The most popular prescription drugs on the market contain a mix of narcotic hydrocodone and an over-the-counter painkiller, like aspirin. You might be more familiar with their brand names like Vicodin and Lortab. They’re the kind of pills people get after a root canal, for instance.
Thursday, the Food and Drug Administration recommended reclassifying those drugs to make them harder for patients to get.
The FDA wants to move hydrocodone combination drugs from a category called Schedule III to Schedule II. That means patients would have to have a written prescription — no more calling it in — and no refills without an actual doctor visit.
For the $8.5 billion painkiller industry, it’s a blow.
“It definitely depresses the demand for that product, and the sales tend to go down,” says consultant David Williams with the Health Business Group.
It’s not just that patients will have to go through more hoops, he says. Schedule II comes with a stigma.
“Now prescribers will realize that these drugs are more dangerous than they may have thought and be less likely to prescribe them,” he says.
Patient advocates and doctors’ groups fought hard against the change. “This burden of having to now physically get themselves to a doctor and get themselves to a pharmacy is a real hardship,” says Cindy Steinberg, national director of policy and advocacy with the U.S. Pain Foundation.
“It’s also a huge expense,” says Bob Twillman with the American Academy of Pain Management. He says patients who used to see a doctor twice a year may have to go as often as once a month.
But prescription painkiller abuse is a growing problem. According to the Centers for Disease Control and Prevention, nearly 15,000 people die every year from overdoses involving opioid painkillers.
Addiction often starts with hydrocodone, according to Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing. He says the Schedule III designation may have led doctors to overprescribe drugs like Vicodin.
“That was communicating to the medical community that they don’t have to worry so much about Vicodin,” he says. “And that’s completely not true.”
But just a day after the FDA recommended tighter restrictions on drugs containing hydrocodone, the agency announced it had approved an even stronger one. Today, new drug Zohydro got the go-head for patients with constant pain that doesn’t respond to other treatment.
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