Drug Injury Watch

Savaysa Label Change In September 2016 Points Out There Is No Established Way To Reverse Its Anticoagulant Effects

Use Of Prothrombin Complex Concentrates (PCC) Or Other Procoagulant Reversal Agents Have Not Been Evaluated In Clinical Outcome Studies

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

In relevant part, from a September 15, 2016 FDA letter to Daiichi-Sankyo, Inc.:

Prior Approval supplemental new drug application provides for changes to SAVAYSA prescribing information based on results of the Phase 1 trial DU176b-A-U158 that evaluated the effects of Prothrombin Complex Concentrate (PCCs) on reversing the pharmacologic activity of edoxaban tosylate. Sections 5.3 ‘Risk of Bleeding’ and 12.2 ‘Pharmacodynamics’ have been updated to include this information.

And here is the "new" section 5.3 Risk of Bleeding part of the Savaysa Prescribing Information document (accessed 9/27/16) -- also  known as the package insert or the drug label:

Reversal of Anticoagulant Effect

There is no established way to reverse the anticoagulant effects of SAVAYSA, which can be expected to persist for approximately 24 hours after the last dose. The anticoagulant effect of SAVAYSA cannot be reliably monitored with standard laboratory testing. A specific reversal agent for edoxaban is not available. Hemodialysis does not significantly contribute to edoxaban clearance [see Clinical Pharmacology (12.3)]. Protamine sulfate, vitamin K, and tranexamic acid are not expected to reverse the anticoagulant activity of SAVAYSA. The use of prothrombin complex concentrates (PCC), or other procoagulant reversal agents such as activated prothrombin complex concentrate (APCC) or recombinant factor VIIa (rFVIIa) may be considered but has not been evaluated in clinical outcome studies [see Clinical Pharmacology (12.2)]. When PCCs are used, monitoring for anticoagulation effect of edoxaban using clotting test (PT, INR, or aPTT) or anti-FXa activity is not useful and is not recommended.

 

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Savaysa (edoxaban) is a factor Xa inhibitor which was approved by the FDA in 2015. Savaysa has the following so-called  "indications" or approved uses:

1. To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; and,
2. For the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5–10 days of initial therapy with parenteral anticoagulant.

For some related news as regards the FDA and Savaysa, see this article, "Xarelto / Savaysa / Eliquis: Antidote Drug AndexXa Is Rejected By FDA In August 2016".

We will continue to monitor the safety profile of Savaysa as well as Eliquis and Xarelto, especially as regards the current lack  of any FDA-approved antidote which would act as a reversal agent for serious bleeding events such as intracranial hemorrhages or  hemorrhagic strokes and gastrointestinal (GI) bleeds.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

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Fall 2016 Update On Fosamax Femur Fracture Lawsuits Is Not Much Different Than What Was Reported A Year Ago

Bottom Line Is That The Fate Of These Lawsuits Against Merck Is In The Hands Of The U.S. Court of Appeals For The Third Circuit

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

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UPDATE: On March 22, 2017 the Third Circuit Court of Appeals reversed the dismissal by U.S. District Court Joel Pisano of all the pending federal court Fosamax - femur fracture cases nationwide on federal preemption grounds. The Third Circuit significantly held that the ultimate question of whether the FDA would have rejected a Fosamax label change by Merck for the increased risk of femur fractures is a question of fact for the jury, rather than for the court, to decide.

(3/23/17)

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For more about this significant ruling, see: "Fosamax - Femur Fracture Lawsuits In Federal Court MDL: March 2017 Appellate Court Ruling Reinstates Lawsuits"

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Back in June 2015 U.S. District Judge Freda Wolfson of the District of New Jersey dismissed the last remaining cases in the Fosamax - femur fracture federal court MDL. However, those cases -- as well as some earlier dismissed Fosamax lawsuits concerning femur fractures -- could be reinstated if plaintiffs win an appeal currently pending before the U.S. Court of Appeals for the Third Circuit.

And since that time the federal court Fosamax MDL has been in a "holding pattern" while the parties wait for the appellate court to issue rulings on at least two appeals regarding the Fosamax label, or package insert, information about the femur fracture side effect. And for the New Jersey state court Fosamax litigation, it appears that the presiding judge is content on waiting for the federal appellate court rulings to be issued.

One of the main legal issues in those pending appeals is whether Merck could have strengthened the Fosamax drug label warnings about this apparent femur fracture side effect.

For additional information about this situation, see this article "Lawyers For Plaintiffs And Drug Company Merck Make Their Arguments To Third Circuit Appeals Court In Fosamax - Femur Fracture Litigation", from January 2016.

The little bit of "new" information about the Fosamax - femur fracture litigation comes from Merck's Form 10-Q SEC filing for the quarterly period ended June 30, 2016 (at pages 18-19 of this 55-page PDF document):

As previously disclosed, Merck is a defendant in product liability lawsuits in the United States involving Fosamax (Fosamax Litigation). As of June 30, 2016 , approximately 4,400 cases are filed and pending against Merck in either federal or state court.... [P]laintiffs in approximately 4,380 of these actions generally allege that they sustained femur fractures and/or other bone injuries (Femur Fractures) in association with the use of Fosamax.... [NOTE: This means the total number of pending femur fracture lawsuits filed against Merck is down 25, from 4,405 as of 3/31/16.]

As of June 30, 2016 , approximately 20 cases were pending in the Femur Fracture MDL, excluding the 515 cases dismissed with prejudice on preemption grounds that are pending appeal and the 520 cases dismissed without prejudice that are also pending the aforementioned appeal. [NOTE: These Fosamax MDL case total numbers are the same as they were as of 3/31/16.]

As of June 30, 2016 , approximately 3,020 cases alleging Femur Fractures have been filed in New Jersey state court and are pending before Judge Jessica Mayer in Middlesex County. [NOTE: This total number of New Jersey cases is down 20, from 3,040 as of 3/31/16.]

As of June 30, 2016 , approximately 295 cases alleging Femur Fractures have been filed and are pending in California state court. A petition was filed seeking to coordinate all Femur Fracture cases filed in California state court before a single judge in Orange County, California. . [NOTE: This total number of California cases is down 5, from 300 as of 3/31/16.]

We do not know the disposition of those cases that have gone away, i.e., been dropped by plaintiffs who have given up or settled by Merck (which seems unlikely).

The reality is that this Fosamax - femur fracture status update sounds all too similar to the last one, and the one before that, etc.

We remain on the look-out for developments in this long-running Fosamax litigation, and we ask you to share with us anything which you might know about these femur fracture cases.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

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Number Of Eliquis Lawsuits Filed Across The Country Is Increasing, But This Drug Injury Litigation Is Still In Its Early Stages

Eliquis Has Caused Irreversible Bleeding Events, Such As Trauma Incidents And Hemorrhagic Strokes, Which Can Be Life-Threatening And Sometimes Fatal

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

Eliquis (apixaban) was approved by the FDA in December 2012. Pfizer and Bristol-Myers Squibb are the two drug companies responsible for Eliquis.

It is important to know that as of September 2016 Eliquis does not currently have an FDA-approved antidote, or reversal agent, for a patient experiencing a trauma-induced bleeding event or needing emergency surgery.

These serious medical conditions have been associated with the use of Eliquis:

• Serious Bleeding Events
• Irreversible Fatal Bleeding Events
• Trauma-induced Atypical Bleeding Incidents
• Gastrointestinal (GI) Bleeds
• Rectal Bleeding
• Hemorrhages
• Brain Hemorrhage
• Intracranial Hemorrhage
• Hemorrhagic Stroke
• Cardiac Bleeds

 

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While an Eliquis antidote will someday be available to help patients suffering an acute bleed, unfortunately, it is too late for some people who suffered serious bleeding events or bled to death, already.

Our law firm is handling Eliquis cases which involve people who had excessive bleeding, bled to death, or experienced other serious side effects of Eliquis.

In recent months we have seen Eliquis lawsuits filed in various states across the country, from New York to Hawaii, from California to Kentucky, from Illinois to Louisiana, as well as in Pennsylvania and elsewhere. We estimate that less than 50 Eliquis lawsuits have been filed to date. That relatively low number of filed Eliquis cases, however, is expected to increase significantly in the months to come.

We will monitor the Eliquis litigation as it develops and, of course, will report noteworthy events as they happen.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review done by attorney Tom Lamb) 

The Essure Birth Control Product: Safety, Regulatory, And Legal Developments Over The Past Several Months

Increasing Number Of Women Who Have Allegedly Been Harmed By The Essure Inserts Have Filed Lawsuits Against Bayer

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

Bayer's Essure® product is a permanent birth control system that a woman can get with a non-surgical procedure to help her stop worrying about an unplanned pregnancy.

But while that may sound all good, the Essure birth control insert product has been surrounded with controversy having to do with its safety and some past clinical trials. Not surprisingly, these issues have resulted in lawsuits filed by women who allege being harmed by the Essure inserts.

Starting with the Essure safety issues, we get the following from a May 31, 2016 "Dear Healthcare Professional Letter" issued by Health Canada with the title "ESSURE (permanent birth control system) - Risk of Serious Complications":

Complications have been reported in some patients with the use of ESSURE (permanent birth control system) including changes in menstrual bleeding, unintended pregnancy, chronic pain, perforation and migration of device, allergy and various non-specific symptoms suggestive of sensitivity or immune-type reactions. Some complications may be considered serious. In some cases, the extent of the symptoms led to the removal of ESSURE. The removal of ESSURE requires surgery and may include hysterectomy.

Post-marketing information suggests that some patients may not always be fully informed of the various possible device and procedure-related complications before they choose whether to proceed with ESSURE.

That same Health Canada document went on to state: "The product labelling for ESSURE will be updated including a new Boxed Warning section to reflect this safety information."

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Shifting from current safety concerns to earlier clinical trials for the Essure product, and from Canada to the US, we get this excerpt from a September 6, 2016 news report, "FDA: No evidence of data manipulation in clinical trials for Bayer’s Essure", published on the MassDevice website:

The [FDA] set out to review the allegations, which accused Bayer of clinical trial misconduct, “notably that clinical trial participants’ medical records were altered to reflect more favorable data about participants’ experiences, and that the sponsor violated the terms of the PMA approval order and violated laws that relate to the manufacturing and marketing of Essure,” according to an FDA release....

After analyzing the forms, the [FDA] said it found “less than 1% of case report form data pertaining to pain, bleeding, device placement/movement and pregnancy were changed during the clinical trials.”

“Although modifications to the case report forms were identified, our analysis did not find evidence the sponsor purposefully modified patient responses to reflect more favorable data for Essure,” the FDA wrote in a report.

The FDA noted that the analysis had “several limitations,” most notably being that the investigation was conducted more than 13 years after the initial premarket approval was granted for the product.

That recent MassDevice article concluded with this rather ominous note:

The FDA said last year that in the 13 years since Essure’s approval, it had received 5,093 complaints, including for pain or menstrual irregularities after using the device, and complaints of the device breaking. In addition to 5 fetal deaths, there were 4 reports of adult deaths for reasons such as infection and uterine perforation, the FDA said.

Which brings us to the legal realm and the numerous lawsuits against Bayer filed by women who experienced various complications allegedly caused by their Essure birth control inserts.

Hundreds of such legal cases have been filed around the country, with the most attention going to Essure lawsuits pending in the Superior Court of California in Alameda County. In early August 2016 Winifred Y. Smith, of that California state court, ruled against the defendant Bayer, which sought to have some of those cases thrown out on three different legal grounds. Judge Smith's rulings in favor of the plaintiffs in those cases mean that Bayer could possibly be held liable for the harm alleged in current Essure lawsuits filed in California. In addition, those legal rulings might also establish the groundwork for future lawsuits against Bayer involving the Essure birth control product.

Be assured that we will continue to monitor safety, regulatory, and legal developments concerning the Essure contraceptive insert from Bayer.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review done by attorney Tom Lamb)