Previous research suggests the FDA’s approval of a drug does not necessarily ensure that a drug has a large or important benefit or that all serious adverse effects of the drug are known. Uncertainties about a drug are greatest in the first few years after approval and for drugs approved solely on the basis of a surrogate outcome, researchers said.
In an Internet-based, randomized, controlled trial of nearly 3,000 participants, researchers found 25 percent of participants mistakenly believed the FDA approves only drugs without serious side effects. Results also showed more than one-third mistakenly believed that the FDA approves only “extremely effective” drugs.
Researchers recommended that physicians provide a brief and simple explanation about the known benefits and harms of a drug and that the FDA more effectively communicate what it knows and does not know about a drug’s effectiveness.
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