SEXUAL DYSFUNCTION AFTER PROPECIA FIRST REPORTED IN EUROPE
Early reports of persistent sexual dysfunction after Propecia first surfaced in Europe. In 2006, The Medical Products Agency (MPA), the Swedish national authority responsible for regulation and surveillance of the development, manufacturing, and marketing of drugs and other medicinal products began investigating reports of persistent sexual dysfunction side effects. This investigation followed case reports of sexual dysfunction that continued after Propecia was discontinued. In 2008, the Swedish Medical Products Agency concluded their safety investigation of finasteride, (Propecia) and advised that finasteride may cause irreversible sexual dysfunction. In 2009, the Swedish Agency’s updated safety information listed difficulty in obtaining an erection that persists indefinitely, even after the discontinuation of finasteride, as a possible side effect of Propecia.
In 2008, Merck & Co. changed the Propecia label in Sweden to include the following warning: In addition, the following have been reported in post-marketing use: persistence of erectile dysfunction after the discontinuation of Propecia.
Also, the United Kingdom’s Medical and Healthcare Products Regulatory Agency (MHRA) cited reports of erectile dysfunction that persisted once use of finasteride had been discontinued. Merck & Co. included the following warning in the United Kingdom for Propecia: In addition, the following have been reported in post-marketing use: persistence of erectile dysfunction after discontinuation of treatment with Propecia.
Similar labeling changes were made in March 2010 in Italy. For a period of time there was a discrepancy between European and North American warning labels regarding the risks of developing persistent sexual side effects from taking Propecia. It took 2 years before Merck revised the United States’ warning in consumer and medical leaflets to include erectile dysfunction that may persist after stopping finasteride. In April 2011, Merck finally strengthened the Propecia warnings to include similar language to the European labels.
Propecia attorneys at the Oracle Law Groupare currently investigating cases involving persistent sexual dysfunction following the discontinuation of Propecia. Oracle Law Group has experienced personal injury attorneys with over 28 years of experience in representing people injured from unsafe products. If you or a loved one has suffered an injury after taking Propecia, please contact one of our experienced dangerous drug attorneys for a free consultation.