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Bayer Temporarily Suspends Global Trasylol Marketing
Bayer HealthCare November 5, 2007
Leverkusen, Germany and West Haven, CT, USA, November 5, 2007
Here are excerpts of what Bayer has released to the public about its decision to remove Trasylol from the market.
Bayer wrote, "
Following consultation with the German Federal Institute for Drugs and Medical Devices (BfArM), the U.S. Food and Drug Administration (FDA), Health Canada, and other health authorities, Bayer announced today that it has elected to temporarily suspend worldwide marketing of Trasylol (aprotinin injection) until final results from the Canadian BART trial can be compiled, received and evaluated. The company took this global action following direction from the German BfArM and requests from the FDA and other regulators that Bayer temporarily suspend Trasylol marketing in their respective countries until final BART data were available. The BART study is an independent randomized, controlled trial being conducted in high-risk cardiac surgery patients."
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Our comments:
- How temporary will this really be? We have been contact by many clients with these problems that we suspect this is a large problem.
- The FDA has stated that they want to see the raw data, and then the FDA will determine for what purposes they think the drug could remain on the market. We expect that use of Trasylol will be very limited in the future. So while it may be a temporary suspension of marketing, it is highly likely that future marekting of this drug will be on a far more limited basis anyway.
- The number of people actually harmed by the drug may never be fully known, since most patients who had this drug administered are not aware of the fact that this was given to them. As a result, those who were injured may not have associated their injury with the administration of the drug.
- Clearly, now, for the first time, Bayer is admitting that it is aware of increased risks of aprotinin use in certain patient populations, and it beleives that these risks should be clearly communicated to physicians responsible for deciding whether or not to use the product.
- Any attempt by Bayer to discount the results of BART, an independent randomized controlled trial, without valid reason and say that results that show an increased rate of death are insignificant when in fact the sponsor considers them significant enough to discontinue the trial would be a downplaying of the actual risks.
Bayer goes on to write, "Once the complete BART dataset is available, Bayer will work with health authorities to evaluate whether these data have any impact on the positive benefit-risk assessment for Trasylol. At that time the temporary marketing suspension will be reevaluated. Additionally, the U.S. FDA, Health Canada and other health authorities have indicated their interest in working with Bayer to create a program for use during the temporary suspension under which physicians in these markets might request and receive Trasylol for treatment of certain surgical patients with an established medical need.
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Our comments:
- Even when/if Trasylol is used again, it will be based on specific patient profiles. No longer will we see this drug used on a broad and general basis.
- When a study gets halted mid-way, it is a sign that something has gone terribly wrong. Thus, the risk of bleeding must have been clearly outweighed by the risks caused by the drug, Aprotinin.
- It may be months before Bayer comes forward with additioanl data. We expect to see final analysis of the data before the spring of 2008.
- While only preliminary, the BART study merely confirms what plaintiffs in lawsuits have alleged all along, that there is an increased and unwarranted risk associated with the use of Trasylol.
- Bayer will certainly try to carve our an population of patients where it can still sell Trasylol. For those, it will require a favorable risk-benefit profile for Trasylol. It is likely that for those patients, we will see new labeling and warnings.
About BART
According to information on the website of the Ottawa Health Research Institute (Institut de recherché en santé d'Ottawa), the BART study -- Blood Conservation using Antifibrinolytics: A Randomized Trial in High-Risk Cardiac Surgery Patients -- is a multi-institutional, blinded, randomized controlled trial to compare the efficacy and safety of the use of aprotinin, aminocaproic acid and tranexamic acid in approximately 3000 high-risk cardiac surgical patients undergoing either re-operation for coronary heart bypass graft (CABG) or aortic valve replacement, or combined valves or valve/CABG procedures.
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