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GlaxoSmithKline (GSK) today announced that the Company has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for the supplemental New Drug Application (sNDA) for Avodart® (dutasteride) for reducing the risk of prostate cancer in men at increased risk for the disease, defined as those who have had a prior negative biopsy due to clinical concern and have an elevated serum
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Reproductive Function: The effects of dutasteride 0.5 mg/day on semen characteristics were evaluated in normal volunteers aged 18 to 52 (n = 27 dutasteride, n = 23 placebo) throughout 52 weeks of treatment and 24 weeks of post-treatment follow-up. At 52 weeks, the mean percent reduction from baseline in total sperm count, semen volume, and sperm motility were 23%, 26%, and 18%, respectively, in the dutasteride group when adjusted for changes from baseline
in the placebo group. Sperm concentration and sperm morphology were unaffected. After 24 weeks of follow-up, the mean percent change in total sperm count in the dutasteride group remained 23% lower than baseline. While mean values for all semen parameters at all time points remained within the normal ranges and did not meet predefined criteria for a clinically significant change (30%), two subjects in the dutasteride group had decreases in sperm count of greater than 90% from baseline at 52 weeks, with partial
recovery at the 24-week follow-up. The clinical significance of dutasteride�s effect on semen characteristics for an individual patient�s fertility is not known.
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Dutasteride and its metabolites were excreted mainly in feces. As a percent of dose, there was approximately 5% unchanged dutasteride (~1% to ~15%) and 40% as dutasteride-related metabolites (~2% to ~90%). Only trace amounts of unchanged dutasteride were found in urine (<1%). Therefore, on average, the dose unaccounted for approximated 55% (range, 5% to 97%). In patients with BPH treated with 5 mg/day of dutasteride
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therapy and periodically thereafter. Assess patient to rule out other urologic diseases prior to treatment. Carefully monitor patients with large residual urine volume or severely diminished urinary flow for obstructive uropathy. I thought it was due to flomax, they did not, but told him to discontinue, just take the avodart. Still suffered from the sever fatigue, and still no weight gain. We went to a doc that specialized in vertigo, and dizziness. They said that the air had been replaced, but the inflammation
is what was causing his headaches, and dizziness, fainting. Air causing the inflamation in the brain, and needs time to resolve, and gave us meds to take. Postmarketing Experience: The following adverse reactions have been identified during postapproval use of AVODART. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Decisions to include these reactions in labeling
are based on one or more of the following factors: (1) seriousness of the reaction, (2) frequency of reporting, or (3) potential causal connection to AVODART. ALL THE PHARMACIES LISTED IN THIS SITE REQUIRE A PRESCRIPTION, if you can't afford to have an Rx refilled by your doctor all our advertisers offer Tele-Health prescribing services. We only list online pharmacies strictly selling non-controlled medicines complying with the "Ryan Haight Online Pharmacy Consumer Protection Act of 2008". Internet/telephone
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