Weight loss pill off shelves due to heart attack risk

By Dr. Ananya Mandal, MDOct 10 2010

Final verdict on a popular weight loss drug Reductil is to be delivered today. It is being debated whether the pill should be taken off the shelves in Australia and New Zealand. The drug Sibutramine sold as Reductil is linked to increased risk of heart attacks.

Drug regulator Medsafe would meet the Medicines Adverse Reactions Committee (MARC) to decide upon the risk benefit ratio of the drug. Pharmaceutical company Abbott has already announced it would immediately stop marketing and distribution of the drug in Australia after there were reports that it could cause overweight people to suffer a heart attack or stroke. The drug was withdrawn in Europe earlier this year. In Australia the drug has been sold since 2001.

According to Abbott Australia spokeswoman Jennifer Stevenson, “Doctors should not issue any new prescriptions for sibutramine… Patients who wish to stop treatment before seeing their doctor can do so at any time.” Patients who have recently bought the drug will be able to return their current supply to their pharmacy for a refund, she added.

Reductil acts by making patients feel full, and thus reduce their food intake. The data against the drug comes from the six-year and 10,000-patient SCOUT (Sibutramine Cardiovascular Outcome Trial). It showed that Sibutramine is linked to 16 per cent more major cardiovascular side-effects. The trial included 790 Australians. The preliminary results were released in November 2009 following which the European Medicines Agency suspended the marketing of the drug while the Therapeutics Goods Administration (TGA) moved in June to tighten the conditions under which it could be prescribed. According to TGA spokeswoman Kay McNiece, it has carried out its own review and consulted the US Food and Drug Administration before deciding to ban the drug on Friday. She said, “Analysis of the final results of the SCOUT study have since confirmed there is an increase in risk of major cardiac events such as heart attack and stroke in obese and overweight patients taking sibutramine.”

According to Dr. James Ritchie who specializes in obesity surgery in Sydney, he has often prescribed Reductil to patients considering gastric banding, to make sure they had tried all options. “It was fairly widely used for people with obesity. About half the patients for bariatric surgery have used it…Some found [the drug] highly effective but the vast majority didn't feel it helped much,” he said. He also said that most of the obesity drugs are fraught with side effects are being removed from the market. “Drug treatment is recognised as one of the most conservative methods of weight reduction… But it seems many medications are steadily dropping off the market,” he said. Of the other drugs is Phentermine, sold as Duromine that can cause sleeplessness, while Xenical, sold over the counter, had side-effects such as diarrhoea. Other weight loss drugs such as Fenfluramine, known as “fen-phen”, have been withdrawn from sale because of health risks.

According to Australian Medical Association vice-president Steven Hambleton the SCOUT trial also showed that the weight loss benefits of Reductil were only 2.5 per cent more than a placebo, a “disappointing” result. “Drugs, in the main, have a disappointing outcome. In the end, it's about ELF - Eat Less Food,” he said.

The Ministry of Health has warned that patients taking the drug need to consult their doctor or pharmacist. Also patients who suffer from heart conditions such as angina, heart failure, abnormal heartbeat or who had had a heart attack should not take the drug.