Health does not withdraw Nolotil, considering that the risk of serious damage is “very low”


On at 16:56


A new evaluation of the drug finds that the incidence of agranulocytosis among people taking it is “very low

Nolotil, the best-selling medicine in Spain, will continue to be dispensed in pharmacies. Health has not accepted the claim of the Association of People Affected by Drugs, which this week has asked the Ministry to “prohibit its prescription” due to the “devastating” side effects it causes in many patients. The group has sued the Spanish Government after collecting some 350 cases of agranulocytosis, an adverse reaction that reduces white blood cells and increases the risk of infections that can be fatal, between 1996 and 2023.

In this context, the Spanish Agency for Medicines and Health Products (AEMPS) has carried out a new evaluation of Nolotil and, as a preliminary conclusion, has determined that the incidence of agranulocytosis among people taking Nolotil is “very low”, in the range of 1 to 10 cases per million users, “in a patient population representative of real clinical practice in Spain, including patients who were receiving treatments for several weeks,” as reported by Health this Friday.

To carry out the analysis, the AEMPS has analyzed the evolution of the consumption of Nolotil, the data on spontaneous reporting of agranulocytosis and the scientific literature published in recent years. Furthermore, following the recommendations issued by the Committee on Safety of Medicines for Human Use (CSMH), held in 2018, a pharmacoepidemiological study in the BIFAP database (Database for Pharmacoepidemiological Research in the Public Environment), which is pending publication.

British origin

Based on all this, the Medicines Agency has “concluded that there are no new findings that change the risk profile” on this serious side effect of Nolotil, which has been known for years and appears in its technical sheet and the prospect. In fact, in 2018 the AEMPS also reviewed the situation, due to the fact that several cases of agranulocytosis were reported, particularly in patients with british originas has happened now, given that the cases collected by the Association of People Affected by Drugs are natives of the United Kingdom, Ireland or the United States who live in Spain.

On that occasion, the Spanish medicines authority concluded that the number of reported cases had increased in parallel with the increase in consumption of the analgesic. And, although it had been suggested that the serious side effect particularly affects people with certain “genetic factors“, there was no data that would allow “either to confirm or rule out more risk in populations with different ethnic characteristics.” That is, they found no evidence that it affects people from northern Europe more, where in several countries (40 worldwide ), the sale of Nolotil is not authorized.

In short treatments

However, the AEMPS issued some recommendations to health professionals, which consist of only prescribing Nolotil in short term treatments, with the minimum effective dose and monitoring the appearance of symptoms compatible with the drop in white blood cells that can cause fatal infections. In addition, it recommended carrying out hematological controls in prolonged treatments, avoiding its use in patients with risk factors and informing the patient that they should interrupt treatment in case of signs of agranulocytosis. Likewise, it was recommended to take special precautions in elderly patients.

And the Ministry of Health now concludes that It is advisable to maintain these recommendations against a serious adverse effect but with a “low frequency of occurrence”. However, he explains that the AEMPS will continue to “evaluate the risk/benefit balance,” as it does with all medications.