فاس نيوز ميديا جريدة الكترونية جهوية تعنى بشؤون و أخبار جهة فاس مكناس – متجددة على مدار الساعة
The European Medicines Agency (EMA) announced on Thursday the suspension of sales of “Oxpreta,” a medication designed to treat sickle cell disease produced by Pfizer, urging doctors to cease its use.
This decision came just one day after the American company announced its voluntary withdrawal of the drug from global markets.
“Oxpreta” is used to treat sickle cell disease, a life-threatening blood disorder primarily affecting millions of individuals of African, Middle Eastern, or South Asian descent.
The agency, headquartered in Amsterdam, confirmed that the Committee for Medicinal Products for Human Use (CHMP) recommended the suspension of the drug’s marketing authorization as a precautionary measure, as data is currently under review.
Clinical studies indicated that patients using “Oxpreta” experienced a higher incidence of vaso-occlusive crises, which can lead to severe complications such as joint inflammation and kidney failure.
The EMA launched an investigation in July after data revealed an increase in mortality rates among patients taking “Oxpreta” compared to those receiving a placebo.
As part of this investigation, the agency recommended that patients stop using “Oxpreta” and advised doctors to monitor patients for any potential side effects following the cessation of treatment.
Sickle cell disease comprises a group of genetic disorders affecting hemoglobin, the protein responsible for oxygen transport in the blood. In affected individuals, hemoglobin transforms into an abnormal shape, causing rigidity and viscosity in red blood cells, which impedes normal blood flow.
Pfizer confirmed that it would withdraw “Oxpreta” from all approved markets, stating that the decision is based on clinical data indicating that the overall benefits of the drug no longer outweigh the risks to patients.
source: fesnews media
