug used to treat high cholesterol. And in September, the agency recalled Axcil and Desirin, herbal supplements made by twc Global of Mountain View, Calif., because the pills contained sildenafil, the active ingredient in Viagra. That drug can interact with nitrates taken for heart problems and may dangerously lower blood pressure.

In September, new ConsumerLab.com tests found that three of the 10 tested B-vitamin supplements had less folic acid than claimed. That may be because folic acid degrades if it's not stored properly, says President Tod Cooperman. Supplement purchasers concerned about quality and safety should be particularly careful about herbals, he says, because they are more likely to be of poor quality or contaminated. He suggests checking out independent laboratories that test supplements, including US Pharmacopeia and his company, ConsumerLab.com, which charges $29.95 a year for access to test data. Simplest of all, buy two different brands of multivitamins and switch daily. That way, he says, if one is subpar, at least the other may measure up.