FDA putting new limits on cold medicine for children

FDA putting new limits on cold medicine for children

FDA is also requiring the addition of safety information about the risks of misuse, abuse, addiction, overdose, death, and slowed or hard breathing to the Boxed Warning, the most prominent warning, of the drug labels for prescription cough and cold medicines containing codeine or hydrocodone.

The Food and Drug Administration released a statement Thursday saying it will require changes to safety labels on prescription opioid cough and cold medicines that contain codeine or hydrocodone, citing the "serious risks" these medicines pose to children. Experts and pediatricians advised that while coughs in those under 18 sometimes do require treatment, usually the coughs were caused by a cold or upper respiratory infection; the risks of the opioid medication would outweigh benefits.

In September, the FDA met with the Pediatric Advisory Committee to determine the dangers associated with using opioids in children's cough medicine. 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.

"Given the epidemic of opioid addiction, we're concerned about unnecessary exposure to opioids, especially in young children", said Scott Gottlieb, MD, FDA commissioner.

"It's critical that we protect children from unnecessary exposure to prescription cough medicines containing codeine or hydrocodone".

Micron Technology (NASDAQ:MU) Rating Reiterated by Deutsche Bank
News articles about Micron Technology (NASDAQ:MU) have trended somewhat positive on Friday, Accern Sentiment Analysis reports. Micron Technology, Inc . (NASDAQ:MU) has a market cap of $51.26 billion and over the last 12 months, MU has risen by 92.66%.

It is important for parents and caregivers to understand that a cough due to a common cold often does not need medicines for treatment. Labeling changes also address safety information for adults, including an expanded boxed warning indicating the risks of using opioid medications, such as misuse, abuse, addiction, overdose, and death.

In 2015, the FDA also announced an investigation into the possible risks of using codeine-containing medicines to treat coughs and colds in children under 18. Past year the restrictions were expanded to include safety labels that carried the contraindication warning, the FDA's most severe warning, to say that it should not be used for patients under the age of 12.

The most commonly experienced side effects by patients using either of these drugs are sleepiness, nausea, vomiting, labored breathing, and others.

Parents whose children are now prescribed cold or cough medication containing codeine or hydrocodone are encouraged to talk with their doctors about other treatment options. Always read the labels on prescription bottles.

Some codeine cough medicines are available OTC in a few states, and FDA is also considering regulatory action for these products.

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