An FDA warning letter has slammed the New Jersey CMO that produced belladonna-treated teething products sold by CVS that the agency last year warned might cause hallucinations and seizures in infants.
The letter, posted Tuesday slams Raritan Pharmaceuticals for failing to test the quality of some of its ingredients and not having manufacturing processes that would ensure consistent ingredient levels. The FDA said that when the agency tested some finished products following during a September inspection, it found excessive levels of belladonna alkaloids in the homeopathic products which were sold by CVS.
The FDA acknowledged that Raritan last year agreed to halt manufacturing and recall three products after intervention by the FDA, but it said at that point that the drugmaker had failed to carefully investigate consumer complaints that the infant teething tablets it produced may have caused seizures in some children.
The agency pointed out that while many homeopathic drugs are manufactured without FDA approval, it has the authority to take action when it finds that products fail FDA standards.
The pathway to the warning label began last September when the FDA sent out a consumer alert warning parents to dispose of homeopathic teething tablets and gels sold by CVS, Hyland’s and others because they posed a potential risk. It said consumers should seek medical care immediately if their child experienced seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating or agitation after using homeopathic teething tablets or gels.
Raritan, a contract manufacturer for Homeolab USA, in November began a voluntary recall of one lot each of three products, CVS Homeopathic Infants' Teething Tablet, Kids Relief Homeopathic Ear Relief Oral Liquid CVS Homeopathic Kids' Ear Relief Liquid
Hyland, which manufactured its own products inhouse, initially responded by insisting its products were safe and then by saying the FDA had not produced any data that would support the agency's contention of a link between homeopathic teething products and adverse effects. But Hyland's told consumers in a separate letter it had decided to stop distributing the products in the U.S. and later recalled its products.
This April, Hyland began a recall of all Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets. At the same time, it insisted that all of them had “met the Company’s safety limit tests and all tested product has been well within an established safety threshold.”
The FDA inspection of the Raritan plant found that facility was not being careful and that some ingredients exceeded the amounts listed on the label. The FDA said the plant had received ingredients without certificates of analysis and was not testing them, or its finished products, to see if they met any standards. When the FDA sampled one lot, it found the material had high variability.
“This variability exposes infants and children who are given your drugs to potentially significant safety hazards from belladonna levels far beyond the labeled content,” the letter said.
The FDA said that as a result of its findings, it could take further steps against Raritan, including refusing “requests for export certificates.”
Editor's Note: This story was updated to reflect that Raritan manufactured homeopathic products only for Homelab USA and sold by CVS, but did not manufacture products for Hyland's.