FDA Announces Revisions to Labels for Cialis, Levitra and Viagra

Potential risk of sudden hearing loss with ED drugs to be displayed more prominently

The U.S. Food and Drug Administration has approved labeling changes for erectile dysfunction (ED) drugs in the class that includes Cialis, Levitra, and Viagra, 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.

In addition, the FDA plans to require the same changes in labeling for the drug Revatio, also a member of this drug class known as phosphodiesterase type 5 (PDE5) inhibitors. Revatio is used to treat pulmonary arterial hypertension (PAH). PAH is a serious medical condition in which continuous high blood pressure in arteries of the lungs weakens the heart muscle and often leads to right heart failure and death.

The FDA asked manufacturers of these drugs to revise product labeling after a very small number of patients taking the PDE5 inhibitors reported sudden hearing loss, sometimes accompanied by 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, 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.

A case report in the April 2007 issue of the Journal of Laryngology & Otology involving sudden hearing loss in a man taking Viagra prompted the FDA to search the FDA’s Adverse Events Reporting System for instances of hearing loss and PDE5 inhibitors. The FDA found a total of 29 postmarketing reports of sudden hearing loss, both with and without accompanying ringing in the ears, vertigo, or dizziness. In most of the cases, the hearing loss involved one ear. The hearing loss was either a partial or complete loss of usual hearing. In approximately one third of cases, the event was temporary. In the remainder, the hearing loss was ongoing at the time of the report or the final outcome was not described.

Although no causal relationship has been demonstrated, the strong relationship between the use of these drugs and sudden hearing loss in these cases warrants revisions to the product labeling for this drug class.

Product Web sites, marketing and educational materials, and advertisements for PDE5 inhibitors will reflect the revised product labeling.

Warning

Call your doctor or seek emergency treatment immediately if you experience any of the following symptoms:
Rash
Painful erection
Prolonged erection (longer than 4 hours)
Fainting
Chest pain
Itching or burning during urination

Stop taking these medications and call a doctor or health care provider right away if you experience sudden or decreased vision loss in one or both eyes. A rare vision problem called NAION has been reported by a few men using these drugs. NAION (nonarteritic anterior ischemic optic neuropathy) causes a sudden loss of eyesight because blood flow is blocked to the optic nerve. People who have a higher chance for NAION include those who:
Are over 50 years old
Smoke
Have heart disease
Have diabetes
Have high blood pressure
Have high cholesterol
Have certain eye problems
How Should These Drugs Be Stored?

These drugs should be kept in its original container and out of reach of children. Store them away from excess heat and moisture (not in the bathroom). Discard any medication that has expired or is no longer needed.

There are only three oral drugs approved by the FDA to treat erectile dysfunction: Cialis, Levitra, and Viagra. All work by increasing the flow of blood into the penis so that when a man is sexually stimulated, he can get an erection.
What Are the Differences Between Cialis, Levitra, and Viagra?

Cialis, Levitra, and Viagra work by a similar mechanism to cause erections. There are subtle differences in how long the drug works and how quickly it works. Levitra works a little longer than Viagra. They both take effect in about 30 minutes. With Levitra, the effects last for about 5 hours. With Viagra, the effects last approximately 4 hours.

Cialis works a bit faster (within about 15 minutes), and the effects last much longer — up to 36 hours in some cases.
If One of These Drugs Isn’t Effective for Erectile Dysfunction, Can I Try Another?

Yes, but because these drugs work the same way, it’s unlikely that you’ll have success with one if you’ve failed to achieve an adequate erection with another.
What Precautions Should I Take Before Taking One of These Drugs?

There are certain situations in which these drugs may not be safe to take. Before taking them, tell your doctor:
If you are allergic to any drugs, including Viagra or other ED medications.
About any prescription or nonprescription medications you are currently taking, including herbal and dietary supplements.
If you are scheduled for surgery, including dental surgery.
If you take nitroglycerin or a long-acting nitrate to treat chest pain. The combination of Cialis, Levitra or Viagra with these drugs can cause dangerously low blood pressure.
If you take alpha-blockers for blood pressure or prostate problems. The combination of Cialis or Levitra with these drugs can also cause dangerously low blood pressure.

In addition, always follow the directions on your prescription label carefully and ask your doctor or pharmacist to explain any part that you do not understand. Take these drugs exactly as directed. Do not take more or less or take it more often than prescribed by your doctor. Do not take these drugs more than once a day.
Who Should Not Take Cialis, Levitra or Viagra?

If you have suffered from a heart attack, stroke or life threatening arrhythmia (irregular heart rate) within the last 6 months you should discuss other options with your doctor. It is also advised to avoid these drugs if you have uncontrolled high or low blood pressure or if you experience chest pain with sex.
What Are the Side Effects of Cialis, Levitra and Viagra?

Side effects are not common but they can occur. Side effects can include:
Headache
Upset stomach or ‘heartburn’
Flushing (feeling warm)
Nasal congestion
Changes in vision (color, glare)
Back pain (with Cialis)

Call your doctor if you experience severe forms of these symptoms or if they do not go away after 4-8 hours.