Feds Demand Stronger Warning on Opioid Labels, But Is It Enough?

Every day in the U.S., 100 people die from drug overdoses. Many drugs are abused, but as documented by the Centers of Disease Control and Prevention (CDC), there’s an epidemic of prescription painkiller abuse. Nearly 3 in 4 prescription drug overdoses are caused by these narcotics, known as opioid pain relievers. Since 1999, the sale of opioids has increased 300%, and they have caused more overdose deaths than cocaine and heroin combined.

Earlier this month, in the latest nod toward slowing the opioid epidemic, the FDA ordered that labels for 20 long-acting opioid products such as oxycodone (OxyContin and Opana) and morphine include warnings about the risks of abuse and death. A petition from Physicians for Responsible Opioid Prescribing (PROP) and Public Citizen had asked the FDA to strike the word “moderate,” and label opioids as appropriate only for severe, chronic pain.

The new labels should appear by December.

Anyone who hasn’t been hibernating in the last year since the problem finally garnered widespread media attention has to know about the danger of opioids, so isn’t this fairly modest measure an example of closing the barn door after the horse is gone?

The new label requirements do not apply to more widely prescribed, fast-acting opioids including hydrocodone, which often are prescribed after surgery, injury or for dental work.

In addition to the new labels, the drugs’ manufacturers must conduct new research studies to identify the doses and consumption practices that are most likely to harm patients.

Opioids originally were intended for limited use for severe pain and for long-term use only when pain is intractable and nothing else will address it, such as for cancer and in hospice care. Like antibiotics, today, they’re overprescribed because doctors and patients don’t take the time to pinpoint the causes and the best treatments to address discomfort. (See our blog, “CDC Says Doctors Overprescribe Painkillers.”)

As described on MedPageToday.com, the FDA’s new label requirement is only part of a greater effort to slow the prescription painkiller epidemic that includes the additional studies and warnings about the risks of neonatal opioid withdrawal syndrome, in which newborns suffer from withdrawal because their pregnant mothers took the drugs.

The actions are supposed to make it more difficult for drug companies to market opioids for chronic, noncancer pain.

Douglas Throckmorton, deputy director of the FDA’s Center for Drug Evaluation and Research, said that changing the label indication to remove use for moderate pain in favor of “pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate” should prompt discussions between doctors and patients about their eligibility for the drugs.

Again, we have to ask-shouldn’t such conversation be routine whenever a doctor prescribes a drug?

Practitioners all too familiar with the challenge of treating opioid addiction welcome the attention to more appropriate prescribing, but others say the agency’s actions leave something to be desired.

“It is not clear to me why the FDA’s actions apply only to long-acting opioids when similar cautions apply to short-acting opioids, like Vicodin,” Michael Von Korff, a member of PROP told MedPage Today.

Andrew Kolodny, president of PROP, told the Los Angeles Times, “This is just more hot air. This makes it look like they are doing something. But they are continuing to allow opioid manufacturers to promote their products for conditions where the risks are likely to outweigh the benefits.”

Other experts told The Times that the initiative failed to address how well patients follow doctors’ orders for opioid use, and that limiting label indications doesn’t address overuse and abuse.