Health Risks Suspected for Two Common Drugs

Updated 12:10 PM ET November 6, 2000
By Gene Emery

  BOSTON (Reuters) -
Two drugs commonly found in weight-loss products may have potentially deadly side effects, according to separate studies set to appear next month in the New England Journal of Medicine.
People taking one drug, phenylpropanolamine, were 16 times more likely to have a stroke than people who did not, one study found. The medication is also widely found in cough and cold remedies.

  The other drug, known as ephedrine or ma huang, is an ingredient in products that claim to enhance energy, not just reduce weight. The results suggest that ephedrine is capable of causing a wide range of ills, from seizures to heart problems.

  The two studies are scheduled to appear in the Dec. 21 issue of the Journal. The publication rarely releases its articles early, but said it did so on Monday "because of the potential clinical and health implications."
Currently, the number of consumers who have been affected by each drug's side effects is unknown.
The phenylpropanolamine study, for example, only looked at people who had already had a stroke. The ephedrine study analyzed reports submitted to the U.S. Food and Drug Administration, which is considering requests to ban or restrict the use of both drugs.

CONSUMERS SHOULD LOOK TO FDA
  The researchers behind both studies said they were not advocating a ban, at least not until the FDA completed its review of the evidence.  "Consumers should look to the FDA for guidance," said Dr. Walter Kernan of Yale University and the chief author of the study on phenylpropanolamine, 6 billion doses of which are sold in the United States each year.  But both Kernan and Dr. Neal Benowitz, an author of the ephedrine study, said the public needed to know that both substances could pose a risk.
 
  Benowitz said people with heart disease, high blood pressure, kidney problems, psychiatric problems or an overactive thyroid gland, or who had suffered a stroke or seizure in the past might want to be wary of ephedrine. Some 12 million Americans use ephedrine annually.

  Benowitz and Dr. Christine Haller, both at the University of California at San Francisco, reviewed 140 patient reports submitted to the FDA and concluded that 43 of the illnesses were "definitely or probably" caused by the drug, and that ephedrine "possibly" caused serious side effects in 44 other cases.

  Ten of the 87 people died, including two men who were regular users of Ripped Fuel, an energy supplement that contains ephedrine. In another case, a healthy 37-year-old woman died after taking Metabolife 356 for just one week.
"Most of the cases involve people in their 30s and 40s who were completely healthy before," Benowitz said in a telephone interview. "When the industry says these products are natural, people think that means they're safe. But that's not necessarily the case."  To assess the risk of stroke from phenylpropanolamine, Kernan and his colleagues questioned patients at 43 U.S. hospitals.

  They found that women who had taken phenylpropanolamine in an appetite suppressant were 16 times more likely to have a stroke. Kernan said that although a rate could not be calculated for men because no men in the study took appetite suppressants, there was no reason to believe men faced a lower risk.  Among people taking a cough or cold remedy containing phenylpropanolamine for the first time, the risk of a stroke was three times higher than normal.