FDA orders new fentanyl warning label following childrens’ deaths from accidental exposure to discarded patches

by Jim Orr

New warning labels about the dangers of the fentanyl will be added to labeling for the pain patch following an announcement by the Food and Drug Administration. The agency’s call to issue the new warnings came after two children died of accidental overdoses after they came into contact with discarded fentanyl patches that were prescribed to a relative.

The new warning labels will contain information about the dangers of the fentanyl patch printed in bright colors to make them more visible. The name of the drug and the dose of the patch will also be printed in long-lasting ink to prevent this vital information from becoming difficult to read because of wear or age.

Fentanyl Overdoses Among Children Due to Accidental Exposure

The FDA’s concerns about the fentanyl pain patch and the risk it poses to children stems in part from the drug’s extreme potency compared to other pain medications. Fentanyl is an opioid painkiller that is about 100 times more potent than morphine. Because of this extreme potency, care must be exercised with how the patch is prescribed to patients. The FDA has warned that fentanyl should only be used on patients who have developed a tolerance for opioid medications, such as cancer patients who have already undergone long-term opioid therapy. When fentanyl is prescribed in other circumstances—such as short term pain or post-surgical pain—an accidental overdose can occur.

Care must also be used when removing and throwing away a fentanyl patch. After the pain patch has been used by a patient, it should be discarded in such a manner that it will not be accidentally found by young children. Due to the high potency of fentanyl, exposure to even a small amount of the medication through a discarded patch can be fatal to a young child.

In April 2013, the FDA issued a warning about the risk of accidental fentanyl overdoses in children who come into contact with discarded pain patches. However, following the two recent deaths caused by just such an occurrence, the FDA felt it was necessary to issue stronger and more visible warnings about the risk of fentanyl to prevent additional deaths such as these from occurring.

Fentanyl Overdose Lawsuits and Our Law Firm

If you or a loved one was the victim of a fentanyl overdose, you may be eligible to file a lawsuit against the manufacturer of the patch. Over the last several years, a number of fentanyl recalls have been issued by pharmaceutical companies due to defectively manufactured fentanyl patches that could expose patients to a dangerous and potentially fatal level of the drug.

The doctor or hospital who prescribed the pain patch could also be responsible for the circumstances that caused a fentanyl overdose to occur. Physicians who prescribe fentanyl to patients who are ineligible to take the drug—including patients with short term or post-operative pain—are putting their patients’ lives at risk through their negligent behavior. When fentanyl is prescribed with other drugs that depress the central nervous system, a combined drug overdose can occur due to the interaction of these medications.

When the wrongdoing of a drug company, a doctor, or hospital leads to a fentanyl overdose, our law firm believes that the responsible parties should be held accountable in a court of law. Heygood, Orr & Pearson has successfully prosecuted more lawsuits involving fentanyl overdoses that all other law firms in the country—combined. Our lawyers have years of legal experience in handling fentanyl cases like yours, and will bring their knowledge and experience to ensure that your legal rights are fully protected.

Our partners—Michael Heygood, Jim Orr, and Eric Pearson—have each been voted as Super Lawyers by their peers for several years in a row.* Our law firm has also been AV-rated, the highest possible ranking by the country’s leading law firm ranking service, Martindale-Hubbell.

For a free legal consultation from our attorneys and to find out whether you may be eligible to file a fentanyl lawsuit, contact 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.