June 27, 2002 LONDON (AP) -- The European agency that evaluates prescription drugs reaffirmed Thursday that the popular diet drug Reductil is safe and effective enough for obese people to take.
A committee of the European Agency for the Evaluation of Medicinal Products reassessed the safety and effectiveness evidence for the drug in response to a request made in March by the Italian Ministry of Health.
Italy suspended sales of the drug, generically known as sibutramine, in March after 50 reports of troublesome symptoms in people taking the pills. Two people had died.
The drug, made by Abbott Laboratories, has also come under attack in the United States, where the consumer group Public Citizen has urged the Food and Drug Administration to ban the medication, citing 28 deaths among the drug's users.
The European agency examined evidence from more than 100 studies in more than 12,000 obese patients. The review included an analysis of the 32 worldwide deaths that have been reported in people taking the drug.
"The committee considers that the risk-benefit profile of sibutramine remains positive," the agency said in a statement Thursday.
It said a more detailed report on the review would be made available next week.
Sibutramine, marketed as Meridia in the United States, has been on the American market since late 1997. It was approved in Europe in November 2000 and is licensed in 70 countries in total.
More than 8.5 million people have taken the pills.
Dr. Eugene Sun, a global pharmaceutical development vice-president at Abbott said the review found that the deaths reported did not implicate the drug.
The assessment ackowledged there were side effects, but found that the benefits of the drug outweighed the risks. The European medicines agency did not demand a change in the drug's labelling, but asked the company to write to doctors throughout Europe reinforcing appropriate use of the medicine.
Obesity is one of the most threatening global health problems and itself carries an increased risk of serious disease and premature death.
Copyright 2002 The Associated Press. All rights reserved.
