Vp-ch-pnv Recall
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Questions & Answers
Side Effects & Adverse Reactions
WARNING
Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
WARNING
Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including an increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
VP-CH-PNV is indicated for the distinct nutritional requirements of patients in need of PRENATAL/POSTNATAL dietary supplementation as determined by a licensed medical practitioner.
VP-CH-PNV should be administered under the supervision of a licensed medical practitioner.
History
There is currently no drug history available for this drug.
Other Information
VP-CH-PNV is an orally administered PRENATAL/POSTNATAL prescription folate / obstetrics medical food specifically formulated for the dietary management of patients with unique nutritional needs requiring increased folate levels.
VP-CH-PNV should be administered under the supervision of a licensed medical practitioner.
Daily Values not established for patients with unique nutritional needs who are in need of supplementation as directed by a licensed medical practitioner.
Other Ingredients: Carmine, Ethyl Vanillin, FD&C Blue #1, FD&C Red #40, Gelatin, Glycerin, Natural Creamy Orange Flavor, Purified Water, Soybean Oil, Soy Lecithin, Titanium Dioxide, Yellow Beeswax.
This product contains fish (tuna) and soy. This product also contains carmine and bovine gelatin.
FOLATE REGULATION
The term "folate" are B vitamins that include folic acid and any forms of active pteroylglutamates regardless of the reduction state of the molecule. Folates, or vitamin B9, are primarily hydrolyzed in the intestinal jejunum and the liver to the active circulating form of folate, l-methylfolate, with an intermediate stable form, 5,10-methylenetetrahydrofolate.
Individuals with genetic polymorphisms for the genes coding methylenetetrahydrofolate reductase (MTHFR) may not be capable of utilizing or metabolizing folic acid adequately for the vitamin B12 dependent methylation cycle.
Folic acid, including reduced forms1 such as folinic acid, may obscure pernicious anemia above 0.1 mg doses, and must be administered under the supervision of a licensed medical practitioner.
The 1971, 1972, 1973, 1980, 1984, 2000, and 2010 Federal Register Notices addressed this concern while establishing that increased folate was proper therapy in megaloblastic anemias - specifically where homocysteine levels were elevated or risk of neural tube defects (NTDs) was at issue. The Federal Register Notice of August 2, 1973 (38 FR 20750) specifically states that:
Dietary supplement preparations are available without a prescription (21 CFR 121.1134). Levels higher than dietary supplement amounts are available only with a prescription.
Folic acid - including reduced forms, may be added to medical foods as defined in section 5(b)(3) of the Orphan Drug Act (21 USC 360ee(b)(3)), or to food (21 CFR 172.345).
Sources