Of the St. Louis American
Labels for Cialis, Levitra and Viagra will soon carry more prominent warnings about the potential risk of sudden hearing loss to men taking the erectile dysfunction drugs.
The new labeling approved by the Food and Drug Administration and announced October 18 will also guide men on what to do if they experience sudden hearing problems.
The FDA plans to require the same changes in labeling for the blood pressure drug Revatio – a member of the same drug class which is used to treat pulmonary arterial hypertension.
The FDA asked manufacturers to revise the product labeling after a very small number of patients taking the PDE5 inhibitors reported sudden hearing loss, sometimes accompanied by dizziness and ringing of the ears.
“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, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer, and acting director of its Center for Drug Evaluation and Research.
Patients taking Cialis, Levitra or Viagra who experience sudden hearing loss should immediately stop taking the drug and seek prompt medical attention. Those using Revatio should continue taking their medication but should contact their health care provider for further evaluation. Because Revatio is used to treat a potentially life-threatening condition, the FDA does not recommend patients abruptly stop taking this medication but should consult their physician if they experience sudden problems with their hearing.