FDA Alert: Unsafe Drugs over the Internet

The Food and Drug Administration (FDA) is alerting consumers that certain drugs (Ambien, Xanax, Lexapro, and Ativan) ordered over the Internet may actually be haloperidol (Haldol), a powerful anti-psychotic that can cause serious symptoms such as difficulty breathing, muscle spasms and muscle stiffness. Haloperidol can also cause agitation or sedation.

The FDA was alerted when recipients complained to the US pharmaceutical manufacturer of one of the mislabeled products. Several consumers sought emergency medical treatment. The tablets that were determined to contain haloperidol came in packages postmarked in Greece.

Photographs of the packages and the tablets can be seen at www.fda.gov/bbs/topics/news/photos/haloperidol.html. Anyone who received tablets resembling those pictured, and did not order haloperidol, should notify the doctor who prescribed the original medication. Consumers can submit a report to the FDA at: www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm.

Last year, the FDA investigated 53 cases of drug counterfeiting. In 2003, a case involved 18 million tablets of fake Lipitor. The counterfeiters embossed the bogus bottles with the Pfizer logo then sold them through a wholesaler in the Midwest where they were sold in legitimate pharmacies. Pfizer was alerted when customers complained about a bitter taste. The pharmaceutical company has now developed a team of 17 former law-enforcement agents to investigate counterfeit drugs.

While cases such as the haloperidol substitution do happen, the most common fraud is the packaging of useless filler in place of medicine. This filler is usually not toxic since that would call attention to the counterfeit. Expensive AIDS treatments are the most likely to be counterfeited. Erectile-dysfunction drugs are also a prime target since the consumer is often unlikely to report that the medicine failed to work.

Another unscrupulous and dangerous practice is "uplabeling" when the supplier boosts profits by, for example, selling a 10mg dose as 40mg. Expiration dates may also be altered.

Costumers who buy drugs over the Internet are particularly vulnerable. "Canadian" sites have been tracked to Belize, Russia and Vietnam. "Generic'" versions of drugs are being sold when there is no legitimate generic available. Though these practices are illegal there is not much regulation in effect. Consumers need to protect themselves. The FDA has a website with tips and information about buying medicine on-line. It can be found at www.fda.gov/buyonline.

In June, 2006, the FDA announced that it would fully implement regulations enacted in 1987. These regulations require pharmaceutical distributors to provide documentation of the "chain of custody" of their drugs throughout the distribution system which means that drugs would be tracked after they leave the factory. Products can now be tracked with a technology that works similarly to the E-ZPass. This is an expensive system, however, and is only used to track some drugs such as Oxycontin

Precautions you can take:

Be very cautious when buying on-line. Do not buy from sites that sell prescription medicine without a prescription. If the price is too good to be true, it probably isn't "true"Ð don't send money or a credit card number. Look for the following seals of approval on the sites:

Pay attention to how your medicine looks and tastes. Pictures of medicine can be found at Drug Digest www.drugdigest.org/DD/PillImages/PillImagesSearch/1,20327,,00.html.

There are legitimate reasons for changes in the appearance of your medicine and a pharmacist will usually explain these when you pick up the prescription. If you have concerns about your medicine, contact your doctor's office.

2/22/07