A fertility drug marketed as Bravelle (Urofollitropin Injection) was the subject of a recall by its manufacturer, Ferring Pharmaceuticals, in October 2015. The recall was announced over concerns that Bravelle’s potency decreased as a result of a shorter than expected half-life.
On October 23, 2015, Health Canada posted a Dear Healthcare Professional letter on its website. In the letter, Health Canada indicated that four (4) lots of Bravelle were the subject of the recall by Ferring.
During testing, decreased potency was noted in the follicle stimulating hormone, or FSH, which would lead to a dramatic reduction in the medication’s effect.
While side-effects associated with the drug are minimal in the short-term, exposure to higher doses does increase the risk of complications in the long-term. Known side effects that have been associated with Bravelle include the possibility of heart problems and ovarian cancer as well as a number of conditions that may affect a woman’s pregnancy.
In addition to the increased risk of pregnancy complications, due to the decreased potency of Bravelle, many women seeking fertility treatments are left with expensive medication that is useless due to the ineffectiveness of the product.