Drug Safety Developments

Boehringer to Pay $931,000 Fine Over Missing Pradaxa Files

Quoted from http://www.businessweek.com/news/2013-12-09/boehringer-to-pay-931-000-fine-over-missing-pradaxa-files-1

 

Boehringer to Pay $931,000 Fine Over Missing Pradaxa Files

By Jef Feeley
Bloomberg News
December 09, 2013

Boehringer Ingelheim GmbH, the German family-owned drugmaker, withheld or failed to preserve “countless” numbers of files sought by patients suing over the company’s blood thinner Pradaxa and must pay a fine of almost $1 million, a judge ruled.

U.S. District Judge David Herndon in East St. Louis, Illinois, who’s overseeing more than 1,700 consolidated lawsuits blaming Pradaxa for causing excessive and sometimes fatal bleeding, concluded Boehringer executives acted “in bad faith” by failing to ensure documents and files about the drug’s development and marketing were preserved.

“The wrongs here are egregious,” Herndon said in today’s ruling. “The gross inadequacy” of the company’s efforts to safeguard documents from Pradaxa files justified a sanction of more than $931,000 against Boehringer, the judge said.

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The Pradaxa Gastrointestinal (GI) Bleeding Debate Continues: Is There An Increased Risk Or A Risk Reduction With Pradaxa Use?

 

FDA: Don't Use Pradaxa Blood Thinner in Patients With Artificial Heart Valves

Quoted from http://health.usnews.com/health-news/news/articles/2012/12/20/fda-dont-use-pradaxa-blood-thinner-in-patients-with-artificial-heart-valves

FDA: Don't Use Pradaxa Blood Thinner in Patients With Artificial Heart Valves

Warning based on European trial showing increased risk for strokes, heart attacks in this group

December 20, 2012

THURSDAY, Dec. 20 (HealthDay News) -- The blood thinner Pradaxa should not be used to prevent stroke or blood clots in patients with mechanical heart valves, the U.S. Food and Drug Administration said in a warning issued Wednesday.

As the agency noted, a clinical trial in Europe was halted recently because patients taking Pradaxa (dabigatran) were more likely to suffer strokes, heart attacks and clots forming on their mechanical heart valves than patients who were taking the older blood thinner warfarin.

Patients in the study who were taking Pradaxa also had more bleeding after valve surgery, the agency said.

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Pradaxa Safety Debate Continues During November 2012 With Many Different Conclusions And Positions

December 2012 Pradaxa Update: Prescription / Sales Numbers And Drug Company Safety Study Results

Boehringer Sued by Hundreds Over Bleeding Tied to Pradaxa

Quoted from http://www.bloomberg.com/news/2012-12-11/boehringer-sued-by-hundreds-over-bleeding-tied-to-pradaxa.html

Boehringer Sued by Hundreds Over Bleeding Tied to Pradaxa

By Jef Feeley & Margaret Cronin Fisk - Dec 11, 2012 12:00 AM ET

Harold Asher never thought to ask why his wife’s doctors prescribed Boehringer Ingelheim GmbH’s blood thinner Pradaxa after she recovered from a stroke.

Barbara Jean Asher took Pradaxa for three months to cut her risk of suffering another stroke. Then, in June 2011, she was rushed to a hospital with internal bleeding that proved fatal, her family said in a lawsuit blaming Ingelheim, Germany-based Boehringer for her death. Asher, 72, a grandmother from a suburb of Palm Springs, California, died when doctors couldn’t stop the hemorrhaging, the family said.

“My generation, you do what your doctor tells you,” Harold Asher, 77, said in a telephone interview on her switch to Pradaxa from an older type of blood thinner. “You don’t ask any questions.”

Hundreds of patients and their families are questioning whether Boehringer executives knew Pradaxa posed a deadly risk to some patients when they brought the drug to the U.S. market in October 2010. Unlike older blood thinners, researchers said, Pradaxa has no antidote to reverse its effects, which can lead to so-called bleed-out deaths.

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A Promising Drug With a Flaw

December 2012 Pradaxa Update: Prescription / Sales Numbers And Drug Company Safety Study Results

Pradaxa Safety Debate Continues During November 2012 With Many Different Conclusions And Positions

A Promising Drug With a Flaw

Quoted from http://www.nytimes.com/2012/11/03/business/a-rising-anti-stroke-drug-is-tied-to-risk-of-bleeding-deaths.html#

A Promising Drug With a Flaw

By KATIE THOMAS
Published: November 2, 2012

Dr. Bryan A. Cotton, a trauma surgeon in Houston, had not heard much about the new anticlotting drug Pradaxa other than the commercials he had seen during Sunday football games.

Enlarge This Image

Jeffrey Phelps for The New York Times

Walter Daumler with a photograph of his sister Doris Daumler, who was on Pradaxa and died in May.

Then people using Pradaxa started showing up in his emergency room. One man in his 70s fell at home and arrived at the hospital alert and talking. But he rapidly declined. “We pretty much threw the whole kitchen sink at him,” recalled Dr. Cotton, who works at Memorial Hermann-Texas Medical Center. “But he still bled to death on the table.”

Unlike warfarin, an older drug, there is no antidote to reverse the blood-thinning effects of Pradaxa.

“You feel helpless,” Dr. Cotton said. The drug has contributed to the bleeding deaths of at least eight patients at the hospital. “And that’s a very bad feeling for us.”

Pradaxa has become a blockbuster drug in its two years on the market, bringing in more than $1 billion in sales for its maker, the privately held German drug maker Boehringer Ingelheim.

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FDA Let Risky Drugs Hit Market, Article Says

Quoted from http://professional.wsj.com/article/SB10000872396390443571904577631883702006726.html

Article Says Agency Let Risky Drugs Hit Market

By THOMAS M. BURTON

September 4, 2012

An FDA effort to speed approval of new medicines allowed drugs for stroke prevention, cancer and multiple sclerosis onto the market without proper safety analysis, according to two drug-safety experts.

In an article to be published Wednesday in the Journal of the American Medical Association, Thomas J. Moore and Curt D. Furberg wrote that the Food and Drug Administration's push to get medicines to market may have compromised prescription-drug safety. They cite an MS drug with apparent adverse effects on the heart and many other risks, and an anticoagulant linked to bleeding that is proving difficult to treat.

"These examples raise the question of whether it was good policy to approve three innovative new drugs with significant safety questions unanswered," Mr. Moore and Dr. Furberg wrote.

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Nashville heart doctors react to Pradaxa reports

Quoted from http://www.tennessean.com/article/20120822/NEWS07/308220114/Nashville-heart-doctors-react-Pradaxa-reports

Nashville heart doctors react to Pradaxa reports

Bobby Allyn

The Tennessean

Since a spate of reports have emerged questioning the safety and effectiveness of a stroke-prevention drug whose national sales last year topped $1 billion, some cardiologists are prescribing the drug more cautiously while others maintain that the harsh accounts are overblown.

According to Dr. Keith Churchwell, executive director of Vanderbilt’s Heart and Vascular Institute, the therapeutic effects of blood-thinner Pradaxa happen more quickly than other drugs. Also, the drug requires fewer exams and dietary restrictions.

“The big reason there’s been a slow response to putting more patients on Pradaxa is because of the significant bleeding. Right now, we don’t have a good mechanism to reverse it,” he said.

Conversely, Dr. George Crossley, who leads the cardiology program at Baptist Hospital, said his team of heart specialists were among the country’s first to test Pradaxa, and by his estimate, the drug is a striking improvement from Coumadin, which has been the leading blood-thinning drug for more than 50 years.

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Insight: Top heart doctors fret over new blood thinners

Quoted from http://www.reuters.com/article/2012/06/14/us-drugs-bloodthinners-idUSBRE85D06G20120614:

Insight: Top heart doctors fret over new blood thinners | Reuters

Insight: Top heart doctors fret over new blood thinners

By Ransdell Pierson

NEW YORK | Thu Jun 14, 2012 6:50am EDT

NEW YORK (Reuters) - For millions of heart patients, a pair of new blood thinners have been heralded as the first replacements in 60 years for warfarin, a pill whose hardships and risks have deterred many from using the stroke-prevention medicine.

But growing complaints of risks and deaths tied to the new crop of drugs have made some top U.S. cardiologists hesitant to prescribe them. Some are proposing a more rigorous monitoring regimen for when they are used.

Most concerns revolve around Pradaxa, a twice daily pill from Boehringer Ingelheim that was approved by the U.S. Food and Drug Administration in October 2010 to prevent strokes in patients with an irregular heartbeat called atrial fibrillation. It was the first new oral treatment for that use since warfarin was introduced in the 1950s.

"The good news is you now have an alternative to warfarin," said Dr. Alan Jacobson, director of anti-coagulation services at the Veterans Administration (VA) healthcare system in Loma Linda, California. "The bad news is you can kill a patient as easily with the new drug as you could with the old drug" if it is not handled properly.

"The average patient doesn't understand anything about the new drug, or what the risks are, or what other medicines he can or can't take," said Jacobson, citing interactions with common painkillers and other drugs that can alter Pradaxa blood levels.

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Drugs most frequently reported for adverse reactions

Quoted from http://www.philly.com/philly/blogs/healthcare/157042255.html

Drugs most frequently reported for adverse reactions

by Michael R. Cohen, R.Ph.

You may be surprised to learn that in 2011, the Food and Drug Administration received 179,855 reports of serious or fatal adverse drug reactions. This was an increase of 15,386 reports (9.4 percent) from the 2010 total. Reports reached the FDA through two mechanisms. Voluntary reports from health professionals and consumers and reports from manufacturers. There were 21, 002 voluntary reports and 158,853 from manufacturers. Manufacturers must report serious events within 15 days of becoming aware.

The 10 drugs with the largest numbers of reports sent directly to the FDA by healthcare practitioners and consumers in 2011 in order of frequency are Pradaxa, Coumadin, Levaquin, Carboplatin, Zestril, Cisplatin, Zocor, Cymbalta, Cipro and Bactrim. Keep in mind that this is not a scientific study of the frequency of adverse drug events in clinical practice. These are the medications that health professionals and consumers told the FDA were causing serious and fatal side effects during 2011. It is interesting to note that just two of these drugs were first introduced in the last decade (Pradaxa and Cymbalta), and only one in the previous year (Pradaxa), suggesting that major drug safety issues are not confined to recently approved drugs.

Pradaxa surpassed all other monitored drugs in several categories, including overall number of reports (3,781), deaths (542), hemorrhage (2,367), acute renal failure (291), and stroke (644). It was also suspect in 15 cases of liver failure. Coumadin has been prominent in the rankings for many years. It accounted for 1,106 reported ADEs overall, including 731 reports of hemorrhage and 72 deaths.

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Pradaxa Patients Can't Stop the Bleeding

Quoted from http://www.houstonpress.com/2012-05-24/news/pradaxa-bleeding-lawsuits/

Pradaxa Patients Can't Stop the Bleeding

There's only one really bad thing about the anti-clotting pill Pradaxa. You can't fall or get cut while taking it because once you start bleeding, there's almost no way to stop it. There's no reversal agent, no antidote.

By Craig Malisow Wednesday, May 23 2012

 

Loraine Franklin died eight months before her 60th wedding anniversary.

Less than 24 hours after Loraine Franklin fell on the kitchen floor of her Georgetown home, she was dead.

It was December 29, 2011, and Franklin's daughters say today that, had Franklin, 80, not been prescribed a blood thinner called Pradaxa, she'd have lived to see the new year and subsequently celebrate her 60th wedding anniversary.

Instead, they say, the fall caused a blow to her head, which caused an intracranial hemorrhage, which doctors at the hospital could not stop....

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Boehringer’s Pradaxa website censured

Quoted from http://www.inpharm.com/news/171671/boehringer-s-pradaxa-website-censured

Boehringer’s Pradaxa website censured

Published on 08/03/12 at 11:46am
Boehringer's Pradaxa website

Boehringer Ingelheim has breached the ABPI’s Code of Conduct over the use of its Pradaxa website.

Pradaxa is a new oral blood thinner with several licences to prevent blood clots and reduce the risk of stroke in certain patients.

Boehringer’s website was suppose to be for medical professionals only, but an anonymous GP said that access to the site’s medical content was “not sufficiently rigorous to restrict access to health professionals only”.

The GP alleges that because of this, Boehringer Ingelheim “clearly intended to facilitate the promotion of Pradaxa to the public”.

The PMPCA, who monitors adherence to the Code, did not agree that the site was being used to advertise to the public.

It did however, find that Boehringer had breached Clause 4.6 of the Code, because the site was found to be promoting Pradaxa but did not give a clear, prominent statement as to where the prescribing information can be found.

The anonymous GP said that the location of the prescribing information was only clarified after prominent claims for Pradaxa - and the PMCPA agreed.

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