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OTC PHENYLPROPANOLAMINE DIET AID CAUTIONS TO BE STRENGTHENED UNDER NEW NDMA LABELING GUIDELINES, WORKING PARTY TELLS FDA AT NOV. 9 "FEEDBACK" MEETING

Executive Summary

NDMA guidelines calling for stronger precautionary statements in OTC phenylpropanolamine diet aid labeling and advertising will begin to take effect in the next three months, the Nonprescription Drug Manufacturers Association phenylpropanolamine working party told FDA at a Nov. 9 OTC drug "feedback" meeting. "We intend to write FDA and state that this [relabeling and revised advertising program] is starting," NDMA Senior VP William Soller, PhD, said. Dexatrim manufacturer Thompson Medical will begin cautionary labeling changes in about six weeks and advertising will "conform" to the new NDMA voluntary labeling guidelines in about three months, company President Dan Rodgers said. Under the proposed guidelines, advertising and labeling will stress the importance of adhering to the 75 mg per day recommended phenylpropanolamine dose. NDMA's prototype labeling cautions that "exceeding the recommended dose has not been shown to result in any additional weight loss." New warnings include: "Exceeding the recommended dose may cause serious health problems....Persons between 12 and 18 are advised to consult their physician before using this product." Consumers are additionally advised to stop use and consult a physician if palpitations or headache occur and not to take the product if they have an eating disorder except under the supervision of a physician. A new drug interaction precautions section states that nasal decongestants are contraindicated and cautions against use with monoamine oxidase inhibitors. A consumer labeling leaflet containing a suggested low-calorie diet and exercise program to be used in conjunction with phenylpropanolamine diet aids will be enclosed in packages, according to the NDMA guidelines. The leaflet will also reiterate cautions about following the labeled doses and advise that "if you have difficulty in losing or controlling weight, experience undesirable side effects while using this product, or are excessively overweight (more than 45% over your ideal weight), you should seek professional medical advice." Under the guidelines, advertising will include cautions "on a rotational basis" that the consumer not exceed the recommended dose or take more than one capsule or tablet per day, and that the product is for adult use only. Soller noted that members of the NDMA working party represent about 90% of appetite suppressants by sales and "over 97%" by advertising and promotion. "Undertaking this...initiative is basically covering all" OTC phenylpropanolamine weight control products sold in the U.S., he said. The "feedback" meeting ostensibly was called to discuss a proposed epidemiologic study of phenylpropanolamine and hemorrhagic stroke. The NDMA working party presented details of a proposed six-month epidemiologic study of phenylpropanolamine use and hemorrhagic stroke incidence in women 15 to 54 years old who were treated at 20 Connecticut hospitals. FDA raised a number of concerns about the design of the study. FDA Acting Epidemiology Branch Chief Joel Freiman, MD, expressed concern that the study design included no control group. "If you really wanted to see if there was an exposure difference between the cases you would need a control group to see what their exposure is." Office of Drug Evaluation I Director Robert Temple, MD, felt that a better estimate of use of phenylpropanolamine- containing products is needed. "You know what the sales are. Can't you make some estimate as to what the exposure rate is?" The working party in turn was concerned that if it conducts a controlled study, FDA may pull phenylpropanolamine-containing weight control products off the market before the study is completed. According to FDA's most recent regulatory agenda, a notice of proposed rulemaking for the OTC Weight Control Monograph is expected to be issued by the close of 1992, although FDA said that it now expects to issue the monograph in early 1993. At the feedback meeting, FDA told the working party that a ban of phenylpropanolamine in the next six months is "highly unlikely."
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