Biological Drugs Not Without Risks

Study Charts Safety Issues Reported After Approval of Various Biological Drugs

Medically Reviewed by Louise Chang, MD on October 21, 2008

Oct. 21, 2008 -- Biological drugs, especially the pioneering ones, may have safety issues that come to light after the drugs' approval.

That's according to a new study, published in tomorrow's edition of The Journal of the American Medical Association.

In response to the study, a journal editorial points out that the FDA's resources for checking drug safety "do not include a crystal ball," and the pharmaceutical industry stresses the importance of reporting adverse reactions to any drug, whether it's biological or not.

Biological Drugs: Safety Study

The new study doesn't uncover new safety issues, and it doesn't focus on any specific biological drug or condition.

Instead, the study is about biological drug safety actions taken by the FDA and its European counterpart from January 1995 to June 2008.

During that time, U.S. and European regulators approved 174 biological drugs to treat a wide range of conditions. Most of those drugs didn't attract any safety-related regulatory action, and none was taken off the market.

But nearly a quarter of the biological drugs -- 41 out of 174 -- together 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.

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.

The first approved biological drugs in a class were more likely to draw regulatory action and should be monitored closely, note the researchers, who included Thijs Giezen, PharmD, of the Utrecht Institute for Pharmaceutical Sciences at Utrecht University in the Netherlands.

An editorial accompanying the study calls for improvements to the FDA's system of collecting reports of adverse drug reactions. The journal's editor in chief, Catherine DeAngelis, MD, MPH, and executive deputy editor, Phil Fontanarosa, MD, MBA, wrote the editorial.

Drug Industry Responds

WebMD contacted the Pharmaceutical Research and Manufacturers of America (PhRMA) for its response to the study and editorial.

Alan Goldhammer, PhD, PhRMA's vice president for scientific and regulatory affairs, tells WebMD that it "isn't 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," Goldhammer says. Because biological drugs work on complicated pathways in the body, he says, safety issues can occur if the drug "doesn't adequately control the pathway or does something that wasn't noticed in the clinical trials."

But that doesn't mean that biological drugs are riskier than nonbiological drugs, Goldhammer notes.

"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," Goldhammer says. "The key thing is to remain vigilant and track and promptly report adverse drug reactions so that labels can be updated, as appropriate."

Unlike the editorialists, Goldhammer says the FDA's current system for reporting adverse drug events "does work" and that the key is to improve reporting of adverse drug events.

Consumers and doctors can report adverse drug events to the FDA's MedWatch program.

Show Sources


Giezen, T. The Journal of the American Medical Association, Oct. 22/29, 2008; vol 300: pp 1887-1896.

DeAngelis, C. The Journal of the American Medical Association, Oct. 22/29, 2008; vol 300: pp 1939-1941.

Alan Goldhammer, PhD, vice president for scientific and regulatory affairs, Pharmaceutical Research and Manufacturers of America.

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