September 2009 Archives

September 29, 2009

FDA Orders Black Box Warning for Generics of Wyeth's Phenergan

The U.S. Food and Drug Administration (FDA) has ordered manufacturers of the promethazine hydrochloride injection to include a black box warning regarding potential dangers associated with the administration of the drug.  Promethazine hydrochloride was formally manufactured by pharmaceutical giant Wyeth under the name Phenergan.  Promethazine is used to treat nausea, vomiting, and pain after surgery and anesthesia, as well as allergy symptoms, motion sickness, and other ailments.

According to the FDA, the warning only applies to the injectable form of the drug which presents a serious risk of tissue damage if improperly administered.  The FDA warns that gangrene and other tissue injuries can be caused by administering promethazine in an artery or under the skin.  Because Phenergan, or promethazine, can potentially leach out of a vein and damage surrounding tissue during intravenous administration, the drug should be injected deep into muscle according to the FDA.

The black box warning label ordered for promethazine follows a March 4, 2009, U.S. Supreme Court decision in the landmark case Wyeth v. Levine.  In Levine, Diana Levine, a musician, had her arm amputated after Phenergan was injected into her vein using the "IV-push" method, entered her artery, and caused gangrene.  A state jury found that Wyeth failed to provide adequate warning of the dangers of such administration and awarded Ms. Levine $6.7 million in compensatory damages.  Wyeth appealed claiming that federal law pre-empted Levine's claim because the warning label had been approved by the FDA and it would be impossible to comply with both state and federal law.  The Supreme Court found against Wyeth and upheld the state court decisions in favor of Ms. Levine.


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September 22, 2009

Trasylol Increases Death Rate Among Heart Surgery Patients

Bayer's drug trasylol, also known under the generic name aprotinin, was widely administered during heart surgery to control bleeding, but research indicates that it may be responsible for a multitude of deaths.

A 2006 study in the New England Journal of Medicine reported that trasylol increased patients' risks of kidney failure, heart attack, and stroke. The researchers concluded that the drug accounted for $1 billion in annual dialysis costs as a result of the 10,000 to 11,000 cases of kidney failure attributed to its use.

Additional studies in the United States and Canada revealed that patients receiving trasylol incurred a much higher death rate than those who had received other drugs

According to a report on CBS News' 60 Minutes, trasylol was given to 52-year-old Joseph Randone in January 2008 to decrease the bleeding risk during what should have been routine heart valve replacement surgery. Shortly after the surgery, he suffered two heart attacks and kidney failure. Eventually, his legs had to be amputated, his eyes sewn shut, and a pacemaker implanted in his heart before his eventual death. His surgeon indicated that he believed trasylol caused the complications.

Bayer allegedly concealed information from one of its own studies about the dangers of using trasylol during an FDA advisory hearing in September 2006. In the face of mounting evidence of the drug's adverse effects, the FDA requested in November 2007 that Bayer stop sales. However, it was not until May 2008 that Bayer recalled any remaining supply of the drug from the market.

On April 25, 2008, Bayer announced that 78 trasylol lawsuits were filed. The first trasylol trial consolidated in a multidistrict litigation is now scheduled to begin on January 18, 2010 in the U.S. District Court for the Southern District of Florida.

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September 14, 2009

Repeat Drunk Driver Charged with Killing Florida Motorcyclist

A Miramar, Florida, driver has been charged with killing a Davie, Florida, resident while driving drunk.  According to reports, the intoxicated driver was taking his 9-year-old daughter to school when he struck the Davie motorcyclist and dragged him 180 feet before coming to a stop.  When the drunk driver was apprehended after fleeing the scene of the accident, breathalyzer results showed his blood alcohol content to be .236 -- nearly three times the legal limit.   This was not the first time the driver has been charged with drunk driving according to the South Florida Sun-Sentinel.  According to their report, the intoxicated driver was wanted in Maryland for failing to appear for a court proceeding after violating his probation for driving under the influence with another charge of DUI.

Unfortunately, motorcycle accidents have been on the rise for the past nine years according to Florida's Department of Highway Safety and Motor Vehicles.  In 2008 alone, there were 9618 motorcycle crashes in Florida which caused the death of 502 motorcyclists and 30 passengers and contributed to over 9000 injured riders.  These numbers include 37 motorcycle accident deaths in Broward County, 44 in Miami-Dade County, and 34 in Palm Beach County.  Drug and alcohol related fatalities in Florida sadly exceeded 1,400 people in 2008.

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September 9, 2009

Hospital Performs Brain Surgery on Wrong Side Three Times

ABC News reported (November 27, 2007) that a Rhode Island hospital was fined $50,000 for committing three serious surgical errors in one year. In two cases, the neurosurgeons operated on the wrong side of the patients head. In the third case, a neurosurgeon drilled on the right side even though the patient's CAT scan showed bleeding on the left side of the brain, but fortunately the error was caught and the hole was closed so that the surgery could proceed on the correct side.

Here are some additional recent examples of wrong site surgery:

  • A Chicago area man had surgery performed on the wrong knee, resulting in serious injury to a healthy knee and unanticipated medical bills.
  • A man was permanently disabled because the surgeon fused the bone in the wrong ankle.
  • A 52-year-old Florida man had the wrong leg amputated and received compensation of $900,000 from the hospital and $250,000 from the surgeon.
  • The right kidney of an 84-year-old woman was mistakenly removed instead of her gall bladder.
  • A 17-year-old girl received the wrong heart and lungs in a transplant and eventually died.
According to the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) Sentinel Event Statistics, between 1995 and June 30, 2009 there were 837 cases of wrong site surgery.

Minimize the Probability of Surgery on the Wrong Site

You can take steps to help prevent wrong site surgery:

  • Investigate your doctor's credentials to determine Board Certification(s) and how many of the same procedures he/she has performed.
  • Investigate the quality of the hospital and its ranking in various specialty areas at websites such as:
    • United States Department of Health and Human Services
    • HealthGrades
    • Consumer Reports
  • Tell the nurses and doctors your full name, why you are having the surgery, and your date of birth. While this may sound obvious, there is at least one known case of two people with the same names but different middle initials having surgery in the same hospital at the same time but for different reasons.
  • Be sure that the doctor initials the site of the surgery as recommended by the American Academy of Orthopaedic Surgeons.
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