The U.S. Food and Drug Administration is warning consumers not to use certain Baczol Antigripal and Baczol Expectorante drug products labeled to contain the ingredients “Sulfametaxazol” (sulfamethoxazole in English) and “Trimetoprim” (trimethoprim in English). The products of concern are labeled in Spanish and marketed as antibiotics for bronchitis, pneumonia, and other respiratory infections. Consumers who have purchased either product should immediately stop taking it and consult a health care professional.
FDA has received reports of these products being sold in stores in Spanish speaking communities in the United States. Baczol products are manufactured by Laboratorios Lopez, a company located in El Salvador.
Sulfamethoxazole and trimethoprim are prescription drug ingredients. These ingredients can cause serious, and even life-threatening adverse reactions in some patients, including liver failure, blood cell abnormalities, and painful skin reactions that can cause skin cells to die and peel off the body in large sheets.
In addition, some Baczol product labels include a non-steroidal anti-inflammatory drug (NSAID) ingredient dipirona. Dipirona is not an ingredient in any FDA approved drug. NSAIDs may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage including bleeding, ulceration, and fatal perforation of the stomach and intestines.
Health care professionals and consumers are encouraged to report any adverse events related to Baczol Antigripal and Baczol Expectorante to FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178