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Reports of Inappropriate Use of Bicillin C-R and Bicillin L-A Resulting in Ineffective Treatment of Syphilis and the Potential for Cardiorespiratory Arrest and Death if Administered Intravenously

Nov 3, 2004 | PharmaLive.com

King Pharmaceuticals and FDA reminded healthcare professionals of postmarketing reports of inappropriate use of Bicillin C-R to treat patients infected with syphilis. Bicillin L-A is the only currently approved penicillin G benzathine product indicated for the treatment of syphilis and Bicillin C-R should not be administered in place of Bicillin L-A. Administration of Bicillin C-R instead of Bicillin L-A in the treatment of syphilis may result in inadequate treatment.

In addition, a BLACK BOX WARNING has been added to the prescribing information of both products to emphasize that these products should only be administered by deep intramuscular injection. They are not intended for intravenous administration and inadvertent intravenous administration of penicillin G benzathine has been associated with cardiorespiratory arrest and death.

Read the MedWatch 2004 safety summary, including links to the "Dear Healthcare Professional" letter below. The revised labels are attached.

Dear Healthcare Professional:

King Pharmaceuticals, Inc. would like to inform you about important labeling changes regarding Bicillin® C-R (penicillin G benzathine and penicillin G procaine injectable suspension) and Bicillin® L-A (penicillin G benzathine injectable suspension). These labeling changes highlight existing precautionary and prescribing information in an effort to provide additional assurance that these products are used and administered appropriately.

Treatment of Syphilis

Bicillin® L-A (penicillin G benzathine injectable suspension) is the only currently approved penicillin G benzathine product indicated for use in sexually transmitted infections, including syphilis. Conversely, Bicillin® C-R (penicillin G benzathine and penicillin G procaine injectable suspension), which consists of a combination of penicillin G benzathine and penicillin G procaine in an injectable suspension, should not be used for the treatment of syphilis.

CDC’s 2002 Sexually Transmitted Diseases Treatment Guidelines1 recommend penicillin G benzathine for the treatment of syphilis infection, consistent with the labeled indications for Bicillin® LA. However, we have recently been made aware of postmarketing reports from multiple STD clinics in the US where Bicillin® C-R has been inappropriately used to treat patients infected with syphilis; therefore, the US Food and Drug Administration, the Centers for Disease Control and Prevention and King Pharmaceuticals feel it necessary to remind practitioners that Bicillin® L-A is the only currently approved penicillin G benzathine product indicated for the treatment of syphilis and that Bicillin® C-R should not be administered in place of Bicillin® L-A for this purpose . Administration of Bicillin® C-R instead of Bicillin® L-A in the treatment of syphilis may result in inadequate treatment.

To help healthcare professionals better distinguish between the two types of Bicillin® and to better assure the proper use of each of these products, Bicillin® C-R (penicillin G benzathine and penicillin G procaine injectable suspension) cartons and syringe labels have been modified to provide greater distinction between the CR and LA products. The background colors for the C-R cartons have been changed from white to pale green (Bicillin® CR) and pale purple (Bicillin® C-R 900/300). Bicillin® L-A cartons will retain the white background. The reminder statement “NOT FOR THE TREATMENT OF SYPHILIS’’ has been added in bold, capital letters to the front panel, the back panel, and one side panel of both the Bicillin® C-R and Bicillin® C-R 900/300 cartons. The statement “Not for the Treatment of Syphilis’’ has also been added in red text to both the Bicillin® C-R and Bicillin® C-R 900/300 syringe labels.

For Deep IM Injection Only

Bicillin® C-R (penicillin G benzathine and penicillin G procaine injectable suspension) and Bicillin® L-A (penicillin G benzathine injectable suspension) should be administered only by deep intramuscular (IM) injection; they are not intended for intravenous (IV) administration. To more prominently emphasize this important safety information to health care professionals, the following WARNING from the current prescribing information has been relocated into a black box appearing between the product name and the DESCRIPTION section, and again at the beginning of the WARNINGS section.

In addition, a new reminder “WARNING: NOT FOR INTRAVENOUS USE’’ has been added in red, bold, all capital letters to the Bicillin® C-R (penicillin G benzathine and penicillin G procaine injectable suspension) and Bicillin® L-A (penicillin G benzathine injectable suspension) cartons and syringe labels.

King Pharmaceuticals, Inc. is committed to the safety of all patients receiving Bicillin® C-R (penicillin G benzathine and penicillin G procaine injectable suspension) and Bicillin® L-A (penicillin G benzathine injectable suspension). Should you have any questions or concerns regarding these important new labeling changes, please contact the King Pharmaceuticals, Inc. Professional Information Services at 1-800-776-3637. It is important that you forward any adverse event information associated with the use of Bicillin® C-R (penicillin G benzathine and penicillin G procaine injectable suspension) and Bicillin® L-A (penicillin G benzathine injectable suspension) to King Pharmaceuticals, Inc. at 1-800-546-4905.

Sincerely,
Charles L. Pamplin III, M.D.
Vice-President, Medical Affairs
King Pharmaceuticals, Inc.


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