invitation European Medicines Agency It came a day after the announcement American pharmaceutical company It will voluntarily withdraw the drug “Oxpreta” from global markets, according to what Agence France-Presse reported.
Oxpreta is used to treat… Sickle cell diseaseIt is a potentially fatal blood disease that mainly affects millions of people of African, Middle Eastern, or South Asian origin.
He mentioned the agency and its headquarters Amsterdam It: “The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that the license for sale of Oxpreta be suspended.”
She added in a statement: “This step is being taken as a precautionary measure while the data is under review.”
Two studies showed that patients who used Oxpreta experienced a greater number of “vaso-occlusive attacks,” that is, severe pain and possible complications such as: arthritis andKidney failure And cerebrovascular accidents.
The European Medicines Agency was originally studying the risks of Oxpreta as part of an investigation that began in July.
The European Medicines Agency said: “This investigation began when data from a clinical trial showed that the number of deaths was higher with Oxpreta compared to those who took a placebo.”
She added, “Another experiment showed that the total number of deaths was higher than expected, recommending against taking it.”
She stressed that doctors should also ask patients to stop using Oxpreta and “monitor them for any side effects after stopping treatment.”
And he got sick Sickle cells It is a group of hereditary blood disorders that cause abnormalities in… Hemoglobin Oxygen-carrying protein.
Healthy blood cells travel through small blood vessels to carry blood Oxygen To different parts of the body, depending US Centers for Disease Control In the United States.
In a person with sickle cell disease, hemoglobin is abnormal, causing it to become… Red blood cells Hard, sticky, and sickle-like, obstructing blood flow.
Pfizer said on Wednesday that it “will voluntarily withdraw the drug Oxbryta from all markets in which it has been approved for sale.”
She explained that her decision “is based on all the clinical data that currently indicates that the overall benefit of Oxpreta no longer outweighs the risks to patients.”
