Health Canada Issues Warning For Proscar, Propecia, Avodart, and Jalyn

Health Canada has issued a warning about Proscar, Propecia, Avodart, and Jalyn, medications prescribed for the treatment of enlarged prostate or mail-pattern baldness.

The drugs may increase risks for a serious type of prostate cancer, said Health Canada, wrote the Brandon Sun. The medications, Proscar and Propecia, both generically known as finasteride, are prescribed for enlarged prostate and male-pattern baldness. Avodart and Jalyn, known generically as dutasteride, are prescribed to treat enlarged prostate, also known as benign prostatic hyperplasia, explained the Brandon Sun.

Health Canada says Proscar, Propecia, Avodart, and Jalyn, and their generic equivalents, may be linked to increased risks for developing high-grade prostate cancer, an aggressive cancer that can grow and spread rapidly, the Brandon Sun explained.

The emerging information follows a Health Canada review of two large international clinical trials that indicated that long-term daily use of Proscar, Propecia, Avodart, and Jalyn, and their generic equivalents, in men age 50 and older, was linked to a small, but increased risk of developing high-grade prostate cancer. The study described long-term use as being four years or more, said the Brandon Sun.

Risk was seen in the 5-mg dose of finasteride, sold as Proscar. The 1-mg strength of the drug sold as Propecia was not included in the trials, but the potential risk was not ruled out, said Health Canada, according to the Brandon Sun. The trials sought to understand if the two drugs could be used in prostate cancer prevention, but found the potential benefit of preventing low-grade prostate cancer was small versus risks for developing the high-grade form of the disease.

As we’ve written, Propecia is part of the drug class 5-alpha reductase inhibitors (5-ARIs), as are Merck’s Proscar and GlaxoSmithKline’s Avodart and Jalyn. According to the U.S. Food & Drug Administration (FDA), almost 5 million men were prescribed one of these drugs during 2002-2009, which work by preventing the androgen testosterone conversion to DHT, a hormone critical to male sexual performance.

We previously wrote that a Colorado man filed suit against the maker of Propecia, claiming the male baldness drug caused him to suffer erectile dysfunction and other sexual problems. The claim is just one of many Propecia lawsuits filed against Merck & Co. by men who say that the drug caused sexual issues. The lawsuit charges Merck with negligence, failure to warn, designing and manufacturing a defective product, misrepresentation, breach of warranty and other charges. The plaintiff seeks compensatory damages for medical expenses, disfigurement, pain and suffering, mental anguish and emotional distress.

Last March, a group of researchers at Boston University published a study that revealed that, in a small number of cases, erectile dysfunction linked to 5-ARIs may continue after the drugs have been discontinued. Other men taking the drugs reported reduced ejaculation and semen volume and depression. In some cases, men experienced problems after taking the drugs.

Such drugs may also increase the risk that users will develop male breast cancer as well as issues with sexual dysfunction and increased risks for high-grade prostate cancer.

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