Saturday, 18 August, 2018


Cough Syrup Containing Opioids Is Dangerous for Kids: FDA

Cough Syrup Containing Opioids Is Dangerous for Kids: FDA Cough Syrup Containing Opioids Is Dangerous for Kids: FDA
Patty Aguilar | 12 January, 2018, 21:18

The U.S. Food and Drug Administration is requiring increased safety labeling on cough and cold medicines to protect kids from opioids. "Both of these determined the risks of slowed or hard breathing, misuse, abuse, addiction, overdose, and death with these medicines outweigh their benefits in patients younger than 18", FDA said.

The move is in response to the opioid addiction epidemic. The panel declared that the risks of using certain opioids in children's cough medications outweigh the benefits.

Gottlieb added that the FDA is taking steps to assure parents that treating the common cold or cough is possible without prescription opioid medicine.

The agency said it is requiring manufacturers to change the wording on their labels to make clear that such products should not be used for anyone younger than 18. Information about these required safety labeling changes are being made available to parents and health care professionals through a Drug Safety Communication. The FDA held a risk-association discussion with its Pediatric Advisory Committee, during which experts indicated that cough due to colds or upper respiratory infections generally did not require treatment, and that the risks of prescription opioid cough therapy use did not outweigh its potential benefits.

Then, last year, the agency warned that the opioids codeine and tramadol could cause life-threatening breathing problems in children and strengthened drug labeling to restrict their use in children younger than 12. Parents of children now prescribed a cough and cold medicine containing codeine or hydrocodone are encouraged to talk to their child's health care professional about other treatment options.

Cough and cold medicines containing opioid ingredients, such as codeine or hydrocodone, should no longer be given to children of any age, according to the US Food and Drug Administration. While today's action was meant to address prescription opioid cough/cold medications, the FDA is considering regulatory action for these OTC products as well.

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