The Food and Drug Administration (FDA) is recommending tighter restrictions on medicines containing hydrocodone, a painkiller found in commonly prescribed and potentially addictive drugs such as Vicodin.
Opponents of the change say it could cause undue hardship for pain patients, while supporters cite widspread and deadly abuse of the popular drugs.
In a major policy shift, the FDA said Thursday that medications containing hydrocodone should be subject to the same restrictions as other narcotic drugs such as oxycodone and morphine.
The Drug Enforcement Administration (DEA) says hydrocodone is consistently among the most abused medicines in the United States each year, alongside oxycodone. Both belong to a family of drugs known as opioids, which also include heroin, codeine and methadone.
For decades, hydrocodone has been easier to prescribe, in part because it is sold only in combination pills and formulas that also include other nonaddictive ingredients such as aspirin or acetaminophen. This has made the drug a top choice among many health care professionals for treating many types of chronic pain, from arthritis to toothaches.
In 2011, U.S. doctors wrote more than 131 million prescriptions for hydrocodone, making it the most prescribed drug in the country, according to government figures.
Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a notice on the agency's website that "the FDA has become increasingly concerned about the abuse and misuse of opioid products, which have sadly reached epidemic proportions in certain parts of the United States."
Until now, Vicodin and other products that contain less than 15 milligrams of hydrocodone have been classified as Schedule III controlled substances. The FDA is now recommending a more restrictive classification — potentially as Schedule II products, in line with opioid painkillers such as oxycodone and morphine.
Woodcock said in the statement that the FDA planned to submit a formal recommendation to the Department of Health and Human Services (HHS) by early December.
Schedule II drugs are those that are deemed to have "high potential for abuse" and could potentially lead to "severe psychological or physical dependence," according to the DEA. Schedule III drugs are those with a “moderate to low potential for physical and psychological dependence."
Any change must be approved by HHS and the DEA, which will make the final decision.
The Controlled Substances Act, passed in 1970, put hydrocodone drugs in the Schedule III class, which is subject to fewer controls. Under that classification, a prescription for Vicodin can be refilled five times before the patient has to see a physician again. If the drug is placed under Schedule II, patients would receive only one 90-day prescription. Also, nurses and physician assistants would not be able to prescribe such medications.
Reclassifying the products would make them harder to obtain — both by addicts and by legitimate pain patients — in other ways as well. Physicians are not allowed to call in a prescription for a Schedule II product to a pharmacy. Instead, patients must present a written prescription.
Opponents of the rule change, including many physicians, have argued for years that restricting pain products further could cause hardship to pain patients, especially the elderly.
"By making hydrocodone more regulated and harder to prescribe and dispense, our patients are probably going to have a difficult time getting control of their pain," said Dr. Brian Bruel of the MD Anderson Cancer Center in Houston.
Proponents, however, say the death toll from abuse is unacceptably high.
Earlier this year the Centers for Disease Control and Prevention (CDC) reported that prescription painkiller overdose deaths among women had increased about fivefold between 1999 and 2010. Among men, such deaths rose about 3.5-fold. The misuse of prescription painkillers was also responsible for more than 475,000 emergency department visits in 2009, a number that had nearly doubled in just five years, according to the CDC.
Regulators are trying to tackle the problem from a variety of angles. In an attempt to restrict supply, the DEA has been putting pressure on wholesale suppliers of prescription drugs to police their customers better.
Several companies, including Pfizer and Endo Health Solutions, have been working to develop tamper-resistant opioids that cannot be easily crushed or dissolved by addicts looking to get a full dose quickly.
Woodcock’s statement said that over the past few years, the FDA has been "challenged with determining how to balance the need to ensure continued access to those patients who rely on continuous pain relief while addressing the ongoing concerns about abuse and misuse." In the end, she said, the level of opioid abuse and the "tremendous amount of public interest" in the matter led the agency to recommend a change.
Al Jazeera and wire services