Pharmacovigilance: Biological Medicines get safety warnings

Biologics are an important and growing part of today’s medicine. Between 2003 and 2006, they represented almost a quarter of the drugs approved by U.S. and European Union regulatory authorities. As per a significant safety report analysis, about a quarter of biological medicines approved in the United States and Europe since 1995 have triggered safety warnings in the years after entering the market. This was found out by Dutch researchers.

Immune system disorders, infusion reactions, infections and cancer concerns were among the reasons for safety warnings for biological medicines, which are made with proteins derived from living cells rather than the chemicals used in typical drugs. Such safety-related actions typically involve a company placing a warning on a drug’s prescribing instructions describing potential harm from using it.  These might drop the sales of the medicines also.

These medicines, called biologics, are typically injected and treat a range of conditions including anemia, rheumatoid arthritis, hepatitis and cancer. Thijs Giezen of Utrecht University in the Netherlands and colleagues tracked safety-related regulatory actions involving 174 biological medicines approved in the United States or the European Union between January 1995 and June 2007. As of June, regulatory actions were taken involving 41 of the medicines, which accounts about 24 percent of the total, the researchers wrote in the Journal of the American Medical Association.

Examples of drugs that drew safety warnings include Genentech Inc’s cancer drug Herceptin due to a heart inflammation called cardiomyopathy and lung problems. Schering-Plough Corp’s arthritis treatment Remicade carries a warning due to increased risk of infections and rare cases of a type of lymphoma. And ImClone Systems Inc’s cancer drug Erbitux carries a warning due to serious and sometimes fatal reactions in about 3 percent of patients. Genentech’s psoriasis drug Raptiva, saying patients given the once-weekly injections are at risk for life-threatening infections.

Post Marketing Surveillance average time for a safety-related regulatory action was about 3 1/2 years after approval, and 71 percent occurred within five years of approval, the researchers said. The post-marketing surveillance is a very important tool to further characterize the safety profile of drugs, said the researchers