Pharmaceutical

FDA orders tighter restrictions on powerful narcotic opioid painkillers

fda logo FDA orders tighter restrictions on powerful narcotic opioid painkillersThe Food and Drug Administration (FDA) is urging doctors to only prescribe the strongest narcotic painkillers to patients who require long-term, round-the-clock treatment that cannot be managed with other treatments. The agency is also requiring the manufacturers of long-acting opioids to change their safety labels to reflect the new prescribing guidelines. The action is designed to curb the growing epidemic of prescription drug abuse and overdoses, which contributed to 16,651 overdose deaths in 2010, according to the Centers for Disease Control and Prevention (CDC). The center estimates that more than 12 million people abuse the drugs every day.

Opioids are a class of powerful painkillers that include Oxycontin, morphine and methadone. The new drug labeling guidelines involve the long-acting and extended-release forms of the drug, which account for less than 10 percent of all opioid prescriptions written in the United States. The guidelines do not include fast-acting opioids, which include the widely prescribed hydrocodone.

The FDA is also ordering manufacturers of opioids to conduct new research to help identify what doses and modes are most likely to cause harm to patients. The safety and efficacy studies are being hailed by some experts as a move in the right direction in the fight against prescription drug abuse, however more work needs to be done to determine how well patients follow doctors’ orders.

The move is designed to cut down on the number of opioid sales, which have increased by fourfold over the past decade. Not coincidentally, the number of drug overdose deaths has skyrocketed as well.

Current indications for long-acting and extended-release opioid narcotics are for “moderate-to-severe pain.” The new language that will appear on safety labels by December will change to say the drugs are for “pain severe enough to require daily, around-the-clock, long-term opioid treatment” for which all other alternative treatments have failed to work.

Source: LA Times