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| |  DEA Intends To Deschedule Fenfluramine And Dexfenfluramine PHILADELPHIA -- May 7, 1997 -- The Drug Enforcement Administration (DEA) has issued a notice of proposed rulemaking in the Federal Register seeking public comment on its intention to deschedule fenfluramine (Pondimin(TM)) and its isomers including dexfenfluramine (Redux(TM)). Yesterday’s notice is a preparatory step taken prior to a final ruling. "By descheduling fenfluramine and its isomer dexfenfluramine, the DEA will be providing patients with appropriate access to pharmacotherapy as a weight management option," said Marc W. Deitch, M.D., Senior Vice President, Medical Affairs and Medical Director of Wyeth-Ayerst Laboratories." "Obesity is epidemic in this country,” he added. "One in three people, or 58 million Americans, is obese. With 300,000 deaths each year caused by obesity and related disorders, finding better solutions for weight management has become a significant challenge. Many obese people have tried unsuccessfully for years to lose weight and maintain that weight loss and may benefit from the additional help a prescription weight loss medication can provide." Descheduling Background Interneuron Pharmaceuticals, Inc. filed a petition with the DEA on March 18, 1991, requesting that fenfluramine and its isomer dexfenfluramine be removed from Schedule IV and all other controls of the Controlled Substances Act (CSA). On September 29, 1995, the Food and Drug Administration's Drug Abuse and Endocrinologic and Metabolic Drugs Advisory Committee unanimously recommended that fenfluramine and its isomers be descheduled. The Department of Health and Human Services (HHS) forwarded its scientific and medical evaluation to the DEA, on June 3, 1996, with a recommendation to deschedule fenfluramine and its isomer dexfenfluramine. Based on the HHS evaluation and DEA's own review, the acting Deputy Administrator of the DEA concluded that, "There is insufficient data available at this time to establish that fenfluramine [and/or dexfenfluramine] has a potential for abuse which warrants control under the CSA." Mechanism of Action Redux(TM) (dexfenfluramine hydrochloride capsules) C-IV, was developed by Wyeth-Ayerst Laboratories and is the only medication indicated for the management of obesity, including weight loss and long-term maintenance. The mechanism of action of Redux is based upon its effects on serotonin, a neurotransmitter in the brain, as demonstrated in in vitro studies. Redux is a serotonin reuptake inhibitor and releasing agent. Serotonin is a messenger in the brain that may affect people's perception of hunger. Redux therapy has been associated with decreased appetite and may make people feel full and lessen their desire to eat. It is not an amphetamine or stimulant. No addictive or drug-seeking behavior has been reported. Redux is serious medicine, as is all pharmacotherapy for the treatment of obesity, and should be prescribed responsibly. Redux is recommended for obese patients with an initial body mass index (BMI) of at least 30 kg/m2 (which is approximately 30% over desirable weight) or a BMI of at least 27 kg/m2 (which is approximately 20% over desirable weight) in the presence of other risk factors (e.g., diabetes, hypertension and hyperlipidemia). Physicians and patients together must carefully evaluate the risks of obesity and obesity-related disease vs. the risk-benefit profile for Redux. Redux is available by physician's prescription in 15-mg capsules to be taken twice daily. Important Warnings and Precautions The most commonly reported side effects include diarrhea, dry mouth and somnolence. In human trials, these side effects were usually mild and disappeared in a few weeks. There is a small risk of developing a serious, potentially life-threatening condition called primary pulmonary hypertension (PPH). PPH is not the same as high blood pressure. This risk is estimated to be about 23 to 46 cases per 1,000,000 users per year, with a five-year survival rate of 55%. Redux(TM) should not be used in patients with hypersensitivity to dexfenfluramine or related compounds or in patients with diagnosed pulmonary hypertension, nor used concomitantly with a monoamine oxidase (MAO) inhibitor or within 14 days of discontinuation of this drug. Redux should not be taken in combination with other selective serotonin reuptake inhibitors, and is not recommended for pregnant or nursing women or people under 18 years of age. In animals receiving high doses of dexfenfluramine for short periods of time that resulted in brain concentrations estimated to be more than 10 times those in humans, neurochemical changes were observed. These changes were generally reversed over time but persisted over a year in one study of three animals. Full prescribing information is available upon request. Wyeth-Ayerst Laboratories, a division of American Home Products Corporation, is a research-oriented pharmaceutical company with leading products in the areas of women's health care, cardiovascular and metabolic disease therapies, central nervous system drugs, anti-inflammatory agents, vaccines, and generic pharmaceuticals. American Home Products is one of the world's largest research-based pharmaceutical and health care products companies and is a developer, manufacturer and marketer of prescription drugs and over-the-counter medications. It also develops vaccines, biotechnology, agricultural products, animal health care and medical devices.
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