In June 2011 the Federal Drug Administration (FDA) added a serious warning to the label on a widely prescribed drug for men called Avodart. This medication is one of a class of drugs called 5-alpha reductase inhibitors linked to an increased risk of high-grade prostate cancer.
What Is Avodart?
Avodart is the brand name of a drug called dutasteride. The drug reduces the production of dihydrotestosterone, a hormone connected with benign prostatic hyperplasia (BPH), a progressive enlargement of the prostate. By slowing the growth of the prostate, Avodart reduces the annoying symptoms that often occur with this condition, such as waking at night to urinate.
When Is Avodart Prescribed?
Physicians prescribe Advodart in cases of diagnosed benign prostatic hyperplasia (BPH). This disorder causes enlargement of the prostate gland, an organ that wraps around the urethra responsible for the production of semen. Symptoms of BPH include difficulty urinating, reduced urine flow, hesitation at the start of urination and increased need to get up to urinate during the night.
Side Effects Of Avodart
The label for Avodart warns about numerous side effects, including erectile dysfunction, decrease in libido, enlarged or painful breasts, and problems with delayed ejaculation. It can cause serious allergic reactions, such as swelling of the face, throat or tongue. Depressed mood and skin reactions can also occur. Patients with liver disease should not take Avodart. Children and teenagers should not take Avodart. Pregnant women or women who may become pregnant should avoid taking or touching Avodart, which can affect the development of the fetus.
Advice to Healthcare Professionals
Because Avodart is linked to increased risk of high-grade prostate cancer, the FDA has issued a number of recommendations to health professionals. The agency recommends checking prostate cancer by the use of prostate specific antigen test and digital exam to ensure that the medication does not cause the cancer to worsen. The FDA’s label exchange includes Avodart and extends to other 5-alpha reductase inhibitors including Proscar, Propecia and Jalyn.
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