FDA Orders Labeling Changes For Certain Cough And Cold Medicines

FDA Orders Labeling Changes For Certain Cough And Cold Medicines

FDA is requiring safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone to limit the use of these products to adults 18 years and older because the risks of these medicines outweigh their benefits in children younger than 18.

In addition to limiting use in children following a comprehensive assessment of the risks and benefits of these products, labelling for adult-only use of prescription opioid cough and cold medicines that contain codeine or hydrocodone will also now include updated safety information.

"It's become clear that the use of prescription, opioid-containing medicines to treat cough and cold in children comes with serious risks that don't justify their use in this vulnerable population", he said. The panel declared that the risks of using certain opioids in children's cough medications outweigh the benefits. The warning will notify people the risks of misuse, abuse, addiction, overdose, and death. If the medicine prescribed for your child contains an opioid, talk to your child's health care professional about a different, non-opioid medicine, or if you have any questions or concerns.

It is important for parents and caregivers to understand that a cough due to a common cold often does not need medicines for treatment. "It's critical that we protect children from unnecessary exposure to prescription cough medicines containing codeine or hydrocodone".

Now, the FDA's latest action to revise safety labeling on some prescription cough and cold products expands the pediatric restrictions that were previously in place.

They go much further than the 2017 labeling rules - restricting use of codeine-containing products to everyone under the age of 18, and including cough-and-cold products that contain a second drug, the opioid oxycodone.

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Parents whose children are 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, the FDA advised.

Common side effects of extended opioid use include drowsiness, dizziness, nausea, vomiting, constipation, shortness of breath and headache.

One physician who's dealt with the aftermath of opioid overuse applauded the move. The federal directive also said mothers who are breast-feeding should not take the medications because the opioids could get passed on to their babies while nursing.

"The opioid epidemic has many origins, but can begin with exposure to [opioids] at young ages", he said.

According to the agency, outside experts said that while some children's coughs require treatment, many get better on their own _ including ones that are the result of respiratory infections. Always read the labels on prescription bottles.

The FDA also says the new changes are " based on an extensive review of available data and expert advice shared at meetings to explore the pediatric use of opioid-containing cough and cold products".

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