FDA issues black box warning about addiction, overdose risks of opioid painkillers

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by Jim Orr

The Food and Drug Administration has announced that it will require the manufacturers of prescription opioid painkillers to add a black box warning to these medications. The new warnings—the toughest ever issued by the FDA regarding opioids—are designed to alert doctors and patients about the dangers of misuse, abuse, addiction, overdose, and death associated with prescription painkillers.

The FDA’s decision to require a black box warning for prescription painkillers comes in response to a growing epidemic of fatal overdoses caused by these medications. Since 1999, more than 165,000 patients have died in the U.S. as a result of opioid painkiller overdoses, including a record 28,647 deaths in 2014. Commonly prescribed opioid medications include fentanyl (Actiq, Duragesic), hydrocodone (Vicodin), hydromorphone (Dilaudid), methadone, morphine (MS Contin), and oxycodone (Percocet, OxyContin).

In a press release announcing the updated warning labels, the FDA stated that the new black box warning was part of a number of steps that the agency was taking to curb this epidemic of fatal opioid overdoses.  The FDA said that it hoped to reverse the growing number of overdoses linked to opioid painkillers while still providing access to these medications for patients who need these drugs to treat severe pain.

In addition to the black box warning, the FDA is also requiring new labels intended to advise physicians about the appropriate use of certain opioid medications known as immediate release, or IR, opioids, which are intended for use every 4-6 hours. The new labeling advises doctors that IR opioids should only be used in cases where pain is so severe that opioid painkillers are required and for which alternative treatments such as over-the-counter pain relievers are not adequate or are not tolerated by the patient. The treatment labels also contain information about the use of opioid medications with pregnant women in order to avoid pregnancy complications such as opioid withdrawal symptoms in the newborn.

The new FDA warnings also contain information about the risk of drug interactions for all opioid medications. When prescription painkillers are administered in combination with medications that depress the central nervous system, cumulative effects of these medications may lead to a combined drug overdose. Patients who suffer a combined overdose as a result of treatment with opioid medications may lapse into respiratory depression or respiratory arrest, which can be fatal if not treated promptly.

The FDA also announced that it was investigating the risks of prescribing opioid painkillers in combination with benzodiazepines, a class of tranquilizer drugs that includes the medications Valium and Xanax. The agency stated that it may take additional action regarding opioids and benzodiazepines once scientific review on the combined effects of these medications is complete.

The FDA’s black box warning on opioid painkillers comes just days after the Centers for Disease Control and Prevention issued new treatment guidelines to limit the number of cases of addiction and overdose caused by opioid painkillers. Although non-binding, the CDC treatment guidelines encourage doctors to use over-the-counter pain relievers to treat patients with pain before prescribing opioid medications.

Lawsuits Filed On Behalf of Opioid Painkiller Overdose Victims

The aggressive marketing of prescription painkillers by the pharmaceutical industry and the overprescription of opioid medications by doctors have played a key role in the rise of opioid overdoses in the U.S. Since 1999, sales of opioid painkillers in the U.S. have risen by an alarming 300%, due both to the aggressive marketing of these drugs by the pharmaceutical industry and the growing willingness of doctors to prescribe opioids even when they may not be needed. As sales of opioid medications has climbed, so too have the number of overdose deaths caused by these medications.

If you or a loved one has been the victim of an overdose or other serious complications caused by opioid overprescription, you may be eligible to file a lawsuit against the manufacturer of the medication they were given as well as the doctor or hospital who prescribed the drug. The first step in filing a lawsuit is to secure the help of an experienced attorney who can help guide you through the process of filing a claim.

The lawyers at Heygood, Orr & Pearson have represented numerous individuals who have been the victim of complications caused by opioid painkiller prescriptions. Our law firm has handled more cases involving the fentanyl pain patch—a powerful opioid painkiller that is about 80-100 times more powerful than morphine—than all other law firms in the country combined.

If you or a loved one has suffered an overdose or other complications resulting from opioid painkiller medications, the lawyers at Heygood, Orr & Pearson are ready to help. For more information about prescription painkiller lawsuits and to learn whether you may be eligible to file a case, contact our law firm by calling toll-free at 1-877-446-9001. You can also reach us by following the link to our free case evaluation form located at the top of this page and answering a few simple questions to get started.