Drug Injury Watch

The Association Between Breast Implants And Anaplastic Large Cell Lymphoma (ALCL) Is Better Understood In Recent Years

Focus On Medical Journal Articles About The Diagnosis And Treatment Of This Breast Implants Lymphoma Cancer Published In 2015

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

In January 2011 the U.S. Food and Drug Administration (FDA) first announced a possible association between breast implants and anaplastic large cell lymphoma (ALCL), which was likened to systemic ALCL and treated accordingly. See "Anaplastic Large Cell Lymphoma (ALCL) In Women with Breast Implants: Preliminary FDA Findings and Analyses".

Over the next couple of years there were some, but not many, medical journal articles reporting on findings about breast implant-associated ALCL (BIA-ALCL) having to do with diagnosis and treatment of this rare form of lymphoma.

For example, from the September 2013 edition of Current Hematologic Malignancy Reports, there was this article, "Breast implant-associated anaplastic large cell lymphoma: a systematic review of the literature and mini-meta analysis":

Breast implant-associated ALCL (BIA-ALCL) is a rare, but likely under-reported entity, which most commonly presents with an effusion developing between the breast implant and the host fibrous capsule that surrounds it. It has been described in association with breast implants used for post-cancer reconstructive surgery and when implanted for purely cosmetic reasons. Two different presentations are seen; presentation with an effusion alone +/- co-existing capsular contracture, without an associated mass, and presentation with a mass lesion +/- an effusion. These two presentations are associated with very different outcomes, with women presenting with effusion alone having an excellent long-term survival, even in the absence of specific therapy other than implant removal. In these women, no further therapy other than implant removal is likely necessary. In contrast, women presenting with a mass lesion have a higher rate of relapse and may require more aggressive therapy.

It seems that the medical literature about this breast implants lymphoma cancer situation grew considerably in 2015, perhaps reflecting a more rapidly developing understanding of the diagnosis and treatment aspects of BIA-ALCL.

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In February 2015 this article, "Breast Implant-associated Anaplastic Large Cell Lymphoma: Updated Results from a Structured Expert Consultation Process", was published in Plastic and Reconstructive Surgery-Global Open. From the Abstract for this article:

[A multidisciplinary panel] agreed that (1) this disease should be called "BIA-ALCL"; (2) late seromas occurring >1 year after breast implantation should be evaluated via ultrasound, and if a seroma is present, the fluid should be aspirated and sent for culture, cytology, flow cytometry, and cell block to an experienced hematopathologist; (3) surgical removal of the affected implant and capsule (as completely as possible) should occur, which is sufficient to eradicate capsule-confined BIA-ALCL; (4) surveillance should consist of clinical follow-up at least every 6 months for at least 5 years and breast ultrasound yearly for at least 2 years; and (5) BIA-ALCL is generally a biologically indolent disease with a good prognosis, unless it extends beyond the capsule and/or presents as a mass. They firmly disagreed with statements that chemotherapy and radiation therapy should be given to all patients with BIA-ALCL.

Next, in the March 2015 edition of Plastic and Reconstructive Surgery, came this report, "Anaplastic large cell lymphoma occurring in women with breast implants: analysis of 173 cases", which provided this information:

[Anaplastic large cell lymphoma (ALCL)] lesions first presented as late peri-implant seromas, a mass attached to the capsule, tumor erosion through the skin, in a regional node, or discovered during revision surgery. The clinical course varied widely from a single positive cytology result followed by apparent spontaneous resolution, to disseminated treatment-resistant tumor and death. There was no preference for saline or silicone fill or for cosmetic or reconstructive indications. Where implant history was known, the patient had received at least one textured-surface device.

In October 2015 Clinics in Plastic Surgery published "Coming of Age: Breast Implant-Associated Anaplastic Large Cell Lymphoma After 18 Years of Investigation", from which we get this excerpt:

Breast implant associated anaplastic large cell lymphoma (BIALCL) is a distinct clinical entity that can present in patients receiving either reconstructive or cosmetic breast implants. Presenting symptoms include onset of a delayed (>1 year after implantation) fluid collection, mass of the capsule, or lymphadenopathy. Treatment has progressed in recent years and most commonly includes implant removal and total resection of the tumor, including capsule, mass, and involved lymph nodes.

Given the developments medical researchers have made in understanding this breast implants lymphoma cancer situation, in March 2017 the FDA provided a summary of updated information it had collected in a new document, "Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)".

We continue to monitor the medical literature for articles about the diagnosis and treatment of BIA-ALCL as well as the various theories about how this rare form of lymphoma (blood cancer) develops in some women with breast implants.

Breast Implants: Lymphoma / Blood Cancer Cases Overview

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The Rare Lymphoma (Blood Cancer) Linked To Breast Implants Which Has Caused Nine Patient Deaths

March 2017 FDA Report Provides Update On Emerging Safety Issue: Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) 

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

In March 2017 the FDA updated its "Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)" information page (accessed 3/31/17).

The most notable new facts are found in the Medical Device Reports part of this FDA breast implants - lymphoma page, specifically the most-current figures on the number of BIA-ALCL cases:

As of February 1, 2017, the FDA has received a total of 359 medical device reports (MDRs) of BIA-ALCL, including nine deaths. There are 231 reports that included information on the implant surface. Of these, 203 were reported to be textured implants and 28 reported to be smooth implants. Most of the reports contained no information about the surface textures of any previous implants. In addition, 312 of the 359 reports included information on implant fill types. Of these, 186 reported implants filled with silicone gel and 126 reported implants filled with saline.

From this March 21, 2017 article, "9 Deaths Are Linked to Rare Cancer From Breast Implants", published by The New York Times (NYT), we get some background information and observations regarding this still-emerging health problem:

About 290,000 women in the United States had implants for breast enlargement in 2016, and 109,000 received them for reconstruction after breast cancer, according to the American Society of Plastic Surgeons.

In many cases when the lymphoma occurs, just removing the implant and the tissue around it eliminates the disease. But some women may need chemotherapy and radiation.

Why there is a difference in risk related to the surfaces is not known, but the body’s reaction to textured implants is different from its reaction to smooth ones, according to Dr. Alex K. Wong, a plastic surgeon and researcher at the University of Southern California’s Keck School of Medicine. Tissue grows into microscopic grooves in the textured implants....

“We’re still trying to find out why the surface matters,” he said, adding that in some cases the cancer seems also to be associated with a certain bacterial infection.

Surgeons use textured implants if they want the implant to stick in place and not move, which is important for newer, anatomically shaped implants that would look bad if they were to shift or turn upside down.

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One may wonder about the timing of this March 2017 FDA update report about a little-known and rare type of lymphoma, or blood cancer, developing in some women who have had breast implant procedures done for augmentation or reconstruction purposes. The same NYT news story provides some contextual information which seems to help understand that issue:

A spokeswoman for the F.D.A., Stephanie Caccomo, said Tuesday’s announcement was made because “in 2016, there were several advances in the description of the disease and treatment recommendations, including recognition of the disease by the World Health Organization and publication of diagnosis and treatment guidelines by the Plastic Surgery Foundation and National Comprehensive Cancer Network.”

Together with other law firms, we are currently investigating breast implant - lymphoma cases as possible products liability lawsuits against the responsible medical device companies.

Of course we will continue to monitor the medical literature and regulatory realm for further developments concerning breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

Breast Implants: Lymphoma / Blood Cancer Cases Overview

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Antidepressant-Related Birth Defect: Heart And Lung Disorder PPHN - Persistent Pulmonary Hypertension Of The Newborn

Increased Risk Of PPHN When Women Use SSRIs Medications Like Celexa, Lexapro, Paxil, Prozac, And Zoloft After Their 20th Week Of Pregnancy

(Posted by Tom Lamb at DrugInjuryWatch.com)

A recent medical journal article, "Prenatal exposure to antidepressants and persistent pulmonary hypertension of the newborn: systematic review and meta-analysis", published by BMJ in January 2014, brought more attention to a serious but often overlooked drug risk presented by some popular antidepressant drugs like Celexa, Lexapro, Paxil, Prozac, and Zoloft.  These prescription medications are in the Selective Serotonin Reuptake Inhibitors, or SSRIs, class of drugs.

From the Abstract for that January 2014 BMJ article:

• Objective  To examine the risk for persistent pulmonary hypertension of the newborn associated with antenatal exposure to antidepressants.
• Conclusions  The risk of persistent pulmonary hypertension of the newborn seems to be increased for infants exposed to SSRIs in late pregnancy, independent of the potential moderator variables examined. A significant relation for exposure to SSRIs in early pregnancy was not evident. Although the statistical association was significant, clinically the absolute risk of persistent pulmonary hypertension of the newborn remained low even in the context of late exposure to SSRIs.

This important finding, however, is not new.

Back in 2006 The New England Journal of Medicine (NEJM) published this article, "Selective Serotonin-Reuptake Inhibitors and Risk of Persistent Pulmonary Hypertension of the Newborn", about a study which had results that were similar to those from the 2014 BMJ article, above.

The Abstract for the 2006 NEJM provides this information:

• BACKGROUND: Persistent pulmonary hypertension of the newborn (PPHN) is associated with substantial infant mortality and morbidity. A previous cohort study suggested a possible association between maternal use of the selective serotonin-reuptake inhibitor (SSRI) fluoxetine late in the third trimester of pregnancy and the risk of PPHN in the infant. We performed a case-control study to assess whether PPHN is associated with exposure to SSRIs during late pregnancy.
• RESULTS: Fourteen infants with PPHN had been exposed to an SSRI after the completion of the 20th week of gestation,.... In contrast, neither the use of SSRIs before the 20th week of gestation nor the use of non-SSRI antidepressant drugs at any time during pregnancy was associated with an increased risk of PPHN.
• CONCLUSIONS: These data support an association between the maternal use of SSRIs in late pregnancy and PPHN in the offspring; further study of this association is warranted....

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Soon after the above NEJM article about the SSRIs - persistent pulmonary hypertension (PPHN) birth defect problem was published Health Canada issued a drug safety alert, as we reported in this March 2006 post, "Health Canada Issues Pregnancy Warning For Antidepressants -- Newborns Whose Mothers Took SSRIs At Increased Risk Of Serious Lung Disorder":

On March 10, 2006 Health Canada issued a warning for women taking antidepressant drugs known as Selective Serotonin Re-uptake Inhibitors (SSRIs) -- including Prozac and Paxil -- and who are pregnant or thinking of becoming pregnant.

Health Canada issued this advisory to draw attention to a recent study published in The New England Journal of Medicine which linked Prozac, Paxil, and other drugs in the SSRI class to a rare but potentially fatal condition in newborns called persistent pulmonary hypertension.  According to the advisory, cases of persistent pulmonary hypertension have been reported in babies born to women who took SSRI antidepressants during the second half of their pregnancies.

While the FDA has looked at this drug safety problem for some years, now, unfortunately the agency has not reached any definitive conclusions and certainly has not taken the necessary actions to prevent future cases of PPHN caused by antidepressants / SSRIs like Celexa, Lexapro, Paxil, Prozac, and Zoloft, despite the severity of this birth defect condition.

From this December 2011 document, "FDA Drug Safety Communication: Selective serotonin reuptake inhibitor (SSRI) antidepressant use during pregnancy and reports of a rare heart and lung condition in newborn babies":

The U.S. Food and Drug Administration (FDA) is updating the public on the use of selective serotonin reuptake inhibitor (SSRI) antidepressants by women during pregnancy and the potential risk of a rare heart and lung condition known as persistent pulmonary hypertension of the newborn (PPHN). The initial Public Health Advisory in July 2006 on this potential risk was based on a single published study.  Since then, there have been conflicting findings from new studies evaluating this potential risk, making it unclear whether use of SSRIs during pregnancy can cause PPHN....

FDA has reviewed the additional new study results and has concluded that, given the conflicting results from different studies, it is premature to reach any conclusion about a possible link between SSRI use in pregnancy and PPHN. FDA will update the SSRI drug labels to reflect the new data and the conflicting results. (See Data Summary).

PPHN occurs when a newborn baby does not adapt to breathing outside the womb. Newborns with PPHN may require intensive care support including a mechanical ventilator to increase their oxygen level. If severe, PPHN can result in multiple organ damage, including brain damage, and even death....

And, likewise, the drug companies responsible for these widely used antidepressants have apparently not taken the obvious steps to heighten awareness of the SSRI - PPHN drug safety issue by getting Prozac, for example, moved to Pregnancy Category D (Prescription drugs which are known to impose health risks for the fetus) -- as Prozac was still included in Pregnancy Category C when I last looked at its Prescribing Information, or drug label (accessed 1/16/14).

For more on the meanings of those FDA categories, see this background article (albeit we posted it back in 2005): "The Safety of Prescription Drugs During Pregnancy -- FDA Uses Five Pregnancy Risk Categories At Present".

Of course, we will continue to watch for and report any significant developments concerning this serious drug safety issue, whether those are on the medical, pharmaceutical, and/or regulatory fronts.

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

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Two Conferences About Big Pharma Conduct: One Past (Selling Sickness 2013), One Future (PharmedOut's 4th Annual Conference)

At Their Respective Websites, You Can See What You Have Missed And What You Can Look Forward To In Washington, DC

(Posted by Tom Lamb at DrugInjuryWatch.com)

In February I attended Selling Sickness 2013 - People Before Profits, which was a diverse conference about the pharmaceutical drug industry, with a focus on several different facets of its conduct and practices.

I want to let you know that the materials used by some of the speakers at this Selling Sickness 2013 conference are now available for download at the conference website on its Presentations page.  These are organized by day, session, and name.  There are missing presentations that will be added as soon as materials are received from the speakers.

And if you want to learn more about the intended subject of any of these presentations you can also view the Official Program for Selling Sickness 2013.

For those of you interested in this past conference about Big Pharma conduct, I want to let you know about a somewhat related conference which is coming up in the relatively short-term future.

PharmedOut, a Georgetown University Medical Center project that advances evidence-based prescribing and educates health care providers about industry marketing practices, is taking place June 6-7, 2013 at Georgetown University.  The project is directed by Adriane Fugh-Berman MD, who recently moderated the Corruption panel at the Selling Sickness 2013 conference.

The theme or title for this year's PharmedOut's 4th Annual Conference is "Medical Behavior in a Commercial World: Who Is Responsible?".  From the PharmedOutweb page for this upcoming conference:

This year's conference will explore the ethical responsibilities of health care providers, medical journals, industry, and payers on therapeutic choices, as well as the effects on public health at large.

At that PharmedOut 2013 conference page you will also access the current schedule by using this Conference At-A-Glance (pdf) link.

From the email announcement which I received earlier today from the PharmedOut Project Manager for this June 2013 conference:

PharmedOut's past conferences have been highly acclaimed by participants, who tend to be physicians, policymakers, and other professionals and students in a range of disciplines and perspectives that don't typically get to converge....

Among our many speakers:

- A former pharmaceutical executive will speak for the first time on ethical conflicts within industry
- Former editor-in-chief of New England Journal of Medicine Marcia Angell MD, chief editor of PLOS Medicine Virginia Barbour MD, and clinical editor at British Medical Journal Elizabeth Loder MD will speak about how medical journal advertising and editorial policies affect public health
- Carl Elliott MD PhD, author of White Coat, Black Hat and Professor at the University of Minnesota’s Center for Bioethics, will discuss industry-funded trials at academic medical centers
- Charles Ornstein of ProPublica will speak about how lessons learned from the Dollars for Docs database will apply  to the Physician Payments Sunshine Act;
- A medical ghostwriter will reveal how he helped sell Low Testosterone syndrome (Low-T) to consumers

Sounds like this one will be another high quality and interesting event concerning the conduct of Big Pharma, as was Selling Sickness 2013. 

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

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"Selling Sickness 2013" Conference In February Will Focus On Various Aspects Of Pharmaceutical Industry

Academic Medical Reformers, Consumer Activists, Health Journalists, And Others Will Gather In Washington, DC To Discuss Big Pharma Conduct and Practices

(Posted by Tom Lamb at DrugInjuryWatch.com)

I want to let you know about an event we will covering next month that should be of great interest to many of you: Selling Sickness 2013 - People Before Profits.

This conference about the pharmaceutical drug industry, with a focus on several different facets of its conduct and practices, will be held in Washington, DC, during February 21-22, 2013.  Its origins and purpose are described on the SellingSickness.com website as follows:

First, there was the 2006 Inaugural Congress on Disease Mongering in Australia which marked a watershed in networking among health care reformers and drug industry critics.  Then, the 2010 Selling Sickness conference in Amsterdam expanded the network and updated the work. Now, Selling Sickness 2013: People before Profits is coming to Washington, DC in February, 2013 to continue the challenge and the international networking.

This conference will bring together academic medical reformers, consumer activists, and health journalists to examine the current scope of disease mongering and to develop strategies and coalitions for change. Topics will include misleading marketing, journalistic standards, over-treatment, over-diagnosis, whistleblowers, new roles for advocates, pharmacovigilance, clinical trials, activist narratives, new conflict of interest areas, evidence-based screening, igniting citizen outrage, and more.

For those interested learning more about this Selling Sickness 2013 event:

• Organizers and Steering Committee
• Schedule for 2/21/13 and 2/22/13
• Speakers at Conference

I am scheduled to attend this conference next month and, afterward, there will be a report posted here about what transpired during these two days in DC. 

Lastly, if you are going to be at this Selling Sickness 2013 conference and would like to meet in person, please feel free to send me an email in advance of the event so that I can look for you there. ______________________________________________________________________________

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

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Prescription Drug Medication Errors Can Be Prevented By Taking Some Common Sense Precautions

Ten Strategies Intended For Pharmacists Can Help Patients Stay Safe, Also

(Posted by Tom Lamb at DrugInjuryWatch.com)

It is relatively well-accepted in the healthcare community that medication errors involving prescription drugs happen more often than they should but the incident rate could be reduced if both pharmacists and patients took certain precautions.

The following set of precautions, from the an article "Pharmacy Dispensing Mistakes: 10 Strategies for Minimizing Dispensing Errors" that was published online by Pharmacy Times a couple of years ago, is intended for pharmacists but includes some points that can be helpful to patients.

Before we get to the list of ten ways that pharmacists might reduce the risk of causing or contributing to medication errors, here is some background about the problem generally from this Pharmacy Times article:

Dispensing errors include any inconsistencies or deviations from the prescription order, such as dispensing the incorrect drug, dose, dosage form, wrong quantity, or inappropriate, incorrect, or inadequate labeling. Also, confusing or inadequate directions for use, incorrect or inappropriate preparation, packaging, or storage of medication prior to dispensing are considered to be errors. Errors occur at a rate of 4 per day in a pharmacy filling 250 prescriptions daily, which amounts to an estimated 51.5 million errors out of 3 billion prescriptions filled annually nationwide.  [footnotes omitted]

Now, here is the list of strategies for pharmacists to adopt in order to reduce the risk of causing a patient possible harm by means of a medication error:

1. Ensure correct entry of the prescription.

2. Confirm that the prescription is correct and complete.

3. Beware of look-alike, soundalike drugs.

4. Be careful with zeros and abbreviations.

5. Organize the workplace.

6. Reduce distraction when possible.

7. Focus on reducing stress and balancing heavy workloads.

8. Take the time to store drugs properly.

9. Thoroughly check all prescriptions.

10. Always provide thorough patient counseling.

This last point is especially important and, for the reasons set forth below, it is unfortunate that many patients are in too much of a hurry to take advantage of this service which is routinely offered and declined daily in pharmacies large and small.

Approximately 83% of errors are discovered during counseling and are corrected before the patient leaves the pharmacy. Therefore, it is important to go beyond offering to counsel and provide counseling for each patient. It is considered good practice to open the container and show the actual medication to the patient during counseling rather than deliver it to the patient in a sealed bag. Completing this process will provide an opportunity for the patient to see the medication and ask questions if it looks different from what he or she has been taking. Counseling should also include the instructions on how to take the medication and appropriate route of administration. Many dispensing errors are attributed to misunderstood directions for use. Educating patients about safe and effective use of their medication promotes patient involvement in their health care, which will likely reduce medication errors.  [footnotes omitted]

In closing -- and this is the real take-away point for patients as regards the above list of prescription drug safety strategies -- while it may take a few more moments before leaving the pharmacy, one should always take advantage of the pharmacist-patient counseling session as the best final precaution for preventing possible harm from medication errors.

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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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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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Many Patients Mistakenly Believe That A Prescription Drug Must Be Safe If FDA-Approved

Safety Problems With New Medications Often Appear Only After Approval And Widespread Use

(Posted by Tom Lamb at DrugInjuryWatch.com)

A medical journal article published in the September 12, 2011 edition of the Archives of Internal Medicine has given some profile to the myth that just because the FDA has approved a prescription drug it must be safe to use.

We start with a couple of brief excerpts from the Abstract for this article, "Communicating Uncertainties About Prescription Drugs to the Public":

Background Many new drugs are aggressively promoted. The public may not realize that even with US Food and Drug Administration (FDA) approval, important uncertainties about the benefits and harms of these drugs remain....

Conclusions A substantial proportion of the public mistakenly believes that the FDA approves only extremely effective drugs and drugs lacking serious side effects.

We move next to some comments and observations about this medical journal article which were presented in this September 12, 2011 news report, "Public Often Unaware of a Drug's Safety Record -- Or Lack of One", by HealthDay reporter Alan Mozes.

First, from Dr. Michael Carome, deputy director of Public Citizen's Health Research Group in Washington, D.C.:

Patients need to be aware that almost any drug has potential side effects," he said. "And for newly approved drugs there's often insufficient information about serious risks, some of which may have gone undetected during the approval process and won't be detected until they're used in the real-world setting on a wide-scale basis.... Unless a new drug is a breakthrough medication for a condition for which there were no previously good options, we recommend that people not take it for at least seven years.

Second, Harvard University's Daniel Carpenter, a professor of government, weighs in:

...the term "FDA-approved" gives patients a mental and emotional security about a drug.... So I'm in sympathy with the policy recommendation that patients ought to be made aware, for example, that we know less about an FDA-approved drug that has been on the market for a day or a year than we do about drugs that have been on the market for five or 10 years.

Because this is the situation, doctors and patients have a role in helping the FDA identify emerging drug-safety issues. From the agency's "Reporting Serious Problems to FDA" page:

In order to keep effective medical products available on the market, the FDA relies on the voluntary reporting of these events. FDA uses these data to maintain our safety surveillance of these products. Your report may be the critical action that prompts a modification in use or design of the product, improves its safety profile and leads to increased patient safety.

Here are links to two pages at our web site, Drug Injury Law, which will tell you more about the FDA's MedWatch program and how to submit a report:

http://www.druginjurylaw.com/drug-injury-reporting.html

http://www.druginjurylaw.com/medwatch-report.html

The September 12 HealthDay news reports concludes in this manner:

Writing in the same [Archives of Internal Medicine] issue, Dr. Deborah Grady, of the department of medicine at the University of California, San Francisco, recommended that the job of selecting the safer, better drug be left to properly trained clinicians.

We agree wholeheartedly with that point.

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An Increase In Complications Due To Surgical Revision Of Defective Sprint Fidelis Leads

Lead Wire Extraction Surgery Might Be More Hazardous Than Once Thought, Including Serious Cardiovascular Injuries And Deaths

(Posted by Tom Lamb at DrugInjuryWatch.com)

The Sprint Fidelis lead wire, a heart defibrillator cable made by Medtronic, was removed from the market in October 2007 due to a defect that caused it to malfunction, which may have resulted in at least five patient deaths.

An April 7, 2009 New York Times news report by Barry Meier, "Removing Medtronic Heart Cables Is Hard Choice", describes what was the then-current thinking about the consequences for patients who had one of these defective Sprint Fidelis leads -- and things have seemingly gotten worse for them since then:

But only now is the full scope of the public health problem becoming clear for the Sprint Fidelis, which is still used by 150,000 people in this country.

In the next few years, thousands of those patients may face risky surgical procedures to remove and replace the electrical cable, which connects a defibrillator to a chamber of the heart.

Medtronic estimates that the cable has failed in a little more than 5 percent of patients after 45 months of being implanted. But as a preventive measure, some patients with working cables are having them removed.

Already, four patients have died during extractions. Experts fear that the toll could quickly rise if such procedures are not performed by skilled doctors at medical centers that have performed many of the operations.

“I think we are just seeing the tip of the iceberg,” said Dr. Charles J. Love, a cardiologist at Ohio State University Medical Center in Columbus, who specializes in cable extractions.

As regards how things may be worse now, to begin, I will quickly touch upon the failure rate aspect by referring back to a couple of articles which I posted here in the past:

From December 2009:  "Sprint Fidelis Lead Wire Failure Rate Could Rise To 30 Percent By Four Years" -- About 260,000 Medtronic Sprint Fidelis Leads Were Implanted In US, With Approximately 143,000 Still Active

From February 2010:  "There Is Disagreement Over The Three-Year Failure Rate For Sprint Fidelis Lead Wires"-- Medtronic Says 4.6 Percent Of Leads Failed, While Reports From Some Hospitals Indicate 9.2 Percent Of Sprint Fidelis Wires Failed

We turn next to the surgical complications aspect.  We will start with an April 2010 Medscape article, "Deaths and Cardiovascular Injuries Due to Device-assisted Implantable Cardioverter–Defibrillator and Pacemaker Lead Extraction" (free registration required) by Robert G. Hauser, M.D. -- who has been an active participant in the debate about the consequences of the Sprint Fidelis recall -- and colleagues. From this Dr. Hauser article, we get these points:

• The controversy surrounding the management of patients who have Sprint Fidelis ICD leads and the report of deaths associated with Sprint Fidelis lead extraction prompted us to examine the worldwide adverse events that have been reported by manufacturers, hospitals, and health providers to the US Food and Drug Administration (FDA). The aim of this study was to determine whether complications due to device-assisted lead extraction might be more hazardous than available data suggest, and whether procedural safety precautions, including standby cardiothoracic surgery, are effective. [footnotes omitted]
• This study shows that device-assisted lead extraction has resulted in fatal cardiovascular injuries often despite emergency surgical intervention. Moreover, the majority of the reported deaths have occurred in the last 2 years, and most of them were caused by lacerations of major veins during laser or mechanical dilator sheath extractions. This finding is timely and important because more than 100 000 patients have underperforming Sprint Fidelis ICD leads that may require replacement. Medtronic has announced that 4 of the 13 deaths due to fractures of Sprint Fidelis leads were associated with the extraction of the failed lead.
• Conclusion  These findings suggest that device-assisted lead extraction is a high-risk procedure and that serious complications including death may not be mitigated by emergency surgery. However, skilled standby cardiothoracic surgery is essential when performing pacemaker and ICD lead extractions. Although the incidence of these complications is unknown,...

And the last part of that Conclusion, above, makes especially significant this June 2010 article, "Complications Associated With Revision of Sprint Fidelis Leads", published by the medical journal Circulation.  From the Abstract for this article:

Background—  It has been observed that replacement of an implantable cardioverter-defibrillator generator in response to a device advisory may be associated with a substantial rate of complications, including death. The risk of lead revision in response to a lead advisory has not been determined previously.

Methods and Results—  .... As of June 1, 2009, there had been 310 lead failures found in 6237 Sprint Fidelis leads in Canada (4.97%) over a follow-up of 40 months. There were 469 leads to be revised, 66% for confirmed fracture. Of the patients who underwent revision, 95% had a new lead inserted, whereas 4% had a pace/sense lead added. The lead was removed in 248 cases (53%), by simple traction in 61% and by laser lead extraction in 33%. Complications were encountered in 14.5% of the lead revisions; 7.25% of these were major, whereas 7.25% were minor. There were 2 deaths (0.43%). The overall risk of complications (19.8%) was greater in those who underwent lead removal at the time of revision than in those whose leads were abandoned (8.6%; P=0.0008).

Conclusions—  The overall rate of major complications that arose from lead revision due to the Sprint Fidelis advisory was significant. This must be taken into account when lead revision is planned in those patients who have not yet demonstrated an abnormality in lead performance.

So the patient who still has a defective Sprint Fidelis lead wire implanted is probably being advised to keep it in place until a break or fracture occurs -- which potentially causes a massive unnecessary shock to the patient's heart, or causes the defibrillator battery to go dead and the implantable heart device fails to deliver a necessary life-saving shock.

If and when the Sprint Fidelis lead wire breaks or fractures, then the patient is faced with a revision surgery which appears to be associated with a significant rate of hazardous, and possibly fatal, complications.

In the end, it seems relatively clear that this is quite an unfortunate situation to be in for any such patient.

P.S.  "Psychological Adjustment in ICD Patients Living With Advisory Fidelis Leads", published early -- August 19, 2010 -- online by The Journal of Cardiovascular Electrophysiology. 

From the Abstract:

• This study focused on the Sprint Fidelis advisory.
• The study had 2 objectives: (1) to examine whether there is adverse psychological adjustment when an ICD is under advisory, and (2) to assess the psychological sequel of advisory ICD component malfunction.
• On one side, the risk of device malfunction and the likely severity of clinical sequelae have to be estimated. This estimate has to be weighed against the risks of surgery to replace the advisory component.

(8/31/10)

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects