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Why Not ED Drugs?
Men taking any of three erectile dysfunction drugs (impotence treatments) -- Viagra, Levitra or Cialis -- are at increased risk for sudden onset hearing loss, prompting the US FDA (Food and Drug Administration) officials to require label changes for the medications.
The FDA is requiring label changes for erection drugs that have the risk of sudden onset hearing loss.
The FDA said manufacturers must change the labels "to display more prominently the serious health risk of sudden onset hearing loss," according to the agency's Web site.
Men taking any of the erectile dysfunction and impotence drugs experiencing sudden onset hearing loss should immediately stop taking the drug and seek medical attention including contacting their physician, the FDA said.
Patients taking Revatio and experiencing hearing loss should not discontinue taking the drug because it is used to treat a potentially life-threatening condition, the FDA said. Those patients are urged to see their physicians immediately.
The FDA is requiring the label change for the entire class of drugs -- called Phosphodiesterase Type 5 Inhibitor, or PD-5 inhibitors.
The FDA says all manufacturers are required to the change their labels.
"This is a public health announcement to let people know the drug does cause serious health conditions," Dr. Robert Boucher said. Boucher is an ear, nose and throat specialist for the FDA who reviewed reports of sudden hearing loss in patients taking these drugs.
The FDA started looking into the link between hearing loss and impotence drugs after the publication of an article written for ENT (ear, nose and throat) specialists in one of the groups medical journals, according to FDA spokeswoman Rita Chappelle. The study reported on men taking Viagra having experienced sudden hearing loss.
This caused the FDA to investigate other reports of sudden hearing loss. The FDA found a number reports, which involved patients experiencing ringing in their ears, vertigo and/or dizziness. In cases, the hearing loss only occurred in one ear, and for about one third of patients, the hearing loss was considered serious by the patients doctor.
Boucher said "these numerous adverse health problem event reports date back to 1996, when Viagra, the first impotence drug, was approved."
"So, we're only talking about a number cases per year which equates to many lives being affected," he said.
He said 65 million prescriptions of all four drugs have been filled worldwide so far.
"This is a number of cases, but because we're talking about a person's ability to hear, we thought it was important to make the label clear that this is a health concern and a possible life changing event," Chappelle said.
There are about 40,000 new cases of sudden occurrence loss of hearing loss in the USA each year, according to the NIH (National Institutes of Health).
Pfizer manufactures Viagra and Revatio and Eli Lilly manufactures Cialis. Levitra, developed by GlaxoSmithKline and Bayer HealthCare, is jointly promoted in the United States by GSK and Schering-Plough Corporation.
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Why Not Viagra or Cialis For Impotence?
Prescription impotence drugs such as Viagra and Cialis are well known to cause a myriad of complications and pose many health risk. And the cost of the erectile drug prescription is generally out of the budget of most guys seeking help with erection problems.
Viagra:
Viagra (Sildenafil Citrate) is used as a therapy for erectile dysfunction, and is administered orally. Sildenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).
Adverse Event |
Percentage of Patients |
Reporting Event |
|
|
VIAGRA N=734 |
PLACEBO N=725 |
| Headache |
16% |
4% |
| Flushing |
10% |
1% |
| Dyspepsia |
7% |
2% |
| Nasal Congestion |
4% |
2% |
| Urinary Tract Infection |
3% |
2% |
| Abnormal Vision |
3% |
0% |
| Diarrhea |
3% |
1% |
| Dizziness |
2% |
1% |
| Rash |
2% |
1% |
Apart from the above, Viagra® has also shown interactions with many other drugs.
What other drugs are known to affect Sildenafil?
•Sildenafil must not be taken if a nitrate drug is also being taken for angina or other heart problems. These nitrates include:
• nitroglycerin (Nitrostat, Nitrolingual,
• isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), and
• isosorbide mononitrate (Imdur, ISMO, Monoket), or
• recreational drugs such as amyl nitrate or nitrite ("poppers")
• Your doctor must be notified before you use Sildenafil, if you are on any of the following medication:
• bosentan (Tracleer);
• cimetidine (Tagamet, Tagamet HB);
• an antibiotic such as erythromycin (E-Mycin, Eryc, Ery-Tab) or clarithromycin (Biaxin);
• doxazosin (Cardura), prazosin (Minipress), Terazosin (Hytrin);
• an antifungal medication such as itraconazole (Sporanox) or ketoconazole (Nizoral);
• carbamazepine (Tegretol), phenobarbital (Luminal), or phenytoin (Dilantin); or
• Rifampin (Rifadin, Rimactane) or rifabutin (Mycobutin).
• If any of the above medicines are being taken, you might require appropriate dosage adjustments or special tests to be taken or you might just not be allowed to use Sildenafil at all.
However, that’s not the end of the list. There might be others that affect Sildenafil too. It is safest to let your doctor know all details of your medications, both prescribed and over-the-counter. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. New medication must not be started unless your doctor is notified of the same.
Cialis:
Cialis(tadalafil) is also a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5), and used in the treatment of ED.
Like Viagra, Cialis too has an enormous list of side effects as listed below:
| |
Placebo |
Tadalafil 5 mg |
Tadalafil 10 mg |
Tadalafil 20 mg |
| Adverse Event |
(N=476) |
(N=151) |
(N=394) |
(N=635) |
| Headache |
5% |
11% |
11% |
15% |
| Dyspepsia |
1% |
4% |
8% |
10% |
| Back Pain |
3% |
3% |
5% |
6% |
| Myalgia |
1% |
1% |
4% |
3% |
| Nasal congestion |
1% |
2% |
3% |
3% |
| Flushing* |
1% |
2% |
3% |
3% |
| Pain in limb |
1% |
1% |
3% |
3% |
The following are the drug interactions caused with Cialis:
• cimetidine (Tagamet, Tagamet HB);
• erythromycin (E-Mycin, Eryc, Ery-Tab) or clarithromycin (Biaxin);
• doxazosin (Cardura), prazosin (Minipress), terazosin (Hytrin);
• itraconazole (Sporanox) or ketoconazole (Nizoral);
• carbamazepine (Tegretol), phenobarbital (Luminal), or phenytoin (Dilantin); or
• rifampin (Rifadin, Rimactane).
*Source, drugs.com
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