FDA having second thoughts about Pradaxa?

[Anonymous]

Good - hopefully they will pull the plug on this dangerous product. Shouldn't have been approved in the first place.

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FDA puts Boehringer's Pradaxa under review
December 8, 2011 — 11:23am ET | By Tracy Staton

Boehringer Ingelheim's new blood thinner Pradaxa is now in the FDA's crosshairs. The U.S. regulator is reviewing reports of serious bleeding in patients using Pradaxa, the first drug approved in a generation of alternatives to the anticoagulant therapy warfarin. The FDA said patients should continue using the drug for now, and Pradaxa offers "an important health benefit when used as directed."

The FDA's safety review comes on the heels of a warning from European regulators issued in November. The European Medicines Agency cited 256 cases of fatal bleeding, saying doctors should be cautious when prescribing Pradaxa. Patients suspected of poor kidney function should be tested before they use the drug, Boehringer advised at EMA's behest, because too much of the drug could build up in a patient's bloodstream if not properly cleared by the kidneys.

The FDA says it's looking at the reports of serious bleeding to determine whether cases are cropping up more frequently than would be expected, PharmaTimes reports. Comparing bleeding events in Pradaxa patients with those in warfarin patients is difficult, however, because warfarin is known to cause bleeding--and bleeding in warfarin patients can be quickly reversed with an antidote. So, warfarin-related bleeding is less likely to be reported, the FDA said.

As PharmaTimes reports, Boehringer said 1.1 million Pradaxa prescriptions were dispensed from October 2010 to August, and 371,000 patients received the drug from U.S. pharmacies. "The clinical effectiveness and favorable safety profile of Pradaxa is positive and remains unchanged," the company said.

Read more: FDA puts Boehringer's Pradaxa under review - FiercePharma

 

[Anonymous]

.....Shouldn't have been approved in the first place.

Guess as a rep you're obviously smarter than the FDA, who did approve it. You crack me up, your a rep talking like you know more shit than what a binder tells you to say. Stick with ordering food, it's really all you reps are good it.

 

[Anonymous]

Guess as a rep you're obviously smarter than the FDA, who did approve it. You crack me up, your a rep talking like you know more shit than what a binder tells you to say. Stick with ordering food, it's really all you reps are good it.

Spoken like a true rep. You represent us well. Especially like like how you said 'shit'....nice touch

 

[Anonymous]

Spoken like a true rep. You represent us well. Especially like like how you said 'shit'....nice touch

very fancy

 

[Anonymous]

Spoken like a true rep. You represent us well. Especially like like how you said 'shit'....nice touch

Thanks, I'll take that as a complement of my job choice then.

 

[Anonymous]

I will die a happy man if this drug gets pulled.

 

[Anonymous]

I will die a happy man if this drug gets pulled.

I will die a happy man if you die alone in a gutter with a half-opened bottle of isopropyl rubbing alcohol next to you.

 

[Anonymous]

I will die a happy man if you die alone in a gutter with a half-opened bottle of isopropyl rubbing alcohol next to you.

Brandon?

 

[Anonymous]

Boehringer censured over Pradaxa marketing
Published on 23/09/11 at 09:24am

Boehringer Ingelheim has been heavily censured by the body which enforces the ABPI’s Code of Practice for the content of a press release and material for spokespeople on its oral anticoagulant Pradaxa.

Chief among a host of breaches, the PMCPA panel ruled Boehringer guilty of breaking clause 2 of the Code – the most serious offence, used only for a firm which has brought “discredit upon, and reduced confidence in, the industry”.

A GP complained after seeing articles in the Daily Mail, Telegraph and Express on 5 April 2011, referring to the use of Pradaxa (dabigatran) to prevent stroke: the drug is not licensed for this, although an application had been made to the European Medicines Agency to extend the licence.

Pradaxa is in fact indicated for the primary prevention of venous thromboembolic events in adults who have had hip or knee replacements.

Therefore two breaches of the Code were ruled: for promoting a prescription only medicine to the public for an unlicensed indication, which was inconsistent with the terms of its marketing authorisation.

While clearing the company of describing Pradaxa as a ‘super pill’ or ‘revolutionary drug’ – which press reports did – or disparaging current option warfarin as a ‘rat poison’, the PMCPA was very concerned about many other elements of the release which had formed the basis for the press reports.

In particular, the panel questioned whether describing Pradaxa as “leading the way in new oral anticoagulants/direct thrombin inhibitors … targeting a high unmet medical need” was a fair reflection of the evidence.

A breach of the Code was also ruled for a lack of information in a consumer press release relating to potnetial side effects, such as major haemorrhage, or any other adverse event.

The PMCPA also found that a contract between Boehringer and one health professional spokesperson whose comments were used by the media did not refer either to the ban on promoting prescription only medicines to the public or the Code requirements on information directed at the public.

This was a “significant omission” since the release was aimed at the consumer press. The spokesperson briefed by Boehringer’s media agency was quoted in the Telegraph describing Pradaxa as preventing “clots better than warfarin but with less bleeding which is pretty much the holy grail for such drugs”.

The panel believed that Boehringer was guilty in effect of encouraging people to ask their doctor to prescribe a specific prescription only medicine.

Adam Hill

 

[Anonymous]

Boehringer censured over Pradaxa marketing
Published on 23/09/11 at 09:24am

Boehringer Ingelheim has been heavily censured by the body which enforces the ABPI’s Code of Practice for the content of a press release and material for spokespeople on its oral anticoagulant Pradaxa.

Chief among a host of breaches, the PMCPA panel ruled Boehringer guilty of breaking clause 2 of the Code – the most serious offence, used only for a firm which has brought “discredit upon, and reduced confidence in, the industry”.

A GP complained after seeing articles in the Daily Mail, Telegraph and Express on 5 April 2011, referring to the use of Pradaxa (dabigatran) to prevent stroke: the drug is not licensed for this, although an application had been made to the European Medicines Agency to extend the licence.

Pradaxa is in fact indicated for the primary prevention of venous thromboembolic events in adults who have had hip or knee replacements.

Therefore two breaches of the Code were ruled: for promoting a prescription only medicine to the public for an unlicensed indication, which was inconsistent with the terms of its marketing authorisation.

While clearing the company of describing Pradaxa as a ‘super pill’ or ‘revolutionary drug’ – which press reports did – or disparaging current option warfarin as a ‘rat poison’, the PMCPA was very concerned about many other elements of the release which had formed the basis for the press reports.

In particular, the panel questioned whether describing Pradaxa as “leading the way in new oral anticoagulants/direct thrombin inhibitors … targeting a high unmet medical need” was a fair reflection of the evidence.

A breach of the Code was also ruled for a lack of information in a consumer press release relating to potnetial side effects, such as major haemorrhage, or any other adverse event.

The PMCPA also found that a contract between Boehringer and one health professional spokesperson whose comments were used by the media did not refer either to the ban on promoting prescription only medicines to the public or the Code requirements on information directed at the public.

This was a “significant omission” since the release was aimed at the consumer press. The spokesperson briefed by Boehringer’s media agency was quoted in the Telegraph describing Pradaxa as preventing “clots better than warfarin but with less bleeding which is pretty much the holy grail for such drugs”.

The panel believed that Boehringer was guilty in effect of encouraging people to ask their doctor to prescribe a specific prescription only medicine.

Adam Hill

This is just one jerk-off's opinion. mouse, click, delete.