In a recent announcement, the FDA has reiterated its warning to parents against the use of homeopathic teething products, particularly those from Hyland’s, which has chosen to cease production of its teething tablets and gels but has not issued a recall.
It’s a common scenario: when our babies began to drool and fuss, many of us reached for Hyland’s Teething Tablets, convinced that a natural approach was safer than pharmaceutical options. After all, homeopathic remedies are often perceived as harmless, given that their active ingredients are diluted to such an extent that they seem undetectable. What could possibly go wrong?
However, revelations obtained through a Freedom of Information Act request have painted a more alarming picture. The FDA initially took action against Hyland’s back in 2010 when the company voluntarily recalled its teething tablets due to the presence of belladonna, a compound that can be dangerous in larger doses. Lab tests revealed that these tablets contained unpredictable amounts of belladonna, raising concerns about safety.
Reports to the FDA regarding adverse effects linked to Hyland’s products date back to 2006. Since the 2010 warning, there has been a troubling influx of reports detailing severe reactions, including seizures, muscle twitching, loss of consciousness, and even fatalities. One heartbreaking report detailed the death of a 5-month-old boy after using the product.
In September 2016, the FDA cautioned consumers about the potential dangers of homeopathic teething tablets and gels, advising parents to seek immediate medical help if their child exhibited symptoms like seizures or difficulty breathing after use. Following the warning, Hyland’s announced its decision to discontinue its teething products to alleviate confusion among parents, yet they maintained that their products were safe for use.
Despite the company’s stance, the records obtained by STAT indicate over 370 adverse events associated with Hyland’s Teething Tablets or Gel between 2010 and 2016, including eight reported deaths. The FDA continues to assess whether these products contributed to any of these fatalities.
Homeopathic remedies, while regulated by the FDA, do not have to prove their efficacy or safety before entering the market. This lack of oversight has led to consumer outrage, with many parents demanding action from the FDA after their children experienced harmful reactions. One parent, whose child suffered from seizures, implored the FDA to intervene.
On January 27, the FDA issued another warning concerning Hyland’s Teething Tablets, revealing that laboratory tests had found inconsistent and sometimes dangerously high levels of belladonna. They urged consumers to refrain from using these products. While Hyland’s has stopped production, they have not taken the step of a voluntary recall.
The FDA lacks the authority to mandate a recall of homeopathic products and has stated that there is no verified health benefit associated with these teething items. Hyland’s continues to assert the safety of their products, stating on their website that they have not received any evidence contradicting their claims.
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In summary, the FDA’s ongoing warnings regarding Hyland’s Teething Tablets highlight the potential dangers of homeopathic remedies for infants. Despite a history of adverse events, the lack of regulatory power means parents must remain vigilant about the products they choose for their children.