Teva’s painkilling med to go over-the-counter

After three months of deliberations with experts, the Health Ministry announced Sunday that the painkilling drug Optalgin may be sold over-the-counter even though some countries bar its use completely and others allow its sale only by prescription.

The decision follows three recent cases in which patients suffered rare complications from the drug, known generically as dipyrone and sold commercially by Teva Pharmaceuticals as Optalgin.

The rare complication that aroused fears about the drug is called agranulocytosis, an acute condition involving a severe and dangerous leukopenia (lowered white blood cell count). People with this condition are at very high risk of serious infections due to their suppressed immune system.

Its sale is barred in the US (since 1977), Canada, Britain and some other countries; in most European countries, it is registered as a prescription-only drug, but in Israel, Mexico, Brazil and Spain, for example, it is a non-prescription drug, the ministry said.

Although there have been reports in world medical literature of serious side effects and even deaths in a small number of cases involving dipyrone, risk of complications ranges between one per 20,000 to one per 1 million cases, the ministry said.

In any case, any painkiller can cause side effects and complications, and taking Optalgin out of the over-the-counter category or barring its use completely could shift use to other drugs. The most common side effects of the alternative medication include liver damage and bleeding.

The ministry said there was no evidence to consider changing its preliminary decision last August such that a doctor’s prescription be required for buying Optalgin. It explained that restricting sales would lead to the abuse of other over-the-counter analgesics that if overdosed can cause complications and even death but are safe if taken properly.

Patients who take Optalgin for chronic conditions will be advised to consult with their family physicians.

In addition, a peer-reviewed research study on Optalgin’s side effects will be conducted at the Israel Center for Diseases Control and Prevention. Doctors will from now on be required to report any serious side effects of the drug to the ministry.

The ministry concluded in a 12-page document that it was difficult to explain such wide differences in complications from use in the drug in various Western countries. If reporting on side effects leads to new information, the ministry said, a new evaluation will be held.