September 7, 2012 — Drug safety experts published an article in the Journal of the American Medical Association warning that the FDA is fast-tracking the approval of medications without proper safety analysis — specifically citing Pradaxa, Gilenya, and Caprelsa. They found that 46% of drugs approved by the FDA last year underwent an accelerated approval process, leading to the approval of new drugs with unknown safety profiles when there are already effective drugs on the market with well-known safety profiles.
The authors of the report were Thomas J. Moore and Dr. Curt D. Furberg. Mr. Moore has written two books on drug safety and is director of QuarterWatch, a drug safety publication. Dr. Furberg is a researcher and professor of medicine at Wake Forest University.
They wrote, “Although enabling new drugs with a favorable benefit-to-harm balance to become available to patients more rapidly is a laudable goal, the underlying question is what public health risks are taken when drugs are approved for widespread use while important safety questions remain unanswered.”
FDA Commissioner Margaret A. Hamburg and Janet Woodcock, director of the FDA’s center for drug evaluation and review, have worked to accelerate the FDA’s drug approval process. In 2011, the FDA approved 35 new medicines, and 16 of these had expedited approval.
Some experts have criticized this process, saying that the FDA does not require companies to produce enough safety data. Once a drug is approved, the FDA rarely forces recalls. It can take many years before studies are complete, after thousands or millions of people have already used the medication.
Dr. Furberg and Mr. Moore cited safety issues with the following drugs that were fast-tracked through the FDA’s approval process:
- Gilenya (fingolimod), which is a Multiple Sclerosis (MS) drug that has been linked to heart problems. The FDA has asked the drug’s manufacturers to conduct ten additional safety studies.
- Pradaxa (dabigatran), an anti-clotting drug that has been linked to severe bleeding risks and lack of reversal agent. The researchers noted that Pradaxa is easier to use than its alternative, Coumadin (warfarin). However, both Pradaxa and warfarin are associated with bleeding, but bleeding in Pradaxa patients “may be more difficult to treat than warfarin-related bleeding.”
- Caprelsa (vandetanib) is an anti-cancer drug usually used for thyroid cancer. The drug was approved after a single trial of 331 patients with late-stage thyroid cancer. Although the drug improved the end point of progression-free survival, the drug was so toxic that overall survival was no different than a placebo. The drug was associated with severe cardiovascular disorders, including sudden death.
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