With this decision, the Medicines Agency intends to allow patients with “serious absorption problems” to continue to benefit from intramuscular injections.
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The National Agency for the Safety of Medicines and Health Products called on patients in a press release on Thursday, September 19, to “prefer the use of vitamin B12 in tablets when the treatment can be taken orally”. Indeed, vitamin B12 (cyanocobalamin) in injectable and drinkable solution from the Zentiva and Substipharm laboratories is currently “under strong supply tension”.
The Agency recommends the tablets to allow patients with serious absorption problems to continue their treatment by intramuscular injection. “The absence of this treatment can lead to a serious risk of anemia in these patients, leading to hospitalization, transfusion and life-threatening prognosis,” specifies the ANSM.
Vitamin B12 in injectable and oral solution “is used by intramuscular (IM) injection in the treatment of vitamin B12 deficiency due to gastrointestinal disease that prevents its absorption (including Biermer’s disease, total gastrectomy, resection of the terminal ileum, Imerslund’s disease)”explains the National Agency for the Safety of Medicines. Orally, “It is indicated in the treatment of deficiencies due to lack of food intake, particularly in strict vegan diets”she added.
The Zentiva and Substipharm laboratories, which market vitamin B12 in injectable (IM) and oral solution, are experiencing supply difficulties. According to them, the situation should be gradually restored. “from November 2024”. Waiting for, “We have asked laboratories to stagger supplies to city pharmacies in order to avoid a stock shortage”specified the ANSM.