hearing loss from cialis

п»ї

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 using the contact information at the bottom of this page.

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.

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

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

Questions and Answers about Viagra, Levitra, Cialis, and Revatio: Possible Sudden Hearing Loss

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.

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.

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.

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.

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.

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.

What are the warning signs? There were no predictable warning signs for sudden hearing loss in the reported cases.

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.

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.

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.

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.

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

Cialis

Treating erectile dysfunction (ED) or treating the symptoms of benign prostatic hyperplasia (BPH). It may also be used for other conditions as determined by your doctor.

Cialis is a phosphodiesterase type 5 (PDE5) inhibitor. It works by helping to increase blood flow into the penis during sexual stimulation. This helps you to achieve and maintain an erection. It is not known exactly how Cialis works to treat symptoms of BPH.

Do NOT use Cialis if:

• you are allergic to any ingredient in Cialis
• you have severe kidney problems or are on dialysis and you will be taking Cialis daily
• you have severe liver problems or certain hereditary degenerative eye problems (eg, retinitis pigmentosa)
• you have certain heart problems (eg, unstable angina, angina during sexual intercourse, uncontrolled irregular heartbeat), low blood pressure, or uncontrolled high blood pressure
• you have had a heart attack within the past 90 days, or you have had severe heart failure or a stroke within the past 6 months
• you are taking a nitrate (eg, isosorbide, nitroglycerin) in any form (eg, tablet, capsule, patch, ointment), or nitroprusside
• you have ED and have been advised by your doctor to avoid sexual activity because of heart problems
• you use certain recreational drugs called "poppers" (eg, amyl nitrate or nitrite, butyl nitrate or nitrite)
• you take another PDE5 inhibitor (eg, sildenafil, vardenafil) or another medicine that contains tadalafil
• you will be using it to treat BPH and you are also taking an alpha-blocker (eg, doxazosin)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Cialis:

Some medical conditions may interact with Cialis. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a deformed penis (eg, Peyronie disease, cavernosal fibrosis), blood cell problems (eg, sickle cell anemia, leukemia, multiple myeloma), or any other condition that may increase the risk of a prolonged erection (priapism)
• if you have a history of a prolonged (more than 4 hours) or painful erection (priapism)
• if you have a history of certain eye problems (eg, retinitis pigmentosa, sudden vision loss, optic neuropathy, macular degeneration) or hearing problems (eg, ringing in the ears, decreased hearing, hearing loss)
• if you have a history of liver or kidney problems, dialysis, lung problems (eg, pulmonary veno-occlusive disease), high or low blood pressure, ulcers, bleeding problems, heart problems (eg, heart failure, irregular heartbeat, aortic stenosis, angina), or blood vessel problems
• if you have a history of a heart attack, a stroke, or life-threatening irregular heartbeat

Some MEDICINES MAY INTERACT with Cialis. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Alpha-blockers (eg, doxazosin), medicines for high blood pressure, nitrates (eg, isosorbide, nitroglycerin), or nitroprusside because severe low blood pressure with dizziness, lightheadedness, and fainting may occur
• Azole antifungals (eg, itraconazole, ketoconazole), macrolide antibiotics (eg, clarithromycin, erythromycin), protease inhibitors (eg, boceprevir, ritonavir), or telithromycin because they may increase the risk of Cialis's side effects
• Barbiturates (eg, phenobarbital), carbamazepine, phenytoin, or rifampin because they may decrease Cialis's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Cialis may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Cialis:

Use Cialis as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Cialis. Talk to your pharmacist if you have questions about this information.
• Take Cialis by mouth with or without food.
• Swallow Cialis whole. Do not break the tablet before swallowing.
• For use as needed. Take Cialis at least 30 minutes before sexual activity, as directed by your doctor. Cialis may work for up to 36 hours after you take it.
• For daily use. Take Cialis regularly at about the same time each day.
• Talk with your doctor if you have questions about how you should take Cialis.
• Check with your doctor before you eat grapefruit or drink grapefruit juice while you are taking Cialis.
• For use as needed. If you miss a dose of Cialis and you still intend to engage in sexual activity, take it as soon as you remember. Continue to take it as directed by your doctor. For daily use. If you miss a dose of Cialis, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses within the same day.

Ask your health care provider any questions you may have about how to use Cialis.

Important safety information:

• Cialis may cause dizziness, drowsiness, fainting, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Cialis with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Cialis may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
• Do not drink large amounts of alcohol (eg, 5 drinks or more) while you take Cialis. Doing so may increase your risk of dizziness, headache, fast heartbeat, and low blood pressure. Check with your doctor before you drink alcohol while you use Cialis.
• Do not take more than the recommended dose, change your dose, or take Cialis more often than prescribed without checking with your doctor.
• Patients with heart problems who take Cialis may be at increased risk of heart-related side effects, including a heart attack or stroke. Symptoms of a heart attack may include chest, shoulder, neck, or jaw pain; numbness of an arm or leg; severe dizziness, headache, nausea, stomach pain, or vomiting; fainting; or vision changes. Symptoms of a stroke may include confusion; vision or speech changes; one-sided weakness; or fainting. Contact your doctor or seek medical attention right away if you experience these symptoms.
• Cialis may rarely cause a prolonged (eg, more than 4 hours) or painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.
• Cialis does not stop the spread of HIV or other sexually transmitted diseases (STDs) to others through sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection or an STD.
• Cialis will not prevent pregnancy. If your partner may become pregnant and you wish to avoid pregnancy, be sure to use an effective form of birth control.
• Cialis may uncommonly cause mild, temporary vision changes (eg, blurred vision, sensitivity to light, blue/green color tint to vision). Contact your doctor if vision changes persist or are severe.
• Rarely, an eye problem called nonarteritic anterior ischemic optic neuropathy (NAION) has been reported in patients who took Cialis. This may lead to decreased vision or permanent loss of vision in some cases. If you notice a sudden decrease in vision or loss of vision in one or both eyes, contact your doctor right away.
• Sudden decreases in hearing and loss of hearing have been reported in some patients who have taken Cialis. Sometimes they also noticed ringing in the ears or dizziness. If you notice a sudden decrease or loss of hearing, contact your doctor right away.
• Do not use other medicines or treatments for ED while you are taking Cialis without first checking with your doctor.
• Be sure to keep all doctor and lab appointments while you are taking Cialis.
• Use Cialis with caution in the ELDERLY; they may be more sensitive to its effects.
• Cialis is not recommended for use in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Cialis is not approved for use in women. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Cialis while you are pregnant. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you use Cialis, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Cialis:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Cough; dizziness; flushing; headache; heartburn; mild back or muscle pain; stomach upset; stuffy or runny nose.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue); burning, numbness, or tingling; chest pain; confusion; decreased urination; fainting; fast or irregular heartbeat; memory loss; numbness of an arm or leg; one-sided weakness; prolonged, painful erection; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe or persistent back or muscle pain; severe or persistent dizziness or headache; slurred speech; sudden decrease or loss of hearing; vision changes (eg, sudden decrease or loss of vision in one or both eyes).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA .

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center. or emergency room immediately. Symptoms may include chest pain; fainting; prolonged erection; severe dizziness; severe or persistent back or muscle pain; severe or persistent vision changes.

Proper storage of Cialis:

Store Cialis at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Cialis out of the reach of children and away from pets.

General information:

• If you have any questions about Cialis, please talk with your doctor, pharmacist, or other health care provider.
• Cialis is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.
• Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Cialis or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Cialis. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Cialis. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Cialis.

Review Date: August 8, 2016

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

More about Cialis (tadalafil)

click the following articleCMGT 410 All Week 2 Course Work – Project Task Listgo herecustom writing service pricesvisit web pagesee morethis web pagepilula xenicalxenical lchfMGT 411 Week 2 Individual Assignment Innovation and Strategic Management Annotated Bibliographyherexenical gunstig kaufenclick herehttp://cpt-emilie.org/map238.phpxenical food and activity plannerclickread articleclick at this pagehow to write a good application essay scholarship

Website URL: