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Cialis, Viagra Labels to Note Amnesia
Aug. 22, 2008 -- All three erectile dysfunction drugs -- Cialis, Levitra, and Viagra -- now list rare reports of transient global amnesia on their labels.
Transient global amnesia, or TGA, is a brief bout of amnesia, not lasting longer than a day, without causing other problems.
Levitra added transient global amnesia to its label earlier this year. And now, FDA records show that Cialis and Viagra will make similar additions to their labels.
Those label changes don't amount to warnings or precautions. Instead, they'll be listed in the "Post-Marketing" section of the drugs' labels.
There's no proof that any of the erectile dysfunction drugs cause transient global amnesia, which can happen for various reasons; it can even be triggered by sex.
Drug Companies Respond
The drug company Pfizer makes Viagra; Eli Lilly and Company makes Cialis. WebMD asked both companies for their comments on their drug's label change.
Sally Beatty, director of Worldwide Communications for Pfizer, emailed Pfizer's statement, which notes that Pfizer "regularly monitors and evaluates any adverse events reported to Pfizer directly or indirectly through secondary sources. We also routinely conduct reviews of both clinical and post-marketing safety surveillance data. To date, the data do not suggest a causal relationship between the use of Viagra and transient global amnesia."
Pfizer also states that when used as prescribed, Viagra has been shown to be a "safe and effective treatment for erectile dysfunction across a broad range of men with ED," and has been used by more than 35 million worldwide since 1998.
Keri McGrath, a spokeswoman for Lilly, tells WebMD that "we carefully monitor safety data associated with the use of Cialis and we review this data for adverse events on an ongoing basis, and this data is regularly shared with the regulatory bodies globally."
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Indication
Uroxatral® (alfuzosin HCl 10 mg extended-release tablets) is an alpha1-blocker for the treatment of the signs and symptoms of BPH.
Important Safety Information
Do not take UROXATRAL if you have liver problems or if you are taking antifungal drugs like ketoconazole or itraconazole, or HIV drugs like ritonavir.
UROXATRAL can cause a sudden drop in blood pressure, especially when starting treatment. This may lead to fainting, dizziness, and lightheadedness. Do not drive, operate machinery, or do any dangerous activity until you know how UROXATRAL will affect you. This is especially important if you already have a problem with low blood pressure or take medicines to treat high blood pressure. There may be an increased risk of low blood pressure and fainting when taking UROXATRAL in combination with blood pressure medication or nitrates, or erectile dysfunction medication.
If considering cataract surgery (clouding of the eyes), tell your eye surgeon that you are currently taking UROXATRAL or have previously been treated with an alpha-blocker.
Before taking UROXATRAL, tell your doctor if you have kidney problems.
Also, tell your doctor if you or any family member(s) have or take medications for a rare heart condition known as congenital prolongation of the QT interval.
BPH and prostate cancer can cause the same symptoms. However, UROXATRAL is not a treatment for prostate cancer.
The most common side effects with UROXATRAL are dizziness, upper respiratory tract infection, headache, and tiredness.
Please see UROXATRAL full prescribing information.
