Introduction
In March 2012, a Salvadoran-American boy aged 7 years living in Maryland developed three slightly painful, well-demarcated, flat, gray-brown patches on his torso. A dermatologist in Washington, DC, suspected a fixed drug eruption (an erythema multiforme-like adverse drug reaction that occurs in the same location each time the person uses a particular medication). The child had recently taken a cough and cold remedy, Baczol Antigripal, which was made in El Salvador and purchased in a Maryland suburb of Washington, DC, without a prescription. The Baczol Antigripal ingredients included the sulfonamide-containing antibiotic trimethoprim-sulfamethoxazole (TMP/SMX), which is a common cause of fixed drug eruption. In June 2013, another Salvadoran-American child, a girl aged 14 years living in northern Virginia, was evaluated for a similar fixed drug eruption likely caused by a Baczol product purchased near her home. In August 2013, staff members from the Children's National Medical Center investigated the availability of Baczol products in grocery stores in Salvadoran neighborhoods of Washington, DC, and neighboring suburbs. TMP/SMX-containing products were found in seven of 19 stores.
Four Baczol products were identified; two listed TMP/SMX as an ingredient and were labeled for sale in El Salvador only. TMP/SMX is a known cause of fixed drug eruptions and other adverse drug reactions and cannot be legally dispensed in the United States without a prescription. On August 20, the Food and Drug Administration (FDA) issued a Safety Alert in English and Spanish.* The FDA advised purchasers of these products to stop taking it and consult a health-care professional. Clinicians should be aware that patients might consume nonprescribed antibiotics and should specifically ask about over-the-counter cold and flu remedies, especially when an adverse drug reaction is suspected.
The dermatologist who diagnosed the first case and learned of the sale of Baczol Antigripal in Maryland notified Maryland's Department of Health and Mental Hygiene that an antibiotic was being sold without a prescription. In April 2012, the department issued an alert regarding Baczol, which is sold in El Salvador as an over-the-counter remedy for the common cold and cough in children. The FDA has issued import refusals for those Baczol formulations that contain TMP/SMX.[1] Use of nonprescribed TMP/SMX poses a public health risk because of possible adverse drug reactions[2] and spread of antibiotic resistance; however, the availability of such drugs is unknown. An investigation was conducted to determine the availability of Baczol products in grocery stores in Salvadoran neighborhoods of Washington, DC, and neighboring suburbs.
Two investigators for the Children's National Medical Center used U.S. Census data to identify heavily Salvadoran neighborhoods in the Washington, DC, area and then searched the Internet for Latino grocery stores in Washington, DC (Columbia Heights and Adams Morgan neighborhoods), Virginia (Falls Church, Alexandria, and Springfield), and Maryland (Wheaton and Silver Spring). Search terms used included "Latino market," "Latino grocery," "Latin American market," and "Latin American grocery." The investigators identified areas within each neighborhood that appeared to have several Latino grocery stores in close proximity. They visited identified stores and conducted scripted questioning for Baczol. Latino grocery stores nearby that had not been found via the Internet search also were assessed with the same scripted materials. The investigators also searched the medical literature but found no cases of fixed drug eruption attributed to sulfonamide-containing drugs sold without prescription.
TMP/SMX-containing products were found in three of seven stores in Washington, DC, one of six stores in Virginia, and three of six stores in Maryland. Two products, Baczol Antigripal (Figure) and Baczol Expectorante, listed TMP/SMX as an ingredient. The labels for both products, written entirely in Spanish, stated that they were for sale in El Salvador only ( Table ). The label for Baczol Expectorante stated explicitly that it was for sale without a prescription. A third TMP/SMX-containing product identified by investigators was Bactrizole, which is made by a different manufacturer in El Salvador ( Table ). None of the three TMP/SMX-containing medications described potential adverse drug reactions on their packaging.
Figure.
Two Baczol products purchased without a prescription from Latino grocery stores in the greater Washington, DC, area: (left) a product with no sulfonamide component, which was exported legally to the United States; (right) a product with TMP-SMX, which according to the label, is intended for sale solely in El Salvador and requires a prescription — 2013
Two additional products, also called Baczol Antigripal (Figure) and Baczol Expectorante, did not contain TMP/SMX. The labels for these products, written in Spanish and English, but otherwise nearly identical to those of their sulfonamide-containing counterparts, stated that they were for sale in the United States without a prescription and had appropriate National Drug Code numbers.
* Available at http://www.fda.gov/drugs/drugsafety/ucm365650.htm.
Morbidity and Mortality Weekly Report. 2013;62(46):914-916. © 2013 Centers for Disease Control and Prevention (CDC)
