Are you using biological drugs?

New generation drugs, known as biologicals because of their resemblance to naturally occurring proteins, are not necessarily safer than traditional chemical-based drugs, according to a new study.

Almost one in four biological medicinal products sold in Europe and the U.S. since 1995 have been cited at least once by regulatory authorities because of safety problems that arose within 10 years after they were approved to for sale on the market. Many of the safety warnings were issued within 5 years after going on the market.

The study, carried out by Dutch researchers at the University of Utrecht, was the first of its kind to conduct a comprehensive follow-up on these new generation drugs.

Biologicals are medicinal products in which the active substance is derived from biological material (such as antibodies, enzymes and hormones) extracted from a living source. They are a relatively new class of medicines that can trigger a response from the body’s immune system. Many of the products are genetically engineered.

The researchers noted that between January 1995 and June 2008, there were 174 biologicals approved in the U.S. and the E.U. (136 in the U.S. and 105 in Europe, but 67 products were approved in both regions). During the same period, regulatory authorities issued 82 safety-related warnings covering 41 products (23.6 percent)

These regulatory actions included 46 warnings of health hazards in the U.S., 17 in the E.U., and 19 warnings of serious health hazards. But none of these products were withdrawn from the market.

Majority of the citations (70.7 percent) were issued within the first 5 years after approval. The average time between introduction to the market and the regulatory action was 3.7 years.

Among the biological drugs mentioned in the report were Humira and Remicade (arthritis drugs), Rituxan and Erbitux (cancer drugs) and Natrecor (heart failure drug). Another drug, Raptiva, used for psoriasis treatment, received a warning last week from the U.S. Food and Drug Administration, because of its link to life-threatening infections and a type of brain illness.

The researchers said the findings underscore the need for regulatory authorities to keep close tabs on biological drugs after they are approved to go on the market. Drug approvals are based on small-scale studies involving patients with better health than the general population. On the other hand, all safety concerns about a drug cannot be discovered before they are marketed; it will take real-world conditions for all safety issues to appear.

Consumers should be aware that biological medicinal products can have many potential side effects that have not been discovered and therefore, not yet listed on the label.

Safety Tips:

* If you are taking biological drugs, make the extra effort to educate yourself about their risks. These drugs can be effective against difficult-to-treat diseases, but they may also carry substantial risks.