Bicillin C-R Not for Use in Syphilis; IV Bicillin L-A/C-R Linked to Cardiac Arrest, Death

Yael Waknine

Disclosures

November 30, 2004

Nov. 30, 2004 — The U.S. Food and Drug Administration (FDA) and King Pharmaceuticals, Inc., have notified healthcare professionals via letter of labeling changes for existing prescribing and route of administration information for penicillin G benzathine (Bicillin L-A and C-R) products to ensure appropriate use, according to an alert sent today from MedWatch, the FDA's safety information and adverse event reporting program.

According to the letter, the 2002 guidelines from the Centers for Disease Control and Prevention recommend penicillin G benzathine for the treatment of syphilis infection, consistent with prescribing information for Bicillin L-A. Bicillin L-A is the only penicillin G benzathine product currently approved for this indication.

The FDA has received postmarketing reports of inappropriate use of penicillin G benzathine and penicillin G procaine injectable suspension (Bicillin C-R) for the treatment of syphilis infections. The FDA emphasizes that Bicillin C-R should not be administered in place of Bicillin L-A for the treatment of syphilis because this treatment may be inadequate.

The carton and syringe labeling for Bicillin C-R has been modified to aid in its identification and prevent its inappropriate use in syphilis therapy. The carton has been changed from white to pale green (Bicillin C-R) and pale purple (Bicillin C-R 900/300); the carton for Bicillin L-A remains white.

In addition, the warning "Not for the treatment of syphilis" has been added in capital and bold letters to the front, back, and one side panel of Bicillin C-R and C-R 900/300 cartons. "Not for the treatment of syphilis" has also been added in red text to the syringe labels of these products.

The FDA has also received reports of cardiorespiratory arrest and death in patients receiving penicillin G benzathine by intravenous injection. Bicillin C-R and Bicillin L-A should not be administered intravenously or mixed with other intravenous solutions.

A black box warning has been added to the safety labeling of Bicillin C-R and Bicillin L-A to remind healthcare professionals that these products should be administered by deep intramuscular injection only. "Warning: not for intravenous use" has also been added in capital, bold red letters to the carton and syringe labeling for these products.

More information concerning these labeling changes may be obtained by contacting King Pharmaceuticals, Inc., Professional Information Services at 1-800-776-3637.

Adverse events associated with the use of Bicillin C-R or Bicillin L-A should be reported to King Pharmaceuticals, Inc., at 1-800-546-4905. Alternatively, this information can be reported to the FDA's MedWatch program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

Reviewed by Gary D. Vogin, MD

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