FDA Declares PPA 'Unreasonably Dangerous'
May 15, 2001
Many doctors are recommending that their patients avoid cold medications and appetite suppressants that contain phenylpropanolamine, more commonly known as PPA. "There are safer alternatives out there, so why take the risk?" asked Dr. Ray Woosley, chairman of the pharmacology department at Georgetown University Medical School. "If it causes even one stroke, that's one stroke too many."
Patients are advised not only to stop purchasing these products, but also to inspect their medicine cabinets for items that may contain PPA. Experts say that there are dozens of over-the-counter and prescription cold and diet drugs that contain PPA. Many people are unaware that their drug of choice contains the substance. Concern has grown over the last decade that PPA may increase the risk of a rare but deadly type of stroke.
The latest cause for concern comes after an FDA advisory commission found that over-the-counter medications containing PPA should not be considered "safe." According to industry records, annually, over 7 million people use products containing PPA, including Contac, Dimetapp, Robitussin, and Alka-Seltzer. The industry claims that the FDA's statement that its products are not "safe" is based on erroneous data.
Both industry leaders and the FDA made clear that the advisory commission's finding is not a recall of PPA. The advisory commission's finding that PPA is not "safe" will be reviewed by FDA leaders who will decide at a later time whether to officially ban all products that contain PPA. However, many doctors question why anyone who knows of the potential danger of PPA would take a drug containing the substance. "Nobody should use any of these products at all," warned industry watchdog, Dr. Sidney Wolfe, director of Public Citizen's Health Research Group.
The cold and diet drug industry strongly disagrees with the FDA's action regarding PPA, citing poor scientific protocol in the manner in which scientists from Yale University conducted the research. "PPA is safe and effective when used according to label directions . . .. The companies are standing behind the product," according to Dr. R. William Soller, director of science and technology for the Consumer Healthcare Products Association, an industry trade group. The Association claims that the FDA and its Yale researchers blindsided the industry, failing to give its members a fair chance to rebut the study's findings.
It is interesting to note that the Yale study that blasts PPA was funded by the cold and diet drug industry. The $5 million study found that people who take products that contain PPA, especially women between the ages of 18 and 49, are more likely to suffer a hemorrhagic stroke. Hemorrhagic strokes are rare, causing bleeding in the brain that can lead to death. While FDA data prior to the Yale study indicated that approximately 44 strokes since 1966 have been associated with PPA, it is well known that over 90% of adverse drug reactions are never reported to the agency. The FDA now believes that some 500 people suffer hemorrhagic strokes each year because of PPA.
The study examined 702 hemorrhagic stroke victims and whether they had taken cold or diet drugs containing PPA. Researchers found that young women were 16 times more likely to suffer a stroke within 3 days of taking a substance containing PPA than those who did not take PPA. The study found no correlation between PPA and stroke occurrence in men. Nevertheless, researchers believe men should also avoid PPA. "The increased risk is small but small is in the eye of the beholder," said Dr. Walter Kernan of Yale. Kernan also said, "I do think it is appropriate for women considering the use of PPA in appetite suppressants, or in a first-time use, to be aware of the results of our study and to consider our study in making a decision about the use of these medications."
The Consumer Healthcare Products Association and other industry trade organizations claim that the Yale study's control group was too small and that other possible causes of stroke were not considered, such as the lifestyle of the victims and their preexisting health conditions. However, watchdog groups like Public Citizen fault the FDA for not acting years ago when concerns over PPA first surfaced. "Instead of taking it off the market, the industry conned them into 'Let's do an epidemiological study,' " says Wolfe of Public Citizen. "It was a delaying tactic. It took three years to design the study and five years to do it and the study merely confirmed what was already known," he added.
-- Article Courtesy of InjuryBoard.com
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