In March 2004, the Los Angeles County Department of Health Services (LACDHS) was notified that a large nonprofit clinic serving the gay and lesbian community in Los Angeles used a nonrecommended preparation of
penicillin to treat
syphilis patients during January 1999-March 2004. The clinic had inadvertently used
Bicillin C-R, a mixture of 1.2 million units (MU)
benzathine penicillin G (BPG) and 1.2 MU
procaine penicillin G, rather than
Bicillin L-A, a preparation that contains the 2.4 MU BPG per dose recommended by CDC.
Bicillin L-A is recommended for treating
syphilis and
upper respiratory tract infections caused by susceptible streptococci.
Bicillin C-R is indicated for
streptococcal infections of the skin and respiratory tract; however, its efficacy in treating
syphilis is unknown. The inadvertent use of
Bicillin C-R, which contains only half the recommended dose of BPG for
syphilis, was discovered after a patient treated for
syphilis read the product insert, which stated that the medication was not indicated for treatment of
syphilis. Review of clinic pharmacy records revealed that it received a shipment of
Bicillin C-R in lieu of an unfilled order for
Bicillin L-A in late 1998 and that the pharmacy subsequently ordered
Bicillin C-R until March 2004. The clinic used
Bicillin C-R as its exclusive formulation of
injectable penicillin during January 1999-March 2004. This report summarizes the investigation of the misuse of
Bicillin C-R at the Los Angeles clinic, which represents the largest occurrence of inadvertent treatment with
Bicillin C-R to date. The investigation led to discussions among CDC, the Food and Drug Administration (FDA), and King
Pharmaceuticals, Inc. (Bristol, Tennessee), whose Monarch
Pharmaceuticals subsidiary markets
Bicillin products. As a result, King
Pharmaceuticals agreed to institute packaging and labeling changes to
Bicillin products to prevent inadvertent treatment of
syphilis with
Bicillin C-R.