The Food and Drug Administration may know all the risks associated with various pharmaceutical drugs, but chances are if you’re a consumer, you don’t. However, if several drug safety experts get their way that may change soon.
Several Dartmouth University researchers recently published an article in the New England Journal of Medicine, arguing that drug labels on prescription medications do not include enough of the information that FDA officials use to make their decision to approve a drug. The experts want this information included on drug labels because it could help patients weigh the benefits and risks of taking certain medications. Furthermore, the researchers say there’s a good reason why drug labels often exaggerate benefits and deemphasize risks: the drug makers are writing their own labels.
The FDA approval process is not as complicated as you may think: in fact, the FDA is required to approve a drug as long as the benefits of taking the drug outweigh the risks. However, as the Dartmouth researchers indicate, the benefits of a drug may be very minimal and potential harmful effects may not be fully understood. In one example, the researchers found that Lunesta, a prescription medication meant to help insomnia sufferers, did very little in helping patients get to sleep faster or sleep longer. Actually, in a clinical study, patients fell asleep only 15 minutes sooner than those taking a placebo and slept only 37 minutes longer. Furthermore, the researchers found similar results with a second drug. Zometa is a medication prescribed to cancer patients with brittle bones. The drug is meant to help reduce skeletal fractures and was approved by the FDA in 2001. However, the FDA found that the drug actually caused increased kidney damage and death when given in the higher dosage (8-mg). Essentially, a patient could still face other physical problems from taking a prescription medication to treat their primary symptoms. The researchers simply want reader-friendly summaries of FDA reviews of medications to supplement the pharmaceutical industry’s drug labels, so that consumers can make informed decisions prior to taking a pill.
