Wednesday, June 16, 2010

US FDA Cautions and ask for a accurate Vitamin D Supplement for Infants

US FDA Cautions on Accurate Vitamin D Supplementation for Infants

The United States Food and Drug Administration on 15 Jun 2010 published a press release on their website alerting medical professionals, caregivers , parents and about liquid Vitamin D supplement US FDA said in the press release , that some of liquid Vitamin D supplement products being sold have droppers which may cause excessive dosing of Vitamin D to infants.

Excessive amounts of Vitamin D can be harmful in case of infants, over dose of vitamin D is characterized by nausea and vomiting, loss of appetite, excessive thirst, frequent urination, constipation, abdominal pain, muscle weakness, muscle and joint aches, confusion, and fatigue, as well as more serious consequences such as kidney damage which may be of irreversible type.

The United States FDA said in its press release that , they have also advised manufacturers of liquid Vitamin D supplements that droppers provided with these products should be clearly and accurately marked for 400 international units (IU). In addition, for products intended for infants, US FDA has recommended that these dropper should not hold more than 400 IU of vitamin D liquid preparation.

Droppers provided with some liquid preparations of Vitamin D supplement could allow parents to accidentally give harmful amounts of Vitamin D to their infant

The American Academy of Pediatrics (AAP) has also recommended a dose of 400 IU of Vitamin D supplement per day to breast-fed and partially breast-fed infants.

This is easy to control when a dropper used to provide a dose , provided by pharmaceutical companies manufacturing liquid dosage form preparations for vitamin D supplement to infant is made such that it do not provide a dose more than 400 IU.

US FDA has recommended peoples to consult with a healthcare provider before giving any of liquid vitamin D supplement products to an infant. US FDA has also asked healthcare professionals and patients to report adverse events or side effects related to the use of these products to the US FDA's MedWatch Safety Information and Adverse Event Reporting Program.

Information about Vitamin D
It is a fat soluble vitamin mainly consisting vit D2 ergocalciferol and vitamin D3 cholecalciferol, Vitamin D refers to D2 or D3 or both.

How vitamin D is produced in human body :
Vitamin D is produced in our body in skin after an exposure to sunlight or ultraviolet light from sun, It is also found naturally in many food items .

Deficiency of Vitamin D causes

Hypocalcaemia , results in to thin, brittle bones, or misshapen bones, and rickets in children
Osteomalacia , osteoporosis. in adults,

Hypocalcaemia is a condition where there is low blood ,serum calcium (deficiency of calcium , calcium is measured clinically as serum calcium level ) it results in to all symptoms associated with calcium deficiency

It is a condition where there is a constant contraction of a skeletal muscle , it is due to low serum levels of calcium such condition is called as titany.

In this situation, the skeletal muscle fibers persistently produce a single and long steady contraction because of they do not get depolarized , it is a summation effect of numerous skeletal muscle contractions which fails to depolarise due to lack of calcium ions resulting in to a single continuous contraction such a contraction is bit painful.

What is the physiological active form of vitamin D

Calcitrol is the physiologicaly active form of vitamin D

Vitamin D cholecalciferol , ergocalciferol are transported to liver where they get converted in to calcidiol which is a prohormone . Calcidiol is then be converted into calcitriol which is the main biological active form of vitamin D.

Calcitriol increases the absorption of calcium into the blood from the gastrointestinal tract,

It decreases the excretion of calcium from body and from blood in to the urine through the kidney, increasing the release of calcium into the blood from bone.

Total summation effect is increase of serum as well as bound calcium level in body.

Harmful effects or Vitamin D toxicity:

Hypercalcaemia , anorexia, nausea, and vomiting , followed by polyuria, polydipsia, weakness, nervousness, pruritus, and ultimately, renal failure. Proteinuria, urinary casts, azotemia, metastatic calcification in the kidneys may develop.

Treatment for Vitamin D toxicity is simply to discontinue the usage or consumption.

So its a potent drug so please consult your healthcare provider before giving it to infant.

No comments: