Label Changes for:
Marcaine and Marcaine with Epinephrine InjectionMarcaine Spinal InjectionBupivacaine hydrochloride and epinephrine bitartrate injection
Changes have been made to the PRECAUTIONS sections of the safety label.
- Marcaine (bupivacaine HCl) injection
- Marcaine with Epinephrine 1:200,000 (as bitartrate)(bupivacaine HCl and epinephrine) injection
- Marcaine Spinal (bupivacaine HCl) dextrose injection
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
Pregnancy Category C
- There are no adequate and well-controlled studies in pregnant women. MARCAINE should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
- Bupivacaine hydrochloride produced developmental toxicity when administered subcutaneously ... In a rat pre- and post-natal development study (dosing from implantation through weaning) conducted at subcutaneous doses of 4.4, 13.3, & 40 mg/kg mg/kg/day, decreased pup survival was observed at the high dose. The high dose is comparable to the daily MRHD of 400 mg/day on a BSA basis.
Carcinogenesis, mutagenesis, impairment of fertility
- Long-term studies in animals to evaluate the carcinogenic potential of bupivacaine hydrochloride have not been conducted. The mutagenic potential .....
- Intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures is an unapproved use, and there have been post-marketing reports of chondrolysis in patients receiving such infusions. The majority of reported cases of chondrolysis have involved the shoulder joint; cases of gleno-humeral chondrolysis have been described in pediatric and adult patients following intra-articular infusions of local anesthetics with and without epinephrine for periods of 48 to 72 hours. There is insufficient information to determine whether shorter infusion periods are not associated with these findings. The time of onset of symptoms, such as joint pain, stiffness and loss of motion can be variable, but may begin as early as the 2nd month after surgery. Currently, there is no effective treatment for chondrolysis; patients who experienced chondrolysis have required additional diagnostic and therapeutic procedures and some required arthroplasty or shoulder replacement.