In the last several weeks, the FDA has announced various drug recalls and alerts that have the potential to impact workers’ comp claims.
One lot of Healthy Living Migraine Relief (acetaminophen, aspirin and caffeine) tablets were recalled due to a missing product label. This product lacks the required over-the-counter (OTC) labeling information, drug facts, and patient usage information. There is significant risk of misuse which could result in permanent liver damage if consumers exceed the recommended dose, combine use with excessive consumption of alcohol or are allergic to the active ingredient which could be life-threatening.
Migraines can arise as the result of traumatic head injury, or certain injuries can exacerbate preexisting migraine conditions. This OTC medication was available through Amazon.
Shifting gears to benzodiazepines, a lot of clonazepam orally disintegrating tablets has been recalled, due to mislabeling with incorrect strength on the carton. Clonazepam can be used to treat seizures, as well as panic and anxiety disorders.
The product lot is being recalled due to mislabeling where an incorrect strength appears on the cartons of some packs to show the product strength as 0.125 mg and not 0.25 mg due to an error at a third-party packager. The blister strips inside the product pack reflect the correct strength of 0.25 mg.
Individuals who are inadvertently prescribed a two-fold overdose of clonazepam would be at risk for the adverse effects of significant sedation, dizziness, ataxia, and confusion. There is reasonable probability for significant, possibly life-threatening, respiratory depression especially for patients with concomitant pulmonary disease, patients who have prescribed dosing near maximal dosing, and patients also taking other medications that could cause additional respiratory depression.
Focusing on pain management, one lot of acetaminophen injections was recalled, due to the possible presence of a bag labeled dexmedetomidine inside the acetaminophen overwrap. If a provider administers dexmedetomidine instead of acetaminophen, there are multiple potential adverse outcomes that may result including varying degrees of sedation, bradypnea, bradycardia, hypertension, and hypotension or more serious and potentially life-threatening outcomes. To date, the manufacturer has received one report of an adverse event.
And in the realm of diabetes and obesity, the FDA issued an alert to providers, compounders, and patients of dosing errors associated with compounded injectable semaglutide products.
The FDA has received reports of adverse events, some requiring hospitalization, that may be related to overdoses due to dosing errors associated with compounded semaglutide injectable products. Dosing errors have resulted from patients measuring and self-administering incorrect doses of the drug and health care providers miscalculating doses of the drug.
The FDA encourages patients to talk with their health care provider or compounder about how to measure and administer the intended dose of compounded semaglutide. Many of the patients who received vials of compounded semaglutide lacked experience with self-injections, according to the adverse event reports. Unfamiliarity with withdrawing medication from a vial into a syringe and coupled with confusion between different units of measurement (e.g., milliliters, milligrams and “units”) may have contributed to dosing errors.
Adverse events included gastrointestinal effects (e.g., nausea, vomiting, abdominal pain), fainting, headache, migraine, dehydration, acute pancreatitis and gallstones.
For ongoing coverage of the latest drug approvals and alerts impacting workers’ comp, visit Med Monitor online.
