FROM CONSUMERAFFAIRS.COM

Insulin and other “homegrown” meds not as safe as you think

A study in the October 22/29 issue of the Journal of the American Medical Association (JAMA) finds that roughly 25 percent of biological medicinal products–things like antibodies, enzymes and insulin–approved since 1995 in the U.S. and Europe have had at least one safety-related regulatory action issued for them 10 years after their approval, including about 11 percent receiving a “black box” warning.

Biologicals are preparations in which the active substance is produced by or extracted from a biological source, such as antibodies, enzymes and hormones. They represent an important and growing part of medical therapies, with more than 250 biologicals having been approved since 1982.

“Between 2003 and 2006, biologicals represented 24 percent and 22 percent of all new chemical entities approved by the U.S. and EU regulatory authorities, respectively,” the authors write. “Biologicals are a relatively new class of medicines that carry specific risks. However, limited information is available on the nature and timing of safety problems with their use that were identified after approval.”

FOR THE COMPLETE STORY:    http://www.consumeraffairs.com/news04/2008/10/biological_medicines.html

~Sandy G.