Texas health officials say no link has been found between a compounded drug and the death of two patients who developed blood infections after receiving it before its recall.
The federal Food and Drug Administration recalled all products produced by Specialty Compounding of Cedar Park, Texas, after reports of bacterial infections affecting 17 patients at two Corpus Christi hospitals. Two of the patients 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 no link between the medication and the deaths has been established.
Texas health officials are working with the Centers for Disease Control and Prevention, a federal health agency in Atlanta. CDC is analyzing samples of the bacteria taken from the patients to see if they're all the same strain and come from the same source. Results are expected next week.
Texas officials told the CDC that the patients who received calcium gluconate manufactured by Specialty Compounding developed bloodstream infections and that most of the infections were caused by Rhodococcus equi, which causes illness in horses. It's rarely seen in people, though there have been reports of it in people with weakened immune systems -- specifically AIDS patients.
An intact sample of the calcium gluconate made by the firm showed growth of bacteria of the Rhodococcus species, the CDC said in a statement.
The company has voluntarily recalled all the products it has manufactured and distributed since May 9, however the common treatment in all cases was calcium gluconate. It said the products were sent directly to patients nationwide, except in North Carolina. They were also distributed to Texas hospitals and physicians.
CDC officials described calcium gluconate as a drug to help people with low calcium levels. That can include heart patients, cancer patients or others. The drug is not specifically for any particular disease, but to bring up calcium levels and counterbalance high levels of magnesium or potassium.
In October, hundreds of people were infected in a fungal meningitis outbreak that was linked to contaminated steroid injections for back pain. The outbreak been blamed for at least 50 deaths nationwide.
Compounding pharmacies mix customized injections, creams and other medications in formulas specified by doctors. They have traditionally been overseen by the 50 state boards of pharmacy across the U.S. But those bodies have struggled to police larger compounding operations that have emerged in recent years, producing medications in bulk and shipping them across state lines.
The New England Compounding Center, the pharmacy at center of the meningitis outbreak, shipped more than 17,600 doses of the pain injection implicated in the case.
Dr. Carmen Catizone, the director of the National Association of Boards of Pharmacy told Senate lawmakers last May that these large compounders are essentially manufacturers, and should be regulated by the Food and Drug Administration.
A Senate proposal, drafted by a bipartisan group of lawmakers, calls these operations "compounding manufacturers," and requires them to register with FDA and meet the same quality control standards as pharmaceutical giants like Pfizer Inc. and Eli Lilly & Co. Traditional compounding pharmacies, generally small operations that work with individual doctors, would continue to be regulated by state pharmacy boards.
Since 2001, there have been 75 reported deaths and more than 1,020 illnesses connected with compounded drugs, according to an assessment released by the Pew Charitable Trusts at the hearing.