An FDA statement said the goal was "to display more prominently the potential risk of sudden hearing loss, and to guide consumers on what to do if they experience sudden problems with their hearing."
Revatio, used to treat pulmonary hypertension, also will get the same labelling changes, the FDA said.
The warnings followed what the administration called "a very small number" of patients reporting hearing loss and at times ringing in the ears and dizziness.
"Because some level of hearing loss is usually associated with the aging process, patients on these drugs may not think to talk to their doctor about it," said Janet Woodcock, MD, FDA deputy commissioner for scientific and medical programs, chief medical officer, and acting director of its Center for Drug Evaluation and Research.
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