FDA Warns Elevated Levels of Belladonna in Homeopathic Baby Products

Homeopathic baby products were found to contain inconsistent levels of belladonna which can harm the baby, FDA warning.

Highlights

Homeopathic baby products contain elevated levels of belladonna.
The United States Food and Drug Administration (USFDA) has confirmed the inconsistent levels of belladonna present in the homeopathic tablets through a lab analysis.
FDA warn consumers to avoid giving belladonna containing products to their children and to dispose if there is any possession.

The United States Food and Drug Administration (USFDA) has recently found inconsistent amounts of belladonna in homeopathic baby products. The quantity of belladonna in the product is found to exceed far more than the quantity mentioned in the label.

Using homeopathic teething tablets containing belladonna may pose a risk to infants and children considering this, Standard Homeopathic Company in Los Angeles, the manufacturer of Hyland’s homeopathic teething products was found to recall the product.

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‘FDA recommends consumers to stop giving their babies homeopathic products containing belladonna.’

The FDA has recommended that consumers must stop using these products marketed by Hyland’s immediately.

Similarly, in November 2016, Raritan Pharmaceuticals has also recalled three belladonna-containing homeopathic products, out of which two were marketed by CVS.

Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, said, “The body’s response to belladonna in children under two years of age is unpredictable and puts them at unnecessary risk.”

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”We recommend that parents and caregivers not give these homeopathic teething tablets to children and seek advice from their health care professional for safe alternatives.”

The safety and effectiveness of the homeopathic teething products have not been evaluated or approved by the FDA. The agency is not aware of the benefits which are labeled to relieve teething symptoms in children.

Medical care must be immediately considered if the child experiences

Seizures
Breathing difficulty
Lethargy
Constipation
Excessive sleepiness
Skin flushing
Difficulty in urination

A safety alert was originally issued by the FDA in 2010 that recommended Hyland’s teething tablet which contains belladonna.

Belladonna Alkaloid Combinations and Phenobarbital

This medication is an anticholinergic and barbiturate combination, prescribed for Irritable Bowel Syndrome and intestinal inflammation.

More than 400 reports of adverse events linked to belladonna teething products were received by the agency.

In September 2016, the FDA warns the use of such products after receiving adverse events.

The American Academy of Pediatrics recommends to gently rub the gums of the child without your finger instead of using teething tablets and gels.

Belladonna
Atropa belladonna is a bushy herb of the nightshade family. It is commonly referred to as the deadly nightshade and contains tropane alkaloids.

Belladonna is commonly used for relieving pain, treatment of motion sickness, treating menstrual problems and peptic ulcer.

References:

FDA confirms elevated levels of belladonna in certain homeopathic teething products - ( http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm538684.htm )

Source-Medindia