FDA Warns of Dangerous Mislabeling Risks Serious Medical Errors, Prompting Recalls and Safety Concerns
A new warning from the U.S. Food and Drug Administration (FDA) highlights a serious risk associated with confusion between unapproved nasal epinephrine solutions and approved injectable epinephrine products. The FDA has reported that the labeling and packaging similarities between the two forms of epinephrine have led to multiple medical errors, including instances where the nasal solution was mistakenly injected into patients. This error can have life-threatening consequences, given that nasal epinephrine is not sterile and is not intended for intravenous use.
The problem specifically involves epinephrine nasal solutions manufactured by BPI Labs LLC in Largo, Florida, and Endo USA in Malvern, Pennsylvania. Endo USA has recalled its unapproved nasal epinephrine product following the FDA’s recommendation, but BPI Labs has yet to comply with the agency’s recall request. Since 2016, the FDA has received more than 25 reports of confusion between the nasal and injectable epinephrine products. At least one of these incidents, reported in 2024, involved a patient mistakenly injected with the nasal formulation.
The Risks of Epinephrine Misadministration
Epinephrine is a critical medication used to treat severe allergic reactions, anaphylaxis, and other life-threatening emergencies. Injectable epinephrine is designed to be administered intramuscularly or intravenously in precisely controlled doses. However, the nasal formulation is meant to be absorbed through the mucous membranes in the nose, making it unsuitable for direct injection into the bloodstream.
When the nasal solution is mistakenly injected, patients are exposed to a high risk of severe complications. The non-sterile nature of nasal epinephrine increases the potential for infections, including sepsis, which can be fatal if not treated promptly. Additionally, because the nasal solution is not formulated for intravenous administration, it may not produce the intended medical effects, leading to treatment failure in emergency situations.
The FDA has emphasized that clear labeling is crucial to preventing these errors, but communication among healthcare providers is equally important. Clinicians must be aware of the risks and ensure that pharmacists, nurses, and prescribers take extra precautions when handling epinephrine products. Physicians like Dr. Alexander Rabin, a clinical associate professor of pulmonary and critical care medicine at the University of Michigan, have expressed concern about the lack of awareness regarding this issue. Dr. Rabin noted that he was unaware of the problem before the FDA’s announcement and emphasized that improved communication between medical professionals is essential to patient safety.
The Impact on Patients and Potential Legal Claims
The confusion between nasal and injectable epinephrine has already led to documented cases of medical errors, and more patients may be at risk if the issue is not promptly addressed. Those who have suffered harm due to misadministration of epinephrine may have grounds to file a lawsuit against the manufacturers responsible for the misleading packaging and labeling.
Medical errors related to drug administration can result in serious injuries, prolonged hospitalizations, and even wrongful death. Patients who were mistakenly injected with a non-sterile nasal solution may have experienced severe infections, organ damage, or treatment failure in a medical emergency. These injuries could have been prevented if the manufacturers had taken adequate steps to differentiate the labeling of their products and if healthcare providers had been properly warned of the risks.
Victims may pursue claims under product liability laws, which hold pharmaceutical manufacturers accountable for defective or dangerous products. If a patient was injured due to misleading packaging or inadequate warnings, they may be entitled to compensation for medical expenses, pain and suffering, and lost income.
The Lawsuit Process and the Importance of Legal Representation
Filing a product liability lawsuit requires a thorough legal strategy to establish the manufacturer’s responsibility for the harm caused. The process begins with gathering medical records and expert testimony to demonstrate that the error was a direct result of the product’s mislabeling or improper distribution.
Once evidence is collected, the injured party can file a complaint against the responsible pharmaceutical company. The lawsuit will outline how the defective product led to injuries and detail the damages suffered by the victim. During litigation, both sides will engage in discovery, exchanging information and gathering additional evidence. If a settlement is not reached, the case may proceed to trial, where a judge or jury will determine liability and compensation.
An experienced product liability attorney is essential for building a strong case against pharmaceutical companies. These corporations often have extensive legal resources and will attempt to minimize their responsibility for injuries caused by their products. Legal representation ensures that victims receive fair compensation and that manufacturers are held accountable for putting public safety at risk.
Damages Available in a Product Liability Lawsuit
Victims who have suffered harm due to epinephrine misadministration may be entitled to financial compensation for their losses. Recoverable damages can include:
- Medical Expenses: Coverage for hospital stays, medications, and ongoing treatments related to the injury.
- Lost Wages: Compensation for missed work while recovering from the effects of a medical error.
- Pain and Suffering: Damages for physical pain, emotional distress, and diminished quality of life.
- Punitive Damages: In cases of gross negligence, courts may award punitive damages to penalize manufacturers for failing to protect public safety.
Patients who have been harmed due to the confusion between nasal and injectable epinephrine may have a right to seek justice. The national product injury law firm Parker Waichman LLP is committed to holding pharmaceutical companies accountable and securing compensation for victims.
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