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The sexual enhancer and its imitation products may not be freely sold in pharmacies, even in low doses.
(Photo: dpa)
The potency pill Viagra and its imitation products may continue to be sold only on prescription. On Tuesday, a majority of an expert committee from the BfArM drug authority in Bonn rejected the release of the Viagra active ingredient sildenafil in a dosage of 25 milligrams for oral use from the prescription requirement. At first there was no justification for this. Only the minutes of the meeting were published.
The vote of the committee is a recommendation to the Federal Ministry of Health (BMG). The Ministry ultimately decides on the amendment of the Drug Prescription Ordinance. However, since the opinion of the expert committee carries weight, the recommendations are often adopted.
At the beginning of 2022, the committee at the BfArM decided against the release of sildenafil from the prescription – but at that time it was about the normally recommended dosage of 50 milligrams. But then BMG department head Thomas Müller caused a stir at an industry event last fall by saying that he could imagine sildenafil being released into self-medication.
The diamond-shaped blue Viagra tablet was launched 25 years ago by the US pharmaceutical company Pfizer. It was the first oral product for erectile dysfunction and gained worldwide fame shortly after its approval. At its peak, the drug brought in more than $2 billion in annual sales.
Viagra is now distributed by publicly traded pharmaceutical company Viatris, which Pfizer formed in 2020 along with drug company Mylan. Since patent protection for the drug expired in 2013, there have been numerous imitation products on the market. According to the market research institute IQvia, there were currently around 70 different products with the active ingredient sildenafil on the market in Germany.
Tadalafil also remains prescription-only
Viagra is one of the most illegally copied and sold drugs in the world. Curbing the illicit trade is considered one of the key arguments for sildenafil’s prescription-free release. Especially since the tablets of dubious sources of unchecked quality can also be a health hazard – “adulterated” tablets were seized again and again.
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Physicians, on the other hand, argue in favor of a prescription because Viagra also has side effects such as headaches and muscle pain, redness of the skin and dizziness and is not compatible with many medications. In addition, erectile dysfunction could be a harbinger of a heart attack or stroke. If sildenafil is released from the prescription requirement, there will also be no control by the prescribing doctor, so the argument goes.
The effect of sildenafil against erectile dysfunction was discovered accidentally. Pfizer originally developed the active ingredient as a treatment for high blood pressure and narrowed heart disease vessels (angina pectoris). When an erection was found to be a common side effect in male patients during clinical trials, Pfizer focused on the further development of sildenafil as a sexual enhancer.
After sales of sildenafil packs in Germany initially more than doubled after the patent expired in mid-2013, prescriptions have been falling again since 2017. According to data from IQVia, the number of packs fell from more than 1.9 million in 2017 to under 1.6 million packs last year. In addition, sales of sildenafil products have fallen from 80 to 58 million euros over the past five years.
Sildenafil is already available without a prescription in various countries, but in some cases it can only be dispensed by specially trained pharmacy staff, such as in New Zealand. Sildenafil is also freely available in Poland, Great Britain, Switzerland and Norway.
In addition to sildenafil, the majority of the expert committee also spoke out against removing the potency-enhancing active ingredient tadalafil in the 10-milligram dosage from the prescription requirement. The original drug called Cialis from the pharmaceutical company Lilly was approved in the EU in 2002 and meanwhile also has many generic imitators.
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