Pharmaceutical manufacturer Hospira has announced that it will not reinstate production of its drug Pentothal (sodium thiopental). The anesthetic agent's use as part of a lethal cocktail administered by prisons in several U.S. states for the death penalty has put it at the center of an international controversy.
"Italy's intent is that we control the product all the way to the ultimate end user to prevent use in capital punishment," Hospira said in a press release issued January 21. "Given the issues surrounding the product, including the government's requirements and challenges bringing the drug back to market, Hospira has decided to exit the market."
Hospira originally ceased producing Pentothal at its North Carolina plant in August 2009 to assess quality control issues, and sought to move production to a facility in Milan instead, according to an article in the Chicago Tribune. The drug makes up a tiny fraction -- less than one-quarter of 1% -- of the company's roughly $4 billion in annual sales, the article noted.
— Dan Rosenberg, Hospira public affairs
officer
However, Hospira representatives said that this did not lessen their efforts to resume production of the drug. "We were diligently trying to get it back on the market," Dan Rosenberg, Hospira public affairs officer, told DrBicuspid.com. "We spent the last month working on this to get it back out."
But after internal deliberations and conversations with the Italian government, Hospira concluded that it would be unable to prevent the drug from reaching American prisons for use in administering the death penalty and opted to stop manufacturing it. "Exposing our employees or facilities to liability is not a risk we are prepared to take," the company said.
The American Society of Anesthesiologists (ASA) expressed disappointment in Hospira's decision. In a statement released January 24, the ASA noted that sodium thiopental "is an important and medically necessary anesthetic agent that has been used for years to induce anesthesia in patients undergoing surgical procedures."
Hospira and the ASA said that they do not condone the usage of Pentothal for capital punishment. While it is not approved for executions in the U.S., state prison officials have skirted those guidelines with "off-label" use, a common practice in which doctors prescribe drugs for purposes not expressly described in its labeling, the Tribune explained.
Drug shortage impact
Pentothal usage has dipped significantly since drugs such as propofol, another Hospira-manufactured drug and one of the most favored anesthetics on the market, and others were introduced. Even so, sodium thiopental is still considered a first-line anesthetic in many cases, including those involving geriatric, neurologic, cardiovascular, and obstetric patients for whom the side effects of other medications could lead to serious complications, according to the ASA.
And despite propofol's popularity, Hospira experienced a recall of that drug in 2009, and the only other domestic producer of propofol, Teva, has ceased production, rendering propofol in perpetual short supply ever since.
"With Pentothal not being manufactured any more, the only thing I see it having an impact on is the continuing shortage for propofol," said Kenneth K. Lee, DDS, a Los Angeles practitioner who has examined the propofol shortage (Pulse, Fall 2010, Vol. 43:4-5, pp. 2-4). "Now, one more substitute drug is not available." Dr. Lee had not used Pentothal for 15 years, he noted -- until his practice ran out of propofol and he was compelled to use it.
Hospira's decision to cease production of Pentothal only accentuates the need to address drug shortages, noted the ASA, calling this an "increasing problem."
"It is an unfortunate irony that many more lives will be lost or put in jeopardy as a result of not having the drug available for its legitimate medical use," the ASA said.
A shortage of Pentothal already exists in the U.S., and several states have had to postpone executions as a result, according to the Tribune article. Oklahoma used pentobarbital, an animal euthanizing agent, instead in two executions, but the practice was halted by the U.S. Supreme Court due to concerns about it falling into the realm of cruel and unusual punishment, the article added.
The remaining doses of Pentothal will soon expire, which could complicate the ability of states such as Ohio and Texas to carry out executions, according to an article in Expatica.
The Associated Press reported that the FDA helped Arizona quickly obtain the drug from the U.K. last fall and was aware that the state intended to use it in an execution. European Union members, all of whom have outlawed the death penalty, responded to Arizona's acquisition with outrage. Germany's Health Minister Philipp Roesler wrote a letter to German laboratories urging them not to fill orders for sodium thiopental from U.S.-based customers, Expatica reported.
An electronic search yielded a number of manufacturers of sodium thiopental abroad including German firms Nycomed, Inresa, and Rotexmedica, Indian firms Kayem Pharmaceutical and Jagsonpal Pharmaceuticals, and Chinese manufacturer and exporter B&K Technology Group.
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