Sole US maker of execution drug halts production and other drug headliners

Drug companies, government agencies and medical researchers made major announcements and discoveries this past week. The only US maker of a lethal-injection drug permanently halts its production. The FDA puts limits on the painkiller acetaminophen. And an antidepressant cools hot flashes.

1. Sole US maker of execution drug halts production

Hospira announced today it will exit the ‘lethal-injection’ market, permanently halting production of its product Pentothal (sodium thiopental).

The company is the only US maker of sodium thiopental, an anesthetic used by some states as part of a drug cocktail administered in capital punishment cases. It’s the first of a sequence of three that paralyzes breathing and stops the heart. "This is not how the drug is intended to be used," says company spokeswoman Tareta Adams.

The drug has been used worldwide to sedate patients undergoing medical procedures, the company says, and stopping its production means that hospital customers who use the drug for medical reasons would not be able to obtain it.

"This will be a challenge for [medical] customers and we regret that," says Adams. Hospira has had discussions with its drug distributors to see if the companies could block the drug from being sold to prisons, but the company ultimately decided there was no way to ensure the drug would not be "misused.”

The company says it has never condoned the use of Pentothal in US capital punishment procedures and believe that they “could not prevent the drug from being diverted to departments of corrections.”

2. FDA sets limits on painkiller acetaminophen

Acetaminophen – an active pain-relieving ingredient of many drugs – has been capped by the Food and Drug Administration in order to reduce liver damage.

The FDA asks manufacturers of prescription combination products with acetaminophen to limit the amount to no more than 325 milligrams per tablet.

The drug is usually combined with opioids such as codeine (Tylenol with Codeine), oxycodone (Percocet) and hydrocodone (Vicodin).

Over-the-counter acetaminophen products won't be affected by this. (I just checked, each caplet of Midol has 500 mg of acetaminophen – but these aren’t combined with narcotics to make more potent painkillers.)

The FDA is also requiring manufacturers to update their labels to warn of the risk for severe liver injury. These 'boxed warnings' are the agency's strongest warning for prescription drugs.

Overdose from these types of products account for nearly half of all US cases of acetaminophen-related liver failure, says FDA’s Sandra Kweder. But she stresses that there’s no immediate danger: liver injury primarily occurs if patients take multiple products containing acetaminophen at a time, exceeding 4,000 mg in a day.

Some 200 million prescriptions were dispensed for acetaminophen/opioid prescription products in 2008, Kweder says, who added that lower-dose versions "won't be any less effective."

3. An antidepressant to cool those hot flashes

The antidepressant Lexapro (escitalopram) significantly cuts the number and severity of hot flashes, offering a potential new treatment for this menopausal symptom.

Hormone replacement therapy (HRT) is the only FDA-approved treatment of hot flashes. But sales of these such drugs fell sharply when a 2002 study found higher rates of cancer and strokes in women who took the estrogen plus progesterone pills.

"One of the reasons for the study was to try to find something other than hormonal therapy," says Ellen Freeman of the University of Pennsylvania School of Medicine.

Her team compared Forest Laboratories' Lexapro to a placebo in 205 healthy women having nearly 10 hot flashes a day when the study started.

After 8 weeks of treatment (10-20 mg per day), women who took Lexapro had half as many hot flashes, and those they had were less severe. Three weeks after they stopped taking Lexapro, their hot flashes came back.

Other antidepressants have been shown to be effective, including GlaxoSmithKline's paroxetine or Paxil, fluoxetine (sold by Pfizer as Prozac) and Pfizer's venlafaxine or Effexor [Reuters].

The study was published in the Journal of the American Medical Association this week, and it was funded by the National Institutes of Health.

Image: FDA

This post was originally published on Smartplanet.com