FDA proposes stricter guidelines for widely prescribed painkiller hydrocodone

hydrocodone 435x303 FDA proposes stricter guidelines for widely prescribed painkiller hydrocodone Proposed new guidelines for painkillers aims to put drugs containing hydrocodone, such as Lortab and Vicodin, in the same category as potent opioids like Oxycontin and morphine. The Food and Drug Administration’s (FDA) recommendation for the highly addictive class of painkillers must first be approved by other Health and Human Service Department officials before it can go into effect.

The major policy change comes more than a decade after the Drug Enforcement Administration (DEA) first asked that hydrocodone-containing drugs be more restricted. Hydrocodone drugs are the most widely prescribed medications in the country, with more than 131 million prescriptions written in 2011 alone. Drugs in this class consistently rank first or second among the most abused drugs in the United States each year, competing for top status against the powerful oxycodone.

Prescription painkiller deaths have increased fivefold between 1999 and 2010, a statistic experts say goes hand-in-hand with the boon in overall use of prescription painkillers.

The FDA and the American Medical Association have long been in favor of keeping restrictions lax for hydrocodone. The drugs, often sold in compounds with other painkillers such as acetaminophen and aspirin, are used to treat everything from general pain, back pain, cough, nasal congestion and Rheumatoid arthritis.

However, Dr. Janet Woodcock said in a statement, “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.”

The agency will make a formal request in early December that hydrocodone be rescheduled as a Schedule II drug, limiting which kinds of medical professionals can prescribe the drug and how many times it can be refilled.

Source: PharmPro