Drug Safety Experts Warn FDA is Approving Risky Drugs

September 7, 2012 — The Journal of the American Medical Association has published a study from two drug safety experts who are warning that the U.S. Food and Drug Administration (FDA) is expediting the approval of new drugs without proper safety analysis. The experts specifically cited Pradaxa, Gilenya, and Caprelsa as examples. They warned that in 2011, 46% of drugs were expedited through the approval process. This could potentially lead to the approval of new drugs with unknown risk-benefit profile when there are already drugs on the market with well-known safety.

The experts who wrote the report are Thomas J. Moore and Dr. Curt D. Furberg. Mr. Moore is the director of QuarterWatch, a drug-safety publication, and he has also written two books on drug safety. Dr. Furberg is a professor of medicine at Wake Forest University and a researcher.

The FDA has implemented a program for expediting the approval of promising new drugs, known officially as the “Expedited Drug Development Pathway.” Dr. Furberg and Mr. Moore 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.”

The program is being implemented by FDA Commissioner Margaret A. Hamburg and Janet Woodcock, who is the FDA’s direct for drug evaluation and review. Under their watch, the FDA has approved 35 new drugs, 16 of which underwent some type of expedited approval process.

Although there are benefits to getting safe drugs on the market quickly, Dr. Furberg and Mr. Moore are concerned that the FDA is approving new drugs without requiring adequate safety data. Other experts are concerned that once a drug is approved, the FDA rarely issues a recall. The FDA sometimes asks manufacturers to conduct additional safety studies, but these can take many years. By the time studies are complete, thousands and sometimes millions of people have used the medication.

Dr. Furberg and Mr. Moore cited safety issues with three drugs that underwent expedited approval:

• Gilenya (fingolimod), a treatment for Multiple Sclerosis (MS) that has been linked to an increased risk of severe cardiovascular disorders. The FDA has recently requested that the manufacturer conduct 10 additional safety studies.
• Pradaxa (dabigatran), an anti-clotting medication used to reduce the risk of stroke in people with atrial fibrillation. The manufacturer of Pradaxa is facing dozens of lawsuits from people who were seriously injured by the medication. It is associated with a risk of bleeding, which is common among blood-thinning medications — but unlike other blood-thinners (like warfarin), the anti-clotting effects of Pradaxa cannot be easily reversed.
• Caprelsa (vandetanib) is a cancer treatment that is usually given to people with thyroid cancer. The FDA approved Caprelsa based on one safety study involving 331 people with late-stage thyroid cancer. The drug is very toxic, and although it improved the patients’ end point of progression-free survival, the overall survival was no different than a placebo. Caprelsa can cause severe heart problems, including sudden death.

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