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ED Drugs Like Viagra May Cause Sudden Deafness: FDA |
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Written by Theresa Maher
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Tuesday, 23 October 2007 |
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Drugs like Viagra, which successfully take care of erectile dysfunction in men, may have an unwanted side effect in the form of sudden hearing loss, according to an advisory released by the U.S. Food and Drug Administration. Other erectile dysfunction drugs implicated in this adverse effect are Cialis and Levitra.
The erectile dysfunction drugs including Viagra belong to a family of drugs called phosphodiesterase type 5 (PDE5) inhibitors. Another drug of the same class, but used to treat pulmonary arterial hypertension (PAH) is Revatio. The FDA said the latter would also carry warnings about possible deafness after consuming it.
Pulmonary hypertension is a condition where persistent high blood pressure in the arteries of the lungs leads to right heart failure and eventually death.
The FDA approved changes in the labels of the above four drugs after case report in the April 2007 issue of the Journal of Laryngology & Otology detailed sudden hearing loss in a man taking Viagra. After examining the FDA’s Adverse Events Reporting System, the agency found 29 postmarketing reports of sudden hearing loss connected to PDE5 inhibitors.
According to the FDA;
* Sudden hearing loss was also accompanied by ringing in the ears, vertigo, or dizziness
* In most cases hearing loss was limited to one ear
* Hearing loss was partial or complete
* In one third of cases hearing loss was temporary
"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," the FDA said.
Viagra is chemically sildenafil and is best known for treating erectile dysfunction. The drug was initially marketed as a high blood pressure and angina relieving medication, but quickly acquired superstar status because of its ability to treat erectile dysfunction in a satisfactory manner.
Produced by Pfizer, the drug is a blockbuster in this category. While other beneficial effects have been attributed to Viagra, it continues to be the number one drug in the ED category.
According to the National Institutes of Health, some side effects associated with Viagra include:
* Headache
* Upset stomach
* Diarrhea
* Dizziness or lightheadedness
* Flushing (feeling of warmth)
* Stuffy nose
In severe cases the drugs has also been known to cause sudden vision loss. Although the FDA did not refer to this, it did warn users they might experience sudden loss of their hearing capacity.
"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," the FDA said.
For more information, please visit
http://www.fda.gov/cder/drug/infopage/ed_drugs/QA.htm
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