Pfizer subsidiary Hospira issued a nationwide recall of its vials used to inject sodium bicarbonate, citing sterility concerns. The recall exacerbates the current shortage of the potentially lifesaving drug.
Hospira is voluntarily recalling sodium bicarbonate and succinylcholine chloride vials that had microbial growth and were susceptible to contamination, which could cause sepsis, the U.S. Food and Drug Administration said Thursday. Forty-two lots of sodium bicarbonate vials were recalled along with seven lots of succinylcholine chloride. Hospira has not received reports of any adverse events associated with the drug, the company said.
Hospitals use a sterile form of baking soda—a sodium bicarbonate solution, which has baking soda as its base ingredient—in vital situations including heart surgery and other emergency events when a patient's blood is too acidic, which can lead to coma and death if left unchecked. The biggest U.S.-based drugmaker, Pfizer, is the main manufacturer of sodium bicarbonate, and said in a May 16 letter that a manufacturing issue involving glass syringes sparked the drug shortage. The supplier shortage has forced providers to delay surgeries and shift operations as they search for new manufacturers and treatment alternatives, healthcare experts said. Succinylcholine chloride, also a critical drug, is used if an anesthetized patient's throat closes.
"It's horrific," said Erin Fox, drug shortage expert and director of drug information at the University of Utah Health Care's Drug Information Service. "Today we lost half of the bicarb vials that we had in stock. We are going to have to further restrict the use of sodium bicarbonate to have enough for truly critical situations."
Pfizer and the other sodium bicarbonate manufacturer, Amphastar Pharmaceuticals, expect to restock the syringes and vials by mid-August, according to the American Society of Health-System Pharmacists. That's probably the best-case scenario, healthcare officials said. It is an example of one of many shortages caused by a lack of drug manufacturers.
The FDA allowed the vetted Australian drugmaker Phebra to export vials of sodium bicarbonate to the U.S. to help alleviate the shortage, but relief comes with a high cost, Fox said.
A 1 liter bag containing 150 milliequivalents of sodium bicarbonate traditionally cost around $40 to make. The imported variety has ballooned to nearly $450, she said.
"Pfizer clearly has the resources to fix whatever poor quality manufacturing issues resulted in this recall," Fox said. "I hope they decide to fix the problem."