Almost a quarter of biological medications approved for everything from anemia to rheumatoid arthritis to hepatitis to cancer since 1995 have triggered safety warnings after entering the market, a new study has found.
The study, published in the Journal of the American Medical Association, says closer monitoring of such medicines is needed.
"Health care professionals should be aware of the specific risks related to the relatively new class of biologicals to be able to provide a link between the use of the biological and the patient presenting with a clinical problem."
The study, led by Thijs Giezen of Utrecht University in the Netherlands, looked at 174 biological medicines approved in the US or the European Union between January 1995 and June 2007. As of June, regulatory actions were taken involving 41, or 24 per cent, of the medicines, including:
- Genentech Inc's cancer drug Herceptin due to a heart inflammation called cardiomyopathy and lung problems
- Schering-Plough Corp's arthritis treatment Remicade due to increased risk of infections and rare cases of a type of lymphoma
- ImClone Systems Inc's cancer drug Erbitux due to serious and sometimes fatal reactions in about three per cent of patients
Just last week, the U.S. Food and Drug Administration ordered warnings for Genentech's psoriasis drug Raptiva, saying patients given the once-weekly injections are at risk for life-threatening infections.
Chemical-based drugs also periodically draw safety warnings from regulators but there is no recent similar data to compare the rates, the researchers said.