Following an investigation of its manufacturing facility by the U.S. Food and Drug Administration (FDA), Standard Homeopathic Co. announced October 24 that it is voluntarily pulling its popular Hyland’s Teething Tablets from all retail shelves. Although Standard Homeopathic maintains that the products are safe, the 107-year-old company said it is initiating the recall “in an abundance of caution” after the FDA identified problems in the manufacture of its Teething Tablets.
In a warning issued October 23, the FDA advised consumers not to use Hyland’s Teething Tablets and dispose of any of the product in their possession. Hyland’s Teething Tablets contain a small amount of belladonna, which can cause serious harm at larger doses. The FDA reported it had found inconsistent amounts of belladonna in the product during a laboratory analysis. The agency also said it had received reports of serious adverse events in children taking Hyland’s Teething Tablets “that are consistent with belladonna toxicity.”
Hyland’s Teething Tablets is an over-the-counter homeopathic product intended to provide temporary relief of teething symptoms in infants and children. In a statement, Standard Homeopathic said its own in-depth analysis, a comprehensive review of the company’s adverse event report log and more than 85 years of safe usage make it confident that Hyland’s Teething Tablets are safe for babies and kids.
“We initiated this voluntary recall to ensure our consumers know that their families’ safety and health are our top priorities,” said Mark Phillips, PharmD, president and chief pharmacist of Standard Homeopathic Co. “We are committed to maintaining and deserving the trust they have placed in Hyland’s. We have worked for 107 years to build relationships with our consumers. We intend to preserve that tradition of trust.” The recall affects all Hyland's Teething Tablets products.
According to the Standard Homeopathic website, homeopathy is a system of medicine based on the observation that high doses of pharmacologically active substances cause symptoms when administered to healthy individuals. These same substances, when prepared in very dilute form, may relieve similar symptoms in conditions resulting from different etiologies. In simple terms, homeopathy in based on the premise that like cures like. Homeopathic products are regulated under the Food, Drug and Cosmetic Act and must go through a premarket monograph approval process with the Homeopathic Pharmacopoeia Convention of the United States (HPCUS).
The FDA advised consumers to consult their health care professional if their child experiences symptoms such as seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using Hyland’s Teething Tablets.
Moms jump in to the conversation
The Internet lit up with comments from parents after the Hyland’s Teething Tablets recall was announced. Some voiced concern over the product’s manufacturing inconsistencies. “If the amounts are inconsistent, then it may not be safe. Mine went straight into the trash and I won’t be buying more,” wrote one parent on Babble’s Strollerderby blog.
Still, many argued that because homeopathic products contain very minute amounts of active ingredients, including belladonna, it would be almost impossible to overdose on these products. Wrote one mother on the Mothering website: “It sounds like uninformed alarmism to me. Homeopathic remedies are among the safest forms of medication. I wouldn't worry about it at all. Matter of fact, I just gave my toddler some Hyland’s a few minutes ago, as she's teething and having trouble sleeping.”
The Facebook page for Hyland’s Teething Tablets—which boasts some 2,800 fans—also came alive with user discussion following the recall announcement. Most messages posted voice support for the safety and efficacy of the product. Wrote one fan: “I have been using these for four years, never had a problem. Even when my oldest found them in the diaper bag and ate half the bottle, he was fine.”
In its press release, the FDA said it had received reports of children consuming more than the recommended dose of Hyland’s Teething Tablets because the product does not have a child-resistant cap.
FDA gets tough on homeopathics
Although Standard Homeopathic sells a wide range of homeopathic products, the Hyland’s Teething Tablets recall have a significant negative effect on the company’s sales and reputation. Hyland’s Teething Tablets are among the most popular products for the company, which has been actively targeting the children’s market with its Hyland’s Teething Tablets, Calms Forté 4 Kids and Sniffles ‘n Sneezes 4 Kids homeopathic products.
Over the past several years, the FDA has been more aggressively scrutinizing the safety of homeopathic and dietary supplement products. The agency’s actions are often linked to adverse event reporting. In June 2009, the agency issued a warning about the homeopathic cold product Zicam after receiving adverse event reports that the product was linked to a loss of smell in some consumers who used the homeopathic remedy. Matrixx Initiatives pulled Zicam from the market later that month even as it maintained the product was safe.
According to Nutrition Business Journal etimates, U.S. sales of homeopathic products grew 10% to $870 million in 2009.