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FDA Strengthens Labels of Two Types of Antibiotics To Ensure Proper Use

ROCKVILLE, MD -- December 1, 2004 -- The Food and Drug Administration (FDA) announced today important labeling changes regarding Bicillin CR (penicillin G benzathine and penicillin G procaine injectable suspension) and Bicillin LA (penicillin G benzathine injectable suspension). These changes include 1) a new boxed warning against intravenous use and 2) a precautionary note for Bicillin CR explaining it is not for treatment of syphilis. King Pharmaceuticals, Inc., the manufacturer of these products, has also issued a "Dear Doctor" letter, highlighting these changes.

In addition to the new boxed warning "WARNING: NOT FOR INTRAVENOUS USE" that has been added to the labeling of both products, the same warning has been added in red, bold, all capital letters, to the Bicillin CR and Bicillin LA cartons and syringe labels. Intravascular administration of Bicillin has been associated with serious adverse effects in postmarketing reports, including cardiorespiratory arrest and death.

The Centers for Disease Control and Prevention's 2002 Sexually Transmitted Diseases Treatment Guidelines recommend penicillin G benzathine for the treatment of syphilis infection, consistent with the labeled indications for Bicillin LA. However, recently King Pharmaceutical, Inc., became aware of postmarketing reports from multiple sexually transmitted disease (STD) clinics in the U.S. where Bicillin CR had been inappropriately used to treat patients infected with syphilis.

Therefore the manufacturer's "Dear Doctor" letter also reminds practitioners that Bicillin LA is the only currently approved penicillin G benzathine product indicated for the treatment of syphilis and that Bicillin CR should not be administered in place of Bicillin LA for this purpose. Administration of Bicillin CR instead of Bicillin LA in the treatment of syphilis may result in inadequate treatment.

To help health professionals better distinguish between the two types of Bicillin, King Pharmaceuticals has modified the cartons and syringe labels. The background colors for the CR cartons have been changed from white to pale green (Bicillin CR) and pale purple (Bicillin CR 900/300). Bicillin LA cartons will retain the white background. The statement "Not for the Treatment of Syphilis" has also been added in red text to both the Bicillin CR and Billin CR 900/300 syringe labels.

FDA urges health care providers and patients to report adverse event information to FDA via the MedWatch program by phone (1-800-FDA-1088), by fax (1-800-FDA-0178) or by the internet

Source: The Food and Drug Administration

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