Ask just about anyone if prescription drugs are safe to take because they receive approval from the US Food and Drug Administration (FDA) before hitting the market, and most Americans will assure you the FDA only approves drugs after they’ve been thoroughly tested and proven to be safe.  Unfortunately, this isn’t the case.  In fact, of every four FDA-approved drugs hitting US pharmacies between 1995 and mid-2007, one of them has proven to risk patient safety to the degree more safety studies are demanded.

The latest issue of the Journal of the American Medical Association (JAMA) carries the story of a Dutch study of prescription drug safety in the United States and the European Union (EU).  In both regions, a particular class of drugs, biologicals, is the focus of a high number of post-approval regulatory actions, including warning letters and strengthened label warnings.

Biologicals, first approved by the FDA in 1982, include all drugs in which an active substance is derived from a biological source.  It was recombinant insulin that won that first FDA approval as a biological drug.

During the time of study, January 1995 to June 2007, 136 approvals were awarded to 174 biologicals in the US.  Of those same 174 biologicals, 105 earned EU approval.

Within five years of approval by either government, 70% of all approved biologicals became the subject of further investigation when a preponderance of adverse side effects was identified.  In many cases, the threat to patient safety involved the effect of the drug on the immune system, leaving the patient vulnerable to life-threatening infections.  Most such drugs came under investigation when on the market less than four years.

Letters describing regulatory action were sent 46 times to doctors in the US and 17 times to doctors in the EU as a result of prescription biologicals.  Nineteen drugs marketed in the US  must now carry the black box warnings on prescription inserts.  These particular warnings, outlined by a big, bold black box, are the strongest warnings currently allowed on US prescriptions.

The authors of the JAMA article urge doctors to become well acquainted with the established links between patient risk and potential side effects of the medicines prescribed and to evaluate each patient on an individual basis.