Consumer advocacy group Public Citizen seeks to have Meridia banned
WASHINGTON A consumer advocacy group is renewing calls for the Food and Drug Administration to ban a popular weight-loss drug amid reports of users of the drug experiencing heart attacks and strokes.
The group Public Citizen announced that it had petitioned the FDA to ban Abbott Labs’ drug Meridia (sibutramine) in light of results from the 10,000-patient SCOUT study, showing that 11.4% of obese patients ages 55 years and older taking the drug had experienced heart attacks, strokes, resuscitated cardiac arrests and deaths, compared with 10% of those taking placebo. Because each study group contained 5,000 patients, Public Citizen called the results statistically significant. The European Union required Abbott to perform the study as a condition for marketing the drug in E.U. countries.
The group first petitioned the FDA to ban Meridia in March 2002, though the FDA refused, saying that Meridia would remain legal until a large, randomized study could provide more conclusive results.
According to published reports, Abbott has responded by saying that the SCOUT study was performed on patients for whom Meridia is mostly not approved or recommended.
Sandoz introduces hypertension generic
PRINCETON, N.J. The generics arm of Swiss drug maker Novartis has introduced a version of a hypertension drug.
Sandoz announced the introduction of the injected drug nicardipine, a generic version of EKR Therapeutics’ Cardene, in 2.5 mg vials. The drug is designed for the short-term management of hypertension when treatment with orally administered drugs is not feasible.
Cardene had sales of $200 million during the 12-month period ended in September, according to IMS Health.
Study finds life expectancy for young adults diminished by obesity
NEW YORK Though the number of Americans who smoke has decreased dramatically in recent years, increases in obesity threaten to erase potential gains in the average life expectancy of young adults, according to a new study.
A team of researchers, led by Susan Stewart of the nonprofit National Bureau of Economic Research, published the study Thursday in The New England Journal of Medicine, forecasting the life expectancy of the average 18-year-old between 2005 and 2020 by comparing data on smoking and obesity.
The researchers used National Health Interview Survey data on smoking from two-year intervals between 1978 and 2006, as well as past trends in body-mass index based on data from the National Health and Nutrition Examination Survey in four- to six-year intervals between 1971 and 2006. They also factored in the 2003 Medical Expenditure Panel Survey to examine the effects of smoking and body-mass index on health-related quality of life.
While declining rates of smoking would increase the average life expectancy of 18-year-olds, increasing rates of obesity would push it back down by eight to 11 months, the researchers found. By contrast, if all adults in the United States became nonsmokers of normal weight, life expectancies would increase by up to five years.
“If past obesity trends continue unchecked, the negative effects on the health of the U.S. population will increasingly outweigh the positive effects gained from declining smoking rates,” the authors wrote. “Failure to address continued increases in obesity could result in an erosion of the pattern of steady gains in health observed since early in the 20th century.”