Patient Information Sheet

Sildenafil citrate (marketed as Viagra)

The issue described in the Alert has been addressed in product labeling; please see Drugs@FDA

This is a summary of the most important information about Viagra. For details, talk to your healthcare professional.

FDA ALERT [7/2005]: A small number of men have lost eyesight in one eye some time after taking Viagra, Cialis, or Levitra. This type of vision loss is called non-arteritic anterior ischemic optic neuropathy (NAION). NAION causes a sudden loss of eyesight because blood flow is blocked to the optic nerve.

We do not know at this time if Viagra, Cialis, or Levitra causes NAION. NAION also happens in men who do not take these medicines. People who have a higher chance for NAION include those who:

• have heart disease
• are over 50 years old
• have diabetes
• have high blood pressure
• have high cholesterol
• smoke
• have certain eye problems

FDA has approved new labels for Viagra, Cialis, and Levitra to include information on possible eyesight loss (NAION).

Stop using Viagra, Cialis, or Levitra if you have a loss in your eyesight. Get medical help right away.

This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.

What is Viagra?

Viagra is a prescription medicine taken by mouth for the treatment of erectile dysfunction (ED) in men. ED is a condition where the penis does not harden and expand when a man is sexually excited, or when he cannot keep an erection. Viagra may help a man with ED get and keep an erection when he is sexually excited. Viagra must be used only under a doctor's care.

Viagra does not:

• cure ED
• increase a man's sexual desire
• protect a man or his partner from sexually transmitted diseases, including HIV. Speak to your healthcare professional about ways to guard against sexually transmitted diseases.
• serve as a male form of birth control

Viagra is only for men with ED. Viagra is not for women or children. Viagra must be used only under a healthcare professional's care.

Who Should Not Take Viagra?

Do not take Viagra if you:

• take any medicines called "nitrates"
• use recreational drugs called "poppers" like amyl nitrate and butyl nitrate
• have been told by your healthcare professional to not have sexual activity because of health problems

What are The Risks?

The following are the major possible risks and side effects of Viagra therapy. This list is not complete.

Viagra can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines such as nitrates and alpha-blockers, and recreational drugs that contain nitrates called "poppers". A sudden drop in your blood pressure could cause you to become dizzy, faint, or have a heart attack or stroke.

Tell all your healthcare professionals that you take Viagra. If you need emergency medical care for a heart problem, it will be important for your healthcare professionals to know when you last took Viagra.

Viagra may uncommonly cause:

• an erection that won't go away (priapism)
• vision changes, such as seeing a blue tinge to objects or having difficulty telling the difference between the colors blue and green

Some common side effects with Viagra include:

• headache
• flushing
• upset stomach
• stuffy or runny nose
• urinary tract infection
• diarrhea

What Should I Tell My Healthcare Professional?

Tell your healthcare professional if you:

• have or had heart problems
• have low blood pressure or have high blood pressure that is not controlled
• have had a stroke
• have liver problems
• have ever had severe vision loss
• have kidney problems or require dialysis
• have retinitis pigmentosa, a rare genetic (runs in families) eye disease
• have stomach ulcers
• have a bleeding problem
• have a deformed penis shape or Peyronie's disease
• have had an erection that lasted more than 4 hours
• have blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia
• are taking a medicine called a protease inhibitor for the treatment of HIV
• are taking medicines called alpha blockers (alpha blockers are sometimes prescribed for prostate problems or high blood pressure)

Can Other Medicines or Food Affect Viagra?

Viagra and certain other medicines can interact with each other. Tell your healthcare professional about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them with you to show your healthcare professional.

Date created: July 8, 2005, updated October 2, 2007

FDA Updates Labeling for Viagra, Cialis and Levitra for Rare Post-Marketing Reports of Eye Problems

The Food and Drug Administration today approved updated labeling for Cialis, Levitra and Viagra to reflect a small number of post-marketing reports of sudden vision loss, attributed to NAION (non arteritic ischemic optic neuropathy), a condition where blood flow is blocked to the optic nerve.

FDA advises patients to stop taking these medicines, and call a doctor or healthcare provider right away if they experience sudden or decreased vision loss in one or both eyes. Further, patients taking or considering taking these products should inform their health care professionals if they have ever had severe loss of vision, which might reflect a prior episode of NAION. Such patients are at an increased risk of developing NAION again.

At this time, it is not possible to determine whether these oral medicines for erectile dysfunction were the cause of the loss of eyesight or whether the problem is related to other factors such as high blood pressure or diabetes, or to a combination of these problems. The new labeling information is available along with additional information for healthcare providers and consumers online at:

Viagra (http://www.fda.gov/cder/consumerinfo/viagra/vIAGRA.htm)

Levitra (http://www.fda.gov/cder/drug/infopage/vardenafil/default.htm)

Cialis (http://www.fda.gov/cder/drug/infopage/cialis/default.htm)

1. What is FDA announcing today?
   
   FDA has approved labeling changes for the phosphodiesterase Type 5 (PDE5) inhibitor class of erectile dysfunction (ED) drugs, Cialis, Levitra, and Viagra.  In addition, FDA plans to revise the labeling for the pulmonary arterial hypertension (PAH) drug Revatio.  This change is being implemented to display more prominently the potential risk of sudden hearing loss.  FDA plans to issue a Healthcare Professional Sheet that will provide additional information about this potential risk.
   
   
2. Why is FDA making this announcement?
   
   The FDA is making this announcement as part of its ongoing commitment to inform consumers of emerging health issues with marketed drugs.  The Agency believes that by making this announcement it will better inform consumers taking these drugs of this possible risk and guide them on what to do if they experience sudden problems with their hearing.
   
   
3. What prompted FDA to request these labeling changes?
   
   A case report in the published literature of sudden hearing loss in a male patient taking Viagra prompted FDA to search the Adverse Event Reporting System (AERS) for postmarketing reports of hearing impairment for all PDE5 inhibitors. FDA found a total of 29 reports of sudden hearing loss, both with and without accompanying vestibular symptoms (tinnitus, vertigo or dizziness), in strong temporal relationship to dosing with Viagra (sildenafil), Cialis (tadalafil) or Levitra (vardenadil).  Hearing loss was also reported in a few patients in clinical trials of these drugs.  There have also been cases of hearing loss reported in patients using Revatio (sildenafil) for the treatment of pulmonary arterial hypertension (PAH).  Though no causal relationship has been demonstrated, FDA believed that the strong temporal relationship between the use of PDE5 inhibitors and sudden hearing loss in these cases warranted revisions to the product labeling for the drug class.
   
   
4. Who is more likely to be at-risk for this possible side effect?
   
   The available information is not sufficient to determine if any type of patient is more likely to be at-risk for this possible side effect.
   
   
5. Is age a factor in being predisposed to hearing loss or to sudden hearing loss?
   
   Hearing loss is very commonly reported in an aging population, especially in patients with risk factors for erectile dysfunction.  However, sudden hearing loss is an uncommon event at any age.  It is not known whether age was a factor in the cases of sudden hearing loss reported in temporal relation to use of the PDE5 inhibitors.
   
   
6. Is this side effect permanent or temporary?
   
   In approximately one third of the 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.  In almost all cases, the hearing loss was one-sided.
   
   
7. What are the warning signs?
   
   There were no predictable warning signs for sudden hearing loss in the reported cases.
   
   
8. What should I do if I experience sudden hearing loss?
   
   Patients taking Revatio for the treatment of pulmonary arterial hypertension who experience sudden changes in their hearing should promptly contact their health care provider for further evaluation. However, patients taking Cialis, Levitra or Viagra for the treatment of ED who experience sudden hearing loss should immediately stop taking the drug and also seek prompt medical attention.
   
   
9. Are there other hearing-related side effects that I need to be on the look out for?
   
   In some cases, sudden hearing loss was accompanied by ringing in the ears and dizziness.
   
   
10. What dosage level puts me at greatest risk for this possible side effect?
    
    The available information is not sufficient to determine if any dosage level puts a patient at greater risk for this possible side effect.
    
    
11. Is there an alternative drug for my erectile dysfunction that doesn't have this possible side effect?
    
    The possible side effect of sudden hearing loss has been reported for all of the PDE5 inhibitors.  You should discuss other treatment options for ED with your healthcare provider.
    
    
12. Is it safe to take these drugs without putting myself at risk for this possible serious side effect?
    
    PDE5 inhibitors are safe and effective for the treatment of ED when taken according to the labeling.  However, all drugs carry risks and you should discuss any concerns you have regarding taking these products with your healthcare provider

FDA News: FDA Announces Revisions to Labels for Cialis, Levitra and Viagra: Potential risk of sudden hearing loss with ED drugs to be displayed more prominently

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. The label revisions can be viewed at: www.fda.gov/cder/drug/DrugSafety/DrugIndex.htm.

For more information:
http://www.fda.gov/cder/drug/infopage/ed_drugs/QA.htm

Information for Healthcare Professionals
Sildenafil (marketed as Viagra and Revatio) Vardenafil (marketed as Levitra) Tadalafil (marketed as Cialis)

FDA SUMMARY [11/2007]:  FDA has received reports of cases of sudden decreases or loss of hearing following the use of PDE5 inhibitors, Viagra, Levitra, and Cialis for the treatment of erectile dysfunction and Revatio for the treatment of pulmonary arterial hypertension.  In some cases, the sudden hearing loss was accompanied by tinnitus and dizziness.  Medical follow-up information was often limited for the cases reported postmarketing, which makes it difficult to determine whether these reports are directly related to the use of one of these drugs, an underlying medical condition, or other risk factors for hearing loss, a combination of these factors, or other factors. Sudden hearing loss was also reported in a few patients in clinical trials of these drugs.  In response to a request from FDA, the manufacturers of Viagra, Levitra and Cialis have revised the labeling for these products to address the potential risk of sudden hearing loss and to guide patients on what to do if they experience sudden problems with their hearing. FDA is currently working with the sponsor to revise the labeling for Revatio. The approved revised labeling for Viagra, Levitra and Cialis includes a new Precaution and updated Adverse Reactions sections.  The revised labeling is available at Drugs@FDA.

This information reflects FDA’s current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.

Report serious adverse events to FDA’s MedWatch reporting system by completing a form on line at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) by mail using the postage-paid address form provided online (5600 Fishers Lane, Rockville, MD 20852-9787),or by telephone (1-800-FDA-1088).

Background

Following the publication of a report in the Journal of Laryngology and Otology (April 2007), FDA conducted a search of its adverse event reporting system for cases of hearing loss in patients taking phosphodiesterase type 5 (PDE5) inhibitors.  Twenty-nine postmarketing reports of sudden hearing loss defined as new hearing loss occurring over a period of 3 days or less following the last dose, both with and without tinnitus and dizziness, were identified.  Sudden hearing loss was also reported in a few patients in clinical trials of these drugs. The labeling for Viagra, Levitra and Cialis  was revised to address this new safety information.  Revatio is sildenafil citrate marketed for treatment of pulmonary arterial hypertension (PAH) and FDA is working with the sponsor to revise labeling for this drug.

Recommendations

For Pulmonary Arterial Hypertension

• Physicians should advise their patients with pulmonary arterial hypertension (PAH) who experience sudden hearing loss while taking Revatio to seek prompt medical attention.
• Patients should be told NOT to discontinue treatment without consulting their physician. 
• Physicians should explain to their patients that pulmonary arterial hypertension is a life-threatening condition and there is a risk of decompensation of their pulmonary arterial hypertension if they stop taking Revatio and are not provided with other treatment options.

For Erectile Dysfunction

• Physicians who prescribe Viagra, Levitra or Cialis for erectile dysfunction should advise their patients to immediately stop taking the drug if they experience any sudden decrease or loss of hearing and seek prompt medical attention.

Information for the Patient

Patients with Pulmonary Arterial Hypertension should :

• NOT stop taking Revatio if you experience any sudden decrease or loss of hearing.
• Seek prompt medical attention; call your healthcare provider

Patients with Erectile Dysfunction should :

• Immediately stop taking the drug if you experience any sudden decrease or loss of hearing
• Seek prompt medical attention

Data Summary

FDA’s analysis included all cases of hearing loss or impairment reported in clinical trials and in the post marketing setting for each of the products Viagra (sildenafil citrate); Levitra (vardenafil HCl); Cialis (tadalafil) and Revatio.  Sildenafil use by patients with pulmonary arterial hypertension is both continuous and at a higher dose than for men taking sildenafil intermittently for erectile dysfunction.

From the postmarketing reports, we identified a total of 29 cases of sudden hearing loss that showed a temporal relationship to dosing with a PDE5 inhibitor. Sudden hearing loss was also reported in a few patients in clinical trials of these drugs.  In many cases, medical conditions and other factors may have contributed to the adverse event.

Clinical trials:

A total of 5 sildenafil treated patients, of the approximately 25,000 sildenafil-treated patients from all clinical studies combined, experienced sudden hearing loss in temporal relation to dosing.

Post-marketing reports:

Fifteen of the postmarketing cases of sudden hearing loss had a temporal relationship and occurred in men ranging in age from 44 to 85. In 5 of the 15 cases, sudden hearing loss occurred after the first dose.   Nine of the 15 cases were unilateral, one was bilateral and 5 did not specify.  Sudden hearing loss was temporary (lasting 24 hrs to 2 weeks) in 4 of the 15 cases. In 8 cases, the sudden hearing loss was ongoing, and in 3 cases it was not reported if the sudden hearing loss was temporary or ongoing.

Levitra :

Clinical Trials:

A total of 3 of the approximately 16,000 patients treated with vardenafil in all clinical studies combined experienced sudden hearing loss in temporal relation to dosing. 

Post-marketing reports:

Five of the postmarketing cases of sudden hearing loss had a temporal relationship and occurred in men ranging in age from 38 to 74.  In 2 of the 5 cases, sudden hearing loss occurred after the first dose.  Two of the 5 cases were unilateral, 1 was bilateral and 2 did not specify. In 3 of the 5 cases, the sudden hearing loss was temporary, and in 2 cases the sudden hearing loss was ongoing.

Cialis :

Clinical trials:

A total of 4 of the approximately 18,000 patients treated with tadalafil in all clinical studies combined experienced sudden hearing loss in temporal relation to dosing. 

Post-marketing reports:

Five of the postmarketing cases of sudden hearing loss had a temporal relationship and occurred in men ranging in age from 58 to 71. In 3 of the 5 cases, sudden hearing loss occurred after the first dose.  Two of the 5 cases were unilateral, 2 were bilateral and 1 did not specify. In 2 of the 5 cases, the sudden hearing loss was temporary, in 2 cases the sudden hearing loss was ongoing, and in 1 case it was not reported whether the sudden hearing loss was temporary or ongoing.

Revatio :

Sildenafil use by patients with PHA is both continuous and at a higher dose than for men taking sildenafil intermittently for erectile dysfunction. 

Clinical Trials:

A total of 5 sildenafil-treated patients among the approximately 660 patients enrolled in all clinical studies reported hearing loss/impairment, including sudden hearing loss.  Four of these cases occurred in an open-label extension study.  Sildenafil therapy was continued in all 5 cases. In 2 cases, the sudden hearing loss resolved (2 months in one case, 1 day in the other). In 3 cases, the hearing impairment was still present at the end of the study.

Post-marketing reports:

A total of 4 reports of sudden hearing loss were received and occurred in 3 women and 1 man ranging in age from 36 to 63.  The time to onset of sudden hearing loss ranged from less than 3 weeks to 11 months after beginning Revatio therapy and all could be reasonably associated with the use of the drug.  All 4 cases involved unilateral hearing loss and were ongoing.  Revatio therapy was continued for three of the reported cases and discontinued in 1 case.