The Directorate of Medicines and Pharmacy (DMP) has lifted the temporary suspension on the drug Immuglo 5%, which strengthens the immune system and combats infections, except for patients with primary immunodeficiency.
The decision, announced in a memorandum issued by the Ministry of Health and Social Protection, follows recommendations from the National Pharmacovigilance Committee. The committee met on Nov. 5 to evaluate the immune-related side effects of Immuglo 5% and another immunoglobulin drug, V-Immune 5%.
The memorandum stated that investigations and analyses of new data on the side effects of the two drugs, both of which contain normal human immune serums, supported the lifting of the ban.
The DMP had initially suspended Immuglo 5% as a precaution while allowing continued use of V-Immune 5%. The decision followed reports from the pharmacovigilance committee of increased side effects, including serious adverse reactions linked to the immunoglobulins in both drugs.
The committee has recommended further investigations into the causes of the rising number of reported side effects. Medical experts have suggested that storage issues, stemming from the drugs’ derivation from human blood, may be contributing factors.
Both Immuglo 5% and V-Immune 5% are designed to enhance the body’s immune system by providing antibodies extracted from healthy human blood. These antibodies help reduce the risk of infection, particularly for individuals with weakened immune systems.
The drugs are administered via injection and are suitable for both adults and children. Patients receiving the treatment must be monitored by a physician for side effects, which can include swelling, redness, and pain at the injection site, as well as skin rash and hot flashes.
The DMP emphasized that it will continue active monitoring of all immune serums to ensure patient safety.
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