Traysol Linked to 1000 Deaths Per Month

60 minutes had a chilling expose a few weeks ago on the Bayer drug Trasylol.

The broadcast told the story of Joseph Radone.  Mr. Radone had heart surgery.  The risk asociated with the surgery was around five percent.  Mr. Radone would be home in a week.

After the surgery, the doctors told the family about "complications" that had occurred.  The doctors told the Joe's wife and daugther that Traysol was responsible for the complications.

Only ten days after the surgery, the New England Journal of Medicine published a study on Trasylol.  According to to the study, there was an "association" between Trasylol and kidney failure and Traysol increased the risk of death in patients given the drug.

As far back as the 1980s, German researchers were concerned with the drug.  In 1992, in one small study, almost 75% of patients given Trasylol had kidney problems afterwards.

After the New England Journal of Medicine study came out, the FDA held and advisory meeting to determine the accuracy of the study. 

At the hearing, Bayer representatives hid previous studies from the FDA.

In 2007, a Canadian study was stopped because too many patients in the study were dying.

After the Canadian study, German authorities banned Trasylol and Bayer temporarily stopped selling the drug.

After 19 operations including having his eyes sewn shut, removing his gall bladder, and having his legs amputated, Joe Randone died.

What do you think about the 60 minutes story?  Bayer's conduct?  Whether the Randone family should be allowed to file a lawsuit against Bayer?

Do you think the 1000s of other patients and families who were harmed by Trasylol should obtain some sort of justice from Bayer for the effects of its drug?

We welcome your comments.

Johnson & Johnson recall dangerous Fentanyl pain patch

On February, 12th, 2008, all 25-microgram-per-hour patches that expire on or before December, 2009 sold in the U.S. were recalled by Johnson & Johnson. 

The recall includes Duragesic and Sandoz brands, both of which are manufactured by the Johnson & Johnson subsidiary Alza Corporation. 

The recall occurred as a result of the potential for a cut along one side of the drug reservoir where fentanyl is stored in gel form, causing a leak of the gel. As fentanyl is a dangerous opioid drug, patients and caregivers who come in contact with a leaking patch may have difficulty breathing, or potentially be victims of a fatal overdose. 

This recall follows a 2004 recall of five lots of 75-microgram-per-hour patches for leaking defects.  Many other lots, of all sizes, that were not recalled suffered from leak defects as well.

In addition to reports of leaking patches, the FDA has investigated deaths and life-threatening side effects in patients who never should have been prescribed the patch. 

Fentanyl pain patches are approved for moderate to severe chronic pain.  They should be prescribed only to patients who are accustomed to powerful narcotic drugs.  The reports of improper prescribing of the patch prompted. the FDA in December of 2007 to issue its second Public Health Advisory regarding fentanyl pain patches. 

The Public Health Advisory stated that "reports indicate that doctors have inappropriately prescribed the fentanyl patch to patients for acute pain following surgery, for headaches, occasional or mild pain, and other indications for which a fentanyl patch should not be prescribed."