Dear Dr. Roach: Could you offer any general advice on how patients should weigh the risks versus benefits when they are prescribed a drug that lists many potentially serious side effects? I once had a specialist suggest that I do a trial of a drug for a noncardiac issue, but my cardiologist cautioned me not to chance it because both my heart status and age put me in a higher risk category for the specific drug.

So, I declined to use it, figuring the risk was too great. The drug in question was also very new to the market. This leads me to ask: Do recently approved drugs pose more of a risk simply because they haven’t been around long enough and used by enough patients to adequately know what their adverse effects will prove to be over time? — K.B.

Answer: It is true that we understand the safety profile of established drugs better than we understand the safety of brand-new drugs. Although any drug needs to be studied extensively before it can be approved by the Food and Drug Administration, it is also true that there are many instances where harms became known only after many people have taken the drugs for years. (Fen-phen and Vioxx are two examples.)

I generally avoid prescribing brand-new drugs until they have a bit of a track record, as long as there are tried-and-true alternatives. But I do have colleagues who are quick to use the newest one. There are certainly times when a new medicine is such an improvement over what exists that it is taken up right away by the medical field in general. There are also drugs that have been used for many years in other countries with a good safety record.

Asking your specialist is another good idea. Your cardiologist knows you, and although they might not know every new drug, they can look up the potential harms from the studies that got the drug approved and apply them to you.

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