Essentiale Forte N in Pregnancy and Lactation

• Composition: Essential phospholipids (diglyceride esters of choline phosphoric acid) + Vit B1 + B2 + B6 + B12 + E + nicotinamide

Indication

• Nutritional support in the management of damaged liver due to chronic liver disease, liver cirrhosis, fatty liver and intoxication by hepatotoxic substances
• used to normalize the various failures of the liver function

Manufacturers Recommendation

• Preparations from soya beans are largely used in human food, and so far, no events have been reported that would suggest any risk during pregnancy.
• Specific results from investigation are not available, therefore, the use of Essentiale Forte N is not recommended during pregnancy and lactation.

Lactation

• The doses of Vit B1,B2,B6 and B12 are above the rda in lactation but they can be used safely although high doses of Vit B6 may inhibit lactation.

Supporting Use

• Some recommendation and studies do suggest use in toxicosis of pregnancy and gestosis of pregnancy
• Phosphatidyl choline is one of the most important nutrients to consume daily for optimal health, especially if you are pregnant.  PC is found in nuts, seeds, dandelion greens, spinach, organ meats and egg yolks
• oral supplementation of Phospholipid carrying n-3 PUFAs (which is a special characteristic of PLs from marine origin) may play an important role, not only in the elderly, but also during pregnancy and infancy, where DHA provision into the brain is essential for neurological development

Fetal Risk

• No adequate data for phospholipids in pregnancy but reported that if used in solutions for parenteral hyperalimentation, they can cause placental insufficiency with fat deposits resulting in abortions and preterm labor.
• The dose of Vit E and nicotinamide is within the recommended dietary allowance (rda) in pregnancy.
• The doses of other Vitamins are above the rda in pregnancy.
• No fetal harm has been reported with high doses of Vit B12.
• No well – controlled data for Vit B1 and B6 in pregnancy but suggested possible association between high doses of Vit B1 and anencephaly and of Vit B6 and phocomelia and infantile convulsions.

Overall Recomendation

 In view of manufacturers recommendation, it is best to avoid the use of Essentianle in pregnancy

• however, if needed due to complications of Cirrhosis leading to/or nutritional depletion for the fetus, the use may be considered
• no specific monitoring parameter is listed

References:

1. MIMS Gateway
2. http://www.allofdrugs.com/info/essentiale-pregnancy.html
3. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3316137/
4. http://safefetus.com/search.php/index/details/DrugId/1435/TradeName/Essentiale/TradeId/3029