FDA Investigating Dangerous Risks of Common Pain Drug

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After recently approving OxyContin for pediatric use, the U.S. Food and Drug Administration (FDA), is now investigating the use of the pain medicine tramadol in children aged 17 years and younger, due to the rare but serious risk of slowed or difficult breathing.

While Tramadol is not FDA-approved for use in children, data show it is being used “off-label” in the pediatric population. Health care professionals should be aware of this and consider prescribing alternative FDA-approved pain medicines for children. This risk of slowed and difficult breathing may be increased in children treated with tramadol for pain after surgery to remove their tonsils and/or adenoids. The FDA is evaluating all available information and will communicate their final conclusions and recommendations to the public when the review is complete.

Tramadol (Ultram, Ultram ER, Conzip, and also as generics) is an opioid pain medication used to treat moderate to moderately severe pain. When taken as an immediate-release oral formulation, the onset of pain relief usually occurs within about an hour. Tramadol is also available in combination with the pain reliever acetaminophen under the brand name Ultracet and as generics.

Parents and caregivers of children taking tramadol who notice any signs of slow or shallow breathing, difficult or noisy breathing, confusion, or unusual sleepiness should stop tramadol and seek medical attention immediately by taking their child to the emergency room or calling 911. Parents and caregivers should talk with their child’s health care professional if they have any questions or concerns about tramadol or other pain medicines their child is taking.

Treating pain in children is important because it can lead to faster recoveries and fewer complications. Untreated pain can potentially result in long-term physical and psychological consequences. According to the National Institute of Health, the greatest advance in pediatric pain medicine is the recognition that untreated pain is a significant cause of morbidity and even mortality after surgical trauma.

Accurate assessment of pain in different age groups and the effective treatment of postoperative pain is constantly being refined; with newer drugs being used alone or in combination with other drugs continues to be explored. There are other pain medicines available that do not have this side effect of slowed or difficult breathing associated with tramadol and are FDA-approved for use in children.

In the body, tramadol is converted in the liver to the active form of the opioid, called O-desmethyltramadol. Some people have genetic variations that cause tramadol to be converted to the active form of the opioid faster and more completely than usual. These people, called ultra-rapid metabolizers, are more likely to have higher-than-normal amounts of the active form of the opioid in their blood after taking tramadol, which can result in breathing difficulty that may lead to death.

Recently, a 5-year-old child in France experienced severely slowed and difficult breathing requiring emergency intervention and hospitalization after taking a single prescribed dose of tramadol oral solution for pain relief following surgery to remove his tonsils and adenoids.1 The child was later found to be an ultra-rapid metabolizer and had high levels of O-desmethyltramadol in his body.

The FDA is urging health care professionals, parents, and caregivers to report side effects involving tramadol to the FDA MedWatch program, using the information in the “Contact FDA” box on their website.

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Lindsey McCoyLindsey McCoy MPA, is an Executive Medical Recruiter and former CEO in the not for profit sector.

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