Injectable and drinkable vitamin B12: prefer tablets to ampoules for oral use

We have been informed by the laboratories concerned that supplies of injectable and drinkable vitamin B12 remain insufficient, and that the situation will not improve before the beginning of 2025 in town pharmacies.

In this context, we remind you that the use of injectable and drinkable vitamin B12 should be reserved as far as possible for patients who need to be treated intramuscularly, or as part of certain chemotherapies.

In conjunction with healthcare professionals, we have reinforced the guidelines for pharmacists and doctors.

Vitamin B12 (cyanocobalamin) in injectable and drinkable solution from Zentiva and Substipharm laboratories is currently under severe supply pressure. We recommend the use of vitamin B12 tablets whenever treatment can be taken orally, to allow continuity of treatment for patients with severe absorption problems requiring intramuscular injections.

Vitamin B12 (cyanocobalamin) in injectable and drinkable solution is used as an intramuscular (IM) injection in the treatment of vitamin B12 deficiency due to gastrointestinal disease which prevents its absorption (notably Biermer's disease, total gastrectomy, resection of the terminal ileum, Imerslund's disease). Orally (by mouth), it is indicated in the treatment of deficiencies due to lack of dietary intake, notably in strict vegan diets.

Laboratoires Zentiva and Substipharm, which market vitamin B12 injectable (IM) and drinkable solutions, are experiencing supply difficulties due to a production stoppage and manufacturing difficulties. According to the information we have received from them, supplies should gradually be restored, and the needs of all patients should be covered from November 2024 onwards.

In this context, we have asked laboratories to stagger supplies to community pharmacies to avoid stock-outs. Supplies to healthcare institutions are being maintained.

As a complement, we recommend vitamin B12 tablets whenever possible. This will enable patients who require intramuscular injections of vitamin B12 to continue their treatment. Failure to do so may result in serious anaemia, leading to hospitalization, transfusion and life-threatening complications.

Patient information
If you usually take vitamin B12 ampoules orally (by drinking them), we ask you to use tablets instead, until supplies return to normal, which is not expected before November 2024. To adapt the dose and frequency of intake, contact your doctor or ask your pharmacist for advice.
Information for pharmacists
Vitamin B12 specialties in injectable and drinkable ampoules are currently under severe supply pressure.
In this context, and until supplies return to normal, which is not expected before November 2024, we ask you to explain the situation to your patients, and to suggest that those who take their vitamin B12 orally temporarily switch to the available vitamin B12 tablets. This will enable patients with absorption problems requiring intramuscular injections to have access to their treatment.
Information for physicians
Vitamin B12 specialties in injectable and drinkable solutions are currently under severe supply pressure, which is not expected to be resolved before November 2024.
We ask you to prescribe vitamin B12 tablets to patients who can take it orally. This should allow access to their treatment for patients with absorption problems (particularly in cases of Biermer's disease, Imerslund's disease, total gastrectomy, terminal ileum resection, etc.) and requiring intramuscular administration.

 

Link to article: https: //ansm.sante.fr/actualites/vitamine-b12-injectable-et-buvable-preferez-les-comprimes-aux-ampoules-pour-lusage-par-voie-orale

Tags: News, Scientific publications