On October 23, 2010, the FDA warned that consumers should stop using Hyland’s Teething Tablets due to a potentially serious risk of injury for children. A Hyland’s Teething Tablet recall was issued after an FDA analysis discovered that the over-the-counter homeopathic remedy may contain varying amounts of belladonna, a potentially toxic ingredient.
STATUS OF HYLAND’S TEETHING TABLET LAWSUITS: As a result of belladonna toxicity or a Hyland’s Teething Tablet overdose, infants and young children could suffer a serious and potentially life-threatening injury.
Product liability lawyers are evaluating the potential for a Hyland’s Teething Tablet lawsuit on behalf of children who may have experienced side effects.
MANUFACTURER: Standard Homeopathic Company
OVERVIEW: Hyland’s Teething Tablets are an over-the-counter homeopathic product that is marketed for providing temporary relief of teething symptoms in children.
The Teething Tablets are manufactured to contain a small amount of belladonna, which can cause serious harm at larger doses. Although it is important for the amount of belladonna to be carefully controlled, the FDA has determined that Hyland’s Teething Tablets may contain an inconsistent amount of belladonna. A number of adverse event reports have been associated with belladonna toxicity or overdose from Hyland’s Teething Tablets.
HYLAND’S TEETHING TABLET SIDE EFFECTS: BELLADONNA TOXICITY: Belladonna is a plant whose leaves and berries are extremely toxic. It is also commonly referred to as “deadly nightshade”, and has been historically used as both a poison and a medicine.
The FDA has received a number of adverse event reports involving belladonna toxicity from Hyland’s Teething Tablets, and it appears likely that the manufacturer has known for some time about the risk of problems for young children
Symptoms of belladonna toxicity or Hyland’s Teething Tablet overdose could include:
- Depressed Level of Consciousness
- Difficulty or Slowed Breathing
- Lethargy or Sleepiness
- Muscle Weakness
- Skin Flushing
- Difficulty Urinating
- Agitation, Disorientation or Hallucinations
HYLAND’S TEETHING TABLET RECALL: On October 23, 2010, the FDA announced that Standard Homeopathic Company has agreed to recall Hyland’s Teething Tabets after FDA analysis and testing determined that tablets may contain varying amounts of belladonna. Substandard control of the manufacturing operation was identified as a reason for the recall, as well as a lack of child resistant caps.
Standard Homeopathic Company has indicated that they are refining their production, packaging and testing protocols.
As a homeopathic product, the FDA has never evaluated and tested the efficacy or safety of Hyland’s Teething Tablets. Such products are not required to undergo FDA approval, and the regulatory agency indicates that they are not aware of any proven clinical benefit offered by Hyland’s Teething Tablets. Once a safety concern has been identified, the FDA can require the manufacturer to have the product approved.
It is unclear whether the manufacturer will be required to submit data establishing Hyland’s Teething Tablets are safe and effective before they are able to market the homeopathic product again.