Claim: Hyland's Teething Tablets have been recalled for causing seizures in children.
Example:[Collected via e-mail, May 2013]
SHARE THIS as much as possible so people know what this "product" can do. When Carter was 7 months old he got his first tooth. I started giving him hylands teething tablets. About 2 weeks later he started "jerking" really
bad. I toke him to the ER at children's where they decided to keep him and put him on a 24 hour EEG. They didn't catch anything that tome so they kept us two more days. When they finally caught him doing it on camera they decided to give him an MRI which he had to be put to sleep for. That came back normal. We made a follow up appointment with neurology and they sent us home. I stopped giving him the teething tablets and he never had a seizure again. I found out in October of that year that they had been recalled for causing brain bleeding and seizures. His speech was delayed and we believe this was the cause. I Got an attorney and after almost 3 years he finally called me on Friday and said we won. I am begging anyone who is thinking about using this to please rethink it, and DO NOT use. They might say it's safe now, but you never know.
Origins: In October 2010, the Food and Drug Administration (FDA) notified consumers that Hyland's Teething Tablets, a homeopathic product, intended to provide temporary relief of teething symptoms in children, was being recalled after that agency received "reports of serious adverse events in children." The FDA stated the tablets contained "inconsistent amounts of belladonna" that could pose a serious risk of harm to children (potentially including seizures) and warned consumers to stop using and discard the product:
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.
FDA has received reports of serious adverse events in children taking this 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.
The FDA has not evaluated Hyland's Teething Tablets for safety or efficacy, and is not aware of any proven clinical benefit offered by the product.
FDA recommends that consumers not use this product and dispose of any in their possession. FDA advises consumers 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.
Nine months later, in July 2011, Hyland's announced the imminent return to market of its teething tablets product, stating it had modified the manufacturing process to ensure uniformity in dosage and had added child-resistant caps to the packaging:
Hyland's voluntarily took Teething Tablets off the market in October 2010. We chose to exercise an abundance of caution by making this decision. Hyland's and the FDA conducted a thorough review of all of our manufacturing processes and reports. Together, 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.
We've added a child-resistant cap and updated the packaging and are introducing new strengths of the same ingredients that have calmed teething babies and their moms for more than 85 years. We have made significant changes in our manufacturing process and introduced rigorous testing protocols. We have kept all of the same ingredients that have made Hyland's Baby Teething Tablets effective and safe and improved effectiveness by increasing the homeopathic potency of each active ingredient. As homeopathic potency increases, raw drug concentration decreases, providing an even wider margin of safety than before.
There have been no further recalls of this product since its reintroduction to market in 2011.
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