Health Ministry says it would consider application to make Viagra a nonprescription drug

But Israel "won't be the first country" to do so, says chief pharmacist Batya Haran.

By JUDY SIEGEL-ITZKOVICH
viagra teva 88 298 (photo credit: Bloomberg)
viagra teva 88 298
(photo credit: Bloomberg)
If the Pfizer pharmaceutical company asked for permission to market Viagra - the erectile dysfunction (anti-impotency) drug - without a doctor's prescription, the Health Ministry's pharmaceutical division will consider it, chief pharmacist Batya Haran told The Jerusalem Post on Thursday. "On principle, we don't take such initiatives of changing conditions of sales and eliminating restrictions," she said. "But if the company comes and requests turning Viagra [or other erectile dysfunction drugs] into over-the-counter [OTC] drugs, we will discuss this." The Post asked Haran if the ministry had a policy on changing the status of such drugs. Viagra (sildenafil citrate) is generally known to be safe, except for specific cases. These include men who already take cardiac drugs containing nitrates such as nitroglycerin for angina pectoris (chest pains due to an inadequate supply of oxygen-rich blood to the heart). Nitroglycerin works by increasing nitric oxide, so men who take nitroglycerin and Viagra together could get into trouble (heart attacks) from the additional nitric oxide. Less seriously, Viagra can have an effect on color vision, causing men to see the world with a bluish tinge for hours. It may also trigger headaches, as it opens up arteries in the brain's lining and causes excess pressure. A minority of Viagra users get painful, long-lasting erections (priapism) and have to see a doctor urgently to solve the problem. Another complication occurs in some men, especially younger ones, who do not suffer from impotence but take it for psychological reasons and end up with dependency on the blue pill. They become unable to maintain an erection without taking it. Weighed against these potential problems is the fact that hundreds of Internet sites and many illegal dealers sell "Viagra" - either the authentic pills, harmless placebos or pills that contain potentially dangerous active ingredients. In this case, the purchasers, who buy the pills without a doctor's permission or prescription, may endanger themselves or just spend a lot of money on a useless pill. The ministry issued a warning only last week about the dangers of purchasing "Viagra" and other pills from unlicensed suppliers. In addition, numerous men suffering from impotence are ashamed to ask their family doctor for a prescription for an erectile dysfunction drug, and especially to have it listed on their health fund's computerized medical file for all physicians to see. They go to private doctors, paying a high fee, to obtain a prescription, instead of a health fund physician. Viagra has been taken by 35 million men since it was approved by the drug authorities and put on the market around the world a decade ago. Pfizer announced Thursday that at the last minute, it canceled its application to the European drug registration authorities for permission to sell Viagra without a prescription. "Pfizer is certain that Viagra 50 mgs. is suitable as an over-the-counter drug that would be supplied by a licensed pharmacist without a prescription," the company said, "in accordance with the criteria defined by the EU for changing the drug's status to OTC. But we decided to call back our request in order to fully examine the various positions that were raised in the Committee for Medicinal Products for Humans (CHMP) of the European Medicines Agency (EMEA). This will make possible the examination of additional information that may be demanded in the future to assess [our request] that will be filed in the future. The CHMP has stated that Viagra is safe for use and should be taken in accordance with the instruction leaflet for the doctor." It is believed that Pfizer wants to be careful to avoid users' lawsuits that could follow complications as a result of OTC status for Viagra. In the past, the ministry has made conditions for drug sales more lenient only in an emergency, Haran said. "We won't be the first country to allow OTC use of Viagra; we want to see what happens in other countries."