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Children's National team alerts FDA to improper antibiotics sales

Scott A. Norton, MD, MPH, chief of dermatology at Children’s National Health System, and two medical students working with him identified improper sales of antibiotics without prescriptions in neighborhood grocery stores in the Washington, DC, area.  Their work prompted the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention  to warn consumers about the drugs.

The medications can have serious side effects that can cause serious skin disorders or have life-threatening adverse reactions.

Beginning in August, 2012, Dr. Norton and his staff investigated the availability of several cold remedies made in El Salvador and illegally imported into the United States. These products, such as Baczol Antigripol and Baczol Expectorante, include a sulfonamide-containing antibiotic, trimethoprim-sulfamethoxazole (TMP-SMX), which is a well-known cause of fixed drug eruption and other serious side effects. The products were labeled in Spanish only and marketed to treat bronchitis, sinusitis, pharyngitis, and other respiratory infections.

In particular, Dr. Norton and his team identified sales of the medications in Latino neighborhood stores and then alerted the FDA, which issued alerts on Aug. 20, 2013, in English and Spanish about illegal sales of prescription antibiotics sold as over-the-counter cold remedies.

TMP/SMX-containing products were found in three of seven stores in Latino neighborhoods in Washington, DC, one of six stores in Virginia and three of six stores in Maryland.  Dr. Norton is concerned that such sales are continuing.

 “Although the particular condition that our patients had, fixed drug eruption, is fairly minor, the children developed large blisters every time they took these medications– and the blisters were on the same sites on the skin each time,” Dr. Norton says. “The sores are painful while they are active and can leave permanent discolorations on the skin. The families and their physicians did not recognize the cause of the eruption and one family was referred to Child Protective Services to make sure there wasn’t physical abuse in the home.”

Dr. Norton’s awareness of the illegal Baczol products began in 2012, when a 7-year-old Salvadoran-American boy developed three slightly painful, well-demarcated, flat gray-brown patches on his torso. In June, 2013, another Salvadoran-American child, a 14-year-old girl who resided in Northern Virginia, was evaluated for a similar condition “likely caused by a Baczol product purchased near her home,” according to a CDC report in November 2013.

“The particular condition, fixed drug eruption, is uncommon, but the presence of the medication in the stores shows that more awareness is necessary,” Dr. Norton says. “I’m particularly concerned that the illegal products may have caused more serious, perhaps life-threatening, side effects – and that no one has been able to determine why these kids became so ill.”
The labels on the cold remedies included the phrase “venta únicamente en El Salvador” [“for sale only in El Salvador”] but were, nevertheless, on shelves of many stores in the DC area.  Consumers who have purchased either product should immediately stop taking it and consult a health care professional.

TMP/SMX is an important and widely used antibiotic but it is a known cause of fixed drug eruptions and other adverse drug reactions and can be dispensed in the U.S. only with a prescription. These ingredients can cause serious, and even life-threatening, adverse reactions in some patients, including kidney and liver failure, blood cell abnormalities, and painful skin reactions.
Baczol products are manufactured by Laboratorios López, a company located in El Salvador.

There is at least one product, also sold under the name Baczol Antigripal, which contains no antibiotics and is imported legally into the United States and sold legally without a prescription. The legal, antibiotic-free product contains ingredients that are similar to those of dozens of over-the-counter cough and cold remedies widely available throughout the US. The boxes of the two Antigripal products, the one allegedly illegally imported with TMP-SMX, and the legally imported one without antibiotics, are nearly identical, Norton says.

In carrying out the investigation, Norton and the two medical students who were working with him 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 those neighborhoods.

The other investigators are Christine C. Yang, State University of New York Upstate Medical University, and Audrey N. Green, Mercer University School of Medicine in Georgia.

 “After the medical students who helped me finished their rotation and left Washington, DC, they checked in other communities and are finding the illegal products for sale in Latino groceries all over the country, in Washington state, Massachusetts, California, and Texas,” Dr. Norton says.

Contact: Emily Hartman or Joe Cantlupe, 202-476-4500.

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