The U.S. Food and Drug Administration has long been concerned about the overuse and abuse of opioid-based hydrocodone drugs. In a statement released Thursday, Janet Woodstock, M.D., the director of the FDA's Center for Drug Evaluation and research, recommended reclassifying the pills as a Schedule II substance.
That would place Vicodin, Lortab and other hydrocodone-based painkillers, the most popular pharmacy drugs in the U.S., under stricter prescribing limits to curb abuse. Hydrocodone is a highly addictive ingredient in these drugs.
According to the statement, "Millions of American patients experiencing an acute medical need or living with chronic pain, opioids, when prescribed appropriately, can allow patients to manage their pain as well as significantly improve their quality of life."
The challenge: the abuse of opioid products is at epidemic proportions in certain parts of the United States. The FDA has long been trying to determine how best to give those who truly need the pain relief continued access, while addressing the ongoing concerns about abuse and misuse.
The FDA released information earlier this year reporting that 131 million hydrocodone products were dispensed in 2011, more than double the number for oxycodone pills, which already have greater restrictions. For years, the Drug Enforcement Administration has been urging the FDA to reclassify the products to Schedule II from III, making them more difficult to obtain and abuse.
The FDA plans on submitting its formal proposal to the Department of Health and Human Services by December.