Optalgin use will remain over-the-counter for now

By
August 22, 2012 23:38

Health Ministry decision follows 3 recent cases of patients suffering rare complications from the painkiller.

Optalgin pills.

Optalgin pills Teva pharmaceuticals 390. (photo credit:Teva Pharmaceuticals)

The Health Ministry, after a discussion by a panel of experts, decided on Wednesday not to prohibit the use of over-the-counter painkiller Optalgin or to make it a prescription drug.

Its sale is barred in the US, Canada, Britain and some other countries.



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The interim 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 complications involved a sudden decline in the patients’ white blood cell count and signs of infection.


All three of the patients – two of them from Kalansuwa – had taken Optalgin in liquid or pill form, for which no prescription is required.

Dipyrone use was barred in the US in 1977. In most European countries, it is registered as a prescription-only drug, but in Mexico, Brazil and Spain, for example, it is a non-prescription drug, the ministry said.

Although there have been reports in the 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 whose possible – and more common – side effects include liver damage and bleeding.

In the first case, the patient had taken Acamol and Nurofen in addition to Optalgin – all painkillers that reduce fever; his condition has since improved. The second patient suffers from serious chronic diseases; she developed stomach aches, diarrhea and headaches and took other drugs besides Optalgin.

Her condition has since improved, the ministry said.

The third patient is a diabetic who had took doses of Nurofen in addition to the antibiotic Augmentin and Optalgin.

She has since been discharged.

There was a fourth “suspected case” at Soroka University Medical Center in Beersheba, the ministry said, in which the Beduin patient from an unrecognized settlement was released a month ago. Her case was looked into by Soroka doctors and a district health officer.

“The involvement of Optalgin cannot be ruled out,” the ministry said. “None of the cases involved taking only Optalgin; they were patients with chronic diseases who took a number of drugs at the same time. Thus we have decided at this stage not to prohibit the use of the drug, because there is no factual basis to change our policy regarding this drug. In general, it is recommended that patients consult with their doctor before taking drugs for pain.”

The ministry encouraged doctors to report any suspicion of side effects involving white blood cell counts and Optalgin or other drugs. It will continue to examine and follow up on cases in which Optalgin is suspected of causing side effects, the ministry said.

The ministry has investigated rumors that the Optalgin in the four cases was counterfeit, but after tests, none of the pills was found to be fake.
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