Drug Injury Watch

YAZ / Yasmin / Ocella Update: October 2011 FDA Study Finds Increased Risk Of Blood Clot Side Effects Like DVT, PE, Stroke, And Heart Attack

Safety Study Findings About Drospirenone (DRSP) Birth Control Pills Will Be On The Agenda For FDA Advisory Committees At Joint Meeting In December 2011

(Posted by Tom Lamb at DrugInjuryWatch.com)

On October 27, 2011 the FDA released its new drug-safety study report, "Combined Hormonal Contraceptives (CHCs) and the Risk of Cardiovascular Disease Endpoints", which included the popular birth control pills YAZ, Yasmin, and Ocella.

This FDA study was intended to determine whether drospirenone (DRSP)-containing oral contraceptives like YAZ, Yasmin, Ocella, etc. -- as well as some other relatively new birth control products, namely the Ortho Evra patch and the NuvaRing vaginal ring -- were associated with an increased risk of cardiovascular side effects such as:

•Venous thromboembolic events (VTE), including deep venous / vein thrombosis (DVT) and pulmonary embolism (PE); and,
•Arterial thrombotic events (ATE), including heart attack / acute myocardial infarction (AMI), and ischemic stroke.

Drospirenone (DRSP) is in the oral contraceptive pills Beyaz, Gianvi, Loryna, Ocella, Safyral, Syeda, Yasmin, Yaz, and Zarah.

In relevant part, this new FDA study found that all of the DRSP-containing oral contraceptives were associated with a significantly higher risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) relative to standard low-dose estrogen birth control pills, with the estimate of relative risk for these DRSP birth control pills being 1.74 (95% CI 1.42 to 2.14).

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Some of the key points made in this October 2011 FDA study report about DRSP birth control pills:

1. For the analysis restricted to new users, only DRSP was associated with a significantly higher risk of both ischemic stroke and heart attack (with this finding restricted to women in the 35-55 years age group only) -- relative risk: 2.01 (95% CI 1.06 to 3.81) -- as well as deep vein thrombosis (DVT) and pulmonary embolism (PE) (associated with DRSP use was in the 10-34 years age group) -- relative risk: 1.77 (95% CI 1.33 to 2.35).
2. Findings suggest that there may be an increase in risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) with DRSP during the early stages of new use relative to the risk from standard low-dose estrogen birth control pills as well as later in time. In more detail, DRSP was associated with significantly higher risk of DVT and PE when used for less than 3 months -- relative risk: 1.93 (95% CI 1.24 to 3.00)] -- as well as during the period of time 6 to 12 months after initial use -- relative risk: 2.80 (95% CI 1.48 to 5.29).
3. DRSP may increase cardiac arrhythmia risks and sudden deaths among users because it has anti-mineralocorticoid activity that may increase potassium levels.

Here are the reasons this FDA birth control safety study, which includes YAZ, Yasmin, and Ocella, was done:

The objective of the FDA-funded study was to assess cardiovascular risks, including the risk of thrombotic and thromboembolic events and death, for several newly approved (early 2000s) products that had sufficient numbers of users to allow for an evaluation of these risks compared to those associated with use of older, more frequently prescribed contraceptives at the sites selected. If an increased risk was observed, the FDA-funded study would subsequently attempt to assess user characteristics and prescribing patterns that might help explain the increased risk. It was recognized at the time that a more in-depth assessment of potential reasons for increased risk would not be possible using only claims and electronic medical records and would require physician and patient contact, something that could be conducted later if needed.  [emphasis added]

The FDA said these new study findings about YAZ / Yasmin / Ocella side effects -- like PE and DVT, as well as strokes and heart attacks -- will be presented by the agency to its Reproductive Health Drugs and Drug Safety and Risk Management advisory committees at a joint meeting which will take place December 8, 2011 in the Washington, DC area.

Of course, we are anxious to hear the discussions about YAZ, Yasmin, Ocella, etc. at the FDA advisory committees meeting and, later, will be watching for any continuation of this FDA DRSP birth control pills safety study -- as the agency's explanation of its reasons for this birth control study, above, suggests is a possibility.

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NuvaRing Update: October 2011 FDA Study Finds Increased Risk Of Pulmonary Embolism (PE) And Deep Vein Thrombosis (DVT)

Will NuvaRing Safety Study Findings Be Addressed By FDA Advisory Committees At Joint Meeting In December 2011?

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE: "October 2013 NuvaRing Label Change: Warnings And Precautions Section Sets Forth Two Competing Medical Studies About Side Effects"

(12/11/13)

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On October 27, 2011 the FDA released its new drug-safety study report, "Combined Hormonal Contraceptives (CHCs) and the Risk of Cardiovascular Disease Endpoints", which included the NuvaRing (etonogestrel / estradiol vaginal ring) -- referred to as "ETON" in this 2011 FDA study report.
 
This FDA study was intended to determine whether the NuvaRing -- as well as some other relatively new birth control products, namely the Ortho Evra patch and all DRSP-containing oral contraceptives like YAZ, Yasmin, Ocella, etc. -- was associated with an increased risk of cardiovascular side effects such as:

• Venous thromboembolic events (VTE), including deep venous / vein thrombosis (DVT) and pulmonary embolism (PE); and,
• Arterial thrombotic events (ATE), including heart attack / acute myocardial infarction (AMI), and ischemic stroke.

In relevant part, this new FDA study found that the NuvaRing was associated with a significantly higher risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) relative to standard low-dose estrogen birth control pills, with the estimate of relative risk for NuvaRing being 1.56 (95% CI 1.02 to 2.37).
 
One of the key points made in this October 2011 FDA study report is that continuous exposure combined hormonal contraceptives such as the NuvaRing "potentially result in higher sustained exposure to estrogen and hence, increased thromboembolic risk".

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Here are the reasons this FDA birth control safety study, which includes NuvaRing, was done:

The objective of the FDA-funded study was to assess cardiovascular risks, including the risk of thrombotic and thromboembolic events and death, for several newly approved (early 2000s) products that had sufficient numbers of users to allow for an evaluation of these risks compared to those associated with use of older, more frequently prescribed contraceptives at the sites selected. If an increased risk was observed, the FDA-funded study would subsequently attempt to assess user characteristics and prescribing patterns that might help explain the increased risk. It was recognized at the time that a more in-depth assessment of potential reasons for increased risk would not be possible using only claims and electronic medical records and would require physician and patient contact, something that could be conducted later if needed.  [emphasis added]

One hopes that those new study findings about NuvaRing side effects -- like PE and DVT, as well as strokes and heart attacks -- are presented by the FDA to its Reproductive Health Drugs and Drug Safety and Risk Management advisory committees at a joint meeting which will take place December 8 - December 9, 2011 in the Washington, DC area.
 
Of course, we will be watching for any continuation of this FDA NuvaRing safety study -- as the agency's explanation of its reasons for this birth control study, above, suggests is a possibility.

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Women Who Used YAZ / Yasmin / Ocella Are Getting Letters From Aetna Medical Insurance Company

Here Is Why Aetna Wants To Know Whether You Have Filed A Gallbladder Or A Blood Clot Lawsuit Against Bayer

(Posted by Tom Lamb at DrugInjuryWatch.com)

We have learned that women who took the birth control pills YAZ, Yasmin, or Ocella while they had medical insurance from Aetna are receiving letters asking questions such as:

• Did you suffer any cardiovascular - or gallbladder - related injury or injuries during or after [the period when you used Yaz, Yasmin, or Ocella]?
• Have you pursued, are you pursuing, or do you intend to pursue a personal injury claim related to your use of Yaz, Yasmin, or Ocella?
• Have you hired or do you plan to hire an attorney to represent you in this claim?

To date, thousands of women who have suffered a cardiovascular, or blood clot, related side effect such as a pulmonary embolism (PE), deep vein thrombosis (DVT), or stroke (CVA), or have had their gallbladder removed, after using YAZ, Yasmin, or Ocella have filed lawsuits against Bayer HealthCare Pharmaceuticals Inc. 

The drug safety controversy concerning these popular birth control pills containing the relatively new progestin drospirenone (DRSP) was recently featured on Nightline from ABC News: "Yaz Birth Control Investigation".

Our law firm has been filing personal injury and wrongful lawsuits involving YAZ, Yasmin, and Ocella since July 2009, and we continue to hear from more women each week -- including some women who have contacted us in recent weeks after getting this Aetna letter.

At our Drug Injury Law website we have more information about YAZ, Yasmin, and Ocella as well as the several other DRSP birth control pills which are currently available in the US: Beyaz, Safyral, Gianvi, Zarah, Loryna, and Syeda.

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Returning to the letter from Aetna asking a woman about her use of Yaz, Yasmin, and Ocella, one could read that letter as this insurance company actually encouraging a woman who suffered a serious blood clot side effect like a PE, DVT, or stroke to sue the drug companies Bayer and Teva Pharmaceuticals, which sells Ocella.

This Aetna letter may raise a question for some people: Why would a health insurance company such as Aetna want a person to sue a drug company like Bayer or Teva?  The answer is addressed briefly in the Aetna YAZ / Yasmin / Ocella letter:

The manufacturers of these drugs may be financially responsible for claims related to any injury or illness that you may have suffered as a result....  If Yaz's manufacturer is responsible for health care claims, we may be able to recover the costs of the medical care from the manufacturer....

Let us try to put this statement by Aetna into context and explain why it is (still) worth your while to file a YAZ / Yasmin / Ocella lawsuit -- for reasons other than just helping Aetna recover from Bayer and Teva the directly-related medical costs that Aetna paid for your PE, DVT, stroke, or gallbladder removal surgery.

The concept of an insurance company getting reimbursed from a lawsuit recovery for medical expenses paid by the insurance company on your behalf for any injury which was due to the actions or conduct of a third party, e.g., the drug company, is generally referred to as "subrogation".

Aetna, or any other insurance company, would only get reimbursed for the directly-related medical costs which it paid.  The "damages" aspect of your YAZ / Yasmin / Ocella drug injury lawsuit would include, in addition to those medical costs, any lost income, your pain and suffering, etc. -- such that there would (still) be legal compensation money paid to you even after the insurance company's subrogation claim had been reimbursed out of the lawsuit settlement money or trial verdict amount.

If you have suffered a serious blood clot side effect like a PE, DVT, or stroke, or had to have your gallbladder removed, after using YAZ, Yasmin, or Ocella, we would be interested in helping you file a lawsuit against the drug companies Bayer and Teva.  You can begin this process by completing our online Case Evaluation form or you can call us on our toll-free number: 800-426-9535.

And to our friends at Aetna:  You should consider sending a similar drug injury subrogation letter to women who have used the NuvaRing birth control product from Merck, Schering-Plough, and Organon.

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New Heart Drug Pradaxa May Be Sending "Early" Drug Safety Signals

ISMP QuarterWatch 2010 4th Quarter: Hemorrhages And Thromboembolic Events Have Been Reported To FDA

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE:  "Boehringer says about 260 deaths related to Pradaxa" (11/12/11, Reuters)

FRANKFURT Nov 12 (Reuters) - Boehringer Ingelheim said that 260 cases of fatal bleeding have been linked to its new stroke prevention pill Pradaxa so far, adding that the risk of death was still below the rate that emerged in the clinical trial that led to the drug's approval.

In early November, the German drugmaker had said that 50 reported deaths were a "reasonable order of magnitude"....

(11/17/11)

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UPDATE: This is the so-called "Dear Doctor" letter sent to healthcare professionals in the United Kingdom (UK) on October 27, 2011 to inform them of new recommendations to assess renal function:

Direct Healthcare Professional Communication on the importance of assessing renal function in patients treated with ▼Pradaxa® (dabigatran etexilate)

Dear Healthcare Professional,

This letter is to inform you of new recommendations to assess renal function in patients being considered for, or already being treated with Pradaxa. These recommendations follow an evaluation of reports of cases of fatal bleeding in Japan. Some of these cases occurred in elderly patients with severe renal impairment, which constitutes a contraindication for Pradaxa treatment....

(11/3/11)

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UPDATE:  "Boehringer says about 50 deaths related to Pradaxa" (11/2/11, Reuters)

FRANKFURT, Nov. 2 (Reuters) - Boehringer Ingelheim's new stroke prevention pill Pradaxa has been linked to about 50 deaths from bleeding across the world since its market launch, the company said on Wednesday, heightening health regulators' attention....

(11/2/11)

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To start, according to the responsible drug company Boehringer Ingelheim Pharma:

PRADAXA is a prescription blood-thinning medicine used to reduce the risk of stroke and blood clots in people with atrial fibrillation not caused by a heart valve problem.

www.Pradaxa.com (accessed 10/13/2011)

The 2010 Quarter 4 QuarterWatch from the Institute for Safe Medication Practices (ISMP) shows that, despite only being on the US market for a year / since October 2010 , the FDA has received an unusually high number of "early" adverse event reports about Pradaxa (dabigatran) involving the drug's effects on blood clotting, namely hemorrhages (too much anti-clotting effect) and thromboembolic events (too little clot inhibiting effect) such as pulmonary embolism (PE) and deep vein thrombosis (DVT).

These ISMP QuarterWatch findings are summarized in an October 2011 article, "Latest review of FDA safety reports shows wide use of Pradaxa", written by Michael Cohen, who is President of the ISMP group:

... [O]ne of the interesting findings in this issue of QuarterWatch involves the new drug Pradaxa (dabigatran etexilate). Within weeks of its launch, Pradaxa generated more reports (307) than 98.7% of the other drugs we regularly monitor. The predominant reported adverse effects were equally divided among bleeding or clotting events....

This large number of reports in the 2-3 months after launch illustrates that serious safety issues are likely to grow as the use of Pradaxa increases and forthcoming new alternatives to Coumadin are approved. The large number of reports just weeks after approval show how quickly a new treatment can spread into wide clinical use.

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To compound the scope of this possible emerging drug safety issue involving Pradaxa, the Cohen October 2011 news article about the ISMP QuarterWatch findings concerning Pradaxa went on to tell us how this relatively new atrial fibrillation heart drug is already being prescribed to a much wider patient population than the actual "indication", i.e., reducing the risk of blood clots and stroke in patients with a heart condition known as atrial fibrillation, for which it has received FDA approval:

We also found that this new drug was immediately used “off-label,” meaning that the FDA has not approved the drug for use in the manner in which it’s being prescribed because its risks and benefits have not yet been systematically studied. Only 36% of reports that listed the indication noted that the drug was being used for the approved indication. Another 46% of reports said the drug was being used to prevent blood clots or stroke in general terms, and other reports clearly specified off-label uses, such as the prevention of deep vein thrombosis postoperatively after hip or knee arthroplasty. The data suggest that physicians were substituting Pradaxa for warfarin across a wide spectrum of conditions, despite not having FDA approval.

Of course, we will continue to monitor the safety profile of Pradaxa and, as always, we welcome any Comments that you may have regarding this relatively new drug from Boehringer Ingelheim Pharma.

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

Medical Clues Include Prior Symptoms, Location Of Thigh Bone Break, And Specific Radiology Findings

(Posted by Tom Lamb at DrugInjuryWatch.com)

For this medical primer about femur fractures which might be associated with Fosamax as well as the several other bisphosphonate osteoporosis medications available in the U.S. we will start with some basic anatomy taken from a document titled "Femur Shaft Fractures (Broken Thighbone)", published by the American Academy of Orthopaedic Surgeons (AAOS):

Your thighbone (femur) is the longest and strongest bone in your body. Because the femur is so strong, it usually takes a lot of force to break it. Car crashes, for example, are the number one cause of femur fractures.

The long, straight part of the femur is called the femoral shaft. When there is a break anywhere along this length of bone, it is called a femoral shaft fracture....

Doctors describe fractures to each other using classification systems. Femur fractures are classified depending on:

• The location of the fracture (the femoral shaft is divided into thirds: distal, middle, proximal)
• The pattern of the fracture (for example, the bone can break in different directions, such as cross-wise, length-wise, or in the middle)
• Whether the skin and muscle above the bone is torn by the injury

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We move next to a recent medical journal article, "Bisphosphonate-Related Complete Atypical Subtrochanteric Femoral Fractures: Diagnostic Utility of Radiography", which was published in the October 2011 edition of the American Journal of Roentgenology (AJR).  From the Abstract of this medical article:

OBJECTIVE.  The objective of our study was to evaluate the diagnostic utility of conventional radiography for diagnosing bisphosphonate-related atypical subtrochanteric femoral fractures.

MATERIALS AND METHODS.  Retrospective interpretation of 38 radiographs of complete subtrochanteric and diaphyseal femoral fractures in two patient groups—one group being treated with bisphosphonates (19 fractures in 17 patients) and a second group not being treated with bisphosphonates (19 fractures in 19 patients)—was performed by three radiologists....

CONCLUSION.  Radiographs are reliable for distinguishing between complete femoral fractures related to bisphosphonate use and those not related to bisphosphonate use. Focal lateral cortical thickening and transverse fracture are the most dependable signs, showing high odds ratios and the highest accuracy for diagnosing these fractures.

Returning briefly to the the AAOS document that we started with for quick definitions of one term used above and two other terms referenced below:

Transverse fracture. In this type of fracture, the break is a straight horizontal line going across the femoral shaft.

Oblique fracture. This type of fracture has an angled line across the shaft.

Comminuted fracture. In this type of fracture, the bone has broken into three or more pieces. In most cases, the number of bone fragments corresponds with the amount of force required to break the bone.

Now we go back several months to the June 2011 edition of the Drug Safety Update published online at the Medicines and Healthcare products Regulatory Agency (MHRA) web site for a piece entitled "Bisphosphonates: atypical femoral fractures".

To facilitate future case reporting and research, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a definition of atypical femoral fracture based on the American Society for Bone and Mineral Research (ASBMR) provisional case definition of atypical femoral fracture1—major and minor features:

Major features

~ Located anywhere along the femur from just distal to the lesser trochanter to just proximal to the supracondylar flare
~ Associated with no trauma or minimal trauma, as in a fall from a standing height or less
~ Transverse or short oblique configuration
~ Complete fractures extend through both cortices and may be associated with a medial spike; incomplete fractures involve only the lateral cortex

 
Minor features

~ Noncomminuted
~ Localised periosteal reaction of the lateral cortex [often referred to in radiology reports as ‘beaking’ or ‘flaring’]
~ Generalised increase in cortical thickness of the diaphysis
~ Prodromal symptoms such as dull or aching pain in the groin or thigh
~ Bilateral fractures and symptoms
~ Delayed healing
~ Comorbid conditions (eg, vitamin D deficiency, rheumatoid arthritis, hypophosphatasia)
~ Use of pharmaceutical agents (eg, bisphosphonates, glucocortoids, proton pump inhibitors)

[footnotes omitted]

Moreover, this MHRA Drug Safety Update article makes these two important points:

1. Specifically excluded are fractures of the femoral neck, intertrochanteric fractures with spiral subtrochanteric extension, pathologic fractures associated with primary or metastatic bone tumours, and periprosthetic fractures.
2. All major features are required to satisfy the case definition of atypical femoral fracture. None of the minor features are required, but sometimes have been associated with these fractures.

We hope these medical resources will be of assistance to patients and their families who are trying to determine if a femur fracture that was low-stress or otherwise unusual, e.g., not resulting from a fall, trauma, etc., might be related to the use of bisphosphonate osteoporosis medications like Fosamax.

As always, please submit any Comments you may have about this medical information or about any particular atypical femur fracture situation, below.

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