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Carbon InformationCALCIUM C LITHIUM C OXYGEN CA OXYGEN-CA OYSTER SH POTASSIUM SODIUM BI
Active Ingredient: AIR; CARB BARIUM CA CALCIUM C CARBON DI LITHIUM C OXYGEN OYSTER SH POTASSIUM SODIUM BI
Side Effects reported to FDA: 15. View Carbon Adverse Reports
Reported deaths: 8
Reported hospitalizations: 1
Sodium Bicarbonate Injection, USP, 7.5% and 8.4%, 50 mL Single Dose Vials - Recall Due to Particulates in Some Vials
AUDIENCE: Hospital Risk Managers, Pharmacy, Emergency Medicine
ISSUE: American Regent and FDA notified healthcare professionals of the nationwide recall of specific lots of Sodium Bicarbonate Injection, USP, 7.5% and 8.4%, 50 mL Single Dose Vials because some vials of these lots contain particulates. Potential adverse events after intravenous administration include damage to blood vessels in the lung, localized swelling, and granuloma formation.
BACKGROUND: Sodium Bicarbonate Injection, USP, is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of blood pigments. Sodium bicarbonate is also indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate.
RECOMMENDATION: Hospitals, infusion centers, clinics and other healthcare facilities should not use American Regent Inc., Sodium Bicarbonate Injection, USP, 7.5% and 8.4%, 50 mL Single Dose Vials with the lot #s list in the firm press release for patient care and should immediately quarantine any product for return.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
[12/28/2010 - Firm Press Release - American Regent]
Have Your experienced Carbon Side Effects? You are not alone. Many patients report unusual symptoms after using Carbon. PatientsVille.com raises awareness about Drug Side Effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.