Homeopathic remedies harmed hundreds of babies

https://www.statnews.com/2017/02/21/hylands-homeopathic-teething-fda/

Homeopathic remedies harmed hundreds of babies, families say, as FDA investigated for years
By Sheila Kaplan @bySheilaKaplan
February 21, 2017

Case 7682299: Aug. 1, 2010. A mother gives her toddler three homeopathic pills to relieve her teething pain. Within minutes, the baby stops breathing.

“My daughter had a seizure, lost consciousness, and stopped breathing about 30 minutes after I gave her three Hyland’s Teething Tablets,” the mother later told the Food and Drug Administration. “She had to receive mouth-to-mouth CPR to resume breathing and was brought to the hospital.”

The company, Hyland’s, promotes “safe, effective, and natural health solutions” that appeal to parents seeking alternative treatments. But the agency would soon hear much more about Hyland’s teething products. Staff at the FDA would come to consider Case 7682299 one of the luckier outcomes.

A review of FDA records obtained by STAT under the Freedom of Information Act paints a far grimmer picture: Babies who were given Hyland’s teething products turned blue and died. Babies had repeated seizures. Babies became delirious. Babies were airlifted to the hospital, where emergency room staff tried to figure out what had caused their legs and arms to start twitching.

Over a 10-year period, from 2006 to 2016, the FDA collected reports of “adverse events” in more than 370 children who had used Hyland’s homeopathic teething tablets or gel, a similar product that is applied directly to a baby’s gums. Agency records show eight cases in which babies were reported to have died after taking Hyland’s products, though the FDA says the question of whether those products caused the deaths is still under review.

(The agency is also investigating two other deaths tied to teething remedies but declined to confirm the manufacturer of the products or provide the case reports.)

Following an FDA warning in September, Hyland’s said that it would no longer manufacture the teething products. But they remained on some store shelves for months, and are still available on the internet. They likely continue to be used in homes nationwide.

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Homeopathy has become a multibillion-dollar industry. Its products are big sellers around the world, and popular with adherents from Cher to Prince Charles. The industry also has political clout: It has been able to exempt itself from many rules proposed by Congress and the FDA over the years.

Unlike pharmaceutical company-produced drugs, homeopathic products don’t have to prove that they are effective at treating anything in particular before going on the market. It is left to the FDA’s drug division to determine whether they are unsafe after they are on the market — a difficult task since the adverse event reports are generally considered to represent only a fraction of the actual incidents and may lack sufficient information to allow for thorough investigations.

“If I’m working in the emergency room and I have a family that comes in with a seizing infant, I may not have the wherewithal to get the history of homeopathic use,” said Dr. Edward W. Boyer, a toxicologist in Harvard Medical School’s emergency medicine department.

In some cases, parents assume that products described as natural remedies, as is the case with Hyland’s tablets and gels, could not possibly result in complications, and never mention their use to a doctor. Without sufficient evidence of a problem, the FDA lacks what it needs to use the enforcement tools it does have.

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In investigating Hyland’s teething products, the FDA focused on an ingredient known as atropa belladonna, an herb known colloquially as “deadly nightshade.”

In diluted form, the substance is not expected to pose any health risk. In 2010, however, FDA inspectors who examined Hyland’s facilities criticized the company for substandard manufacturing practices and found inconsistent levels of atropa belladonna in its products.

The agency issued a public warning, noting “reports of serious adverse events in children taking this product that are consistent with belladonna toxicity.”

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In September 2016, the FDA announced that it was investigating more adverse events reports and recommended that consumers stop using Hyland’s and other homeopathic teething products and dispose of any in their possession. Some stores, including Target and CVS, which sold Hyland’s and other homeopathic teething products, pulled them in response.

The FDA also asked Hyland’s to recall its products again. But this time Hyland’s stood its ground, and the agency has no authority to enforce a recall of homeopathic products.

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Several weeks ago, on Jan. 27, the FDA issued another warning, saying that laboratory analysis of Hyland’s teething tablets found levels of belladonna “sometimes far exceeding the amount claimed on the label.” The agency warned consumers not to use the products and to seek medical care immediately if their child has seizures, difficulty breathing, lethargy, muscle weakness, or other problems after using homeopathic teething products.

The FDA also said there was no evidence that they actually worked.

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One problem the FDA has in doing so is a matter of staffing: The agency has a medical officer review each report from manufacturers, but it doesn’t have someone who can routinely follow up with the patient, the patient’s family, or physician for missing records necessary to take a serious enforcement action.

“Is it fair to criticize FDA for the time lag between 2010 and now?” says Patricia Zettler, a former FDA counsel and associate law professor at Georgia State University. “I think the agency is in a tough position, with these kinds of products and with adverse event reports in general. They are not necessarily a perfect indication of something happening with a drug.”

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Outraged by the standoff between FDA and Hyland’s, Connecticut Democratic Representative Rosa DeLauro introduced a bill last week called the Recall Unsafe Drugs Act. The proposal would give the FDA mandatory recall authority over homeopathic products and drugs.

“Hyland’s refusal to recall its teething tablets, despite numerous health and safety warnings from the FDA, is downright shameful,” DeLauro said, adding that the company “is choosing instead to prioritize the company’s profits and reputation before the safety of our children.”

“As it stands the FDA would have to go through an arduous legal process to take action against manufacturers such as Hyland’s. This is unacceptable and threatens the health and safety of American families.’’

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