The case of the death of the young girl who took Optalgin and the report that this is the second case this year in Israel, caused public panic over the question of the safety of taking the popular pain reliever.
Is the medicine that calms headaches and forgets the pain for a moment, really so dangerous and can cause our death? And if so, how does the Ministry of Health allow its sale to the public?
Optalgin, from the Teva company, is the trade name of ‘Diferon’, and according to estimates, it is one of the best-selling drugs in Israel.
The drug may cause a serious side effect called agranulocytosis, which causes a sharp decrease in the number of white blood cells and severe damage to the immune system, exposing those affected by it to an increased risk of infections.
This is a rare side effect. The risk in the world population is currently estimated at about 0.2-2 cases per million days of use, of which 7% are fatal.
That is, in a country the size of Israel, if each of the residents took one pill a month, a maximum of ten people would die here per year as a result.
Is it better to use other pain relievers? It turns out that paracetamol can also cause this side effect, and any painkiller can lead to problematic side effects.
However, due to the risk involved in taking the drug, dozens of countries around the world, including the USA, prohibit the use of Opthalgin. In other countries, the drug is only given with a doctor’s prescription. In Israel, it is an off-the-shelf drug that can be bought without any supervision.
Prof. Peter Schonhofer, an expert in clinical pharmacology from Bremen, Germany, previously claimed in an interview he gave to Yediot Ahronoth following another case of death from taking Otelgin in Israel, that the drug is much more dangerous than claimed.
In the 1980s – the period when the IAAA study was conducted – he was the head of the department for safety in drug marketing at the Ministry of Health in West Germany, and by virtue of his position he was responsible for investigating the safety of Diferon.
According to him, it is not a one in a million side effect, but one in a thousand. “The incidence of the phenomenon is much higher, and is actually one case per 1,000 users per year, because there is underreporting in the reporting systems. Indeed, a Swedish study published in 2002 found that the incidence of this side effect is one case per 1,000 – users per year.”
The Ministry of Health considered making Optalgin a prescription drug a decade ago, but in the end, a committee established to discuss the issue decided against it – while recommending that chronic patients consult a doctor before using it.
The Ministry of Health decided to recommend that chronic patients consult a doctor before taking painkillers, as a general recommendation. It was also decided to encourage doctors to report side effects from taking medication, and not make it a prescription drug on the grounds that these are complex and rare cases.
It should be noted that in its response Teva, the company that manufactures Optalgin, stated that “Diferon, the active ingredient in Optalgin, has been marketed in Israel and in many countries around the world for decades and many millions of patients use it, every year, for pain relief – effectively and safely. It should be emphasized that Optalgin meets the requirements The strictness of the Ministry of Health, as well as of other central health authorities in the world.”
What is said in the article should not be considered a substitute for professional medical advice