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Hydrocodone Painkillers Could Get Tighter FDA Control

Hydrocodone FDA Restrictions

Hydrocodone painkillers could see tighter control from the US Food and Drug Administration (FDA). The drug, an opioid painkiller, is found in vicodin and other commonly prescribed medications.

Vicodin and other products that have less than 15 milligrams of hydrocodone are classified at Schedule III controlled substances. However, the FDA is considering reclassifying them as Schedule II products, in line with painkillers like morphine and oxycodone.

If the painkillers are reclassified, it would make them more difficult to obtain, for addicts and for patients who actually need them, reports Reuters.

Physicians can’t call in a prescription for a Schedule II drug, and patients can’t have as many refills before they have to return to their doctors for another written prescription.

The Drug Enforcement Administration is calling for tighter FDA control of hydrocodone products, but the change has to have the approval of the Department of Health and Human Services and the DEA.

The FDA proposed the new restrictions in an online statement on Thursday, reports CNN. The agency explained that it “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.”

While the new restrictions would make it more difficult for addicts to acquire hydrocodone, opponents of the change, including doctors, have argued that further restricting pain medication would cause hardship for pain patients, especially the elderly.

Proponents of the change argue that the death toll from prescription painkiller overdoses is simply too high. About three of four prescription drug overdoses in the United States are caused by opioid painkillers, according to the Centers for Disease Control and Prevention (CDC).

A panel of outside medical experts voted in January to reclassify hydrocodone products after discussing the matter for two days. The FDA also argued that it didn’t come to the decision lightly, but that it conducted a “thorough and careful analysis of extensive scientific literature, review of hundreds of public comments on the issue, and several public meetings” to discuss the matter.”

The decision to change the classification of hydrocodone will be submitted in early December and the change will likely go into effect early next year.

[Image via ShutterStock]

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