Drugs given Fast Track review by the US Food and Drug Administration (FDA) may have higher health risks and more side effects, argue two authors last week (September 5) in the Journal of the American Medical Association (JAMA).
In 2011, the FDA expedited approval for nearly half of all 35 new drugs it reviewed. Many of the drugs chosen for the Fast Track process are aimed at treating ailments with unmet medical needs, such as certain types of cancer and multiple sclerosis. In their article, the JAMA authors focus on three drugs—vandetanib, fingolimod, and dabigatran—that were approved despite serious toxicity and concerns regarding safe dosing. As an example, the blood thinner dabigatran (also called Pradaxa) was approved for lowering the risk of stroke in patients with irregular heart beat. However, within less than a year, “Pradaxa accounted for more serious adverse drug events reported to the FDA during the second quarter of 2011 than any other regularly monitored drug,” mostly for increasing risk of uncontrolled bleeding in older patients, wrote the authors (one of whom is consulting for patients who have entered litigation for the side effects of dabigatran).
But safety is not an absolute measure, as drugs for illnesses such as cancer are permitted to have harsher side effects than preventative measures like vaccines. "Making regulatory decisions about drugs always involves uncertainty and risk," an FDA spokesperson told Ed Silverman at Pharmalot Blog. “FDA works directly with the affected patient populations and treating physicians when considering just how much uncertainty and risk are reasonable to accept.”
(Hat tip to GenomeWeb.)