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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Avodart Shot Down by FDA

The drug Avodart (dutasteride) has been largely recommended by doctors to treat benign prostatic hyperplasia (BPH) since 2002.  BPH is a symptomatic condition of the prostate, resulting in an enlarged prostate gland.  The drug works by blocking enzymes that promote prostate growth and has been shown to relieve symptoms such as frequent and difficult urination.  In many cases, Avodart has eliminated the need for prostate surgery altogether.

More recently, GlaxoSmithKline (GSK) has pushed to extend the usage of Avodart to reduce the risk of prostate cancer.  Nearly 1 million men are currently estimated to be at risk for prostate cancer in the United States.  But on December 1, 2010, an FDA advisory panel voted 14-2 to recommend against the expanded use of the drug.

Researchers have recently conducted clinical trials to determine dutasteride’s efficacy in preventing prostate cancer.  A randomized controlled trial, named REDUCE, studied the effects of the drug.  The trial focused on 6,729 men who received either dutasteride or a placebo.  The results for the effects of the drug were compared to the results of the placebo.  It was found that an overall reduction of 22% in the incidence of prostate cancer over the course of four years occurred in those men who had taken the dutasteride.

Despite these seemingly promising results, the reduction rate was found only in less fatal prostate cancer that often does not need treatment.  In the more aggressive subtypes of cancer, no reduction was found in the incidence of cancer.  Researchers concluded that the use of this drug may delay diagnosis of prostate cancer to the point that the cancer becomes untreatable.

GlaxoSmithKline has received a response letter from the FDA regarding Avodart.  Despite the recent decision, the company may still intend to gain future approval.

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FDA Votes Against BPH Drugs for Prostate Cancer

The FDA advisory panel recently shut down Avodart’s, GlaxoSmithKline’s, Proscar’s, and Merck’s request to expand labeling of dutasteride and finasteride.  Currently, these two drugs are used for the treatment of benign prostatic hyperplasia (BPH).  Yet the pharmaceutical companies had goals to expand the market to include prevention of prostate cancer in men at risk for the disease.

The companies based their goals on clinical trial evidence showing that men who took these 5-alpha-reductase inhibitors had a reduced risk of prostate cancer compared with men who received a placebo.  However, the Oncologic Drugs Advisory Committee was concerned with the additional data showing that use of the drugs increased the incidence of high-risk tumors.  Researchers, on the other hand, believe that the reason for the increased incidence relates to the reduction in prostate size brought about by the two drugs, which increases the likelihood that needle biopsies will detect high-risk tumors if they are present.

The panel members felt so strongly about the increased high-risk tumor data that the committee voted against the expansion of dutasteride by a vote of 14-2, with two members abstaining.  By a vote of 17-0, the panel rejected an expanded indication for finasteride.

The pharmaceutical companies and panel members scrutinized two major studies central to the expansion requests.  The Reduction by Dutasteride of Prostate Cancer Events (REDUCE), which randomized 8,200 high-risk men ages 50 to 75 to receive either dutasteride or placebo, found that dutasteride was associated with a 23% reduced risk of prostate cancer after four years.  The Prostate Cancer Prevention Trial (PCPT), which randomized approximately 19,000 healthy men older than 55 years to receive finasteride or placebo, showed that men who received finasteride had a nearly 25% decreased risk of prostate cancer after seven years.

“I think the committee was given a very difficult task:  In effect, they were charged to certify that these drugs, if approved for widespread use for prostate cancer risk reduction, would be unambiguously safe,” said Gerald L. Andriole, MD, lead investigator for the REDUCE trial.  “There is no doubt that men who receive these drugs need careful follow-up and close monitoring of their PSA levels.  I suppose the committee members were not convinced such close monitoring would occur.”

According to Dr. Andriole, the reason that more high-grade tumors surfaced in the studies is because of the design of both studies and the effects of the drugs, resulting in significant biases.  These biases could account for most of the excess high-grade cancers identified in the studies.  “Excess high-grade tumors have not been seen in other trials evaluating these drugs for BPH,” noted Dr. Andriole, Chief of Urologic Surgery at Siteman Cancer Center, Barnes-Jewish Hospital in St. Louis, and the Robert K. Royce Distinguished Professor at Washington University School of Medicine in St. Louis.  “In fact, there are two BPH trials where dutasteride reduced prostate cancer [risk] by 40% to 50% and there was no increase in high-grade tumors.  And, in REDUCE, if we create a model to account for the biases against dutasteride, it suggests that there are actually fewer high-grade tumors.  Similar models are available for PCPT as well.”

Dr. Andriole believes that if physicians are familiar with the drugs, follow the clinical trials, and understand how the drugs affect PSA levels, then they should be allowed to continue to use them for prostate cancer risk reduction, after discussing the pros and cons with patients, as has been recommended by both the American Society of Clinical Oncology and the American Urological Association.

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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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