Anesthesiologists Ask FDA to Okay Importation of Sodium Thiopental

Robert Lowes

February 11, 2011

February 11, 2010 — The American Society of Anesthesiologists (ASA) has asked the US Food and Drug Administration (FDA), for the sake of patient safety, to work with foreign governments to allow for the importation of sodium thiopental (Pentothal, Hospira) because domestic production of the controversial agent ceased in 2009.

Noting shortages of another anesthetic, propofol (Diprivan, AstraZeneca), the ASA stated in a letter last month to the FDA that "a dangerous reduction in the availability of anesthesia induction medications" has come to the point "that the safety of American patients is now in jeopardy."

"Thiopental remains a mainstay of anesthesia induction medications," the ASA said. "Its availability must be ensured."

Anesthesiologists have coped with the disappearance of sodium thiopental — also used in lethal-injection executions of death-row inmates — from their supply cabinets by substituting other agents. With certain patients, however, substitutions come with risks that reflect the differing hypotensive qualities of general anesthetics. Sodium thiopental does not lower blood pressure as much as other agents do, such as the popular propofol. As a result sodium thiopental is the preferred anesthetic for geriatric, cardiovascular, and neurosurgical patients, for whom too much of a drop in blood pressure could lead to complications, according to the ASA.

The ASA letter to the FDA also noted that propofol is not recommended for obstetrics, including cesarean deliveries, because it can cross the placenta and possibly lead to respiratory depression. "Thiopental is still the drug of choice for induction of general anesthesia during cesarean delivery," the ASA stated.

In an interview today with Medscape Medical News, ASA President-elect Jerry Cohen, MD, said anesthesiologists are learning to substitute propofol for sodium thiopental and manage its greater hypotensive effects. "A lot of times we use vasopressors," said Dr. Cohen. "It’s amazing how well we’ve done under the circumstances."

Dr. Cohen said he does not possess any data on the rate of adverse events associated with propofol and its hypotensive qualities. A lack of data, however, does not translate into a lack of worry.

"When you have enough near misses or problems, and when you have to use other drugs to reverse induction effects, you increase the odds of those [adverse] events," said Dr. Cohen, an associate professor in the Department of Anesthesiology at the University of Florida College of Medicine, Gainesville.

What further complicates the situation is that ephedrine, one kind of vasopressor, has been in short supply from time to time, he said. "When you come into the operating room, sometimes you don’t have the drugs you had yesterday."

A Pariah Drug?

The World Health Organization includes sodium thiopental on its list of essential drugs, but its role in capital punishment also makes the agent something of a pariah.

Hospira had been the only FDA-approved source of sodium thiopental, but in 2009 it stopped making the drug, reportedly because of manufacturing issues. Hospira had hoped to resume production at a plant in Italy, but authorities in that country insisted that sodium thiopental made there not be used in lethal-injection executions in the United States. Reasoning that it could not prevent wholesalers from selling the drug to US correctional agencies, Hospira announced in late January that it would exit the sodium thiopental market here.

State correctional departments, however, imported the anesthetic through a chain of intermediaries that led to the pharmaceutical company Sandoz, headquartered in Holzkirchen, Germany. Yesterday, Sandoz announced that it is instructing its subsidiaries not to sell or export the product to the United States or to supply it to any distributors or third parties who may be selling it in this country.

In most lethal injections, sodium thiopental is the first step in a 3-step process. The anesthetic is designed to spare the condemned person the pain and distress of 2 agents that follow — 1 to stop respiration and the other to trigger cardiac arrest.

Six death-row inmates in the United States have sued the FDA in a federal court to shut down the importation of foreign sodium thiopental, arguing that it is an unapproved product that may prove ineffective in inducing pain-free unconsciousness during an execution. The lawsuit includes a copy of a memo purportedly from the FDA stating that it has permitted state correctional departments to import the drug and that substances used for "state-authorized lethal injections" fall outside its jurisdiction.

"Accordingly, FDA chooses to continue to defer to law enforcement on all matters involving lethal injection," the memo stated.

Contacted by Medscape Medical News, the FDA declined to comment on its policy regarding the use of sodium thiopental in capital punishment, the source of the memo cited in the federal lawsuit, or the agency’s response to the ASA request to allow the drug’s importation for surgical procedures.


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