After Teething Tablets Recalls & Warnings, FDA Cracks Down on Homeopathic Drugs

Published on December 21, 2017 by Laurie Villanueva

The U.S. Food & Drug Administration (FDA) announced this week that it would be taking a new regulatory approach to homeopathic drugs.

The new initiative follows several teething tablets recalls for homeopathic products that  the agency said posed a risk to infants and children.

FDA to Take Risk-Based Approach to Homeopathic Drugs

According to a statement published on December 18th, the FDA’s new risk-based approach is aimed at addressing situations in which:

  • Homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits.
  • Situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices.

“In recent years, we’ve seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer. In many cases, people may be placing their trust and money in therapies that may bring little to no benefit in combating serious ailments, or worse – that may cause significant and even irreparable harm because the products are poorly manufactured, or contain active ingredients that aren’t adequately tested or disclosed to patients,” said FDA Commissioner Scott Gottlieb, M.D.

“Our approach to regulating homeopathic drugs must evolve to reflect the current complexity of the market, by taking a more risk-based approach to enforcement. We respect that some individuals want to use alternative treatments, but the FDA has a responsibility to protect the public from products that may not deliver any benefit and have the potential to cause harm.”

The FDA’s risk-based approach will focus on:

  • Products with reported safety concerns
  • Products that contain or claim to contain ingredients associated with potentially significant safety concerns
  • Products for routes of administration other than oral and topical
  • Products intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions;
  • Products for vulnerable populations
  • Products that do not meet standards of quality, strength or purity as required under the law

Belladonna in Teething Tablets

Many homeopathic products will fall outside of these categories and remain available to consumers. Examples of products that may fall under the risk-based enforcement program include those that contain belladonna and other ingredients harmful to infants and children.

Belladonna was the ingredient that prompted the FDA to issue its September 2016 warning for homeopathic teething remedies that had allegedly injured hundreds of children. The products had also been implicated in 10 deaths.

Belladonna is often used in homeopathic medications due to its sedative effects. However, exposure to excessive amounts of belladonna can prove toxic for children. Symptoms of belladonna poisoning include:

  • Difficulty breathing
  • Lethargy
  • Excessive sleepiness
  • Muscle weakness
  • Skin flushing
  • Constipation
  • Difficulty urinating
  • Agitation
  • Seizures
  • Death

Teething tablets recalls have since been announced for products marketed by Raritan Pharmaceuticals and Hyland’s Homeopathic.

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