Recalls of drugs used in heart surgeries seem to be escalating. In the past few months, drugs such as Digitek, Heparin and Trasylol have all been recalled for one reason or another. Unless you’re a doctor or pharmacist, keeping track of which drugs have been recalled – and why – can be a difficult task.

Major recalls

The list of recalled drugs used in heart surgeries is getting longer. The following major recalls have occurred in the past few months:

• Digitek: Digitek, manufactured by Avantis and used to treat heart failure, was recalled in April 2008 after the company realized that some of the tablets may contain double the strength of medication which could pose a risk of digitalis toxicity in patients with renal (kidney) failure.

  Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia (which is a resting heart rate of less than 60 beats per minute). The Digitek recall was classified as a Class I recall, the most serious type, meaning that serious injury or death may occur. Several reports of illnesses and injuries have been received.

  The products are distributed by Mylan Pharmaceuticals, Inc. under a Bertek label and UDL Laboratories, Inc. under a UDL label.

• Heparin: Heparin, manufactured and/or marketed by Baxter Healthcare, B.Braun Medical, AM2 PAT and Covidien recalled their Heparin products in early 2008 after certain lots of the drug were found to be contaminated. The raw ingredient in Heparin, which is used to prevent blood clots in cardiac procedures raw, comes from pig intestines. Most of the companies receive their raw Heparin from Scientific Laboratories of Wisconsin.

  The U.S. Food and Drug Administration (FDA) has also classified this as a Class I recall and reported that 81 deaths have been linked to contaminated Heparin. While the exact cause is still unknown, the FDA suspects that the problem originated in China.

• Trasylol: Trasylol, manufactured by Bayer AG, was pulled off the market in November 2007 after studies revealed that the drug may increase the risk of kidney failure and sudden death. Trasylol was used to limit bleeding in heart surgeries.

  Dr. Dennis Mangano published a study in January 2006 that found Trasylol use doubled patients’ risk of kidney failure, heart failure and had a 181 percent increase in the risk of stroke. Dr. Mangano, who was featured in a recent CBS 60 Minutes segment in early 2008, claims that Bayer knew about these issues many years ago, but refused to take the drug off the market – a decision that may have caused 22,000 patients to die in vain.

If you or a loved one may have been injured due to Digitek, Heparin or Trasylol use, contact an attorney whose practice focuses in this area of law to discuss your situation. The consultation is free, without obligation and strictly confidential. To contact a qualified attorney, please click here. We may be able to help.