Comments on: FDA Issues Half-Hearted Public Health Advisory About Trasylol http://the-health-gazette.com/303/fda-issues-half-hearted-public-health-advisory-about-trasylol/ Your interactive source for health news, views and reviews Thu, 29 Mar 2012 17:48:23 +0000 hourly 1 http://wordpress.org/?v=3.3.2 By: Health Gazette http://the-health-gazette.com/303/fda-issues-half-hearted-public-health-advisory-about-trasylol/comment-page-1/#comment-116 Health Gazette Mon, 18 Dec 2006 13:07:01 +0000 #comment-116 FDA and Bayer Pharmaceuticals notified healthcare professionals of revisions to the prescribing information for Trasylol. The new labeling has a more focused indication, a new Warning that Trasylol administration increases the risk of renal dysfunction and may increase the need for dialysis in the perioperative period, and stronger warnings about anaphylactic reactions. In addition, due to the higher risk for anaphylactic reactions, re-administration of Trasylol to patients with a known or suspected exposure during the past 12 months is contraindicated. Clearly Trasylol, or Bayer, enjoys quite a favored position in the FDA's view of risk-reward ratios. It is a pitty that where money is involved no one seems to care about the people who take and suffer from this drug. Peter ________________ Dr Peter Tylee Editor FDA and Bayer Pharmaceuticals notified healthcare professionals of revisions to the prescribing information for Trasylol. The new labeling has a more focused indication, a new Warning that Trasylol administration increases the risk of renal dysfunction and may increase the need for dialysis in the perioperative period, and stronger warnings about anaphylactic reactions. In addition, due to the higher risk for anaphylactic reactions, re-administration of Trasylol to patients with a known or suspected exposure during the past 12 months is contraindicated.

Clearly Trasylol, or Bayer, enjoys quite a favored position in the FDA’s view of risk-reward ratios. It is a pitty that where money is involved no one seems to care about the people who take and suffer from this drug.

Peter
________________
Dr Peter Tylee
Editor

]]> By: Health Gazette http://the-health-gazette.com/303/fda-issues-half-hearted-public-health-advisory-about-trasylol/comment-page-1/#comment-115 Health Gazette Sun, 01 Oct 2006 14:38:27 +0000 #comment-115 Well the FDA <b>finally</b> has released the results of its deliberations relating to Trasylol. Once again there is a marked reluctance to remove this nasty drug from circulation evident in the tone of the FDA's safety alert. On 29 September -- quite a long time after their reluctant initial actions to investigate the growing clinical evidence against this drug -- they finally have indicated their bias in quite stark terms. <blockquote> [UPDATED 09/29/2006] FDA held a public advisory committee meeting September 21, 2006 to discuss the safety and overall risk-benefit profile for Trasylol. The committee discussed the findings from the two published observational studies, the Bayer worldwide safety review, and the FDA review of its own post-marketing database. On September 27, 2006, Bayer told FDA that it had conducted an additional safety study of Trasylol. The preliminary findings from this new observational study of patients from a hospital database reported that <b>use of Trasylol may increase the chance for death, serious kidney damage, congestive heart failure and strokes</b>.[emphasis added] While FDA conducts its evaluation of this new safety study, it is recommended that physicians should consider limiting Trasylol use to those situations where the clinical benefit of reduced blood loss is essential to medical management and outweighs the potential risks.[Shouldn't this be the norm?] Physicians should carefully monitor patients for the occurrence of toxicity, particularly to the kidneys, heart, or brain, and promptly report observed adverse event information to FDA's MedWatch program or Bayer. </blockquote> Clearly, even with additional damning data from Bayer, the FDA persists in keeping this lethal drug in use. Contrast this with the way the FDA has recently treated manufacturers of some alternative health products, which they condemned simply as being "non approved" drugs. It seems that it is OK for an approved drug to kill and maime but a product that does neither (but may represent a threat to the market for approved drugs) must be swiftly removed from circulation, even seized by federal agents. This goes way beyond simple double standards. Peter ________________ Dr Peter Tylee Editor Well the FDA finally has released the results of its deliberations relating to Trasylol. Once again there is a marked reluctance to remove this nasty drug from circulation evident in the tone of the FDA’s safety alert.

On 29 September — quite a long time after their reluctant initial actions to investigate the growing clinical evidence against this drug — they finally have indicated their bias in quite stark terms.

[UPDATED 09/29/2006] FDA held a public advisory committee meeting September 21, 2006 to discuss the safety and overall risk-benefit profile for Trasylol. The committee discussed the findings from the two published observational studies, the Bayer worldwide safety review, and the FDA review of its own post-marketing database. On September 27, 2006, Bayer told FDA that it had conducted an additional safety study of Trasylol. The preliminary findings from this new observational study of patients from a hospital database reported that use of Trasylol may increase the chance for death, serious kidney damage, congestive heart failure and strokes.[emphasis added] While FDA conducts its evaluation of this new safety study, it is recommended that physicians should consider limiting Trasylol use to those situations where the clinical benefit of reduced blood loss is essential to medical management and outweighs the potential risks.[Shouldn't this be the norm?] Physicians should carefully monitor patients for the occurrence of toxicity, particularly to the kidneys, heart, or brain, and promptly report observed adverse event information to FDA’s MedWatch program or Bayer.

Clearly, even with additional damning data from Bayer, the FDA persists in keeping this lethal drug in use. Contrast this with the way the FDA has recently treated manufacturers of some alternative health products, which they condemned simply as being “non approved” drugs.

It seems that it is OK for an approved drug to kill and maime but a product that does neither (but may represent a threat to the market for approved drugs) must be swiftly removed from circulation, even seized by federal agents. This goes way beyond simple double standards.

Peter
________________
Dr Peter Tylee
Editor

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