Pfizer says that it has chosen to withdraw its application to European regulators to market a 50mg dose of its erectile dysfunction blockbuster Viagra as an over-the-counter treatment.

The New York-based drugs giant says the decision has been taken in order to “fully consider comments” from the European Medicines Agency's Committee for the Medicinal Products for Human Use. The latter has expressed concerns that if Viagra (sildenafil) is made available OTC, there would be no medical supervision which could delay diagnosis of possible cardiovascular disease. ED is often one of the first signs of such a problem.

The CHMP is also concerned about potential misuse of the drug, deliberately or otherwise, and it could lead an increase in people taking Viagra recreationally.

Pfizer does not share the CHMP’s concerns and says it believes Viagra “is a suitable candidate for non-prescription supply” and “meets the criteria set out by the European Commission guideline for changing the classification of a medicinal product to non-prescription”. The firm added that “millions of men in Europe are currently circumventing the healthcare system when seeking ED medicines, exposing themselves to unnecessary risks of medicines from uncontrolled sources and the missed opportunity to get important health information from a healthcare professional”.

Rory O’Connor, Pfizer vice president of medical and regulatory affairs, said that since its introduction over a decade ago, Viagra has been used by more than 35 million men worldwide and “has a proven safety profile that has been well established in extensive post-marketing studies and in more than 120 clinical trials,” The company added that the withdrawal of the application “will enable evaluation of further information and additional data that may be required to allow any future assessments under the centralised procedure”.