Tuesday, June 16, 2009

Viagra in the European Union

In 2008, the Commission of the placing on the market (AMM) European (CHMP) has been tasked to decide on an application for "switch" by the firm Pfizer for sildenafil (Viagra) in disorders of the erection. A "switch" is a transformation from a drug "subject to medical prescription" to drug "not subject to medical prescription. Mid-2008 the CHMP issued a negative opinion and the end of 2008, the firm Pfizer withdrew its request. In 2009 Viagra is still available in the European Union only on medical prescription. 

Several reasons have motivated this unfavorable opinion of the CHMP, including a risk of delayed diagnosis of an underlying disease with symptoms such as erectile dysfunction, such as a coronary artery, a potential use, apart from indications of RCP, especially for recreational purposes, an adaptation of the notice as to information on risks (against-indications, side effects, interactions) is too complicated for use without medical advice. 

Sildenafil exposure to troublesome side effects, even severe, such as cardiovascular disorders (myocardial infarction, stroke, QT prolongation), visual and auditory. The combination with nitrates and calcium channel blockers exposes them to sudden arterial hypotension and cardiovascular disease. Sildenafil is metabolised by the CYP3A4 isoenzyme of cytochrome P450, with a risk of interactions with inducers and inhibitors of this isoenzyme. Sildenafil is an inhibitor of CYP 2C9 isoenzyme of cytochrome. 

In practice, sildenafil is help for some patients with erectile dysfunction, but its use is not commonplace. Faced with a complaint of erectile dysfunction, it is essential to achieve first a minimum balance, such a condition to remove organic or psychological cause or drug. Maintaining the status of medicine "subject to medical prescription” for Viagra will be in this direction. 

Another positive outcome related to the absence of "switch" advertising to the general public for Viagra does not remain "officially" prohibited since such advertising is banned in the European Union for medicinal products "subject to medical prescription".

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