Recent Label Change For These Drugs Made In Canada But Not In U.S., Yet
(Posted by Tom Lamb at DrugInjuryWatch.com)
On August 4, 2011 Health Canada issued this Information Update, "Finasteride (Propecia, Proscar): Potential rare risk of breast cancer in men", which let us know about a possible new drug safety issue.
As background, Propecia, which is a one-milligram dose of finasteride (the active ingredient), is used to treat male-pattern hair loss. Proscar, a five-milligram finasteride pill, is prescribed for benign prostatic hyperplasia or BPH, which is a non-cancerous enlargement of the prostate. Both Propecia and Proscar are made by the drug company Merck. Generic versions of both medications are also available in the U.S. and Canada.
From this Health Canada item we learned:
- Most of these reports of male breast cancer have been in association with the Proscar 5mg pill.
- Patients taking Proscar, Propecia, or any generic finasteride drug should report any changes in their breasts to their doctor. Changes might include breast enlargement, lumps, tenderness, pain or nipple discharge.
- The package insert, or label, for Propecia, Proscar, and several of the generic finasteride products has already been updated in Canada to include information on the potential risk of male breast cancer. Similar label changes to the remaining generic drugs will follow in Canada.
This August 4, 2011 report from CBC News, "Male breast cancer alert for baldness drug", provided this additional bit of information:
Up to March 31, Health Canada received two reports of male breast cancer involving the five-milligram dose and no reports involving the one-milligram dose, the department said in an email.
As of August 12, 2011, however, there had been no announcement by the FDA or Merck about any label revision in the U.S. to add a warning about male breast cancer.
We will continue to monitor this emerging drug safety issue and, in particular, watch to see if there is a corresponding label change for Proscar and Propecia here in the U.S.
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