Ettusen liv i måneden) (cbsnews.com (60 Minutes))

Bayer underslo alvorlige bivirkninger Bayer A.G., the German pharmaceutical giant, failed to reveal to federal drug officials the results of a large study suggesting that a widely used heart-surgery medicine might increase the risks of death and stroke, the Food and Drug Administration announced Friday. (nytimes.com 29.9.2006)

Lege: 22 000 døde under forsinket tilbaktrekking (reuters.com 15.2.2008)

Trasylol Pulled From Worldwide Market FDA says clotting drug poses increased death risk, while company says drug still has benefits. (healthfinder.gov 5.11.2007)

Kanadensisk studie med Trasylol (aprotinin) tillfälligt stoppad
(lakemedelsverket.se 31.10.2007)

FDA - MedWatch - Trasylol (aprotinin) - Important revisions to the WARNINGS section of Prescribing Information (fda.gov 15.12.2006)

Aprotinin Injection (marketed as Trasylol) Information (fda.gov 15.12 2006)

Aprotinin Injection (marketed as Trasylol) Information
fda.gov 14.5.2008
[UPDATE 5/14/2008]: Following publication of the Blood conservation using antifibrinolytics: A randomized trial in a cardiac surgery population (BART) study in the May 14, 2008 online issue of The New England Journal of Medicine, Bayer Pharmaceuticals, the manufacturer of Trasylol (aprotinin), notified the FDA of their intent to remove all remaining supplies of Trasylol from hospital pharmacies and warehouses. [See FDA Statement]. (...)

Bayer hurt by damaging Trasylol data, sued over Kogenate
pharmatimes.com 21.2.2008
Days after a critical TV documentary on the drug, two new large studies have confirmed an increased incidence of death and kidney damage among patients given Bayer’s currently-suspended blood loss agent Trasylol.

The studies, which are published in the latest issue of The New England Journal of Medicine, claim that Trasylol (aprotinin), which reduces bleeding during coronary artery bypass grafting, has been proved as an effective treatment but its safety profile has to be questioned.

The first study, carried out by staff at Brigham and Women's Hospital, Harvard Medical School, analysed data from over 78,000 CABG cases. 33,517 patients received Trasylol and 44,682 were given aminocaproic acid. Overall, 1,512 aprotinin patients (4.5%) and 1,101 aminocaproic acid patients (2.5%) died and the authors noted that after adjustment for 41 variables, Trasylol was associated with a 64% greater risk of death and an increased need for dialysis. (...)

One Thousand Lives A Month (Ettusen liv i måneden)
cbsnews.com (60 Minutes)
(CBS) This is the story of a drug that was on the market for 14 years and may have contributed to the deaths of thousands of patients. Trasylol, made by Bayer, is given in the operating room to control bleeding. It was a big money maker.

As correspondent Scott Pelley reports, Bayer marketed Trasylol aggressively until it was used in about one third of all cardiac bypass operations in America.

But then, in 2006, a study showed widespread death associated with Trasylol, and as it turns out there was concern long before that.

How much did Bayer know? And why did it take Bayer and the U.S. Food and Drug Administration nearly two years to take the drug off the market after major studies revealed the danger? Two years - during which it's estimated Trasylol was contributing to the loss of one thousand lives a month. (...)

Bayer braces itself for Trasylol documentary on US TV (Bayer forbereder seg på Trasylol-reportasje på amerikansk TV)
pharmatimes.com 15.2.2008
Bayer and its lawyers will doubtless be watching the investigative US television programme 60 Minutes on Sunday which will include the claim from a researcher that the lives of 22,000 patients could have been saved if the Food and Drug Administration had removed the firm’s blood loss agent Trasylol from the market two years ago.

The makers of the programme, CBS, have released some extracts from the programme which include claims by researcher Dennis Mangano that Bayer placed the drug's success before patient well-being. The company voluntarily suspended sales of Trasylol (aprotinin), used to limit bleeding in heart surgery, after a Canadian study was stopped because of patient deaths.

Dr Mangano was the author of a study published in the Journal of American Medical Association in January 2006, which associated the drug's use with kidney failure requiring dialysis and increased death of those patients. Between the study’s publication and November 2007, when Bayer pulled the drug, "there were approximately 431,000 patients who received the drug," he says. "As I calculated, 22,000 lives could have been saved. It’s about a 1,000 lives per month," Dr Mangano tells 60 Minutes. (...)

(Anm: Autoimmune attack underlying kidney failure. Interstitial nephritis, a common cause of kidney failure, has a complex and largely unknown pathogenesis. In a new published paper in The Journal of the American Society of Nephrology, a team of researchers led from Karolinska Institutet shows how interstitial nephritis can develop from an autoimmune attack on the kidney's collecting duct. (medicalnewstoday.com 24.3.2016).)

22,000 died amid delayed Bayer drug recall: doctor (Lege: 22 000 døde under forsinket tilbaktrekking)
reuters.com 15.2.2008
NEW YORK (Reuters) - The lives of 22,000 patients could have been saved if U.S. regulators had been quicker to remove a Bayer AG drug used to stem bleeding during open heart surgery, according to a medical researcher interviewed by CBS Television's 60 Minutes program.

The drug Trasylol was withdrawn in November at the request of the FDA after an observational study linked the medicine to kidney failure requiring dialysis and increased death of those patients. (...)

(Anm: Autoimmune attack underlying kidney failure. Interstitial nephritis, a common cause of kidney failure, has a complex and largely unknown pathogenesis. In a new published paper in The Journal of the American Society of Nephrology, a team of researchers led from Karolinska Institutet shows how interstitial nephritis can develop from an autoimmune attack on the kidney's collecting duct. (medicalnewstoday.com 24.3.2016).)

Bayer withdraws heart surgery drug
BMJ 2007;335:1015 (17 November)
The German drug company Bayer has suspended worldwide marketing of Trasylol (aprotinin), its antifibrinolytic drug, after the requests of the drug regulating authorities in Germany and Canada and the advice of the Food and Drug Administration in the United States. Infusions of aprotinin have been used to stop excessive bleeding during heart surgery. (...)

Försäljningen av Trasylol stoppad
lakemedelsvarlden.se 5.11.2007
Läkemedelsföretaget Bayer har beslutat att sluta sälja Trasylol. Detta efter att en kanadensisk studie visat på ökad dödlighet hos patienter som behandlats med läkemedlet. (...)

Heart Surgery Drug Pulled From Market
nytimes.com 5.11.2007
WASHINGTON, Nov. 5 — Pressured by regulators, the German pharmaceutical giant Bayer AG announced Monday that it had agreed to withdraw the controversial heart surgery drug Trasylol after a Canadian study suggested that it increased death rates. (...)

Because of concerns that supplies of alternative medicines could run short, the agency has asked for a phased withdrawal of the drug, which is given before heart surgery to reduce the risks of excessive bleeding.

Bayer said in a statement that it still believed Trasylol was beneficial when used as directed. The F.D.A. said it would try to accommodate doctors who still wanted to use the drug by allowing Bayer to provide it as part of a study.

About 200,000 patients around the world received Trasylol last year, 110,000 of them in the United States, Bayer said. The drug, known generically as aprotinin, has had F.D.A. approval since 1993. (...)

Trasylol Pulled From Worldwide Market
healthfinder.gov 5.11.2007
FDA says clotting drug poses increased death risk, while company says drug still has benefits. (...)

MONDAY, Nov. 5 (HealthDay News) -- Bayer AG suspended worldwide sales of Trasylol, a clotting drug using during heart surgery to prevent bleeding, on Monday following a request from the U.S. Food and Drug Administration to remove the drug from the American market for safety reasons.

The FDA cannot identify a patient population in which the use of Trasylol (aprotinin) outweighs the risk, Dr. John K. Jenkins, director of the FDA's Office of New Drugs, said at an early morning news conference Monday. (...)

Kanadensisk studie med Trasylol (aprotinin) tillfälligt stoppad
lakemedelsverket.se 31.10.2007
Den kanadensiska BART-studien med Trasylol har tillfälligt stoppats då data visade på en ökning i total mortalitet i aprotinin (Trasylol)-armen jämfört med de patienter som antingen fick aminokapronsyra eller tranexamsyra. Under tiden data från studien analyseras ytterligare, är det viktigt att Trasylol endast används enligt godkänd produktresumé. (...)

Bayer's Trasylol should stay on US market says panel
pharmatimes.com 13.9.2007
A Food and Drug Administration panel has said that Bayer’s controversial Trasylol, which is used to reduce blood loss during heart surgery, should continue to be sold in the USA, despite the potential health risks.

The agency’s Cardiovascular and Renal Drugs and the Drug Safety and Risk Management Advisory Committees has backed Trasylol (aprotinin) following an ongoing review since two studies published in 2006 suggested that the drug doubled the risk of kidney failure. Since then, two other studies have suggested that it could also increase the risk of death. (...)

(Anm: Autoimmune attack underlying kidney failure. Interstitial nephritis, a common cause of kidney failure, has a complex and largely unknown pathogenesis. In a new published paper in The Journal of the American Society of Nephrology, a team of researchers led from Karolinska Institutet shows how interstitial nephritis can develop from an autoimmune attack on the kidney's collecting duct. (medicalnewstoday.com 24.3.2016).)

Aprotinin linked to excess deaths after coronary artery surgery
Shortcuts from other journals
BMJ 2007;334:336-337 (17 February)
Last year 246 000 Americans received aprotinin during coronary artery surgery.

Aprotinin reduces bleeding and has been licensed for use during coronary artery surgery since 1993 in the United States. More recently, aprotinin has been linked to renal toxicity; cardiovascular, cerebrovascular, and pulmonary vascular side effects; and now deaths. (...)

In October last year, Bayer acknowledged that it failed to keep the FDA informed of data that could have had a bearing on the outcome of an advisory panel meeting looking at the safety of Trasylol. (...)

Costly bypass medication may raise death risk later
usatoday.com 7.2.2007
An expensive drug given to coronary artery bypass surgery patients to prevent excessive bleeding is linked to an increased risk of dying as long as five years after the operation, researchers report Wednesday.

More than 4 million patients worldwide have received aprotinin, sold as Trasylol, since 1985, the scientists write in the Journal of the American Medical Association. The Food and Drug Administration approved Trasylol for use in coronary bypass surgery patients in 1993. Last year, it was used 246,000 times in the U.S., the researchers say. (...)

Dangerous Deception — Hiding the Evidence of Adverse Drug Effects (Farlig bedrag — Å skjule bevis på uheldige legemiddeleffekter)
NEJM 2006;355:2169-2171 (November 23)
September 30 is becoming a day of infamy for drug safety. On that date in 2004, Merck announced that rofecoxib (Vioxx) doubled the risk of myocardial infarction and stroke, and the company withdrew the drug from the market after 5 years of use in more than 20 million patients. On September 30, 2006, a front-page article in the New York Times reported that the Food and Drug Administration (FDA) had issued a warning that the antifibrinolytic drug aprotinin, widely used to reduce perioperative bleeding in patients undergoing cardiac surgery, could cause renal failure, congestive heart failure, stroke, and death. (...)

Observational Studies of Drug Safety — Aprotinin and the Absence of Transparency
NEJM 2006;355:2171-2173 (November 23)
Aprotinin was approved by the FDA in 1993 as a means of reducing perioperative blood loss and the need for blood transfusion in patients undergoing coronary-artery bypass grafting. Neither the clinical trial database that led to approval nor the numerous randomized, controlled trials conducted after approval identified an association between aprotinin and any short-term increase in the risk of death or nonfatal cardiovascular events or any serious renal toxic effects (except for a transient increase in the serum creatinine concentration). However, in early 2006, two observational studies were published that raised serious concerns about the drug's safety.2,3 (...)

One study, by Mangano et al.,2 evaluated 4374 patients undergoing coronary-artery bypass surgery. (...)

How can the results of these trials and the study by Karkouti et al. appear to be so different from the findings of Mangano et al.? Part of the problem may derive from the inability of observational studies to identify and measure all relevant covariates that may influence the outcome; similar studies using a few different covariates can sometimes come to opposite conclusions. (...)

Bayer To Investigate Drug Safety Mistake
forbes.com 13.10.2006
Bayer blames its failure to tell the Food and Drug Administration about a safety study of its heart surgery drug Trasylol on two unnamed employees and has hired a lawyer to investigate exactly how the company could make such an "error."

A panel of doctors convened by the FDA had given the drug a clear bill of health on Sept. 21, but six days later the drug agency revealed that Bayer (nyse: BAY - news - people) had failed to tell it about an examination of hospital records by 67,000 patients. The FDA found out about the results only because of the outside researcher Bayer contracted to conduct the study: Alexander Walker, an adjunct professor at Harvard who now works at Ingenix, a drug safety research outfit that is part of United Healthcare (nasdaq: UAHC - news - people). (See: Bayer's Big Mistake.)
Bayer may have violated the law by failing to release the results, according to one critic. (...)

F.D.A. Says Bayer Failed to Reveal Drug Risk Study
nytimes.com 29.9.2006
WASHINGTON, Sept. 29 — Bayer A.G., the German pharmaceutical giant, failed to reveal to federal drug officials the results of a large study suggesting that a widely used heart-surgery medicine might increase the risks of death and stroke, the Food and Drug Administration announced Friday.

Bayer scientists even appeared at a public meeting called by the F.D.A. on Sept. 21 to discuss the possibility that the drug, Trasylol, might have serious risks. But they did not mention the study or its worrisome results.

In a highly unusual move, the food and drug agency released a public health advisory saying it had learned of the study’s existence only on Wednesday. Preliminary results of the study demonstrate “that use of Trasylol may increase the chance for death, serious kidney damage, congestive heart failure and strokes,” the advisory said. (...)

The disclosure comes exactly two years after Merck announced it was withdrawing its arthritis drug, Vioxx, after a study showed that it doubled the risks of heart attacks. Since then, members of Congress and even top scientific advisers have concluded that the F.D.A. lacks the regulatory authority and the money needed to detect and protect against drug dangers. (...)

Bayer's Big Mistake
forbes.com 29.9.2006
Pharmaceuticals German drug giant Bayer failed to tell the U.S. Food and Drug Administration of a study that connected a controversial heart surgery drug to dangerous side effects and death, even as FDA convened a panel of experts to evaluate the drug's safety.

The company notified the FDA after it was asked to do so by the scientist conducting the study.

Bayer said in a statement that it "mistakenly" did not tell the FDA about the evaluation of 67,000 hospital records regarding the drug Trasylol, which is used to prevent bleeding during open-heart surgery. According to a Public Health Advisory from the FDA, the new study linked Trasylol to increased risk of death, serious kidney damage, congestive heart failure and strokes. (...)

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