The main intention is to alert individuals who are allergic to cobalt, which is a component of vitamin B12.
Taiwan Food and Drug Administration announced the need for adding precaution of use last month, after evaluating the risk associated with vitamin B12’s use.
In the case of non-prescription OTC products, the package insert should include the statement: “If you have encountered the following circumstances, please consult physicians, pharmacists, assistant pharmacist before usage: individuals who are aware of their allergies towards cobalt.”
The package insert should also state that the product contains cobalt, and that there have been instances where patients allergic to cobalt have developed allergic contact dermatitis.
Similarly, prescription vitamin B12 would also need to state the above, as well as side effects or adverse reactions that can happen to the skin or the immune system based on user reports.
Some of the adverse effects listed include abnormalities in the skin and subcutaneous tissues.
Examples include skin rash, itch, acneiform eruption, angioedema, dermatitis, and erythema multiforme.
There have also been instances of serious allergic reaction or anaphylaxis - which are adverse effects that should be printed on the product label.
Manufacturers should incorporate these adverse effect warnings into their products’ package insert before November 15 this year.
Failure to do so would result in the discontinuation of their drug permit licenses.
Vitamin B12 is key in the central nervous system and instrumental in healthy red blood cell formation.
Vitamin B12 insufficiency has been linked to higher risk of gestational diabetes, according to the S-PRESTO clinical trial conducted in Singapore. This is one of the largest and most comprehensive birth cohort studies in Singapore.
Both vitamin B12 and B6 are also important for fertility, as they are vital for the maturation of oocyte - a cell in the ovary.
Vitamin B12 can be found in poultry, milk, dairy, seafood such as clams, oysters, and cereals that are fortified with the vitamin.
This could also be a reason why vitamin B12 deficiency tends to be common in lacto-vegetarians.
Findings of a study published in the Journal of the Formosan Medical Association in 2021 reported significantly higher frequencies of microcytosis – a sign of iron deficiency anaemia - among lacto-vegetarians.
They are also more likely to have macrocytosis or enlarged red blood cells, as well as blood haemoglobin, red blood cells, and serum vitamin B12 deficiencies than healthy control subjects.
The study involved 280 women, including lacto-vegetarians and healthy control subjects in Taiwan.
