Safety – Not Efficacy – Issue for Homeopathic Remedies

Image provided by FDA
Image provided by FDA

Hyland’s is back in the news. The homeopathic company, you may remember, recalled its teething product – a tablet for babies to reduce the discomfort of teething — in 2010 after consumers reported health problems in children consistent with belladonna toxicity. And, you might recognize belladonna by its other name, deadly nightshade, a plant whose berries and leaves are so toxic it has been used as a poison throughout history.

Back in 2010, parents said their children experienced seizures and other symptoms consistent with belladonna poisoning after taking Hyland’s Baby Teething Tablets. These symptoms included seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, and agitation.

The Food and Drug Administration recalled the product in October 2010 citing “reports of serious adverse events in children.”

Belladonna - Image from Kohler's Medicinal Plants - 1887Upon investigation, the agency found real reason for alarm. Its laboratory analysis identified “inconsistent amounts of belladonna” in the tablets. The agency also claimed some tablets contained up to 16x the amount of belladonna that was safe for children.

In its public statement, the agency said “The tablets are manufactured to contain a small amount of belladonna, a substance that can cause serious harm at larger doses. For such a product, it is important that the amount of belladonna be carefully controlled. FDA laboratory analysis has found that Hyland’s Teething Tablets contain inconsistent amounts of belladonna.”

The FDA also said it received reports of children ingesting more that the recommended number of tablets because the containers did not have child resistant caps.

It’s rather unbelievable to us that a company which manufactured tablets for children with “inconsistent” or unsafe amounts of belladonna could stay in business. Nevertheless, after nine months off the market, in July, 2011, Hyland’s announced the return of its Teething Tablets saying “We identified manufacturing processes of Teething Tablets that could be improved to ensure uniformity in dosage. We also used this opportunity to refine the production, packaging and testing protocols on this product.” The company also said, “We have kept all of the same ingredients that have made Hyland’s Baby Teething Tablets effective and safe…”

Now, a Texas woman is claiming that her infant suffered belladonna-type symptoms after ingesting a Highland’s Baby Teething Tablet to soothe teething discomfort. In September 2015, the woman took her eight-month-old infant to the hospital after the child experienced seizures. She claims she would not have administered the tablet had there been appropriate labeling. By this, we assume she means a belladonna warning.

Responding to the incident Hyland’s said in a September 2, 2015 press release: “There is NO scientific link between homeopathically-prepared belladonna, or Hyland’s Baby Teething Tablets, and seizures.”

The company also says “…a 10-pound child would have to accidentally ingest, all at the same time, more than a dozen bottles of 135 Baby Teething Tablets before experiencing even dry mouth from the product.”

Let’s leave aside the question of management competence that permitted “inconsistent” and unsafe amounts of belladonna to be manufactured in a product for infants and children. Let’s also refrain from making a judgement on the claims by the Texas woman. Let’s stipulate that Hyland’s made a good faith effort to correct deficiencies in its product. And, let’s also stipulate that the company will probably respond appropriately if there is a labeling issue.

Our issue is that although some parents firmly — even fervently — believe in the efficacy of homeopathic drops and tablets, like Hyland’s Teething Tablets for babies, homeopathic medicines aren’t tested or evaluated by the FDA.

The FDA: Safety and Efficacy

Many parents swear by the results they’ve obtained from homeopathic medicines such as Hyland’s Teething Tablets and we don’t for a minute doubt them. But it’s important to understand that most scientists consider homeopathy as a pre-scientific philosophy that has essentially zero scientific plausibility.

But that not really the issue. Parents should be free to administer homeopathic medicines to their children…provided the medicine is safe. The problem is that the FDA doesn’t regulate them at all …hence problems like the Hyland’s Teething Tablet recall.

We’re not particularly interested here in reviewing FDA standards for regulating drugs in any detail. It’s not necessary. Those standards include safety – written into the Act authorizing the agency in 1938 – and efficacy – amendments written into the original act in 1968 demanding manufacturers demonstrate their medicines aren’t just safe, they’re also effective.

Homeopathic remedies present a special case. The scientific community dismisses homeopathy as little more than quackery. Clinical studies proving the efficacy of various remedies are non-existent. So, under existing regulatory standards, how should the FDA treat homeopathic remedies?

The agency is currently reviewing its regulatory framework for homeopathic medicines with a view toward bringing them under some type of regulatory umbrella and we think it could easily adopt a standard that focused on safety – the original mission of the agency – while allowing parents to administer homeopathic remedies to their children if they wish.

The objective is to keep children safe. Period.