Friday, June 25, 2010

Propofol's Annus Horribilis

The one year anniversary of Michael Jackson's death is upon us.  With his death came the worst kind of notoriety for our favorite anesthetic propofol.  Previously, patients had no clue what kind of anesthetic they were receiving.  All they knew was that they did not wake up until the surgical procedure was finished and that was fine with them.  Now when they ask about their anesthetic, the word "propofol" elicits a universal "Oh, the Michael Jackson drug."  I've even had patients tell me they refuse to get propofol because of MJ's death.  Only after carefully explaining the negligent role of Dr. Conrad Murray do they understand that there is nothing wrong with the drug, just the administration of it by an incompetent physician.

The following twelve months did not improve propofol's reputation.  In July 2009, the FDA forced TEVA to recall 57,000 vials of propofol.  At least forty people were sickened by a batch of bacterially contaminated drug. Two lots of drugs were found to contain bacterial endotoxin.  Luckily despite some fevers and chills nobody died despite their sepsis.

Then in March 2010 Hospira was forced to recall several lots of propofol when tiny particles of stainless steel from their manufacturing vats were found in some specimen.  There were no reports of embolic injuries to patients with this finding. 

Finally in the greatest bombshell of propofol's horrific year, a jury in Las Vegas last month awarded a couple $500 million when the husband contracted hepatitis C after receiving propofol at an endoscopy center.  Dozens of patients were contaminated when the medical staff used a single bottle of propofol on multiple cases.  The jury ruled that Teva and Baxter were at fault for selling the center extra large vials of propofol, thus tempting the staff to use them on multiple patients to save money, despite the fact the bottles clearly state they are for single use only.  The pharmaceutical companies vowed to appeal but the week after the ruling, Teva decided to pull out of the propofol market completely. 

So what will the next year bring for propofol?  Is the end nigh?  Now that Teva has withdrawn from the market there are only two manufacturers left, and one of them is European.  The continued fear of lawsuits against this low margin generic drug may eventually force these last two companies to also drop their propofol production.  Then where will we stand?  There is still the old standby pentathol.  Maybe our pharmacy can dig up a few dusty boxes of them in the back of their cabinets. Versed and demerol is still widely used by gastroenterologists everywhere who refuse to use the services of an anesthesiologists. 

Then there is the promise of fospropofol, the water soluble successor to propofol.  It is a precursor drug that is metabolized into propofol in the body.  There is less risk of bacterial contamination because it is not preserved in a lipid medium.  It produces less discomfort with injection.  However because it is a precursor drug its affects maybe slightly more difficult to titrate than propofol.  Since it is a new drug it is also much more expensive.  Fospropofol is classified by the FDA as a controlled substance, similar to narcotics. So the ease of reaching into the anesthesia cart's drug drawer to grab a bottle of propofol will be a distant memory for anesthesiologists. The next year may prove to be quite consequential to our dear old friend.

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