FDA strengthens hearing loss warning for erectile dysfunction drugs

NEWS IN BRIEF — Posted Nov. 26, 2007

Print  |   Email  |   Respond  |   Reprints  |   Like Facebook  |   Share Twitter  |   Tweet Linkedin

An alert about the risk of hearing damage associated with the use of phosphodiesterase type 5 inhibitor medications is being made more prominent on these drugs' labels, under changes approved last month by the Food and Drug Administration. Instructions for patients on what to do if this problem develops also have been added, the agency announced.

The possibility of hearing loss has long been on the label, but the FDA asked drug manufacturers to make these changes because it received 29 postmarket reports of this adverse event after patients took sildenafil (Viagra and Revatio), tadalafil (Cialis), and vardenafil (Levitra). There also have been case reports published in the scientific literature. Most instances involved hearing loss in one ear. One-third of cases resolved quickly.

A causal relationship has yet to be demonstrated, but patients taking these drugs for erectile dysfunction who start having problems hearing are being advised to stop using them and see their doctor. Patients prescribed the medications for pulmonary hypertension should not discontinue them but also are being told to seek prompt medical attention.

"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, the agency's deputy commissioner for scientific and medical programs.

Note: This item originally appeared at

Back to top



Read story

Confronting bias against obese patients

Medical educators are starting to raise awareness about how weight-related stigma can impair patient-physician communication and the treatment of obesity. Read story

Read story


American Medical News is ceasing publication after 55 years of serving physicians by keeping them informed of their rapidly changing profession. Read story

Read story

Policing medical practice employees after work

Doctors can try to regulate staff actions outside the office, but they must watch what they try to stamp out and how they do it. Read story

Read story

Diabetes prevention: Set on a course for lifestyle change

The YMCA's evidence-based program is helping prediabetic patients eat right, get active and lose weight. Read story

Read story

Medicaid's muddled preventive care picture

The health system reform law promises no-cost coverage of a lengthy list of screenings and other prevention services, but some beneficiaries still might miss out. Read story

Read story

How to get tax breaks for your medical practice

Federal, state and local governments offer doctors incentives because practices are recognized as economic engines. But physicians must know how and where to find them. Read story

Read story

Advance pay ACOs: A down payment on Medicare's future

Accountable care organizations that pay doctors up-front bring practice improvements, but it's unclear yet if program actuaries will see a return on investment. Read story

Read story

Physician liability: Your team, your legal risk

When health care team members drop the ball, it's often doctors who end up in court. How can physicians improve such care and avoid risks? Read story

  • Stay informed
  • Twitter
  • Facebook
  • RSS
  • LinkedIn