Teva’s painkilling med to go over-the-counter
Ministry announces painkiller Optalgin may be sold over-the-counter even though some countries bar its completely.
Optalgin pills. Photo: Teva Pharmaceuticals
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
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.
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
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
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.
take Optalgin for chronic conditions will be advised to consult with their
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