ST LOUIS (MD Consult) - On October 23, 2010, the US Food and Drug Administration (FDA) issued a warning about a possible risk of adverse events that may result from the use of Hyland's Teething Tablets, a homeopathic product intended to provide temporary relief of teething symptoms in children. The FDA recommends that consumers refrain from using these tablets and to dispose of any tablets in their possession. The manufacturer, Standard Homeopathic Company, is issuing a voluntary recall of the product.

Hyland's Teething 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. An FDA laboratory analysis revealed that Hyland's Teething Tablets contain inconsistent amounts of belladonna. In addition, the FDA has received reports of serious adverse events occurring in children taking this product that are consistent with belladonna toxicity. The FDA also has received reports of children who consumed more tablets than recommended because the containers do not have child-resistant caps.

The FDA is advising consumers to consult a 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 receiving Hyland's Teething Tablets.

Hyland's Teething Tablets are sold over-the-counter in retail outlets. The FDA has not evaluated this product for safety or efficacy, and is not aware that its use provides any proven clinical benefit.

An ongoing inspection of the manufacturer's facilities also indicates substandard control of the manufacturing operation.

The FDA is urging health care professionals and consumers to report adverse effects associated with the use of Hyland's Teething Tablets through its MedWatch Adverse Event Reporting Program.

圣路易斯(MD Consult)——2010年10月23日，美国食品药品管理局(FDA) 发布一则警告，使用海德出牙片可能有发生不良事件的风险，海德出牙片是顺势公司生产的一种可暂时缓解儿童牙部症状的产品。FDA推荐消费者停用这些药片并废弃存有的所有药片。生产商标准顺势公司(Standard Homeopathic Company)正针对此产品发布一则主动召回令。

海德出牙片含有少量的颠茄，较大量的颠茄会对人体产生严重损害。对于这类产品，严格控制颠茄量很重要。一项FDA实验室分析显示海德出牙片的颠茄量超标。此外，FDA已收到儿童使用该产品后发生严重不良事件的报告，这些不良反应与颠茄毒性相符。FDA还收到由于药瓶未使用防止儿童开启的瓶盖而导致儿童的使用剂量超出推荐剂量的报告。

FDA建议消费者，如果使用海德出牙片后孩子出现抽搐、呼吸困难、嗜睡、睡眠过度、肌无力、皮肤潮红、便秘、排尿困难或烦躁不安等症状，则咨询医护专业人员。

海德出牙片在零售药店以非处方药销售。FDA尚未评估该产品的安全性或疗效，也不清楚其是否有确凿的临床收益。

正在进行的一项对生产厂家设备的审查也显示生产操作的控制不达标。

FDA鼓励医护专业人员和消费者通过其MedWatch Adverse Event Reporting Program上报与使用海德出牙片相关的不良反应。