Advice on safe use of medicines containing sibutramine

22 Jan 2010

The Department of Health (DH) today (January 22) drew public attention to the safe use of medicines containing sibutramine.

It was discovered through the department's active surveillance that the European Medicines Agency, based on results of a recent study, considered the risks of subutramine to be greater than their benefits and that the agency's Committee for Medicinal Products for Human Use has recommended suspension of marketing authorisation for medicines containing sibutramine.

A DH spokesman noted that the Food and Drug Administration (FDA) of the United States, after reviewing the relevant study data, had requested manufacturers to add a new contraindication to the label stating that sibutramine is not to be used in patients with a history of cardiovascular diseases including history of coronary artery disease, stroke or transient ischemic attack, arrhythmias, congestive heart failure, peripheral arterial disease and uncontrolled hypertension.

The FDA will complete its full review and convene a meeting to determine if additional regulatory actions should be taken to ensure safe use of the medicines later.

In Hong Kong, the DH has seriously considered the possible side effects, volume of demand and made an immediate risk assessment of medicines containing sibutramine.

The spokesman said a total of 40 registered drugs contained sibutramine and are prescription drugs. The existing package inserts carry a warning that the medicines should not be used in patients with a history of coronary heart disease, congestive heart failure, arrhythmias or stroke.

The Registration Committee of the Pharmacy and Poisons Board will review the relevant data in an upcoming meeting in early February.

Sibutramine is a Western medicine used as an appetite suppressant. Its side effects included increased blood pressure and heart rate, psychosis and possibly convulsion. People with heart problems should not take it.

The spokesman advised members of the public using the drugs to consult healthcare professionals to determine whether continued use of sibutramine was appropriate. Their doctors should be informed about any problems encountered after treatment.

The spokesman added that weight control should be achieved through good diet and appropriate exercise. Members of the public should not use prescription drugs on their own. Healthcare professionals should be consulted before using any medication for weight control.