FDA Teething Tablets Warning Echoed by Irish Regulators

Published on October 18, 2016 by Sandy Liebhard

Just weeks after the U.S. Food & Drug Administration (FDA) cautioned against the use of homeopathic teething tablets and gels, regulators in the Republic of Ireland have taken similar action. On October 17^th, the Irish Health Products Regulatory Authority (HPRA) warned that certain teething remedies manufactured in the U.S. could cause infants and children to suffer serious complications, and strongly advised parents to avoid using these products.

None of the U.S.-made teething tablets or gels referenced by the HPRA warning are licensed or sold in Ireland. However, they can be purchased online. The warning a does not include two homeopathic teething products manufactured in Ireland by Nelsons.

Irish parents and caregivers have been advised to dispose of any U.S.-sourced homeopathic teething remedies they may have. Immediate medical advice should be sought if a child experiences any complications following ingestion of these products, including:

• Seizures
• Difficulty breathing
• Lethargy
• Excessive sleepiness
• Muscle weakness
• Skin flushing
• Constipation
• Difficulty urinating
• Agitation

FDA Warning and Fallout

The HPRA’s action was prompted by a warning issued late last month by the U.S.  FDA. The agency is currently investigating more than 400 adverse events, including 10 infant deaths, potentially linked to homeopathic teething pills and gels. In the U.S., these products are sold under various brand-names including Hyland’s and Baby Orajel Natural’s.

Following the FDA’s warning, CVS announced that it was withdrawing all homeopathic teething medications from its retail stores. Affected products included:

• Baby Orajel Naturals Gel for Teething Pain, .33 oz
• Baby Orajel Naturals Gel for Teething Pain Nighttime Formula, .33 oz
• Baby Orajel Naturals Tablets for Teething Pain, 125 Count
• CVS Homeopathic Infant’s Teething Tablet, 135 Count
• CVS Homeopathic Infants’ Teething Liquid, .85 oz
• Hyland’s Baby Nighttime Teething Tablets, 135 Count
• Hyland’s Baby Teething Gel, .5 oz
• Hyland’s Baby Teething Tablets, 13 Count
• Hyland’s Baby Teething Tablets, 135 Count
• Hyland’s Teething Gel, .33 oz

Hyland’s later announced that it would discontinue U.S. sales of its homeopathic teething remedies. The same company announced a teething tablet recall in 2010, after the products were linked to a number of adverse events. The FDA determined that the pills contained inconsistent amounts of belladonna, which can be poisonous if ingested in large amounts.