Another new drug found to have severe adverse effects years after FDA approval

A trial presented recently at the American College of Cardiology found that a novel medication for preventing gout increased both cardiovascular and all cause deaths compared to an older medication.

One of the principles of good medicine is to weigh benefits, risks, alternatives and unknowns when making any medical decision. In a post in June we discussed that many medications approved by the FDA are found to have serious problems years after heir initial testing.

Some of my colleagues and I like to call the first several years of initial use of a newly approved drug the phase 5 trial. That means it continues to be tested by trial and error, as opposed to with the rigorous testing before approval.

Because of the unknowns, we like to save novel medications for use only when there are no alternatives. That way we gain experience when the benefits are stronger than the unknown risks.

Make sure you ask your doctor about the alternatives, risks, and unknown risks of any new drug they prescribe. Although they may think they are using a better drug for you, you may prefer to wait until it has finished its phase 5 trial before you submit to taking it. Especially, as in the case of this new drug, there is a very good alternative.