FDA Hopes to Tighten Access to Vicodin, Lortab and Other Opioids

FDA recommends reclassifying hydrocodone to make it harder for people to misuse the medication

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) Opioids are a commonly prescribed type of medication used to treat chronic pain conditions and post-surgical pain. But the FDA has concerns that people may be misusing opioids and wants to tighten access to one of these medications.

After reviewing and evaluating the use of hydrocodone — a type of opioid — the FDA has recommended reclassifying the medication to make it harder for people to get.

According to the FDA, misusing opioids like hydrocodone can have very dangerous consequences, including death. As such, it is important that people adhere to the recommendations listed on the packaging.

"Take your medications only as prescribed."

The FDA groups medications based on their safety and potential to be misused. Medications are ranked from Schedule I to Schedule V. Schedule I medications are the most potentially dangerous, while Schedule V medications are the least potentially dangerous. Medications with less then 15 milligrams of hydrocodone are currently listed as Schedule III.

Schedule III medications are considered to carry a low to moderate chance of physical dependence and a high chance of psychological dependence. The potential for abuse is less than that of a Schedule I or Schedule II medication but more than that of a Schedule IV medication.

After reviewing scientific research, receiving input from healthcare providers, government institutions and patients and reviewing public comments, the FDA has recommended that medications with less than 15 milligrams of hydrocodone be reclassified as Schedule II medications.

Schedule II medications are considered to have a high potential for abuse and mental and physical dependence. These medications are considered dangerous.

Long-term use of opioids like hydrocodone can cause dependence and lead to addiction. People who have developed a dependence for opioids and try to stop taking them may experience any of the following symptoms:

  • Restlessness
  • Muscle and bone pain
  • Insomnia (difficulty sleeping)
  • Diarrhea
  • Vomiting
  • Cold flashes with goose bumps
  • Involuntary leg movements

The National Institutes of Health (NIH) states that in order to prevent dependency or a potential overdose, it is important to take opioids only as prescribed and to not combine them with other medications unless specifically instructed by a doctor.

The NIH further notes that patients should not share their pain medications with others, and that they should store these medications in a safe place where others do not have access to them.

The FDA reported that opioids can be a safe and effective treatment option for pain when used properly, but their widespread misuse in some parts of the US can not be ignored. The FDA will submit their formal recommendation to the US Department of Health and Human Services in December to reclassify hydrocodone as a Schedule II medication.

To learn more about hydrocodone or the FDA’s proposal, visit the FDA website.

Review Date: 
October 25, 2013
Last Updated:
December 30, 2013