FDA orders stronger opioid painkiller warnings in response to rising number of prescription drug overdose deaths

by Jim Orr

The Food and Drug Administration has ordered stronger warning labels for long-acting opioid painkillers in response to the growing number of fatal overdoses that have occurred in recent years with these drugs. The new painkiller warnings will restrict how and to whom these powerful drugs can be prescribed in the hopes of reducing the number of deaths and other complications caused by opioids.

The new FDA warnings will affect only the long-acting and extended-release versions of drugs such as oxycodone and morphine, which are sometimes sold under the brand names OxyContin and Opana. Commonly prescribed painkillers such as hydrocodone—which are used to treat short term pain—will not be affected by the new warnings.

Under the new guidelines, the FDA is directing that long-acting, extended-release painkillers should only be prescribed to patients who require long-term, around-the-clock pain relief and for whom less potent opioid painkillers have been ineffective. Under the previous warnings, these long-acting painkillers could be prescribed for moderate to severe pain and did not mention that they should only be used on patients who had been unsuccessfully treated with less powerful drugs.

The FDA’s decision to strengthen its warnings about long-acting opioid painkillers comes at a time when these drugs have become a major public health concern. In 2010, prescription drug overdose surpassed car accidents as the leading cause of preventable death in the United States for the first time. A study undertaken by the Los Angeles Times found that about half of these prescription drug deaths were attributable to opioid painkiller overdoses.

The FDA says that it also hopes that the new regulations will reduce the risk of addiction and abuse for patients who are prescribed opioid painkillers. Because narcotic painkillers can be habit-forming, patients who are prescribed these drugs are at risk of becoming addicted, which could increase their risk of suffering an overdose.

In addition to the new painkiller warnings ordered by the FDA, the agency has also called on the manufacturers of these medications to conduct safety studies in order to determine the safest way that they can be prescribed to patients while still minimizing the risk of overdose, addiction, abuse, tolerance, and other complications. The FDA has also called for better patient education to warn pregnant women who may be prescribed opioid painkillers about the risks that their babies may be born with withdrawal symptoms if they use these medications during pregnancy.

Doctors and Hospitals Must Prescribe Opioid Painkillers With Care

The FDA’s new warning about painkillers contains a crucial piece of information about these drugs—the way that doctors and hospitals prescribe opioids to their patients has a direct outcome on the risks these medications can pose. The FDA believes that by changing the way that doctors prescribe opioid painkillers—getting them to exercise greater care before providing these drugs to patients—will reduce the number of fatal overdoses caused by these medications each year.

When doctors and hospitals fail to exercise proper care when prescribing opioid medications, they may be putting the health—and even the lives—of their patients at risk. Patients who are given painkillers that are more powerful than what is needed to treat their symptoms, or who are given large prescriptions with more pills than necessary, are more likely to suffer an accidental overdose or to become addicted to their medications. In other cases, opioid medications such as fentanyl can be prescribed with other drugs that depress the central nervous system, leading to a combined drug overdose.

Heygood, Orr & Pearson fights for painkiller overdose victims

If you or a loved one has been the victim of complications from an opioid overdose, the doctor or hospital who prescribed these drugs may be to blame. Many doctors who prescribe strong painkillers to their patients have little experience with pain management, causing them to prescribe drugs that are too powerful or in doses that exceed what a patient requires. Sadly, many of these mistakes end in addictions, overdoses, or deaths that could have been prevented.

Heygood, Orr & Pearson has represented numerous clients who have been the victim of complications from excessive painkiller prescriptions by doctors or hospitals. The attorneys at our law firm have handled more cases involving the fentanyl pain patch—a powerful opioid painkiller about 100 times more potent than morphine—than all other law firms in the country combined.

Our partners—Michael Heygood, Jim Orr, and Eric Pearson—have each been chosen by their peers as Super Lawyers in the state of Texas for several years in a row.* Our firm has also been given the highest possible rating for law firms by Martindale-Hubbell, the nation’s leading law firm rating service.

For more information about opioid painkiller lawsuits and to find out if you are eligible to file a case, contact the lawyers at Heygood, Orr & Pearson by calling toll-free at 1-877-446-9001, or by filling out the free case evaluation form located at the top of this page.


Michael Heygood, James Craig Orr, Jr. and Eric Pearson were selected to the Super Lawyers List, a Thomson Reuters publication, for the years 2003 through 2013.

by Jim Orr

Jim Orr is a licensed attorney and a partner at HO&P focusing on business and personal injury litigation. Jim was selected multiple times to the Super Lawyers List and has tried 70+ cases to verdict.