Warning

1997-52
September 15, 1997

Warning not to use products containing fenfluramine (PONDERAL, PONDERAL) or dexfenfluramine (REDUX)

OTTAWA - Health Canada is warning consumers not to use appetite suppressants containing fenfluramine (PONDERAL, PONDERAL PACAPS, PONDIMIN) or dexfenfluramine (REDUX). These are prescription drugs used in the short-term treatment of obesity. They are meant to be used alone but may also be prescribed in a non-approved combination therapy known as fen-phen (fenfluramine and phentermine).

The manufacturers of products containing fenfluramine and dexfenfluramine have agreed to suspend their sale in the US and Canada as of Monday, September 15, 1997. This voluntary recall was prompted by the high incidence of serious heart valve disease recently observed in patients in the US and associated with the use of these appetite suppressants.

This action is based on these new findings which revealed that approximately 30 per cent of patients taking these drugs, who were evaluated, had abnormal echocardiograms even though they had no symptoms. The US findings suggest that the drugs are the likely cause of heart valve problems. In Canada, three potential cases are under investigation.

Health Canada urges all individuals who may have consumed these products to consult their doctor immediately for appropriate patient follow-up.

The first indication of the development of valvular heart disease is usually the occurrence of a new heart murmur (abnormal sound as the blood flows over a valve). More severe symptoms of the disease include shortness of breath, loss of tolerance to physical activity and fluid retention in the legs and lungs.

The manufacturers of the affected products are Wyeth-Ayerst Canada Inc. (PONDIMIN) and Servier Canada Inc.(PONDERAL, PONDERAL PACAPS and REDUX).

This warning follows a Health Canada information sheet issued on July 11, 1997, advising health professionals against prescribing fen-phen, or any other combination of anti-obesity drugs, until further information became available.

Media Inquiries:
Cathy Petersen
Health Canada
(613) 941-3177