Drug Injury Watch

Fall 2012: Two Recent Medical Reports Regarding Safety Of Pradaxa, Boehringer Ingelheim's Anticoagulation Drug

Use Of Pradaxa After ACS Is Associated With Increased Rate Of Major Bleeding, And Concomitant Use Of Pradaxa With Multaq Is Contraindicated

(Posted by Tom Lamb at DrugInjuryWatch.com)

When Pradaxa (dabigatran) is used to prevent thrombotic events after an acute coronary syndrome (ACS), it is associated with increased rates of major bleeding that offsets any antithrombotic benefit, according to a September 24, 2012 (Online First) Archives of Internal Medicine article, "Use of New-Generation Oral Anticoagulant Agents in Patients Receiving Antiplatelet Therapy After an Acute Coronary Syndrome".

From the Abstract for this medical journal article:

Results  For the period January 1, 2000, through December 31, 2011, we identified 7 prospective randomized placebo-controlled clinical trials that met the study criteria, involving 31 286 patients. Based on the pooled results, the use of new-generation oral anticoagulant agents [i.e., Pradaxa as well as Xarelto (rivaroxaba) and the not yet FDA-approved Eliquis (apixaban)] in patients receiving antiplatelet therapy after an ACS was associated with a dramatic increase in major bleeding events (odds ratio, 3.03; 95% CI, 2.20-4.16; P < .001)....

Conclusion  The use of [Pradaxa as well as Xarelto and Eliquis] is associated with a dramatic increase in major bleeding events, which might offset all ischemic benefits in patients receiving antiplatelet therapy after an ACS.

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Next, on September 20, 2012 the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a new contraindication for the Multaq, "Co-administration with dabigatran" -- or the concomitant use of Multaq and Pradaxa -- which concerns the safety of both of these alleged unsafe drugs.

We will continue to watch for safety issues involving Pradaxa and significant developments here.

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Subtrochanteric Femoral Fractures With Use Of Oral Bisphosphonates: Fosamax, Actonel, And Boniva

These Fractures Have Several Atypical Characteristics: Prodromal Symptoms, Occurrence With Minimal Trauma, Distinctive Radiographic Changes

(Posted by Tom Lamb at DrugInjuryWatch.com)

Three new medical journal articles about bisphosphonate-related femur fractures came to our attention in early September 2012.

The first, "Seek and ye shall find - subtrochanteric stress fractures in patients on oral bisphosphonate therapy; an emerging problem", points out in the Introduction section of its Abstract: "This fracture is often preceded by pain and distinctive radiographic changes, and associated with a characteristic fracture pattern."

In more detail, from the Results section of this article from the Journal of Bone & Joint Surgery, British Volume:

Results  11 fractures were found in 10 patients matching the inclusion criteria outlined. All were female, and taking bisphosphonates for a mean of 4.3 years. 5 of the 10 patients described prodromal symptoms, for an average of 7.8 months before fracture. Although all fractures were deemed low velocity, 5 of 11 were atraumatic. 3 patients have had bilateral subtrochanteric fractures. Presence of the distinctive radiological ‘bleb’ was common. Surveillance on 2 patients shows lateral cortical blebs on the contralateral femur which merit close follow up.

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The second article is "Atypical subtrochanteric femoral shaft fractures: role for mechanics and bone quality.", from the August 29, 2012 edition of Arthritis Research & Therapy.  In part, the authors set forth some of the unique characteritics commonly found in atypical femoral fractures (AFF) in the subtrochanteric region or the diaphysis with patients using bisphosphonates such as Fosamax (alendronate), Actonel (risedronate), Boniva (ibandronate):

These fractures have several atypical characteristics, including occurrence with minimal trauma; younger age than typical osteoporotic fractures; occurrence at cortical, rather than cancellous sites; early radiographic appearance similar to that of a stress fracture; transverse fracture pattern rather than the familiar spiral or transverse-oblique morphologies; initiation on the lateral cortex; and high risk of fracture on the contralateral side, at the same location as the initial fracture.

The last article, "Spontaneous incomplete transverse subtrochanteric femoral fracture with cortical thickening possibly secondary to risedronate use: a case report.", from the Journal of Medical Case Reports, discusses an atypical femur fracture secondary to relatively short-term Actonel use:

We consider this case report not only interesting but also important and unusual because it is about a patient who developed a potentially rare and serious side effect of long-term bisphosphonate use, estimated to affect 2.3 in every 10,000 patients, and who presented with a pelvic X-ray that showed the characteristic features of atypical fractures secondary to [Actonel (risedronate)] use. In addition, most of the documented cases have been associated with many years of bisphosphonate use whereas our patient had been on risedronate for only four years.

We will continue to monitor the journals for developments in the medical literature concerning femur fractures associated with bisphosphonates such as Actonel, Boniva, and Fosamax.

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Multaq Associated Lung Disease And Pulmonary Toxicity Pointed Out By New Safety Warnings In September 2012 Revised Label

Heart Drug Multaq Can Cause Pulmonary Fibrosis And Pneumonitis; Symptoms Are Inflammation Of The Lungs, Including Scarring And Thickening

(Posted by Tom Lamb at DrugInjuryWatch.com)

Multaq (dronedarone) is a drug used to treat abnormal heart rhythm (atrial fibrillation or atrial flutter).

In September 2012 the FDA informed the drug company Sanofi-Aventis that it had approved some label changes for Multaq, including one about certain types of lung disease and pulmonary toxicity as being serious side effects of Multaq use.

From a September 7, 2012 FDA letter to Sanofi-Aventis, we get this information directed at doctors:

Full Prescribing Information

10. Under Warnings and Precautions, the following new sub-section has been added:

5.6 Pulmonary Toxicity

Cases of interstitial lung disease including pneumonitis and pulmonary fibrosis have been reported in patients treated with MULTAQ in the post-marketing setting [see Adverse Reactions (6.2)]. Onset of dyspnea or non-productive cough may be related to pulmonary toxicity and patients should be carefully evaluated clinically. If pulmonary toxicity is confirmed, MULTAQ should be discontinued.

It is unclear at this point whether there will be any so-called "Dear Doctor" letter sent regarding this new Multaq drug safety issue.

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And from that same September FDA letter, there is this information for patients who may use Multaq:

Medication Guide

3. Under “What are the possible side effects of MULTAQ,” the following information has been added:

Inflammation of the lungs, including scarring and thickening. Call your doctor if you develop shortness of breath or a dry cough during treatment with MULTAQ.

As some of you already are aware, no doubt, the safety profile of Multaq has been beaten down quite a bit in the past couple of years.

• December 2011: FDA said Multaq increased the risk of serious cardiovascular events, including death, when used by patients in permanent atrial fibrillation (AF).
• July 2011: FDA said some clinical trial data showed a two-fold increase in death, as well as a two-fold increases in stroke (CVA) and hospitalization for heart failure in patients receiving Multaq compared to a placebo.
• January 2011: FDA issued a drug safety alert for Multaq concerning severe liver injury, such as liver failure requiring liver transplantation, associated with Multaq use.

We will continue to watch for any "Dear Doctor" letter from Sanofi-Aventis about this September 2012 Mutlaq label change as it concerns interstitial lung disease and pulmonary toxicity, such as pulmonary fibrosis and pneumonitis.

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Third Boles vs. Merck Fosamax Trial In September 2012 Involves Only The Damages Amount Aspect

Brief History Of This ONJ / Jaw Lawsuit: First, Mistrial; Second, Jury Verdict For Plaintiff But Award Reduced By Judge

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE: We have been informed that there will not be a third Boles trial after all because just prior to its start Merck and the attorney for Shirley Boles agreed to a stipulation of damages amount that will be reduced to a judgment in favor of the plaintiff.  By agreement, the damages amount is confidential.

(9/20/12)

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In mid-September 2012 there will be another trial in the federal court Fosamax MDL for osteonecrosis of the jaw (ONJ) / jaw injury cases, but this lawsuit is far from being a "new" matter in that drug injury litigation.

On September 18, 2012 the Boles v. Merck & Co., Inc., 06 Civ. 9455 (JFK), case is set for a new jury trial on damages before United States District Court Judge Joseph F. Keenan, who is presiding over IN RE: FOSAMAX PRODUCTS LIABILITY LITIGATION, MDL No. 1789 (Southern District of New York).  This is the third time Judge Keenan will being seeing a trial of this particular Fosamax ONJ lawsuit.

In fact, the Boles case was the first Fosamax trial in the federal court Fosamax MDL.  It involves Shirley Boles, of Walton Beach, Florida, who used Fosamax from 1997 to 2006 and eventually developed osteonecrosis of the jaw (ONJ), which has been described as jawbone tissue death.

The outcome of that first Boles trial is reported in this September 11, 2009 Reuters article, "Merck lawsuit over Fosamax ends in mistrial":

U.S. District Judge John Keenan declared the mistrial two days [after] giving the New York jury considering the case a "cooling off period" in light of supposed acrimony among jurors.

A Merck lawyer on Wednesday referred to an "unsubstantiated claim" of a chair being thrown in the jury room.

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As for the second Boles v. Merck Fosamax trial, it ended with a jury verdict of $8 million for the plaintiff in June 2010.

However, this result was later changed when Judge Keenan decided to significantly reduce the amount of that jury award against Merck in the second Boles trial while upholding the plaintiff verdict, as reported in this October 5, 2010 Bloomberg article, "Merck Fosamax Verdict Cut to $1.5 Million From $8 Million".

From that October 2010 news report:

Keenan ruled that the $8 million verdict was unreasonably high. He said Boles may choose between a reduced award of $1.5 million or a retrial to determine damages.

“A significant damage award is warranted, but the $8 million deviates substantially from what would be reasonable compensation,” Keenan wrote.

Soon after that reduction of the jury award by Judge Keenan, the attorneys for Shirley Boles informed the court that they would prefer to have a retrial on the damages aspect of the lawsuit as opposed to accepting the $1.5 million.

And that set the stage for "Boles III", as some observers are referring to this third Boles v. Merck trial which is scheduled to start in mid-September 2012.

Of course, we will be monitoring this Boles Fosamax - ONJ trial and report its outcome, here.

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