Key Takeaways

A new study has found that the Food and Drug Administration (FDA) has a history of approving prescription opioids with limited data. Currently, the U.S. is in the midst of an opioid crisis.

The study, which was published in theAnnals of Internal Medicine, analyzed data from new drug applications for opioids submitted to the FDA between 1997 and 2018.The researchers analyzed 48 new drug applications, which were largely for new dosages of opioids or new formations.

Of the 39 new drug applications that were approved for treating chronic pain, only 21 had at least one pivotal trial to support its use. Most trials ran for a median of 84 days and enrolled about 299 patients. Researchers discovered that 81% of the drugs were approved based on study designs that excluded patients who could not tolerate the drugs, had early bad side effects, or didn’t experience many immediate benefits.

About 20% of the new drug applications for chronic pain pooled safety reviews, with seven of them reporting non-medical use, and 15 reporting patients who developed tolerance to the medication.

Eight of the nine medications that received new drug approval had trials that ran for only one to two days and enrolled around 329 patients.

“Between 1997 and 2018, the FDA approved opioids on the basis of pivotal trials of short or intermediate duration, often in narrowly defined pain populations of patients who could tolerate the drug,” the researchers wrote in the paper. “Systematic collation of important safety outcomes was rare.”

Opioids Basics

Opioids are a class of drugs that are used to reduce pain, according to the Centers for Disease Control and Prevention (CDC). Opioids include the following:

The Opioid Crisis

The National Institute of Drug Abuse (NIDA) calls opioid misuse a “serious national crisis,” noting that the total economic burden of prescription opioid misuse is $78.5 billion a year.That includes the costs of health care, lost productivity,addiction treatment, and involvement of the criminal justice system.

The U.S. is facing a record number of drug overdose deaths. In 2018, more than 67,000 Americans died of a drug overdose death—of those, almost 70% involved opioids, the CDC says.

The NIDA says the crisis began in the late 1990s when pharmaceutical companies reassured the medical community that patients would not become addicted to prescription opioid pain relievers. As a result, healthcare providers started to prescribe them more.

It soon became apparent that the medications could be highly addictive, and opioids overdose rates increased.

Now, the NIDA says that up to 29% of patients who are prescribed opioids for chronic pain misuse them, and between 8% and 12% developed an opioid use disorder. Up to 6% of those who misuse prescription opioids transition to heroin.

The FDA’s Role in the Crisis

“Despite the scope of America’s ongoing opioid epidemic, little is known regarding the FDA’s approval of new opioid products over the past two decades,” study co-authorCaleb Alexander, MD, a professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health, tells Verywell.

Alexander argues that the FDA could more tightly regulate opioids before they’re approved. “The FDA has regulatory flexibility in the requirements they set for market access, and our findings suggest that the agency did not use this to require opioid manufacturers to produce more information about the safety and effectiveness of prescription opioids prior to market entry,” he says.

Finally, Alexander says, “the FDA should also re-label chronic opioids so that the labeling for these important products better reflects the conditions under which they have been studied for regulatory approval.”

What This Means For YouPrescription opioid abuse remains a problem in the U.S., where the FDA has a history of approving drugs based on short-term, limited data. If you’re prescribed opioids for pain, talk to your doctor about the potential for addiction and serious side effects.

What This Means For You

Prescription opioid abuse remains a problem in the U.S., where the FDA has a history of approving drugs based on short-term, limited data. If you’re prescribed opioids for pain, talk to your doctor about the potential for addiction and serious side effects.

In 2018, the FDA released aStrategic Policy Roadmapin which the agency vowed to ensure better prescription practices, support treatment for people who are addicted to opioids, and increase efforts to stop the illegal shipment of opioids into the country.The FDAalso saysthat it plans to take steps to help with alternative treatments for chronic pain.

The FDA has released apublic timelineof “selected activities” and “significant events” designed to address opioid misuse and abuse. More recently, the agency has approved Olinvyk (oliceridine), an opioid designed for the management of moderate to severe acute pain in adults.

6 Sources

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.

Centers for Disease Control and Prevention.Opioid basics.

National Institute of Drug Abuse.Opioid overdose crisis.

Centers for Disease Control and Prevention.Understanding the epidemic.

U.S. Food and Drug Administration.Health innovation, safer families.

U.S. Food and Drug Administration.FDA approves new opioid for intravenous use in hospitals, other controlled clinical settings.

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