FDA Drug Safety Warnings

The next issue of The Medical Letter will include an article on an FDA warning about the risk of QT prolongation and cardiac arrhythmias with the SSRI antidepressant citalopram (Celexa). The warning, which was based on case reports sent to the agency and on an unpublished study of QT prolongation with various doses of citalopram, included recommendations to restrict the types of patients who could use the drug and limit the maximum doses they could take.

What are the consequences of recommendations like these? One consequence is that every physician who prescribes citalopram for patients who have one of the conditions that the FDA said would increase the risk, or for any patient in doses higher than the newly recommended maximum, does so at his or her peril of a malpractice suit. A related consequence is that patients taking the drug who have one of the newly forbidden conditions, or are taking doses higher than now recommended by the FDA, and are doing well, may lose an effective treatment for their depression.

What is the quality of recommendations like these? If a pharmaceutical manufacturer submitted an application for approval of a new drug to the FDA and based it on evidence like this, the application would not be successful, to say the least. If The Medical Letter reviewed a new drug and detected that claims for the drug were made on the basis of uncontrolled case reports and unpublished data lacking almost all of the usual details, we would find it difficult to be kind.

So what is the FDA to do when this sort of information becomes available to the agency? They will be damned if they do and damned if they don’t publish a warning. The medical malpractice situation is not their fault. So they publish and include all the caveats they can think of to protect patients who are doing well on the drug and their prescribers.

Now what is the poor practitioner to do? We cannot say; all we can do is offer a careful evaluation of the evidence.  And that will be in the next issue of The Medical Letter.

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