Tag Archive | "avodart"

FDA Calls for Warning Labels on Drugs for Enlarged Prostate


The U.S. Food and Drug Administration is calling for new warning labels on part of a class of medications used to primarily treat enlarged prostate called 5-alpha reductase inhibitors (5-ARI). This new warning is based on the results of two large prostate cancer trials where it shows that the medications may raise the risk of developing an aggressive form of prostate cancer. The drugs involved include popular medications sold under brand names Proscar and Propecia (sold by Merck & Co.) and Avodart and Jalyn (sold by GlaxoSmithKline).

Propecia, a lower dose version of Proscar and is prescribed to treat hair loss in men is updating its label even though it was not included in the trials. FDA said “the applicability of the Avodart and Proscar studies to Propecia is currently unknown.”

FDA is advising doctors not to start patients on these drugs until prostate cancer and other urological conditions have been ruled out. Prostate cancer can mimic the symptoms of an enlarged prostate.

Recent research has also shown that Proscar, Propecia and Avodart are all associated with increased risk of erectile dysfunction in men who take the medications.

According to FDA, between 2002 and 2009 almost 5 million men were prescribed one of these medications and of these nearly 3 million men were between the ages of 50 and 79.

“What both studies show conclusively is there is about 1% increase in being diagnosed with high-grade prostate cancer if you got these drugs even though you are less likely to get a low-grade cancer. You have to weigh the 24% reduction against the 1% increased incidence of high-grade disease.” says Dr. Anthony D’Amico, chief of genitourinary radiation oncology at Brigham and Women’s Hospital in Boston. He added, “These drugs should only be used in men who have an additional indication to take them beyond prostate cancer prevention.”

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Dutasteride and Finasteride May Contribute to Irreversible Sexual Dysfunction in Men


Dutasteride (Avodart), a drug frequently prescribed to treat enlarged prostate and Finasteride (Proscar and Propecia); a drug frequently prescribed to treat hair loss may contribute to erectile dysfunction, depression and loss of libido. Symptoms may even persist after the medication stopped.

This is according to a study led by Abdulmaged M. Traish, a professor of biochemistry and urology at Boston University School of Medicine. The team searched for available medical literature for reports of sexual side effects associated with Finasteride and Dutasteride. Of the men taking the drugs, 8% reported erectile dysfunction and 4.2% reported reduced libido while those taking the placebo only 4% of men reported erectile dysfunction and 1.8% of men reported reduced libido. The researchers also noted that reduced ejaculation, reduced semen volume and depression were also reported by some men.

The drugs (Dutasteride and Finasteride) work by blocking androgen but androgen is needed for erectile function, libido and ejaculation, and for just feeling good.

Traish said “as a physician you have a responsibility to take the time and explain to your patient that maybe not everyone will have these side effects, but you may, and in some cases they are irreversible””.

Dr. Bruce R. Kava, an associate professor of urology at the University Of Miami Miller School Of Medicine agreed that “these drugs do cause some of these problems but they haven’t convinced me yet, based on the data, because they don’t have any long term data”. He added that most urologists discuss potential side effects with their patients but usually “don’t discuss long term consequences that are irreversible, because most of us have not been aware of any long term problems from these drugs”.

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Experts Disagree on Prostate Cancer Prevention Drugs


Prostate cancer is the second-leading cause of cancer death in men. However, there is good news.  Drugmaker GlaxoSmithKline (GSK) produces a medicine called Avodart, generically known as dutasteride, which can reduce your risk of developing the disease. An international, four-year, placebo-controlled and randomized study conducted by GSK revealed that dutasteride cut the risk of prostate cancer by 23% — a fantastic result. However, despite these findings, many medical professionals advise against prescribing this drug. In an editorial by published in The New England Journal of Medicine, Dr. Patrick Walsh raises several issues regarding the study and its conclusions.

Walsh questions whether the dutasteride-prevented cancers were clinically significant. While the drug did lead to a significant reduction in low-grade prostate cancer incidence, the more lethal, higher-grade cancers were mostly not affected. Also disconcerting was an increase in heart failure discovered among patients taking dutasteride.

Finally, Walsh questions the study’s conclusions. He believes the drug doesn’t prevent cancer, but only temporarily shrinks tumors that have a low potential for being lethal. While the drugs do successfully treat prostate conditions by reducing prostate-specific antigen levels and shrinking the gland, he worries that the drug lead to worse problems later on by lulling men into a false sense of security.

However, the study’s lead author Dr. Gerald Andriole, chief of urological surgery at Washington University School of Medicine, disagrees. “The major problems with screening for prostate cancer using PSA . . . is what has been referred to “overdiagnosis” and “overtreatment,” he notes. As well as preventing BPH-related problems, “both finasteride and dutasteride actually improve the ability of PSA [tests] to detect the most aggressive cancers,” a desirable outcome of the study that will be reported in a later paper, and one that could reduce the chance of overdiagnosis. Instead, he recommends that PSA tests be used differently for men on the drugs, adjusting for the expected lower levels shown in patients taking dutasteride and finasteride.

Men worried about prostate cancer will likely rejoice to hear that they might be able to reduce their risk. However, the experts still disagree on the drug’s effectiveness, or even safety. As always, the best plan of action is to discuss treatment options with your doctor or medical health professional.

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Side Effects of Avodart—A Benign Prostatic Hyperplasia Drug


One of the most common drugs prescribed for benign prostatic hyperplasia, or BPH, is Avodart.  Avodart may be used as the sole medication or may be prescribed in combination with other common drugs used for the same condition.  The active ingredient in Avodart is dutasteride, which inhibits the conversion of testosterone to dihydrotestosterone (DHT).  Researchers have found that the symptoms of BPH, specifically the enlargement of the prostate gland, are a result of increased levels of DHT in the blood.  Therefore, Avodart has been engineered to prevent the unwanted growth of the prostate and, in fact, shrink the gland.  This, in turn, will alleviate such BPH symptoms as poor urine flow, frequency and hesitancy of urination, and inability to completely empty the bladder.

Currently, Avodart is available in capsule form.  But due to its chemical make-up, it has the ability to irritate the mucosa.  For this reason, the capsule must be swallowed whole without breaking up or chewing the casing.  Further, if a patient is allergic to any ingredients either in the drug itself or the capsule, Avodart may not be the correct treatment of choice for benign prostatic hyperplasia.

One of the long standing reasons to avoid taking drugs such as Avodart is the fact that it and other drugs like it remain in the patient’s blood for up to six months after the final dose.  Those who have opted for Avodart treatment are recommended to not donate blood.  This recommendation is extremely important as researchers have revealed that Avodart can cause birth defects if taken during pregnancy.

The most common side effects of the drug deal with general allergic reactions.  This includes itching of the skin, hives, swelling of the lips, tongue, face, and throat, and breathing difficulties.  If you are taking Avodart and are experiencing any of these symptoms, immediately discontinue taking the medication and seek medical treatment to prevent any progression of the symptoms.

Given the main function of Avodart, which is to inhibit the production of DHT, another specific side effect related to taking the medication is linked to reduced levels of DHT.  With reduced levels of DHT in the body, a loss of libido, lack of sexual drive, impotence, or erectile dysfunction may ensue.  Also, reduced amounts of semen production during the time of ejaculation, breast enlargement, and breast tenderness have been reported.  Report any of these side effects to your physician as soon as possible.

As its name suggests, benign prostatic hyperplasia is a benign growth of the prostate gland.  Diagnosis does not indicate prostate cancer or increase risk for cancer.  Medications such as Avodart are prescribed by many doctors, despite their many side effects.  Patients have begun to look toward natural supplements, which do not carry adverse side effects, to treat symptoms of common urological problems like BPH.  If you are interested in alternative, safer routes toward alleviating symptoms, talk to your doctor about clinically tested, effective natural supplements.

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