A drug to relax muscles during surgery got labeled as a drug to raise blood pressure
One lot of surgical drug cisatracurium besylate got recalled by Meitheal Pharmaceuticals on Thursday because some got put in bottles labeled as surgical drug phenylephrine hydrochloride, which has an almost opposite function.
This is a rather dangerous packaging snafu.
The Meitheal-written, FDA-posted recall notice says “there is a reasonable probability” that a patient needing phenyleprhine, but getting cisatracurium instead could suffer “a fast onset of muscle paralysis and decrease in oxygen.
“If this is not quickly diagnosed and treated, severe illness or death can occur within minutes.”
In very simplistic terms, cisatracurium brings the muscles down and phenylephrine brings the blood pressure up.
“Cisatracurium besylate is used to maintain neuromuscular relaxation during major surgical procedures, primarily to facilitate endotracheal intubation,” the National Center for Biotechnology Information says.
“Phenylephrine injection is used to treat hypotension (low blood pressure) that may occur during surgery,” the Mayo Clinic says.
This covers lot No. C11507A, 10-vial cartons of Cisatracurium Besylate Injection, USP 10mg per 5mL. The mis-labeled bottles have the labels for Phenylephrine Hydrochloride Injection, USP 100mg per 10mL. The lot number is the same, as is the expiration date of October 2021.
Any customers with this product are asked to not open it if it hasn’t already been opened. Whether opened or not, separate it from other drugs and return it to Meitheal. Those with questions about this recall can call Meitheal, 844-824-8426, Monday through Friday, 9 a.m. to 7 p.m., Eastern time.
If this or any other drug causes a medical problem, after notifying a medical professional, let the FDA know via its MedWatch Adverse Event page or by filling out a form you can get by calling 800-332-1088.
This story was originally published January 28, 2021 at 6:21 PM with the headline "A drug to relax muscles during surgery got labeled as a drug to raise blood pressure."
