Published in The Journal of the American Medical Association, the study doesn’t uncover new safety issues nor does it focus on any specific biological drug or condition. It is about biological drug safety actions taken by the FDA and its European counterpart from January 1995 to June 2008, which approved 174 biological drugs to treat a wide range of conditions. Many of those drugs did not attract any safety-related regulatory action, and none was taken off the market.
However, 41 out of the 174 biological drugs had 82 safety-related regulatory actions: 46 letters from the FDA to U.S. doctors, 17 letters from European regulators to doctors in Europe, and 19 “black box” warnings (the FDA’s sternest warning).
Catherine DeAngelis, MD, MPH, and executive deputy editor, Phil Fontanarosa, MD, MBA, wrote an editorial in response to the study calling for improvements to the FDA’s system of collecting reports of adverse drug reactions. DeAngelis pointed out that the FDA’s resources for checking drug safety “do not include a crystal ball.”
On the other hand, Alan Goldhammer, PhD, vice president for scientific and regulatory affairs of PhRMA (Pharmaceutical Research and Manufacturers of America), stresses the importance of reporting adverse reactions to any drug, whether it’s biological or not.
According to Goldhammer, it’s not surprising that safety issues sometimes come up once a drug goes on the market. “The clinical trials never capture all of the safety or, for that matter, efficacy value of a given drug,” he said.
Since biological drugs work on complicated pathways in the body, Goldhammer said that safety issues can occur if the drug “doesn’t adequately control the pathway or does something that wasn’t noticed in the clinical trials.”
Also, Goldhammer pointed out that it doesn’t make biological drugs to be riskier than nonbiological drugs.
“It’s not fair to say that any drug is riskier than another because we really don’t know at the time of approval what all is going to be found out once drugs are given to a much broader and larger number of people when approved for marketing,” said Goldhammer. “The key thing is to remain vigilant and track and promptly report adverse drug reactions so that labels can be updated, as appropriate.”
Biological drugs are made from living organisms or its products and are used in the prevention, diagnosis, or treatment of cancer and other diseases. Also known as biologic or biological agent, biological drugs include antibodies, interleukins, and vaccines.
Many biological drugs work on the immune system, and immune system problems (such as greater infection risk) were the most common safety issues that drew regulatory action.
Mark Walters is a part-time writer and a part-time researcher. He is currently self-studying various Far Eastern languages and is an avid fiction reader. He is currently writing articles oriented towards consumers of pharmaceutical products.
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