Two Texas Patients Who Received Recalled Drug DieAug 16, 2013
The U.S. Food and Drug Administration (FDA) announced the recall of all products produced by Specialty Compounding of Cedar Park, Texas, following reports of bacterial infections affecting 17 patients at two Corpus Christi hospitals.
Two of the patients who received the drugs died, but Chris Van Deusen, spokesman for the Texas Department of State Health Services, said that the cause of death is not yet known, and that no link between the medication and the deaths has been established, the Associated Press (AP) reports.
The Centers for Disease Control and Prevention (CDC) is analyzing bacteria samples from the patients to see if the strains are the same and from the same source. The CDC expects results next week. Texas officials told the CDC that the patients who received calcium gluconate manufactured by Specialty Compounding developed bloodstream infections, most of which were caused by Rhodococcus equi, which causes illness in horses. Though this infection is rarely seen in people, it sometimes occurs in those with weakened immune systems, specifically AIDS patients, according to the AP.
The CDC tested an intact sample of Specialty Compounding’s calcium gluconate and it showed growth of the Rhodococcus bacteria species. The company voluntarily recalled all products manufactured and distributed since May 9, though the infections were attributed only to calcium gluconate. The company said in a statement that the products were sent directly to patients nationwide, except in North Carolina, and were also distributed to Texas hospitals and physicians, according to the AP.
Compounding pharmacies have been in the spotlight since last fall, when hundreds of people nationwide were infected in a fungal meningitis outbreak linked to contaminated steroid injections for back pain. The outbreak has been blamed for at least 50 deaths and more than 700 illnesses. Compounding pharmacies are normally overseen by state pharmacy boards, but recent expansion in the scope of manufacturing and distribution by some compounders has prompted calls for compounders to be regulated by the FDA as other drug manufacturers are.