Drugmaker set to cease production of propofol


NEW YORK -- The drugmaker Teva said Friday it won't make any more of its sedative propofol, which could intensify a shortage of one of the most common anesthetics in the U.S.

The drug is hard to manufacture and the company gets little or no profit from it, said Denise Bradley, a spokeswoman for Teva Pharmaceutical Industries Ltd. The company had to halt production and recall some of the drug last year because of manufacturing issues, and it is facing a raft of propofol-related civil lawsuits stemming from the hepatitis C outbreak in Las Vegas.

In the first civil trail stemming from the outbreak, a jury this month found Teva and another drug company liable for a Henderson man's infection and awarded $500 million in punitive damages, including $356 million against Teva.

But Teva's decision to stop propofol production was "in no way related to the litigation in Las Vegas," Bradley said.

Dr. Alexander Hannenberg, the president of the American Society of Anesthesiologists, said propofol is by far the most common intravenous anesthetic in the U.S., used for general anesthesia and for sedation because when it's used properly, patients wake up quickly and side effects are rare. Hannenberg said the drug is often used in surgeries and is becoming more popular in procedures like spinal or epidural anesthesia.

"Probably at least 75 percent of the anesthetics given in the U.S. involve propofol," he said. "It's huge."

The Food and Drug Administration says there has been a shortage of the drug since last fall because manufacturing problems forced both Teva and Hospira Inc. to suspend manufacturing and recall some of their versions of the sedative. With no U.S. companies making the drug, the agency authorized the importation of a version approved in Europe called propovan.

The FDA said the European manufacturer, APP Pharmaceuticals, is covering most of the demand for propofol and it is working with APP to increase supplies.

Teva, based in Israel, has not made any propofol since mid-April, but plans to sell what it had already made. Hospira, based in Lake Forest, Ill., said it cannot resume selling the drug until the FDA approves changes to its manufacturing procedures.

Britain's AstraZeneca PLC developed the brand name version of the drug, which is called Diprivan, but no longer sells it.

In Las Vegas, Teva's decision means more scrambling for medical providers trying to find propofol and suitable alternative anesthetics, all of which were already more expensive because of the propofol shortage, said Dr. Daniel Orr, director of oral and maxillofacial surgery at the UNLV School of Dental Medicine.

"Those costs will have to be paid by someone -- ultimately the patients," he said.

The five hospitals within The Valley Health System have been using propovan while saving stocks of propofol for patients with peanut allergies, spokeswoman Gretchen Papez said.

Few companies make propofol because it is complicated to manufacture. It's an emulsion -- a combination of two liquids that don't blend together chemically -- and it must be stored very carefully because bacteria can contaminate it more easily than other drugs.

Further complicating matters is the fact that some of the drugs that could be used in place of propofol also are in short supply, Hannenberg said. Sodium pentathol might be used as an alternative for general anesthesia, but right now it's extremely hard to get. He said the problem is that many of these drugs are made by few companies, or only one company, so they are hard to replace when supply problems occur.

Hannenberg, a practicing anesthesiologist, said drugs like Valium might be used as sedatives in place of propofol. But pentathol and Valium are more likely to produce side effects including nausea.

Teva still faces more than 200 lawsuits stemming from Las Vegas' hepatitis C outbreak linked to two endoscopy clinics run by Dr. Dipak Desai.

At the first trial, lawyers for Henry and Lorraine Chanin argued that propofol vials had inadequate warning labels and that Teva and Baxter Healthcare Services should have withheld 50-milliliter vials of propofol from endoscopy centers because they tempted nurses to reuse the vials instead of throwing away leftover sedative.

Local health officials blamed the outbreak on nurse anesthetists reusing propofol vials between patients after they had become contaminated by syringes that were reused on patients with hepatitis C.

Despite previous outbreaks and knowledge that 50-milliliter vials were being misused, the companies continued to make and sell them to the endoscopy centers because they were more profitable than safer 10-milliliter vials, the Chanins' lawyers argued during the three-week trial.

The jury agreed and awarded the Chanin's more than $5 million in compensatory damages and $500 million in punitive damages, with Teva paying $356 million and Baxter paying $144 million.

Both companies have said they plan to appeal that verdict, and Teva said that if the man contracted hepatitis C from the clinic, it was because the drug was "blatantly misused." Teva said it believes propofol is safe and effective when it is used properly.

Will Kemp, Lorraine Chanin's lawyer, said Teva's decision to stop making propofol would have little effect on the pending lawsuits, though it could lead to a massive settlement if the company looks to end all ties to the drug.

"You'd think they would want to start settling these cases," he said. "Shut the whole propofol drawer."

The drug became infamous last year when it was connected to the death of Michael Jackson. The singer died in June after overdosing on propofol and other sedatives that were administered by his personal doctor, who has been charged with involuntary manslaughter. Dr. Conrad Murray used the drugs to help Jackson sleep.

Review-Journal reporter Brian Haynes contributed to this report.

 

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