Letter - Plegine

As with all medical products, healthcare professionals are strongly encouraged to report any serious adverse events that are associated with the use of Plegine (phendimetrazine tartrate) to either FDA's MedWatch program by phone (1-800-FDA-1088), fax (1-800-FDA-0178) or mail (using postage-paid form) to FDA, HF-2, 5600 Fishers Lane, Rockville, MD 20852-9787, or to Wyeth-Ayerst.

This is the retyped text of a letter from Wyeth-Ayerst. Contact the company for a copy of any referenced enclosures.

June 26, 1998

Re: Plegine® (phendimetrazine tablets)
WARNING regarding Valvular Irregularities and Primary Pulmonary Hypertension

Dear Health Care Professional:

Wyeth-Ayerst Laboratories, Division of American Home Products Corporation, wants to call your attention to a new warning added to the labeling of Plegine® (phendimetrazine tartrate tablets). The boxed warning states:

Anorexigens have been reported to be associated with the occurrence of serious regurgitant cardiac valvular disease, including disease of the mitral, aortic, and/or tricuspid valves. In one literature report, 24 patients, who received combination therapy with fenfluramine and phentermine for treatment of obesity, were found to have regurgitant cardiac valvular disease; five of these patients required valvular surgery. The valves of these five patients were found to have a gross pathologic and/or histologic appearance resembling that seen in patients with alterations in serotonin metabolism. In these reports and other reported cases, fenfluramine was taken generally in combination with phentermine. However, there are some reports in which valvular disease was seen in patients taking fenfluramine alone.

Primary pulmonary hypertension (PPH) - a rare, frequently fatal disease of the lungs - has been found to occur with increased frequency in patients receiving anorexigens. (See WARNINGS.)

There have been reports of PPH and valvular irregularities in users of Plegine (phendimetrazine tartrate tablets).

The safety and effectiveness of the combined use of Plegine with other anorexigens in the treatment of obesity have not been established, and there is no approved use of these products together in the treatment of obesity. Plegine is approved only as a single agent for short-term use (i.e., a few weeks).

Wyeth-Ayerst has received information concerning patients who had taken phendimetrazine and experienced valvular abnormalities and/or primary pulmonary hypertension. It appears that all patients had a history of using at least one other anorexigen. Since the removal of Pondimin® (fenfluramine hydrochloride tablets) C-IV and Redux™ (dexfenfluramine hydrochloride capsules) C-IV from the market in September 1997, there have been reports that physicians are prescribing phendimetrazine in combination with phentermine in a limited number of cases. We emphasize that such concomitant use is not indicated.

In light of this information, Wyeth-Ayerst would like to remind you of two important points in connection with phendimetrazine products, including Plegine® (phendimetrazine tartrate tablets):

Phendimetrazine is not indicated for concomitant use with any other anorexigenic drug. Wyeth-Ayerst does not recommend such concomitant use and does not know of any adequate and well-controlled studies demonstrating the safety and effectiveness of these drugs when used in combination.

Phendimetrazine is not indicated for long-term use. The labeling clearly states that it is indicated only for short-term use of a few weeks.

Sincerely,

Philip J. de Vane, M.D.
Vice President, Clinical Affairs
and North American Medical Director

Wyeth-Ayerst Laboratories
Division of American Home Products Corporation
P.O. Box 8299
Philadelphia, PA 19101-8299

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