While watching a recent news broadcast, I heard the Food and Drug Administration had approved the painkiller, OxyContin, for use in certain children.

I became concerned, when I heard children as young as 11 years old could be administered this drug.

But when I learned the children who would receive OxyContin suffer from severe pain, I went to the FDA’s website to understand the reasoning behind this approval.

According to the FDA, in a conversation with Sharon Hertz, director of the Division of Anesthesia Analgesia and Addiction Products, Office of New Drugs with the Center for Drug and Research, Hertz said in the U.S., extended-release opioids are used to manage chronic pain in adults, from low back pain to osteoarthritis to cancer-related pain.

“To manage pain in pediatric patients, physicians often have to rely on their own experience to interpret and translate adult data into dosing information for pediatric patients,” Hertz said.

Hertz said to give health care providers more information on the safe use of drugs in pediatric patients, the FDA can use its authority to ask manufacturers of drug products to conduct studies to obtain pediatric-specific information.

“We requested the manufacturer of the pain management drug OxyContin perform studies evaluating safety and other important information when used in pediatric patients,” Hertz said. “This program was intended to fill a knowledge gap and provide experienced health care practitioners with the specific information they need to use OxyContin safely in pediatric patients.”

Hertz said opioids are powerful medications used to manage pain when they are prescribed and used properly.

U.S. Senator Joe Manchin, D-WV, disagrees with the FDA’s decision to approve OxyContin for use in children.

In his letter to Dr. Stephen Ostroff, acting commissioner with the FDA, Manchin said, “Today, there are 2.1 million Americans abusing or dependent on opioids. In addition, 44 people die every day as a result of a prescribed opioid overdose.”

Manchin’s letter further states, “This recent [FDA] decision, which will increase the likelihood that children as young as 11 years old will be prescribed OxyContin, is a horrifying example of the disconnect between the FDA approval process and the realties of this deadly epidemic.”

Dr. J. Nathan Hagstrom, M.D., MHCM, at Lehigh Valley Health Network Children’s Hospital, said approving OxyContin for use in children ages 11 to 16 is not going to increase the heroin or OxyContin addiction problem.

OxyContin itself is abused by people who crush it, he said.

Hagstrom said when the drug is taken as prescribed by people with severe pain it is not addictive.

The doctors who will be prescribing OxyContin have experience with it and are very careful to monitor for misuse, Hagstrom said.

Hagstrom said OxyContin has been around for awhile.

“We have been using it for children with chronic pain, cancer or are dying from sickle cell anemia, for 10 years, since it was approved.”

This recent approval was guided by dosing guidelines specific to children in that age group, Hagstrom said.

“I don’t see the use of OxyContin increasing because of this approval,” Hagstrom said. “Once again, this [approval] was more about getting data and creating guidelines for the use of a medication in a pediatric age group where this medication was already being used.”

As a former caregiver, I know it is important to communicate and work with the doctors when caring for a patient who needs medication around the clock.

·As with any medication, make sure you understand the doctor’s orders before leaving his or her office.

·Follow all guidelines set by the doctor when administering medications to a patient.

·Always read the labels on the medication bottles and the enclosed information.

·Store all medications away from children and individuals not authorized to administer it.

Take the time to be informed by speaking with experts.

When you hear something concerning, speak with a specialist, research the issue via the Internet and read books or articles on the subject.

Susan Bryant

editorial assistant

Parkland Press

Northwestern Press