HSA says warning on stroke, heart attack risk on packaging is enough

POPULAR weight-loss drugs such as Reductil, banned in the European Union (EU) last month for raising one's risk of heart attacks and strokes, will continue to be sold in Singapore.

The Health Sciences Authority (HSA) here said the drugs carry sufficient warning on their packaging, so it will allow their continued sale.

The EU's health authority had suspended the sale of a number of such drugs containing sibutramine, which has been found to increase the risk of heart attacks and strokes by as much as 20 per cent.

The four weight-loss drugs with sibutrarnine available in Singapore - all of which need a doctor's prescription - are Reductil, Ectiva and Reducade from Abbott, and Sienfig from Apotheca Marketing.

Ihe HSA has so far received three reports of patients on such weight-loss drugs who had palpitations or raised blood pressure levels. They stopped taking the drugs and have since recovered.

Three other anti-obesity drugs available here - Xenical, Duromine and Panbesy - do not contain sibutramine.

A multimillion-dollar, six-year study of 10,000 patients sponsored by Abbott had exposed the risks of taking drugs with sibutramine.

Conducted in more than 300 centres in 16 mainly European countries, the trial had set out to prove that obese people, who already face higher risks of heart attacks and strokes, would lower this risk by taking anti-obesily drugs to shed weight.

However, the study found that for patients with cardiovascular risks, the drug actually raised - not lowered - their risk of heart attacks and strokes.

The European Medicines Agency (EMEA), which regulates medical safely in the EU, took action based on unpublished interim data and directed doctors to stop prescribing, and pharmacists to stop dispensing, such drugs.

It also advised pstients to talk to their doctors about switching to other weight-loss medicines.

In Britain alone, 86,000 people were on drugs with sibutramine last year. Britain took the cue from the EU.

Over in the United Slales. where sibutramine is marketed under the name Meridia, the Food and Drug Administration (FDA) has decided to wait for the full study to be released.

This is expected in a few months.

Meanwhile, the FDA has asked the manufacturers to put further warnings on their packaging, such as one advising those with blood pressure readings of over 145/90 against taking the drug.

It has also advised doctors to stop the medication for patients who fail to lose at least 5 per cent of their weight within three to six months of treatment, since continued treatment is likely to be ineffective and exposes the patients to unnecessary risk.

In Singapore, the HSA has advised patients taking such drugs to see their doctors if their blood pressure readings go up. or if they have palpitations, irregular heartbeat or symptoms of heart attack or
stroke.

Dr Stanley Liew, an endocrinologist with Raffles Hospital, said drugs with sibutramine are generally more effective and he will continue using them, but with greater care.

He said doctors here rarely prescribe the medicine for more than a year in any case, because it can usually bring down a patient's weight by between 5 and 10 per cent in that time. He noted that patients
in the study experienced higher risk after several years on sibutramine.