Another diet pill taken off shelves after it’s proven risky

Reductil increases chances of heart attacks and strokes.

By JUDY SIEGEL-ITZKOVICH
The hopes of the obese to lose weight by swallowing a pill instead of exercising and following a healthful diet dropped on Sunday, when the Health Ministry announced that the sale of the Abbott Laboratories drug Reductil – imported by Teva Pharmaceuticals – was halted, because users face significantly higher risks of heart attacks and strokes.
The drug was taken off the permitted medications list by the European Medicines Agency last January, followed by the US Food and Drug Administration this month.
The Health Ministry’s drug registrar, Rahel Gutman, said that after hearing about EMA’s decision, she immediately released a directive that the drug should not be taken by people with cardiovascular disease. As most of the obese have or are at high risk for heart disease, it is being removed from the shelves, and anyone taking the drug should consult with his cardiologist or primary care physician about a possible replacement drug. People with a supply should bring it to the pharmacy where they purchased it.
Teva set up a phone number for queries from its Reductil customers at 1-800-302- 666.
The ministry’s pharmaceutical division head, Batya Haran, told The Jerusalem Post she did not know how many Israelis take the drug, as this is a company secret.
On January 21, 2010, the European Medicines Agency recommended suspension of marketing authorizations for sibutramine following a six-year study of 10,000 patients called SCOUT (Sibutramine Cardiovascular Outcome Trial), which showed an increased risk of nonfatal but serious cardiovascular events in patients with a known or high risk for cardiovascular disease.
In August, the US Food and Drug Administration added a new contraindication for patients over 65 years of age due to the fact that clinical studies of sibutramine did not include sufficient numbers of such patients. Earlier this month, it asked Abbott to withdraw Reductil (sibutramine hydrochloride monohydrate) from the US market.
Worries that Reductil caused problems are not new; it was known to affect the heart rate and blood pressure of patients who took it, but some thought that if patients lost weight with it, they would be at lower risk. But they were not, according to SCOUT.
Sibutramine was originally launched and marketed by Knoll Pharmaceuticals, and more recently manufactured and marketed by Abbott Laboratories, under brand names such as Reductil, Meridia and Sibutrex. It is a neurotransmitter reuptake inhibitor that significantly reduces the reuptake of serotonin, norepinephrine and dopamine. Previous appetite-suppressive drugs that have been found to be dangerous, including fenfluramine and phentermine, are banned now as well.
Obesity experts believe it is so difficult to find a safe medication to reduce weight because during most of the human race’s existence, people suffered from an inadequate diet, and the body evolved to preserve adequate weight rather than cooperate with ways to reduce weight.
Meanwhile, a new study posted online by JAMA: The Journal of the American Medical Association that will be in the October 27 print edition found that lifestyle interventions, including physical activity and structured weight loss programs, can result in significant weight loss for overweight, obese and severely obese adults.
The online report coincides with the Annual Scientific Meeting of the American Obesity Society. US statistics indicate that 68 percent of the population are overweight and a third of these obese.
In a one-year intensive lifestyle intervention study of diet and physical activity, Dr. Bret Goodpaster of the University of Pittsburgh’s School of Medicine randomized a group of 130 severely obese adult individuals in two groups to assess weight loss for one year. One group was randomized to diet and physical activity for the entire 12 months, while the other group had the identical dietary intervention, but with physical activity delayed for six months.
The researchers found that “intensive lifestyle interventions using a behaviorbased approach can result in clinically significant and meaningful weight loss and improvements in cardiometabolic risk factors in severely obese persons... Our data make a strong case that serious consideration should be given by health care systems to incorporating more intensive lifestyle interventions similar to those used in our study.”