"As required by the bipartisan FDA Food Safety Modernization Act (FSMA), the U.S. Food and Drug Administration today proposed a rule that would require the largest food businesses in the United States and abroad to take steps to prevent facilities"...
Anemia is a manifestation that requires appropriate investigation to determine its cause or causes. Folic acid alone is unwarranted in the treatment of proof vitamin B12 (liver-stomach concentrate with intrinsic factor) deficiency states, such as pernicious anemia.
As with all preparations containing intrinsic factor, resistance may develop in some cases of pernicious anemia to the potentiation of absorption of physiologic doses of VITAMIN B12 (liver-stomach concentrate with intrinsic factor) . If resistance occurs, parenteral therapy, or oral therapy with so-called massive doses of VITAMIN B12 (liver-stomach concentrate with intrinsic factor) may be necessary for adequate treatment of the patient. No single regimen fits all cases, and the status of the patient observed in follow-up is the final criterion for adequacy of therapy. Periodic clinical and laboratory studies are considered essential and are recommended.
Pregnancy Category C: Animal reproduction studies have not been conducted. It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can effect reproduction capacity. It should be given to a pregnant woman only if clearly needed.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.
Safety and effectiveness in children below the age of 10 have not been established.
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
Additional B12 Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Weight Loss Wisdom
Get tips, recipes and inspiration.