Drug Injury Watch

June 2014 Benicar FDA Drug Safety Communication: Did It Decrease Or Increase Public Concern About The Risk Of Cardiovascular Death

Benicar, Azor, Tribenzor, Benicar HCT, And Other Blood Pressure Medicines Containing Olmesartan: Cardiovascular Mortality In Not A Side Effect Risk, Or Is It

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE: "FDA Once Again Reaches Conclusions At Odds With Its Own Staff"  (Forbes, Larry Husten, 7/14/14)

Once again the FDA has reached a conclusion that is directly opposed by some of its own scientists.  Last month the FDA affirmed the safety of olmesartan, a popular blood pressure lowering drug (sold as Benicar and other names). But that reassuring view is not shared by the  FDA scientists who performed the study that provided the basis for the review. And now outside experts are also raising concerns about the drug....

(7/15/14)

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UPDATE: Recent Benicar label change according to the June 13, 2014 FDA Letter:

Under ADVERSE REACTIONS/Post-Marketing Experience, the following test [sic] was added:

Data from one controlled trial and an epidemiologic study have suggested that high-dose olmesartan may increase cardiovascular (CV) risk in diabetic patients, but the overall data are not conclusive....

Overall, these data raise a concern of a possible increased CV risk associated with the use of high-dose olmesartan in diabetic patients. There are, however, concerns with the credibility of the finding of increased CV risk, notably the observation in the large epidemiologic study for a survival benefit in non-diabetics of a magnitude similar to the adverse finding in diabetics.

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In June 2014 FDA announced that the agency had completed its safety review of Benicar, Azor, Tribenzor, and Benicar HCT, finding no clear evidence of increased cardiovascular risks associated with use of these blood pressure medication containing olmesartan in diabetic patients. 

Four years earlier, in June 2010, the FDA issued a Drug Safety Communication letting doctors and patients know that two clinical studies found that patients with Type 2 diabetes taking Benicar had a higher rate of death from a cardiovascular cause compared to patients taking a placebo.

So does this mean that Benicar is not associated with cardiovascular-related deaths, at all?

From the very title of this June 2014 announcement, "FDA Drug Safety Communication: FDA review of cardiovascular risks for diabetics taking hypertension drug olmesartan not conclusive; label updates required", one does not get much assurance that this conclusion is tried and true.

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Moreover, a well-regarded medical journalist covering cardiology news, Larry Husten, takes issue with that conclusion in his June 24, 2014 article "FDA Ends Olmesartan Safety Review, But...".

From this article, which was posted by Forbes magazine on its website:

A careful reading of the FDA announcement, however, suggests that although the agency did not find clear evidence of increased cardiovascular risk it also did not find clear evidence of safety. Only one study examined by the FDA focused on the “subgroup of interest, i.e., diabetic patients taking high-dose olmesartan,” and it did not provide any reassurance....

This FDA communication is quite strange, in my opinion. It doesn’t sound like there’s much strong evidence either way in this case. But it seems to me that if the FDA takes four years to conduct a safety review, and if the only relevant evidence it analyzes appears to support the earlier concerns, then it shouldn’t just conclude the safety review. If anything the safety concern has increased, not decreased.

We will continue to watch for new medical journal articles concerning that study or any other research which shows an increase in cardiovascular mortality and deaths associated with Benicar.

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

Drug Injury Case Evaluation - Free & Confidential  (Legal case review done by attorney Tom Lamb)

Higher Doses Of Statin Drugs Such As Lipitor Associated With Higher Risk Of New-Onset Diabetes Mellitus (DM), Or Type-2 Diabetes

Recent Canadian Study Published In BMJ Medical Journal Suggests The Increased Risk Of Diabetes Seems To Be Highest In The First Four Months Of Statin Use

(Posted by Tom Lamb at DrugInjuryWatch.com)

According to the Parke-Davis, Division of Pfizer, Prescribing Information for Lipitor (accessed 6/18/14):

• [LIPITOR pills are:] White, elliptical, film-coated tablets containing 10, 20, 40, and 80 mg atorvastatin calcium.
• The recommended starting dose of LIPITOR is 10 or 20 mg once daily.
• The dosage range of LIPITOR is 10 to 80 mg once daily.

In our January 2014 article, "Pfizer's Lipitor Statin Drug For Treatment Of High Cholesterol Linked To An Increased Risk Of Type-2 Diabetes In Some Older And Post-Menopausal Women", we listed some of the medical journal articles reviewed by the FDA prior to issuing its February 2012 Lipitor - diabetes warning.

More recently, in May 2014, BMJ (formerly known as the British Medical Journal) published this article, "Higher potency statins and the risk of new diabetes: multicentre, observational study of administrative databases", which further implicates higher doses of Lipitor as a possible cause of new-onset Type-2 diabetes in some adult women.

From the Abstract for this May 2014 BMJ aritcle:

Results  In the first two years of regular statin use, we observed a significant increase in the risk of new onset diabetes with higher potency statins compared with lower potency agents (rate ratio 1.15, 95% confidence interval 1.05 to 1.26). The risk increase seemed to be highest in the first four months of use (rate ratio 1.26, 1.07 to 1.47).

Conclusions  Higher potency statin use is associated with a moderate increase in the risk of new onset diabetes compared with lower potency statins in patients treated for secondary prevention of cardiovascular disease. Clinicians should consider this risk when prescribing higher potency statins in secondary prevention patients.

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For some contextual information concerning this recent statins - diabetes medical journal article we refer to this June 9, 2014 Reuters news report, "Higher doses of statins linked to diabetes risk":

The researchers considered rosuvastatin (brand name Crestor) prescribed at 10 milligrams or more per day, atorvastatin (Lipitor) at 20 mg or more and simvastatin (Zocor) at 40 mg or more to be higher-potency statins. All other dosages were considered lower potency.

About 3,600 of the patients were diagnosed with diabetes within two years of starting the drugs, according to results published in BMJ.

Those prescribed a higher-potency statin were 15 percent more likely to be diagnosed with diabetes than those given lower dosages....

The first major statin trial was published in 1994, but researchers did not suspect a link with diabetes until 2008, said David Preiss. He has studied statins and diabetes at the University of Glasgow in Scotland and was not part of the new study.

After that, two major trials were published which found that taking a statin puts people at slightly higher risk of developing diabetes and taking a stronger statin puts them at slightly higher risk than taking a weaker statin, he said.

“Commonly used statins, such as simvastatin, atorvastatin and rosuvastatin, taken at a lower dose probably puts one at 10 percent higher risk of developing diabetes,” Preiss said. “Taking these same statins at high doses probably pushes this up to about 20 percent.”   [emphasis added]

We will continue to monitor this emerging drug-safety issue concerning association between new-onset diabetes mellitus (DM), or Type-2 diabetes, and higher doses of Lipitor as well as other statins. 

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

Drug Injury Case Evaluation - Free & Confidential  (Legal case review done by attorney Tom Lamb)

About 2000 YAZ / Yasmin / Ocella / Gianvi Blood Clot Cases Are Still Not Settled More Than Two Years After Bayer Began Settlement Mediations

Bayer Reports That As Of April 8, 2014 Settlement Negotiations Have Resolved "approximately 8,560 claimants in the U.S. for a total amount of about US$1.74 billion"

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE: December 2014 YAZ / Yasmin Litigation Update: Still Over 2000 DVT And/Or PE Cases Not Settled According To Bayer's Most Recent Financial Report

(12/15/14)

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UPDATE: Summer 2014 Update YAZ / Yasmin / Ocella / Gianvi Litigation: Bayer Reports On Total Settlements And Number Of Pending Claims

(9/12/14)

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Soon before the first federal court MDL trial was scheduled to start back in January 2012 Bayer decided to begin to attempt to negotiate settlements for YAZ / Yasmin / Ocella / Gianvi blood clot lawsuits, e.g., deep vein thrombosis (DVT) or pulmonary embolism (PE), on a case-by-case basis.

And while Bayer has settled a significant number of these cases over the past two years, there are still thousands of more drospirenone (DRSP) birth control DVT and PE lawsuits that have not been negotiated to a final settlement agreement, yet.

As of early April 2014 there were reportedly about 2000 unresolved YAZ / Yasmin / Ocella / Gianvi claims -- and that number apparently does not include the filed and unfiled Beyaz and Safyral blood clot cases, as there is not any mention of those cases by Bayer in recent their recent DRSP drug injury litigation updates.

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YAZ/Yasmin/Ocella/Gianvi/Beyaz/Safyral
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From the Stockholders’ Newsletter First Quarter 2014 (PDF document) issued by Bayer, at page 50:

Yasmin™/YAZ™: As of April 8, 2014, the number of claimants in the pending lawsuits and claims in the United States totaled about 3,900 (excluding claims already settled). Claimants allege that they have ­suffered personal injuries, some of them fatal, from the use of Bayer’s drospirenone-containing oral contraceptive products such as Yasmin™ and/or YAZ™ or from the use of Ocella™ and/or Gianvi™, generic versions of Yasmin™ and YAZ™, respectively, marketed by Barr Laboratories, Inc. in the United States.

As of April 8, 2014, Bayer had reached agreements, without admission of liability, to settle the claims of approximately 8,560 claimants in the U.S. for a total amount of about US$1.74 billion. Bayer has only been settling claims in the U.S. for venous clot injuries (deep vein thrombosis or pulmonary embolism) after a case-specific analysis of medical records on a rolling basis. Such injuries are alleged by about 1,920 of the pending unsettled claimants. Bayer will continue to consider the option of settling such individual lawsuits in the U.S. on a case-by-case basis.

Our previous article about this litigation was "YAZ / Yasmin Products Liability Litigation: February 2014 Bayer Information About The Number Of Claims, Lawsuits, And Settlements", which included Bayer's report that as of February 10, 2014 venous clot injuries (deep vein thrombosis or pulmonary embolism) were alleged by about 1,950 of the pending unsettled claimants.

The litigation update article before that was titled "During 2013 Bayer Has Had More Than 2000 YAZ / Yasmin Lawsuits For Blood Clots That Are Not Settled".

In re-reading those articles again, now, it seems that Bayer's settlement efforts have slowed down over the past year, for whatever reason(s).

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

Drug Injury Case Evaluation - Free & Confidential  (Legal case review done by attorney Tom Lamb)

June 2014 Fosamax - Femur Fracture Litigation Update: Thousands Of Cases Pending, But No Trial Dates Currently Scheduled In Federal Court MDL Nor New Jersey Multicounty Litigation

Merck Corporate SEC Filing for First Quarter 2014 Provides Information About Numbers Of Lawsuits In Various Court Jurisdictions Being Worked Up For Some Possible Trials In The Future

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

(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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We have our first 2014 update from Merck on the Fosamax - femur fracture litigation.

From the Merck SEC Form 10-Q for the quarterly period ended March 31, 2014 (at page 19 of PDF document):

• [In the Fosamax Femur Fracture MDL] Judge Pisano set a May 5, 2014, trial date for the bellwether trial of a case in which the alleged injury took place after January 31, 2011. Following the completion of fact discovery, the court selected Sweet v. Merck as the next Fosamax Femur Fracture MDL case to be tried on May 5, 2014, but plaintiffs subsequently dismissed that case. As a result, the May 2014 trial date was withdrawn.
• As of March 31, 2014, approximately 2,785 cases alleging Femur Fractures have been filed in New Jersey state court and are pending before Judge Higbee in Atlantic County Superior Court.
• As of March 31, 2014, approximately 525 cases alleging Femur Fractures have been filed 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. The petition was granted and Judge Steven Perk is now presiding over the coordinated proceedings.
• Additionally, there are six Femur Fracture cases pending in other state courts.
• Discovery is ongoing in the Fosamax Femur Fracture MDL and in state courts where Femur Fracture cases are pending and the Company intends to defend against these lawsuits.

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For the New Jersey Fosamax Multicounty Litigation, we want to report that the case Unanski v. Merck, which had been scheduled for trial back in March 2014, was postponed for reasons have to do with the trial court Judge, Carol Higbee, being elevated to a New Jersey appellate court position on short notice.  It is uncertain at the present time when the Unanski case will be rescheduled for trial.

Previously, we posted this article: "Merck Faces More Than 4100 Fosamax - Femur Fracture Lawsuits As Of September 30, 2013 According To SEC Corporate Filing".

As we have been doing, we will continue to monitor the Fosamax - femur fracture litigation and report significant developments as they become publicly available.

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

Drug Injury Case Evaluation - Free & Confidential  (Legal case review done by attorney Tom Lamb)

European Drug Safety Regulators Reviewing Hydroxyzine-Containing Medicines Such As Atarax And Vistaril For Heart Side Effects

Adverse Events Monitoring Data And Medical Studies Have Identified Possible Increased Risk For Cardiovascular Problems Including Arrhythmias

(Posted by Tom Lamb at DrugInjuryWatch.com)

In early May 2014 the European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) announced it was reviewing the safety of hydroxyzine-containing medicines because of cardiac concerns.

Hydroxyzine is a medicine used generally by mouth or sometimes by injection for:

• relief of anxiety disorders;
• premedication before surgical procedures;
• relief of urticaria or various other conditions associated with pruritus (itching); and,
• treatment of sleep disorders.

In the US,  hydroxyzine-containing drugs include Atarax (Roerig, a division of Pfizer) and  Vistaril (Pfizer Labs and Roerig, each a division of Pfizer).

From this May 8, 2014 EMA Announcement, "Review of hydroxyzine-containing medicines started":

The review was requested by the Hungarian medicines agency (GYEMSZI-OGYI) over concerns about the side effects of these medicines on the heart. This followed an examination of the benefits and risks by a marketing authorisation holder for hydroxyzine. Data from drug safety monitoring (pharmacovigilance) and published experimental studies identified a potentially increased risk of alterations of the electrical activity of the heart and arrhythmias (irregular heartbeats)....

The European Medicines Agency will now review the available data on the benefits and risks of hydroxyzine-containing medicines in all authorised indications, and issue an opinion on the marketing authorisations of these medicines across the EU.

We will watch for the results of this drug safety review in Europe concerning Atarax, Vistaril, and other hydroxyzine medications.

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

Drug Injury Case Evaluation - Free & Confidential  (Legal case review done by attorney Tom Lamb)