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.
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
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
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.
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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
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
Her condition has since improved, the ministry said.
third patient is a diabetic who had took doses of Nurofen in addition to the
antibiotic Augmentin and Optalgin.
She has since been
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
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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