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TMP-SMX products sold OTC led to adverse reaction
Recent episodes of fixed drug eruption were associated with antibiotics containing trimethoprim-sulfamethoxazole that were made in El Salvador and sold in the Washington, D.C., metro area, according to a report in MMWR.
In March 2012, a Salvadoran-American boy aged 7 years developed fixed drug eruption after taking Baczol Antigripal, a cough and cold medicine that was sold without a prescription in a store in a Salvadoran neighborhood in a Maryland suburb. In June 2013, a Salvadoran-American girl aged 14 years also developed fixed drug eruption. She also had used a Baczol product purchased in a grocery store in a Salvadoran neighborhood in northern Virginia.
Investigators at Children’s National Medical Center in Washington, D.C., investigated the availability of Baczol products in Salvadoran suburbs and found products that contained TMP-SMX in seven of 19 stores. Four different products were identified, two of which were labeled for sale in El Salvador only.
The FDA issued a safety alert in English and Spanish that advised purchasers to not use the products and to consult a health care provider. The FDA also has issued an import refusal for Baczol formulations that contain TMP-SMX, which is sold as an over-the counter remedy for children with cold and cough in El Salvador.
TMP-SMX is a common cause of fixed drug eruption and requires a prescription in the United States.
“Clinicians should be aware that patients might consume nonprescribed antibiotics and should specifically ask about over-the-counter cold and flu remedies, especially when there is a suspicion of an adverse drug reaction,” the investigators wrote.
Disclosure: The researchers report no relevant financial disclosures.