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FDA warns against giving children drugs containing benzocaine

2019/05/20 19:05:27

Image for illustrative purposes only / Image taken from Pixabay

Taipei, May 20 (CNA) Children under two years of age should not be given drugs containing benzocaine, a numbing agent, under any circumstances, Taiwan Food and Drug Administration (FDA) announced Monday, due to safety concerns.

The FDA made the announcement in a news release, citing a discovery by authorities in the United States that benzocaine can have a rare, yet serious side effect on children under two years old.

FDA official Huang Chyn-liang (黃琴喨) told CNA in a phone interview Monday that researchers have found Benzocaine can cause a condition called methemoglobinemia, which reduces the amount of oxygen in a person's blood and can in some situations have dangerous side effects, particularly in children under two.

Huang said although there have been no reports of Benzocaine-related methemoglobinemia in Taiwan, the authorities decided on Monday to advise that no Benzocaine-containing drugs be given to children under two after a series of drug safety assessments.

Taiwan approved the use of benzocaine containing drugs to treat gastric ulcers, gastroenteritis and mixed hemorrhoids in 1971, according to Huang.

Benzocaine is widely used in Taiwan, Huang said, adding that the authorities have so far approved the use of 62 drugs containing Benzocaine, including both prescription drugs and over-the-counter drugs.

In 2012, following the example of the United States and Canada, Taiwan's FDA required labels of marketed benzocaine products to contain warnings stating "such drugs should not be given to children under two unless under the advice and supervision of medical professionals."

In May 2018, the U.S. FDA warned against using products containing benzocaine to treat teething pain in children under two after learning that parents and caregivers who wanted to ease a child's pain turned to oral creams that contain the agent.

Huang urged doctors and pharmacists to inform patients that such products can no longer be given to children under two, and called on parents to ensure pharmaceuticals are placed out of the reach of children.

In the event an individual experiences pale, gray, or blue-colored skin, lips, or nails; confusion; elevated heartbeat; shortness of breath; or unusual tiredness after taking Benzocaine-contained medicine, he or she should seek immediate medical attention, Huang added.

(By Chang Ming-hsuan and Chung Yu-chen)