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Trayslol, has been used to reduce bleeding, especially in heart bypass surgery. It is a medication that is administered to patients without their knowledge as part of the administration of drugs incident to their surgery. Trayslol is also known as aprotinin. Manufactured by Bayer, Traslol has been widely used since the 1990s . It was first revealed in January of 2006  that Trayslol administration increased the risk of renal toxicity. Trayslol has also been linked with increased risk of kidney failure, cardiovascular events (myocardial infarction or heart failure), cerebrovascular events such as a stroke, encephalopathy or coma. The FDA issued an alert  and warned physicians to monitor patients for problems. Bayer recently admitted that  a large study suggested that Trasylol increases the risks of severe side effects. It has removed the drug from the market.

A  New England Journal of Medicine study reported that patients given Trasylol had a more than 50 percent higher death rate than patients who got other, cheaper drugs. The patients receiving the drug were heart patients so it was not readily apparent to the treating physicians that the fatal outcome was related to the administration of Trayslol.

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Fentanyl is a opiate 100 times more powerful than morphine. Originally this drug was put out as Duragesic®  made by Johnson & Johnson. Although originally it was used in operations, it later was applied in patches for patients with chronic serious pain. Numerous generic versions of the fentanyl patch, including Sandoz (manufactured by Alza), Mylan, Watson and Actavis hit the market. Although intended for only serious pain symtoms, some doctors prescribed it to those not needing such a potent medication. "Fold-over defects" and "stringer leakers" have caused leakage from the patches to over-medicate and kill patients.

A second Public Health Advisory regarding fentanyl pain patches has been issued, which 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."

Johnson & Johnson recalled approximately 32 million patches because of possible leak defects. The recall includes Duragesic® and Sandoz brands. Actavis Inc., the United States manufacturing and marketing division of the international generic pharmaceutical company Actavis Group HF announced that 14 lots of fentanyl transdermal system CII patches sold in the United States are being voluntarily recalled.

Once again, patients have relied vainly on the FDA, pharmaceutical companies and their treating physicians for a good faith review of the medications prescribed.  

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The FDA announced that onersulfated chondroitin sulfate has been found as a contaminant in Heparin, a bloodthinning drug distributed by Baxter Internation Inc. This contaminant  does not occur naturally. The question is how the Heparin became contaminated.

Hundreds have been injured, including 19 deaths.  Adverse reactions include: refractory hypotension leading to organ damage, organ failure, shock, and death. Baxter began recalling  Heparin in January .

Heparin is used before certain  surgeries, including coronary artery bypass graft surgery, and in kidney patients before they undergo dialysis. Heparin is often initiated using a high bolus dose given directly into the bloodstream.  This administration is the most risky for adverse effects.

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FDA issued an early communication about new safety information and the request for additional data concerning  the risk of death in patients treated with cefepime. The May 2007 issue of The Lancet Infectious Diseases (Efficacy and safety of cefepime: a systematic review and meta-analysis) reported the increased mortality with the use of cefepime, a broad spectrum B-lactam antibiotic currently approved for the treatment of a variety of infections due to susceptible strains of microorganisms. The article describes a higher all-cause mortality in patients treated with cefepime compared to other B-lactam antibiotics. If someone has been prescribed this drug, I recommend that they contact their treating physician to discuss this breaking news.
Read the complete MedWatch 2007 Safety Summary including a link to the Early Communication Sheet regarding this ongoing safety review at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Cefepime

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