Finasteride (Proscar, Propecia) and dutasteride (Avodart, Jalyn): may increase the risk of high-grade prostate cancer

Starting date:

March 19, 2012

Posting date:

March 19, 2012

Type of communication:

Information Update

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Product Safety, Disease, New safety information

Audience:

General Public

Identification number:

RA-110005532

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Health Canada is informing health professionals and the public that the prescription drugs finasteride and dutasteride may be associated with an increased risk of developing a serious form of prostate cancer known as high-grade prostate cancer. High-grade prostate cancer is an aggressive type of prostate cancer that grows and spreads more quickly than low-grade prostate cancer. This type of cancer is rare, and the increased risk seen with finasteride and dutasteride drugs is still considered very small.

New warnings on this risk have been added to the Canadian drug labels for finasteride and dutasteride products. Finasteride is available under the brand names Proscar (5 mg finasteride) and Propecia (1 mg finasteride) and their generic equivalents (all of which contain "finasteride" in their name). Dutasteride is available under the brand names Avodart and Jalyn (a combination drug product containing dutasteride and tamsulosin).

Finasteride and dutasteride are for use in men only. Proscar, Avodart, and Jalyn are used for the treatment of benign prostatic hyperplasia (BPH), which is an enlargement of the prostate that is not cancerous. BPH is a common condition in men over 40. Propecia is used to treat male pattern hair loss.

The new safety information is based on Health Canada's review of two large international clinical trials: the Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial. The trials showed that the long-term daily use (over 4 years) of finasteride (5 mg) and dutasteride in men aged 50 years and older was associated with a small but statistically significant increased risk of high-grade prostate cancer. The 1 mg finasteride strength (Propecia) was not included in these trials but a potential risk has not been ruled out.

The purpose of the clinical trials was to provide evidence in support of a new use for finasteride and dutasteride: to prevent prostate cancer. Both trials showed that the possible benefits of these drugs in preventing low-grade prostate cancer are small relative to the risk of developing high-grade prostate cancer. Finasteride and dustasteride are not approved for the prevention of prostate cancer in Canada.

The Canadian labels for the brand name drugs have been updated to inform about the increased risk of high-grade prostate cancer associated with these drugs and to emphasize that these drugs are not approved for the prevention of prostate cancer. Updates to the generics will follow.

As noted in the drug labels, before prescribing Proscar, Avodart, and Jalyn, healthcare practitioners should evaluate patients thoroughly to rule out other urological diseases, including prostate cancer as the symptoms of BPH and prostate cancer are similar.

Patients with questions or concerns about their treatment with finasteride or dutasteride should talk to their health professional. Patients should not stop taking their medication unless they have been advised to do so by their health professional. Patients taking these drugs should see their doctor for periodic follow-up evaluations.

Drug labels, or "Product Monographs," contain important prescribing and safety information for health professionals and patients, and are available by search of Health Canada's Drug Product Database.

Report health or safety concerns

To report suspected side effects to these or other health products, please contact Health Canada's Canada Vigilance Program toll-free at

1-866-234-2345, or visit MedEffect Canada for more information on how to report.

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