Recently, the U.S. Food and Drug Administration issued a new regulation which requires drug manufacturers to cut their maximum dosages for popular sleep aids. The aim of the regulation is to decrease the lingering effects of sleeping pills, such as drowsiness and distraction, and to thereby reduce the occurrence of car accidents and related incidents.
The announcement of the new regulation has caused many to wonder about the liability of doctors, pharmacists and others that prescribe and provide these powerful medications. Can medical professionals be found guilty of medical malpractice when their patient takes a drug they prescribe, following the prescription instructions down to the last detail, and causes a harmful or even fatal car accident?
The new regulation covers only sleep aids containing the drug zolpiderm. Unfortunately, those medications, which include Ambien, Edluar, Intermezzo and Zolpomist, as well as generic versions, are some of the most-prescribed sleep aids in the U.S. Under current FDA regulations, the maximum dosage for women is 10 milligrams or 12.5 milligrams for extended-release formulations. The new regulation will effectively cut those maximum dosages in half.
Interestingly, only women will be affected by the new regulation, as a result of recent research which found that females metabolize zolpiderm much slower than men. Drug manufacturers are recommended, but not required, to lower the dosage limits for men.
It is not known whether the previous dosage limits led to any medical malpractice lawsuits, but it is certainly conceivable that they did. Any doctor or pharmacist that prescribes or provides a medication that is improper or harmful for a patient can be held liable for the results of the patient’s use of that medication. So if someone was prescribed a dosage that was too high, their medical provider could be held responsible even if the prescription was well within legal limits.
Source: Associated Press, “FDA requires lower doses for sleep medications,” Matthew Perrone, Jan. 10, 2013