Drug Injury Watch

Fresenius GranuFlo Product Has Been Associated With Heart Problems And Cardiopulmonary Arrest During Dialysis Treatment

Fresenius Failed To Warn About Risks Of Sudden Heart Attack, Stroke, And Death Caused By GranuFlo Increasing The Level Of Bicarbonate In Blood

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE: Federal court GranuFlo / NaturalLyte Multi-District Litigation / MDL No. 2428 established by means of March 2013 Transfer Order: IN RE: FRESENIUS GRANUFLO/NATURALYTE DIALYSATE PRODUCTS LIABILITY LITIGATION

(4/2/13)

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The dialysis product GranuFlo from Fresenius was used by approximately one-third of the 400,000 patients with late-stage kidney failure requiring dialysis per year at a time when Fresenius apparently knew that GranuFlo caused an increased risk of metabolic alkalosis that could result in cardiopulmonary arrest, sudden heart attack, stroke, or death.

When Fresenius first learned about the dangerous side effects associated with GranuFlo and what it did to warn doctors and patients about the nature of the problem is the subject of a growing number of GranuFlo lawsuits filed against Fresenius.

This much is known already about the GranuFlo dialysis treatment safety problem:

(1) A November 4, 2011 Fresenius internal memo about the GranuFlo safety problem was sent to Fresenius physicians and the estimated 1,800 Fresenius dialysis clinics, only.  That (some may call it "secret") memo was not sent to the 1,500 unaffiliated dialysis clinics, i.e., not owned by Fresenius, where GranuFlo may have been used nor to the nephrologists and other doctors who cared for dialysis patients.

(2) What led to this Fresenius internal memo being created and distributed selectively to only some obviously interested parties?  At an April 2009 Boston conference of nephrologists and dialysis practitioners it was noted that cardiopulmonary arrest was noted to be the leading cause of death for dialysis patients.  After this conference Fresenius did a case-control study that identified 941 patients who suffered cardiopulmonary arrest during their dialysis treatment at one of the 667 Fresenius clinics (of 1800 total) in the year 2010.  That study confirmed the use of GranuFlo was involved with those 941 patient events, such as heart attacks and sudden cardiac deaths.  These findings were presented in the Fresenius November 2011 internal memo.

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(3) The FDA came to the GranuFlo problem relatively late -- compared to what Fresenius had known, before.  First there was a March 2012 FDA Class I recall -- the most serious type of FDA recall -- concerning GranuFlo which included this "Reason for Recall":

The manufacturer is cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in Fresenius' Naturalyte Liquid and Granuflo Dry Acid Concentrate. Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death.

It was only with this FDA action that Fresenius issued its March 29, 2012 notice about GranuFlo ("Subject: Risk of Alkalosis with acetate containing dialysis acid concentrates", i.e., Granuflo powder and Fresenius NaturalLyte Liquid product lines).

Later, in May 2012, the FDA issued this warning document: "FDA Safety Communication: Dialysate Concentrates and Alkali Dosing Errors with Hemodialysis".

Given these facts, personal injury and wrongful death lawsuits have been filed against Fresenius for the following medical conditions, or side effects, associated with GranuFlo use by hemodialysis patients:

• Cardiopulmonary Arrest (CPA) / Cardiac Arrest
• Heart Attack / Myocardial Infarction (MI)
• Sudden Cardiac Death
• Stroke (CVA)

Most dialysis patients who suffered one of these side effects will not know whether GranuFlo was used as part of their treatment.  However, this should not stop you from contacting us about a possible case.

Likewise, it does not matter if the side effect occurred in connection with a dialysis treatment at a non-Fresenius clinic (for example, DaVita) because GranuFlo was distributed by Fresenius to "other" dialysis clinics that were not part of the Fresenius clinics system.

We would be interested in speaking with any patient who developed a heart problem or a stroke during their dialysis treatment or soon thereafter, as well as the surviving spouse or family of those unfortunate patients who died.  You can call 800-426-9535.

P.S.  Fresenius began marketing its GranuFlo Dry Acid Concentrate dialysate product here in the U.S. back in 2003.  We are interested in investigating possible cases involving any of the above serious medical conditions, or side effects, associated with GranuFlo use by hemodialysis patients going as far back as this 2003 "introduction-to-market" date and up until August 2012.

(11/5/12)

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NuvaRing: Plaintiffs' Expert Reports Made Available By New Jersey Judge Based On Public's Right Of Access To Judicial Proceedings

Defendants Had Sought To Keep Sealed Some Documents That Show NuvaRing Estrogen Levels Were Apparently Concealed Or Misrepresented By Organon

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE: A similar Order was issued on October 25, 2012 in the federal court NuvaRing MDL by U.S. District Court Judge Rodney Sippel.

(10/30/12)

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In a defeat for Defendants Organon USA Inc., Organon Pharmaceuticals USA Inc., and Organon International Inc. ("Defendants"), on October 22, 2012 New Jersey State Court Judge Brian R. Martinotti issued an Order that allows public access to documents for which Organon had sought to keep restricted access, only.

As background, in July 2012 the Defendants filed six motions to exclude certain testimony by Plaintiffs' experts; all six motions included documents which Organon filed under seal, i.e., restricted access. Like similar motions filed in the federal court NuvaRing MDL, these NJ motions contained a discussion of both parties' relevant expert reports and expert depositions, which were included as exhibits to the motions and designated as confidential pursuant to the Protective Order entered by U.S. District Court Judge Rodney Sippel, who is presiding over the NuvaRing MDL proceedings.

Whereas Judge Sippel ruled in September 2012 that only the expert motions and memorandums in support should be unsealed, i.e., public access, -- as seen in "Disturbing Information About NuvaRing Safety Found In Motions On Experts Recently Unsealed By Federal Court MDL Judge" -- Judge Martinotti went further and unsealed, in addition, the expert reports and expert depositions which were exhibits to those motions.

The fundamental basis for this October 2012 ruling by Judge Martinotti was an established public policy of New Jersey -- specifically, there is a presumption that the public has a right of access to judicial proceedings, which includes the public's right to inspect judicial records.

Among the unsealed documents is an expert report by a pharmacologist, Shelley Ann Tischkau, Ph.D., prepared for Plaintiffs in the NuvaRing litigation. As part of this work, Dr. Tischkau analyzed Organon's Study #34128, which is the one and only study that Organon did to actually measure the levels of estrogen in women using the NuvaRing.

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In her expert report for the Plaintiffs, Dr. Tischkau pinpoints facts shown in the "confidential" Study #34128 which were concealed or misrepresented by Organon, to the doctors who prescribe the NuvaRing and in fact to the governmental bodies which supervise the safety of drugs.

Based on review of this newly available Tischkau expert report, we have learned that:

• In pharmacokinetics study #34128, Organon only tested the NuvaRing on 16 people to see how much estrogen got into their blood, and it was so high in two women that Organon dropped them out of the study report without disclosing this reduction in number.
• Organon presents a chart in the Prescribing Information which shows estrogen levels from day 1 - 21 but the drug company omits day on day zero (first 24 hours) which is much higher estrogen.
• When testing the NuvaRing, Organon found they had bursts of estrogen which they could not control, and ultimately decided they would just have to live with that situation.
• And related to that last point, before resigning themselves to the fact they could not control it, Organon applied for a patent for a way to avoid the estrogen bursts with new technology but did not follow through with it.

The NuvaRing birth control product was initially approved by the FDA in October 2001, when Organon USA Inc. was the responsible drug company. Since that time, first, Organon was acquired by Schering-Plough and, later, Merck took over Schering-Plough and Organon.

In contrast to these expert findings above, and apparently in order to promote the NuvaRing, those drug companies have claimed that the NuvaRing provides the least amount of estrogen of any contraceptive and that, unlike, the birth control pill, this low amount of estrogen is steadily released into the woman user over the 21-days cycle.

As regards the more than 1000 NuvaRing lawsuits that have been filed to date in the NJ state court and federal court MDL litigations, these Plaintiff expert findings are significant because the higher the levels of estrogen or the more these estrogen levels vary from day to day, the greater the risk of a blood clot forming and developing into a deep vein thrombosis (DVT) or pulmonary embolism (PE).

No wonder the Defendants' lawyers argued to Judge Martinotti that the unsealing of these expert materials would be damaging to Organon's reputation.

Fortunately, Judge Martinotti saw the NuvaRing litigation as a high public-interest case which involved both health and safety, such that he rejected this argument by the Defendants and pointed out any harm to Organon's reputation is irrelevant.

NOTE TO LAWYERS (AND MARKETERS) WHO MAY THINK ABOUT COPYING THIS ARTICLE FOR USE ON THEIR SITE -- AND PASSING IT OFF AS THEIR INTELLECTUAL WORK: Some deliberately placed inaccuracies are in this article which, though not significant to potential clients reading this, will be telltale that you used this article without our permission and without doing your own analysis of these unsealed documents.

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New Obesity Drug Qsymia / Qsiva Gets Gets Negative Opinion By European Medicines Agency (EMA)

Combination Pill Of Topamax And Phentremine Was Approved By FDA, But EMA Points To Heart Side Effects, Birth Defects, And Other Safety Issues

(Posted by Tom Lamb at DrugInjuryWatch.com)

On October 18, 2012 European drug regulators took a different course than the FDA with regard to a new anti-obesity medication which contains the active ingredient in Topamax, topiramate, and phentermine. This new diet-drug pill is called Qsymia here in the US and Qsiva in Europe.

For some background on this decision by the European Medicines Agency (EMA), we look to this October 19, 2012 Fierce Pharma news report, "EMA committee shoots down Vivus diet pill":

Vivus wasn't expecting a warm reception from European officials, and those expectations bore out. The committee said it was worried about Qsiva's long-term effects on the heart and blood vessels, particularly because Qsiva contains the active ingredient phentermine, once notorious for its use in the fen-phen diet-pill combo. Phentermine isn't approved in Europe, though it is in the U.S.

The drug's other active ingredient, topiramate [brand name: Topamax], is a seizure remedy that's been on the market for years--and known to carry a risk of birth defects. Plus, the [EMA's Committee for Medicinal Products for Human Use (CHMP)] noted concerns about long-term psychiatric effects, because depression and anxiety cropped up in clinical trials, and long-term memory and attention problems.

As for the actual determination, we get these details from this European Medicines Agency document (PDF), "Refusal of the marketing authorisation for Qsiva (phentermine / topiramate)":

The CHMP noted that the main studies showed clinically relevant weight loss following treatment with Qsiva but had concerns about the medicine’s long-term effects on the heart and blood vessels, particularly due to the effects of phentermine, which is known to increase the heart rate but whose long-term effects are not clear. Secondly, there were concerns about the long-term psychiatric effects (depression and anxiety were reported in the studies) and cognitive effects (such as problems with memory and attention) related to the topiramate component of Qsiva. Topiramate is also known to be potentially harmful to the unborn baby if taken by pregnant women.

With regard to that last point, having to do with the Topamax (topiramate) component of Qsymia / Qsiva, we have covered the birth defect safety issue associated with this anti-seizure drug before:

FDA Seeks Information About Topamax-Related Oral Cleft Birth Defect Cases -- Request For Historical Incidence Data Made In Connection With NDA For New Obesity Drug  (February 2011)

Topamax During Pregnancy Increases Risk Of Cleft Lip And/Or Cleft Palate Birth Defects -- Oral Clefts In Babies Are 20 Times More Likely With Women Who Used Topamax (topiramate) After Getting Pregnant  (March 2011)

Returning to the Fierce Pharma report about the EMA's negative opinion on Qsymia / Qsiva:

Vivus says it plans to appeal the CHMP's decision. Cowen & Co. analyst Simos Simeonidis said new reviewers will look at Qsiva during its appeal, which may improve its chances. Regardless of the outcome--and regardless of the expected slow-but-steady build in prescriptions, Simeonidis figures that the demand for obesity drugs and Qsymia's early reputation for "robust weight loss" will fuel peak sales of $1.6 billion in the U.S. by 2019.

We will continue to monitor the safety profile of Qsymia in the US, where this new obesity drug has been available for patient use since July 2012.

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Intramedullary Nailing Surgery Is Successful Treatment For Patients With Femur Fractures From Use Of Fosamax Or Other Bisphosphonates

People Who Suffer These Atypical Femoral Fractures Are Well Treated With This Surgical Procedure Using Rod-Like Nail, With Low Rate Of Complications

(Posted by Tom Lamb at DrugInjuryWatch.com)

According a recent article about a presentation -- Clinical and functional outcomes in patients who sustained bisphosphonate-associated complete femur fractures. Paper #71. -- done in early October 2012 at the Orthopaedic Trauma Association Annual Meeting:

Intramedullary nailing is a successful treatment for patients with bisphosphonate-associated complete femur fractures and displays a low rate of complications and high return to baseline function at 1 year....

In more detail, from that October 12 article published online by OrthopedicsToday, "IM nailing effective for patients with bisphosphonate-associated femur fractures":

“Our findings suggest that atypical femoral fractures are well treated with cephalomedullary nail,” Kenneth A. Egol, MD, said during his presentation at the Orthopaedic Trauma Association Annual Meeting 2012. “They take twice as long as the typical femur fractures to heal. Two out of three patients are completely pain-free at follow-up. There was a 15% risk of an incomplete fracture. These results give physicians information to give patients who sustain these injuries.”
 
Egol and colleagues studied 68 patients who sustained 101 atypical femoral fractures associated with bisphosphonate use that were treated at one institution during a 7-year period....

The final study cohort included 35 patients with 44 complete displaced fractures and eight patients with eight incomplete fractures. The patients had an average age of 69 years and had an average 8.5 years of bisphosphonate use.

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Over the past few years we have written extensively about atypical low-stress femur fractures in patients who used Fosamax, Boniva, Actonel, or other medications used to treat osteoporosis which are in the bisphosphonate class of drugs.  Here are some of our most recent articles:

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

 

Drug Injury Watch: Fosamax Femur Fractures: Many Impending Cases Go Unrecognized By Doctors And Radiologists Due To Subtle Characteristics

 

Drug Injury Watch: New Australian Study Supports An Apparent Association Between Long-Term Fosamax Use And Certain Types Of Femur Fractures

 

Drug Injury Watch: Risk Of Femur Fractures From Osteoporosis Drugs Fosamax, Boniva, Actonel, And Reclast Related To Number Of Years Used

 

Drug Injury Watch: 1,165 Fosamax - Femur Fracture Lawsuits Pending As Of December 31, 2011 According To Merck

 

Drug Injury Watch: Women Who Use Bisphosphonates Like Fosamax And Boniva Have Increased Risk Of Femur Fracture / Thigh Bone Breaks

 

Drug Injury Watch: How One Might Determine Whether The Femur Fracture Is Related To A Bisphosphonate Such As Fosamax

 

We will continue our coverage of bisphosphonate-related femur fractures going forward.

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Tekturna And Other Aliskiren Related Blood Pressure Medications Can Cause Renal Failure, Kidney Complications, And Strokes

Concomitant Use Of Tekturna With ACE Inhibitors And ARBs Contraindicated In Patients With Diabetes; Plus An FDA Caution Regarding Renal Impairment

(Posted by Tom Lamb at DrugInjuryWatch.com)

Tekturna (aliskiren) was approved by the FDA for marketing in March 2007 after it was evaluated for safety in 6,460 patients, and only 1250 patients were treated for longer than 1 year.  As we have learned too often with many newly marketed drugs, the true incidence of serious adverse events may not be realized until many thousands or millions of exposures have occurred in a patient population less homogeneous than the group participating in the premarketing trials.  And that scenario may be the case with Tekturna as well as the other aliskiren related drugs:

• Tekturna HCT (aliskiren hemifumarate and hydrochlorothiazide)
• Tekamlo (aliskiren hemifumarate and amlodipine besylate)
• Amturnide (aliskiren hemifumarate, amlodipine besylate, and hydrochlorothiazide
• Valturna (aliskiren hemifumarate and valsartan).  NOTE: Novartis stopped marketing Valturna in July 2012, i.e., withdrawn from the market.

Tekturna is taken orally and prescribed to treat high blood pressure (hypertension). In December 2011 the drug company Novartis announced the termination of its clinical ALTITUDE study of Tekturna after researchers observed an increased number of serious side effects in the study’s participants.

For a concise report of that development and the subsequent FDA action, we look to this April 2012 article by journalist Larry Husten: "Aliskiren (Tekturna) Gets New Warning and Contraindication From FDA":

The FDA has issued new warnings about antihypertensive drugs containing the direct renin inhibitor aliskiren (including Tekturna, Amturnide, Takamio, and Valturna) when used in combination with ACE inhibitors or angiotensin receptor blockers (ARBs). The FDA now states that  these drug combinations are contraindicated in patients with diabetes, and it is new warning to avoid the use of this combination in patients with moderate to severe renal impairment (GFR <60 mL/min).

The new warnings are based on preliminary data from the ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints) clinical trial. As previously reported here, ALTITUDE was terminated last December when the independent Data Monitoring Committee (DMC) found an increased risk for non-fatal stroke, renal complications, hyperkalemia, and hypotension in patients taking aliskiren after a median followup of about 27 months. More than 8,500 patients  with type 2 diabetes and renal disease were randomized to receive aliskiren or placebo in addition to an ACE inhibitor or an ARB.

Click here to read the FDA Drug Safety Communication.

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More recently, in connection with the FDA warning about Tekturna, Amturnide, Takamlo, and Valturna, the consumer advocacy group Public Citizen called for a "Black-Box Warning" for Tekturna and certain other high blood pressure medications -- angiotensin-receptor blockers (ARBs), angiotensin-converting-enzyme (ACE) inhibitors -- so that doctors are alerted to avoid using them in any combination due to the serious side effects which were revealed in the ALTITUDE trial.

From this October 4, 2012 press release, "Widely Used Blood Pressure Drugs Should Include a Strong Warning Against Use of Drugs in Combination, Public Citizen Tells FDA":

The use of ACE inhibitors and ARBs in combination has become commonplace in recent years due to a theoretical belief that such combination use would confer an added benefit over the use of the drugs individually. However, this theory has been unequivocally disproven in two large studies involving tens of thousands of patients with heart disease and diabetes that failed to show any clinical advantage of combination therapy. On the contrary, the studies showed a higher rate of several life-threatening side effects, such as low blood pressure, kidney failure and dangerously high blood potassium levels, in patients taking the drugs together compared with patients on only one of the medications.

A third study [i.e., ALTITUDE] involving the combined use of the new drug [Tekturna (aliskiren)] with ACE inhibitors and ARBs in patients with diabetes and kidney disease was halted early for identical reasons: a higher rate of the same serious side effects with no added benefit with combination use. An aliskiren/ARB combination drug, Valturna, was withdrawn from the market shortly thereafter.

Despite this wealth of data, the FDA has failed to respond by adequately warning doctors and patients of the clear danger of the combined use of ACE inhibitors, ARBs and [Tekturna] ....

If you are interested in learning more, see the Public Citizen document: "Petition to the FDA for Black Box Warnings on ACE Inhibitors, ARBs, and Aliskiren".

Essentially, the FDA should make Novartis add a Black-Box warning to the Tekturna label so as to inform doctors and patients that, as made apparent by the ALTITUDE study, patients with Type-2 diabetes are more likely to experience the following side effects than are patients with Type-2 diabetes who are not taking Tekturna:

•  Increased blood potassium levels (hyperkalemia)
•  Kidney (renal) damage
•  Low blood pressure (hypotension)
•  Stroke

We will continue to monitor the safety issues involving Tekturna, and report significant developments here.

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Disturbing Information About NuvaRing Safety Found In Motions On Experts Recently Unsealed By Federal Court MDL Judge

Newly Available Expert Analysis Of Confidential Drug Company Data Reveals That NuvaRing Estrogen Levels In Studies Were A Cause For Concern, And The Method Of Reporting Was Misleading

(Posted by Tom Lamb at DrugInjuryWatch.com)

In the pending NuvaRing litigation a federal judge recently unsealed some significant documents previously protected under claims of confidentiality. These "new" documents are remarkable because they show that several drug companies responsible for the NuvaRing have done reports which were misleading and the results were a cause for concern.

As background, the NuvaRing birth control product was initially approved by the FDA in October 2001, when Organon USA Inc. was the responsible drug company. Since that time, first, Organon was acquired by Schering-Plough and, later, Merck took over Schering-Plough and Organon.

According to Merck, as of December 31, 2011, there were approximately 950 NuvaRing lawsuits filed by women who had suffered serious blood-clot side effects such as pulmonary embolism (PE) and deep vein thrombosis (DVT).  Today there are reportedly more than 1000 cases, and that number will continue to grow as more women file these drug injury legal claims against Merck, Organon, and Schering-Plough.

The majority of these NuvaRing lawsuits are filed in the federal court NuvaRing MDL, which is situated in the U.S. District Court for the Eastern District of Missouri, with Judge Rodney Sippel presiding.

In early September 2012 Judge Sippel issued an Order that made public for the first time some significant findings in Organon records made by experts retained by Plaintiffs. This expert review information was unavailable until now due to confidentiality claims asserted by the Defendants. Those defense claims were denied by this Order about certain motions related to expert reports.

Contained in the newly released documents is information not publicly revealed before now about some studies which Organon did concerning the measure of estrogen in a small group of women in order to prove that the NuvaRing was safe.

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Set forth in the unsealed papers are a motion to exclude testimony by a pharmacologist, Shelley Ann Tischkau, Ph.D., who was selected by the plaintiffs to study internal reports from Organon. One of the studies she reviewed was #34128 -- which is the one and only study that Organon did to actually measure the levels of estrogen in women using the NuvaRing. In her expert report, as recounted on the motion to exclude her testimony, Dr. Tischkau pinpoints some important safety facts shown in the confidential Organon study which would have been of significant interest to the doctors who prescribe the drug.

Based on a review of these newly available Organon NuvaRing study-related documents, we have learned the following facts:

• In pharmacokinetics study #34128, Organon only tested the NuvaRing on 16 people to see how much estrogen got into their blood, but evidently only 5 were actually reported on, and she pronounced this misleading.
• When testing the NuvaRing, Organon found there were bursts of estrogen released, which was a cause of concern in that higher levels of estrogen increased the risk of clotting.
• There was striking and significant variability in the blood levels of estrogen in the subjects in this study, and an unusual discrepancy in the levels of the subjects of this study, and there was an unreasonable variability in the time for subjects to reach maximum blood levels of estrogen.

The reason these Plaintiff expert findings are significant to the NuvaRing litigation is because the higher the levels of estrogen or the more these estrogen levels vary from day to day, the greater the risk of a blood clot forming and, in turn, a deep vein thrombosis (DVT) and/or a pulmonary embolism (PE) developing in women using the NuvaRing.

NOTE TO LAWYERS (AND MARKETERS) WHO MAY THINK ABOUT COPYING THIS ARTICLE FOR USE ON THEIR SITE -- AND PASSING IT OFF AS THEIR INTELLECTUAL WORK: Some deliberately placed inaccuracies are in this article which, though not significant to potential clients reading this, will be telltale that you used this article without our permission and without doing your own analysis of these unsealed documents.

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