April 22, 1997
FDA says Redux shows no unexpected side effects
WASHINGTON (AP) - The Food and Drug Administration says it continues to monitor the cases of patients experiencing side effects while taking the anti-obesity drug Redux, but says thus far there have been no unexpected findings.
``The data to date regarding Redux do not raise any red flags,'' agency spokesman Don McLearn said Monday.
The agency's comment came after The Associated Press reported Friday that many scientists question why the government has let Redux sell so long without having the manufacturer, Wyeth-Ayerst Laboratories, study a possible brain-damaging side effect. The FDA approved Redux for sale a year ago, and that study is expected to begin soon, the agency says.
The AP also reported Friday that some critics fear the potent drug is being inappropriately prescribed to many Americans, including those not severely overweight.
The FDA said Monday that it had provided incorrect information to the AP about one specific case cited in the story, the death of a woman who had been prescribed Redux.
The woman weighed 220 pounds, not 120 pounds as it had said earlier, the FDA said. The agency also disclosed Monday, based on further information provided by Wyeth-Ayerst Laboratories, that the woman also had been taking an anti-anxiety drug.
A local coroners' inquest determined she had very high levels of that anti-anxiety drug in her body when she died, and ruled the death was a homicide, not an accidental death or suicide. Local and state officials continue to investigate the death and no criminal charges have been filed.
The company that developed Redux, Interneuron Pharmaceuticals Inc., and Wyeth-Ayerst Laboratories reiterated on Monday their position that scientific evidence has shown Redux to be safe when used as recommended.
Initial data collected about patients reveal ``no evidence indicating a higher-than-expected occurrence of adverse events related to the central nervous system,'' the companies said in a joint statement.
The FDA examines all reports of adverse reactions among patients taking prescription drugs, such as Redux.
To date, it has received notification of 18 deaths of patients who had been taking Redux, including three suicides, and is examining all those cases, said McLearn, the agency spokesman.
The FDA said that, based on information collected thus far, it had not noted any side-effect patterns inconsistent with what its scientific advisers expected when the agency approved Redux.
The FDA insists that only the severely obese try Redux, because its users have 23 times the average risk of a rare but often fatal lung ailment called primary pulmonary hypertension.
Yet, recent side-effect reports sent to the agency listed weights for just 27 of 51 patients - and 14 were below the government weight guidelines for use of the drug, the FDA says.
In addition, the FDA approved Redux on the condition that Wyeth-Ayerst study whether the drug damages the human brain cells that produce serotonin. Previous studies in mice, rats, monkeys and baboons show that high doses destroy those cells - raising fears of side effects such as depression if the same thing happens to people.
The study of effects on human brain cells is expected to start soon,
the FDA says.
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