A Fourth of Biological Drugs Subject to Safety Notices After Approval

In the past few years, biological drugs, such as the MS treatment <"http://www.yourlawyer.com/topics/overview/tysabri">Tysabri, the arthritis drugs Humira and Remicade, and the cancer drugs Rituxan and Erbitux, have been plagued by safety worries.  According to a new report, a quarter of all biological drugs have been the subject of new safety warnings shortly after they were put on the market.

Biological drugs 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.  Such drugs affect the body’s immune system, and relieve symptoms by suppressing that system.

Many had once thought that that biological drugs might be safer than traditional chemical-based medicines. A new study conducted by Dutch researchers, and published in The Journal of the American Medical Association, shows that assumption to be wrong. The study examines biological drug safety actions taken by the FDA and its European counterpart from January 1995 to June 2008.  In that time period, US and European regulators approved 174 biological drugs to treat a wide range of conditions.

According to the study, a quarter of those drugs — 41 out of 174 — together had 82 safety-related regulatory actions: 46 letters from the FDA to US doctors, 17 letters from European regulators to doctors in Europe, and 19 “black box” warnings — the FDA’s sternest warning. Researchers found that most of the warnings came within five years of a drug’s approval.

Many biological drugs have been linked to opportunistic infections and other disorders associated with a suppressed immune system.   For instance, just this week, the psoriasis drug Raptiva received a new black box warning because of its link to progressive multifocal leukoencephalopathy, or PML, a serious, often fatal brain infection.  Other biological drugs linked to PML include Tysabri, and Rituxan.

Humira, Remicade, Enbrel and Cimizia have all been associated with opportunistic fungal infections, as well as leukemia, lymphoma and other cancers in children and young adults.  Enbrel has also been linked to deadly infections, including tuberculosis.

The researcher who conducted the study say their findings indicate that biological drugs need to be subject to greater scrutiny.  An editorial accompanying the study calls for improvements to the FDA’s system of collecting reports of adverse drug reactions.

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