The FDA recently approved the dangerous drug OxyContin for use in children between the ages of 11 and 16 who are suffering from severe pain, according to a report from Medscape Medical News. But is this medication actually safe for children? OxyContin is the brand name of a formula of the drug oxycodone, which is a type of opioid pain medication. In addition to being a commonly abused prescription drug, it can result in serious side effects.
According to the article, “the child’s pain must be severe enough to require around-the-clock, long-term treatment and not managed well by other treatments.” Before approving the drug for use in certain kids, the FDA sought numerous studies that analyzed its safety for children and teens. According to Sharon Hertz, the director of the Division of Anesthesia, Analgesia, and Addiction Products with the FDA’s Center for Drug Evaluation and Research, the studies supported the FDA’s approval of OxyContin for younger people in limited circumstances.
As Dr. Hertz explained, “the new study data and resulting pediatric indication for OxyContin give doctors more specific information on how to safely manage pain in their pediatric patients” following surgery or physical trauma. Before children can be prescribed OxyContin, the FDA will require that they are already tolerating a specific minimum dose of oxycodone for a period of time before taking the time-release formula of OxyContin.
When it comes to children dealing with severe pain, OxyContin should not be the first opioid drug used, Hertz emphasized, but, “the data show that changing from another opioid drug to OxyContin is safe if done properly.” The warnings on the medication will be the same for adults and kids, and the FDA will require postmarketing studies to determine how safe the drug is for use in younger patients.
OxyContin and Opioid Drugs: What Do You Need to Know?
What are opioids? According to a fact sheet from WebMD, opioids are a particular type of narcotic pain medication. They are often prescribed for moderate to severe pain that is not responding well to other types of pain medication. Commonly prescribed opioids include but are not limited to:
- Hydrocodone/acetaminophen (known more commonly by names like Lorcet or Vicodin);
- Meperidine (more commonly known as Demerol);
- Oxycodone (the ingredient in brand name drugs like OxyContin and Roxicodone); and
- Oxycodone and acetaminophen (known by the brand names Percocet, Endocet, and Roxicet).
When these drugs are not taken properly—and even when they are—they can produce serious side effects.
Opioid drugs can be particularly dangerous if they are taken in combination with certain antidepressants, antihistamines, or sleeping pills. These prescription drugs can also have serious interactions with other medications and supplements, so you should always make sure your doctor knows about other drugs and treatments you use.
Much too often, opioid drugs result in patients becoming dependent on them, and in some cases addicted. For patients who are dependent upon medications like OxyContin, ceasing use of the drug can result in serious withdrawal symptoms, including but not limited to:
- Muscle pain;
- Anxiety; and
If you or your child took an opioid drug and have suffered serious side effects as a result, you may be able to file a claim for financial compensation. You should discuss your case with a dangerous drug attorney to learn more about your rights.