A homeopathic remedy for the teething pain in children is being recalled because the tablets may cause serious health risks. Hyland’s Teething Tablets, sold over-the-counter at retail outlets, are manufactured to contain a small amount of belladonna, a substance that can cause harm at larger doses. For a product of this nature, it is imperative that the amount of belladonna be carefully controlled.

Food and Drug Administration (FDA) laboratory analysis has found that Hyland’s Teething Tablets contain inconsistent amounts of belladonna. The agency has received reports of serious adverse events in children taking the product that are consistent with belladonna toxicity. The FDA has also received reports of children who consumed more tablets than recommended because the containers do not have child resistant caps.

Belladonna, also known as deadly nightshade, is a perennial herbaceous plant native to Europe, North Africa and Western Asia. It is one of the most toxic plants found in the Western hemisphere. In small doses, it does have a long history of use as a medicine. Symptoms of belladonna toxicity include tachycardia, loss of balance, staggering, headache, rash, flushing, dry mouth and throat, slurred speech, confusion, hallucinations, delirium and convulsions, and can be lethal.

The FDA says it has not evaluated Hyland’s Teething Tablets for safety or efficacy, and is not aware of any proven clinical benefit offered by the product. The agency recommends that consumers not use the product and to dispose of any in their possession. Consumers are advised 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.

Any adverse events with this or any other product should be reported to the FDA MedWatch Adverse Events Reporting Program at www. FDA.gov/MedWatch.