Many biological medicines draw safety warnings

By Will Dunham

WASHINGTON (Reuters) - 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, Dutch researchers said on Tuesday.

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.

These medicines, called biologics or biologicals, 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.

Some biologics, including vaccines, were excluded.

As of June, regulatory actions were taken involving 41 of the medicines, or 24 percent of the total, the researchers wrote in the Journal of the American Medical Association.

Such safety-related actions typically involve a company placing a warning on a drug’s prescribing instructions describing potential harm from using it. Sometimes warnings reduce a drug’s sales.

Chemical-based drugs also periodically draw safety warnings from regulators but there is no recent similar data to compare the rates, the researchers said.  Continued…


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