Friday, February 16, 2024, 17:46
A complaint filed against the Ministry of Health and the Spanish Medicines Agency AEMPS over the prescription of the painkiller Nolotil is currently being heard in Spain’s High Court, the Audiencia Nacional. This drug is banned in the UK and is thought to carry a higher risk of agranulocytosis, a serious side effect that can lead to death, as detailed in the product’s side effect information .
ADAF, an association set up for people who suffer from the negative effects of the use of medicines, acted after the deaths of several patients prescribed Nolotil (one of the brands selling the active ingredient Metamizole) in Spain. . The lawsuit, which was filed last November and reached the attorney general’s office in January, shows that Spanish authorities failed to take this information into account and to carry out “actual, appropriate, up-to-date and responsible pharmacovigilance.” He is accusing the government of
Medical officials say that agranulocytosis occurs very rarely in Spain (approximately 1 in 10,000 people) and that this is related to the length of time that patients have been taking metamizole. However, this drug should be prescribed only if the patient can be followed up. ADAF therefore considers that a serious reckless offense was committed due to “passive” behavior, which caused “harm and even death to some patients”.
The drug has killed 45 people in recent years and affected 125 other patients, according to the group’s data. ADAF provided evidence of harm caused by the drug and communication of adverse events to AEMPS and private companies from the medical records of a “wide range of people” affected in Spain (both Spanish nationals and foreign patients). . . According to legal sources consulted by the European Press Agency, which has access to the case, there have been several complaints from individuals in this regard, and a parallel analysis is underway at the Madrid public prosecutor’s office.
ADAF said that many officials from the AEMPS, which is responsible for pharmacovigilance in Spain, and various health authorities “are not acting responsibly in their duties because they have not alerted the medical and health community to urgent matters such as an immediate ban on prescriptions.” “It has not been carried out,” he claims. In Spain, the sale of products containing metamizole to foreigners is prohibited in countries such as the United States, United Kingdom, Ireland, Sweden, Japan, and Australia.
On December 1, the day this incident was reported in the media, AEMPS issued a statement announcing that it would maintain its recommendations for metamizole to prevent the risk of agranulocytosis after conducting a new review of metamizole. did. Similarly, SEFAP, the Spanish Association of Primary Care Pharmacists, claimed that “there is no new evidence that changes the risk profile of this drug.”
The group that filed the lawsuit believes authorities are “turning a blind eye” and that many people have “died and suffered very serious side effects.” Citing the alleged criminal conduct, the group said it “found gross recklessness and criminal conduct.” These include, among other things, the omission or deliberate concealment of drug safety information, the failure to conduct appropriate and responsible pharmacoepidemiological studies, and the inactivation of safety and precaution protocols. ”
“Why in Spain, despite the signs and warnings in pharmacovigilance, do AEMPS and medical and pharmaceutical companies choose to issue small information memos that they know are not being complied with?” Group also said:
The group said this serious situation was particularly affecting the British public and that there had been a “lack of attention to, or disregard for, published independent research warning of under-reporting and risks, as well as errors in prescriptions in general”. It emphasizes that.
In 2018, the data sheet for metamizole was reviewed by AEMPS following a case report of agranulocytosis, specifically in a patient in the UK. The regions in Spain with the largest numbers of British residents are Andalusia, Levante (Costa Blanca), the Balearic Islands, and the Canary Islands. The study’s conclusion was that the increase in cases paralleled an increase in the number of people using the painkiller, which is the most widely used treatment of its kind in Spain.
Experts believe that there are no data to confirm or rule out the incidence of genetic factors that explain differences in the appearance of the disease depending on the country of origin. Nevertheless, tourists are advised not to prescribe Nolotil or Buscapina compositum, two brands whose active ingredients are sold, ADAF said.