Regulators sent a stern letter to HomeoLab listing the problems it discovered during a recent inspection at the homeopathic pharmaceutical manufacturer’s labs. It noted the company’s “significant violations” in the way it manufacturers infant products, which included the inconsistent use of the deadly poison belladonna; commonly known as deadly nightshade.
The strongly-worded letter listed two main problems:
- HomeoLab did not have proper controls in place to check the manufacturing process to make sure its products were consistently made.
- The company failed to test samples to check purity, strength and quality of the products.
These sorts of measures should be complied with in any manufacturing company, but when one of the ingredients is deadly nightshade, it must be carefully monitored to ensure there aren’t excess concentrations of the poison in products.
Homeopathy is an arguably controversial form of medicine where therapists believe that poisonous substances can be used to treat similar ailments when diluted and used in small doses. However, regulators have been investigating some 400 reports of infants experiencing seizures, losing consciousness, and, in extreme cases, dying after using homeopathic products containing belladonna. These symptoms are all consistent with deadly nightshade poisoning.
Regulators previously found the same problem in Hyland’s products, who stopped distributing products in April 2017. However, it refused to recall the products and still offer them as safe for use; rejecting assertions that the belladonna ingredient is linked to infant seizures. Instead, they have been blaming underlying conditions causing severe allergic reactions.
In June 2017, regulators sent a similar warning to Raritan Pharmaceuticals for failing to check the quality of its homeopathic teething products for babies. The FDA slammed Raritan for its apparent inconsistent and varied manufacturing process and failure to test in-process blends to check that products were properly mixed. Last November, Raritan had already recalled three of its products when regulators found inconsistent levels of belladonna in them. These were:
- CVS homeopathic Infants Teething Tablets
- Kids Relief Homeopathic Ear Relief Oral liquid
- CVS Homeopathic Kids Ear Relief Liquid
The regulator reminds parents that teething infants don’t need medication. It suggests the use of much safer alternatives like gentle gum massages and cold teething signs.
Despite this, homeopathic treatments for infants still exist. If parents were fully warned of the risks of infant products containing belladonna, they may probably be much less inclined to give them to their babies. HomeoLab’s Kids teething relief liquid is still available online for use by new-born babies, infants and young children up to nine-years-old.
It boasts key points such as:
- Trusted by mothers
- Safe, effective relief
- No side effects
- No drug interaction
Drug manufacturers, whether they work with synthetic drugs or natural botanic, must ensure that that the manufacturing process is properly controlled and monitored. Needless to say, products should be tested to ensure they’re safe and consistent.