The Potential of Sudden Hearing Loss Prompts FDA Mandated Label Changes
Sudden hearing loss among people taking two separate classifications of drugs has prompted the Food and Drug Administration to require new label warnings. One class of drugs involves those taken for erectile dysfunction and the other is taken by people to treat a severe high blood pressure situation.
An FDA investigation into hearing loss followed on the heels of a report in the April issue of the Journal of Laryngology & Otology of a man experiencing the problem after taking Viagra®. The search into the FDA Adverse Events Reporting System turned up 29 cases that involved erectile dysfunction drugs or the drug Revatio® which is used for control of severe hypertension. In most cases, the hearing loss was accompanied by ringing in the ears, vertigo or dizziness. Usually, the hearing loss involved one ear and resulted in either a partial or complete loss of usual hearing. In approximately one third of the cases the event was temporary, but in the remainder, the hearing loss was ongoing.
Cialis®, Levitra® and Viagra® are the most common types of heavily advertised drugs aimed at helping men with erectile issues. The drug Revatio® is used to treat pulmonary arterial hypertension, a serious medical condition in which continuous high blood pressure in the arteries of the lungs weakens the heart muscle and often leads to heart failure and death, according to the FDA report.
“Because some level of hearing loss is usually associated with the aging process, patients taking these drugs may not think to talk to their doctor about it,” said Dr. Janet Woodcock, M.D., the FDA’s deputy commissioner for scientific and medical programs and acting director of its Center for Drug Evaluation and Research. The FDA instructions to Cialis, Levitra and Viagra users is to discontinue the drug and immediately seek medical attention if hearing problems develop. Revatio users are instructed to continue taking their medication, but they should contact their healthcare provider for further evaluation. Because Revatio is taken to treat a potentially life-threatening situation, the FDA does not recommend abruptly stopping usage if hearing loss occurs.
The strong relationship demonstrated between the use of these drugs and sudden hearing loss warrants revisions in product labeling, according to the FDA. In the future, Cialis, Levitra, Viagra and Revatio products will bear warnings regarding sudden hearing loss and the course of action to take if such an event happens.