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European and American drug regulators had two starkly different reactions this week to data on an obesity drug. The raw data from the study indicated that people with certain health problems who took the prescription diet drug Meridia had more heart attacks, strokes and other cardiovascular problems than people getting a placebo.
Last week, the European Medicines Agency advised doctors and pharmacists to stop prescribing and dispensing European equivalents of Meridia. The Food and Drug Administration, looking at the same study data on Thursday, took a less forceful step and asked Abbott Laboratories, the maker of Meridia, to put a stronger warning on its label.
The F.D.A. said the new warning should indicate that the drug was not to be used by people who have a history of heart attacks or strokes, or who have uncontrolled high blood pressure.
Abbott, which sells Meridia in Europe under various brand names, including Reductil and Ectiva, indicated Friday that it would comply with the F.D.A.’s labeling request and with the European advisory by suspending sales of the drugs in Europe.
Meridia contains the ingredient sibutramine, which works by increasing neurotransmitter activity in the brain, helping people to feel full after a meal and thereby reducing their food intake. The company said the drug was safe and effective when used in appropriate patients.
Some experts said the finding that Meridia actually increased such risk in some high-risk patients rather than reduce it could raise questions about the safety of other diet drugs.
“The European Medicines Agency has acted appropriately,” said Dr. Sidney M. Wolfe, the director of the health research group at Public Citizen, a consumer advocacy group in Washington. His group has long asked the F.D.A. to ban Meridia, including a petition last month saying that in the drug’s 12 years on the market it has been linked to more than 80 deaths, including 30 people under age 50.
“The F.D.A. has acted recklessly,” Dr. Wolfe said.
The European Medicines Agency had requested the study in 2002 because of concerns about side effects like higher blood pressure. The company gave preliminary results from that study to European and American regulators late last year.
The Scout trial was a six-year study involving about 10,000 overweight and obese people who had a history of heart disease or diabetes, or both. About 11.4 percent of those who took the drug had a heart attack, stroke, or died from cardiovascular causes, compared to 10 percent of those getting the placebo, according to data from the study released by the F.D.A.
After reviewing the initial data and questioning Abbott, the European agency said on Thursday that the benefits of sibutramine diet drugs did not outweigh their risks. The suspension of sales is to remain in place, the agency said, unless and until Abbott provided rigorous data identifying a population of people for whom the drug’s benefits did outweigh its risks, the agency said.
If you or a family member has been personally injured because of the fault of someone else: by the use of dangerous and defective drugs, bad products, or toxic injury etc then please contact the Fort Worth Texas Defective Drugs Product Liability Attorney Dr. Shezad Malik. For a no obligation, free case analysis, please call 214-390-3189 or Contact Me Online.