Nearly one in four recently approved products in a relatively new class of medicines needed some type of regulatory action because of safety issues that arose after they came on the market, researchers report today.
The Dutch scientists focused on 174 medicines called biologicals that were approved in the USA and/or the European Union between January 1995 and June 2007. Biologicals are defined as medicines whose active substance comes from a biological source. The first biological approved by the U.S. Food and Drug Administration was recombinant insulin in 1982, according to the new report.
"However, limited information is available on the nature and timing of safety problems with their use," the authors write in this week's Journal of the American Medical Association.
Of the 174 biologicals, 136 were approved in the USA, 105 in the European Union and 67 in both. And 41 of the 174 were the subjects of a total of 82 safety-related regulatory actions, although none was withdrawn.
Regulatory actions included 46 different letters sent to U.S. doctors and 17 sent to European Union doctors about new safety concerns, and 19 "black box" warnings — the sternest kind — in the USA. Often, the safety problem was related to the product's effect on the immune system, which resulted in infections. For example, the arthritis and psoriasis biological Enbrel, approved in the USA in 1998, received a black box warning about a serious infection risk this past May.
On average, the regulatory action came about 3 years and 8½ months after the biological was approved. Seven out of 10 came within five years after approval. Biologicals that were the first of their kind were four times more likely to require a regulatory action than those that weren't.
The authors cautioned that "health-care providers should be aware of the specific risks related to the relatively new class of biologicals" so they can recognize links between treatments and patients' problems.
"The human body is in a constant state of change, and the effects of some drugs will manifest only after exposure over time," JAMA editor Catherine DeAngelis and executive deputy editor Phil Fontanarosa write in an accompanying editorial.
Yet, Fontanarosa noted Tuesday at a press briefing about this week's issue of JAMA, many post-market studies manufacturers agree to as a condition of FDA approval are either never completed or not completed in a timely manner.
News release derived from


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