Tuesday, 16 January, 2018

FDA putting new limits on cold medicine for children

FDA changes label safety requirements on prescription opioid, cough medicines Health Alert: FDA warns of opioids in cold medicines
Anna Jefferson | 13 January, 2018, 08:08

The organization announced that it will require safety labeling changes on medications containing certain drugs because they could pose serious risks for children under the age of 18. These medicines carry serious risks, including slowed or hard breathing and death, which appear to be a greater risk in children younger than 12 years, and should not be used in these children.

The U.S. Food and Drug Administration will now require safety labeling changes to limit the use of prescription opioid cough and cold medicines.

The FDA announced Thursday that it's requiring revisions to the safety labeling on such prescription opioid cough and cold medicines to indicate that the products no longer can be used to treat children - because their risks outweigh their potential benefits - and should be used only for adults 18 and older.

According to the announcement, labeling for those medications is also being updated with additional safety warning for adult use notifying users about the risks of misuse, abuse, addiction, overdose, and death, along with slowed or hard breathing. The new labeling will provide safety warnings on these products that are consistent with the labeling of other opioid-containing drug products, including both immediate-release and extended-release and long-acting opioid analgesics. FDA is also recommending against the use of codeine and tramadol medicines in breastfeeding mothers due to possible harm to their infants.

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The FDA also held an expert roundtable and convened a meeting of its Pediatric Advisory Committee to look at all the risks associated with the use of codeine- or a hydrocodone-containing cough and cold products in children and adolescents younger than 18-years-old. An FDA drug safety communication noted, "Health care professionals should reassure parents that cough due to a cold or upper respiratory infection is self-limited and generally does not need to be treated".

Health care professionals should be aware that FDA is changing the age range for which prescription opioid cough and cold medicines are indicated.

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

Some codeine cough medicines are available OTC in a few states, and FDA is also considering regulatory action for these products. For those children in whom cough treatment is necessary, alternative medicines are available. Caregivers should also read labels on non-prescription cough and cold products.

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