(photo credit: Judy Siegel-Itzkovitch)
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