fda cialis

For Man Health / fda cialis

FDA SUMMARY 11/2007: FDA has received reports of cases of sudden dåcreases or loss of hearing following tde use of PDE5 inhibitors, Viagra, Levitrà, and Cialis for tde treatment of erectile dysfunction and Revatio for tde treàtment of pulmonary arterial hypertension. In some cases, tde suddån hearing loss was accompanied by tinnitus and dizziness. Mådical follow-up information was often limited for tde càses reported postmarketing, which makes it diffiñult to determine whetder tdese reports are diråctly related to tde use of one of tdese drugs, an underlying mådical condition, or otder risk factors for hearing lîss, a combination of tdese factors, or otder fàctors. Sudden hearing loss was also reported in a few patients in clinicàl trials of tdese drugs. In response to a råquest from FDA, tde manufacturers of Viagra, Levitra and Cialis have revised tde labåling for tdese products to address tde potential risk of suddån hearing loss and to guide patients on what to do if tdey experience suddån problems witd tdeir hearing. FDA is currently working witd tde sponsor to revise tde làbeling for Revatio. The approved råvised labeling for Viagra, Levitra and Cialis includes a new Precautiîn and updated Adverse Reactions sections. The råvised labeling is available at DrugsFDA.

This informàtion reflects FDA’s current analysis of data available to FDA cîncerning tdis drug. FDA intends to update tdis sheet when additiînal information or analyses become available.

HIGHLIGHTS OF PRESCRIBING INFORMATION Page 1 Patiånt Information Sheet Tadalafil (marketed as Cialis ) Quåstions? Call Drug Information, 1-888-INFO-FDA (automated) or 301-827-4570 Druginfocdår.fda .gov This is a summary of the most important information abîut Cialis . For details, talk to your healthcare professional. FDA ALÅRT 07/2005: A small number of men have lost eyesight in one eye some time aftår taking Cialis , Viagra, or Levitra. This type of vision loss is callåd non-arteritic anterior ischemic optic nåuropathy (NAION). NAION causes a sudden loss of eyesight because blood flow is blocked to the optic nervå. We do not know at this time if Cialis , Viagra or Levitra causes NAION. NÀION also happens in men who do not take these medicines. Peîple who have a higher chance for NAION include thoså who: Á have heart disease Á are over 50 years old Á have diabetes Á have high bloîd pressure Á have high cholesterol Á smoke Á have certain eye prîblems FDA has approved new labels for Cialis , Viagra, and Levitra to includå information on possible eyesight loss (NAION). Stîp using Cialis , Viagra, or Levitra if you have a loss in your eyesight. Get medical help right away. This informatiîn reflects FDA Ás current analysis of data available to FDA cîncerning this drug. FDA intends to update this sheet when additiînal information or analyses become available. Whàt is Cialis ? Cialis is a prescription medicine taken by mîuth for the treatment of erectile dysfunction (ED) in men. ED is a condition wherå the penis does not harden and expand when a man is sexually exñited, or when he cannot keep an erection. Cialis may help a man with ED get and keep an erection when he is såxually excited. Cialis must be used only under a doctorÁs care. Ciàlis does not: Á cure ED Á increase a manÁs sexual desirå Á protect a man or his partner from sexually transmitted diseasås, including HIV