FDA links some prostate drugs to cancer risk

Jun 09, 2011

(AP) -- The Food and Drug Administration expanded the warning label on a group of prostate drugs Thursday, saying they may increase the risk of a more serious form of prostate cancer.

The FDA is updating the warning information on a group of drugs including PLC's Avodart and & Co.'s Proscar, which are used to shrink the prostate. The warning indicates the drugs are linked to a greater risk of high-grade prostate cancers. While the drugs have been shown to reduce the risk of overall, the FDA said the drugs were linked to an increased risk of more serious cancers.

Earlier this year, Merck, based in Whitehouse Station, N.J., and British drugmaker GlaxoSmithKline asked the FDA to approve the drugs as preventive treatments for prostate cancer, but the agency refused, citing the risk of high-grade cancer. In March, GlaxoSmithKline said it was abandoning global efforts to get Avodart approved as a preventive cancer drug.

The agency is basing its conclusions on a review of two studies in which about 27,000 men 50 and older used the drugs for several years. The FDA said the risk of high-grade prostate cancers is small, but doctors should be aware of it.

The drugs are also known as dutasteride and finasteride, respectively. Finasteride is also available as a low-cost generic.

Explore further: Determine patient preferences by means of conjoint analysis

3 /5 (1 vote)
add to favorites email to friend print save as pdf

Related Stories

FDA reviews 2 new drugs to reduce prostate cancer

Nov 29, 2010

(AP) -- Health regulators said Monday that two drugs from GlaxoSmithKline and Merck reduce the risk of prostate cancer in men, though scientists questioned the drugs' overall benefit, since the tumors they prevent are usually ...

Study finds possible heart risk with prostate drug

Mar 31, 2010

(AP) -- Full results of a big study testing a drug for preventing prostate cancer show a higher risk of heart failure, a surprise finding that could dampen enthusiasm for expanding its use.

Drug may slow growth of early prostate cancer

Feb 15, 2011

A new study suggests a way to help men with early, low-risk prostate cancer avoid being overtreated for a disease that in most cases will never threaten their lives. It found that a drug can slow the growth of these tumors ...

Generic prostate drug helps find high-risk cancers early

Sep 11, 2007

Men now have another good reason to consider taking finasteride, a well-known generic drug that shrinks an enlarged prostate and reduces the risk of getting prostate cancer by 25 percent. A new study from the Southwest Oncology ...

Recommended for you

Determine patient preferences by means of conjoint analysis

Jul 29, 2014

The Conjoint Analysis (CA) method is in principle suitable to find out which preferences patients have regarding treatment goals. However, to widely use it in health economic evaluations, some (primarily methodological) issues ...

FDA approves hard-to-abuse narcotic painkiller

Jul 25, 2014

(HealthDay)—A new formulation of a powerful narcotic painkiller that discourages potential abusers from snorting or injecting the drug has been approved by the U.S. Food and Drug Administration.

Race affects opioid selection for cancer pain

Jul 25, 2014

(HealthDay)—Racial disparities exist in the type of opioid prescribed for cancer pain, according to a study published online July 21 in the Journal of Clinical Oncology.

FDA approves tough-to-abuse formulation of oxycodone

Jul 25, 2014

(HealthDay)—Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended release) has been approved by the U.S. Food and Drug Administration as a long-term, around-the-clock treatment for severe ...

User comments : 0