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Epipen Recall

 

The U.S. Food and Drug Administration is alerting consumers to Meridian Medical Technologies’ voluntary recall of 13 lots of Mylan’s EpiPen and EpiPen Jr (epinephrine injection) Auto-Injector products used for emergency treatment of severe allergic reactions. This recall is due to the potential that these devices may contain a defective part that may result in the devices’ failure to activate. The recalled product was manufactured by Meridian Medical Technologies and distributed by Mylan Specialty.

While the number of reported failures is small, EpiPen products that potentially contain a defective part are being recalled because of the potential for life-threatening risk if a severe allergic reaction goes untreated. Consumers should keep and use their current EpiPens if needed until they get a replacement. Consumers should contact Stericycle at 877-650-3494.

As stated on the product label, consumers should always seek emergency medical help right away after using their EpiPens, particularly if the device did not activate.

At this time, the 13 lots identified – distributed between Dec. 17, 2015, and July 1, 2016 – are the only EpiPen lots impacted by the U.S. recall. Consumers who have EpiPens from lots that are not included in this recall, do not need to replace their EpiPen prior to its expiration date.

Product/Dosage NDC Number Lot Number Expiration Date
EpiPen Jr Auto-Injector, 0.15 mg 49502-501-02 5GN767 April 2017
EpiPen Jr Auto-Injector, 0.15 mg 49502-501-02 5GN773 April 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 5GM631 April 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 5GM640 May 2017
EpiPen Jr Auto-Injector, 0.15 mg 49502-501-02 6GN215 September 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM082 September 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM072 September 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM081 September 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM088 October 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM199 October 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM091 October 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM198 October 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM087 October 2017

 

The FDA asks health care professionals and consumers to report any adverse reactions or device malfunctions to the FDA’s MedWatch program, by:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

 

EpiPen Recall Carton

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Dr. Joanna Sexter is published in the February 2017 issue of Pediatrics Journal

Increasing Awareness of Sudden Death in Pediatric Epilepsy Together
As seen in Pediatrics Journal
February 2017, VOLUME 139 / ISSUE 2

Lapham G, Gaillard WD, Sexter J, et al. Increasing Awareness of Sudden Death in Pediatric Epilepsy Together. Pediatrics. 2017; 139(2):e20163127

Abbreviation:
SUDEP — sudden unexpected (or unexplained) death in epilepsy persons
The death of any child is tragic. When the death is sudden and unexpected, it can seem especially incomprehensible. Henry was 4 years old when he died only a few weeks after his epilepsy diagnosis; his parents were devastated and never knew that death could occur; no physician had discussed the possibility with them. Henry was an otherwise healthy child, had a history of febrile seizures, and died in his sleep before his epilepsy workup was complete and before his medication was likely therapeutic. Since Henry’s death 8 years ago, together and independently, Henry’s parents, pediatrician, and neurologist have sought understanding and opportunities to advance awareness and prevention around epilepsy-related mortality. These efforts have launched a multidisciplinary partnership between Children’s National Health System and the University of Virginia to develop an educational research program to systematically raise provider and patient awareness of sudden unexpected (or unexplained) death in epilepsy persons (SUDEP) and other risks associated with epilepsy. This article gives voice to these different experiences and underscores the value of families and providers working together to improve care and prevent death.

Although epilepsy is a common childhood disorder, all of us were impacted by Henry, who died, suddenly and unexpectedly, as a result of his seizure disorder. Our partnership started with Henry’s mother, Henry’s pediatrician, and Henry’s neurologist and now includes an educational research program that incorporates parent advocacy, nursing, neuropsychology, psychiatry, neurology, and basic science expertise.

Henry’s Mother

As a bereaved mother, I was desperate to make sense out of our tragedy. I searched for understanding and connection to others who shared my experience and ultimately connected with other parents at Citizens United for Research in Epilepsy. I joined their efforts to fund epilepsy research, including SUDEP, and raise awareness about the devastating effects of epilepsy. Through this experience, I learned that rigorous scientific pursuit can affect change and that families can play an important role in the process. One effort that I am especially proud of is my work with other families and professionals to create Partners Against Mortality in Epilepsy, a biannual scientific meeting for families and professionals that seeks to advance SUDEP research and prevention strategies by bringing different stakeholders together to learn from one another. Through these efforts and others, I have met many bereaved family members and the most consistent thing I hear is that they wish they had known about SUDEP. I have more recently had the opportunity to engage with my son’s care team, who also cares deeply about this fundamental gap in knowledge. Most families want to know all risks associated with epilepsy and providers face barriers (ie, lack of knowledge, lack of time) when meeting these needs. Together, we are working to educate local providers and families about the risks associated with epilepsy and arm them with knowledge to mitigate harm and death.

Henry’s Pediatrician

As Henry’s pediatrician, it was not until a conversation with Henry’s mother that I heard the term SUDEP for the first time. I had no experience with a child ever dying from epilepsy, nor was this something I ever discussed with parents. Since Henry’s death, I am more cautious during the early stages of a diagnosis of epilepsy, when medication may not yet be at a therapeutic level. A specific change that I have instituted since learning about SUDEP is stressing, especially to parents of children with nocturnal and tonic clonic seizures, the importance of medication adherence, because seizure control is the best way to minimize SUDEP risk. I make sure that parents are working with their neurologist to achieve this goal. I also now talk with parents about nighttime supervision and monitoring options, which I previously had not discussed. There is 1 study that demonstrates the benefit of nighttime supervision,1 and I discuss with families the range of possibilities, including using an infant monitor, having the child sleep in the same room, or having a nighttime sitter. The benefit of sleeping in the same bed rather than using an infant monitor is that the adult may be able to detect the child’s seizure better if the seizure can’t be seen or heard on an infant monitor. With all supervision methods, there is the opportunity to be able to intervene to stop the seizure and assure safety. The drawbacks of nighttime supervision in the form of cosleeping include potential disruption to family dynamics and developmental socialization and that it is considered one of the greatest risks in sleep-related infant deaths. Nighttime supervision is costly when hiring a nighttime sitter that is not the parent, and disrupts sleep schedules if it is the parent; however, closer monitoring may only be needed on a short-term basis until there is confidence regarding the level of control and frequency of seizures. In addition to supervision, there are ongoing studies regarding monitoring devices, which include monitoring heart rate and respiration. The hope is that an alarm could alert the parents, who could then go in the child’s room and ensure that the child is in a safe position and administer a rescue medication as needed. The drawbacks are that these devices are still under investigation and current devices may give families a false sense of security or produce too many false alarms. Ultimately, the family will decide how to monitor seizures by considering the costs and benefits of available options. Regardless, I recommend that the family have rescue medications on hand in case of prolonged or clusters of seizures.

Discussing these options with patients and their families introduces them to the term SUDEP and underscores the importance of treatment adherence. During these conversations, I encourage parents to discuss mortality risk with their child’s neurologist. Collaboration among pediatricians and pediatric neurologists is critical to the successful treatment and education of our patients with epilepsy and their families; however, we appreciate that in more rural environments, this may present a challenge due to distance. Yet another reason that the primary care physician needs to be well informed.

Henry’s Neurologist

As Henry’s neurologist, I was taught during my pediatric and neurology training that epilepsy is a benign disease and that when children die, the cause is primarily from the underlying disease (eg, brain tumor, degenerative, or metabolic disease). Henry proved, sadly, that epilepsy can be deadly and is not a benign disease. In fact, 24% of patients with childhood onset epilepsy will die within 40 years, 3 times the expected mortality rates.2,3 Before Henry’s death, I would wait for families to raise their fears, to the extent they occurred, by asking them nonspecifically if they had any questions. If the concern for mortality was not raised, I would often defer the conversation for another visit, if at all. After Henry’s death, I still wait patiently for families to raise their own questions and fears, but if that question does not arise before the close of a clinic visit, I now directly ask what their greatest fear is, and it is invariably harm from seizures and death. When there is no response to my question, then I ask directly, “Do you fear your child will be harmed or die from their seizures?” Capable and skilled physicians do not often discuss mortality.4, Yet, families wish to discuss these matters at the first visit, not later, and expect their doctor to do so.5,6 This is part of our duty and responsibility as physicians. For many children who have “uncomplicated” epilepsy, the data may be reassuring because most children’s risk of death is similar to all children, although death in this low-risk population can occur.3 SUDEP incidence is lowest in young children, but is higher in adolescence (cumulative risk, 1.6%), and peaks in younger adulthood (ages 31–40 years).7 The overall risk is 33 per 100 000 patient years, but 9 per 100 000 patient years if uncomplicated (normal exam, normal MRI, no developmental disability).3 For other children, if epilepsy begins in early childhood and never fully remits, the average cumulative risk of SUDEP is ∼8% by age 70 years.7 The large majority who die will do so from their underlying disease and from pulmonary failure. Of the 15% to 20% of epilepsy-related deaths, the large majority are SUDEP-related, but suicide should not be forgotten.3 Those at highest risk of death (97 per 100 000 patient years) have early epilepsy onset and frequent generalized tonic clinic seizures (the risk declines with

Developing Our Partnership

Henry’s story and those of others who have died unexpectedly are a wake-up call that there is too much we do not know. It became clear to all of us that education is our most powerful tool and that we do not need to wait for all of the answers before we start preventing SUDEP. At the time of Henry’s death, searches for information on the internet came up empty; since then, there are resources for providers and families with information about the facts, prevention strategies, printed brochures, and how to talk about SUDEP (www.epilepsy.com/learn/impact/mortality/sudep).10 Despite this progress, work still remains to be done. Over several meetings, we developed our first project that brings together many areas of expertise and seeks to change primary and specialty care provider knowledge and practice. On a local level, we are implementing systems that will lead to improved quality of care and, ultimately, we aim to change outcomes. Our work has leveraged local foundation funding and we are connected with broader, federally funded efforts that delineate the risks of SUDEP, examine possible mechanisms of SUDEP (including cardiac failure, cardiac arrhythmia [eg, channelopathies], central apnea, autonomic instability, and pulmonary edema), and, most importantly, identify effective monitoring and devise interventions to decrease mortality. We support efforts to work with medical examiners to recognize epilepsy as a cause of death, promote registries that include DNA collection, and develop clinical and translational research to advance understanding.

Our partnership between families and providers has played a significant role in highlighting care and education areas that needed strengthening and, in the case of SUDEP, needed to be brought out of the shadows entirely. Moreover, our work together has shaped a program of research that includes a novel first finding that 85% of pediatricians do not know about SUDEP.11 Through their energy and drive, Henry’s family has worked closely with our institution and private foundations to promote important SUDEP initiatives. Their efforts, along with those of so many other families and providers, have accelerated the study of an important field (mortality in epilepsy) and, in doing so, have enabled the National Institutes of Health to fund a significant multicenter SUDEP research effort (http://csr.case.edu/index.php/Main_Page). Furthermore, these efforts have helped to create a scientific committee within the American Epilepsy Society dedicated to SUDEP, additionally solidifying the importance of this issue within our community. When families and providers unite, they can more efficiently impact multiple levels of research and care that advance understanding and action around the full scope of a disease.

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Stork’s Childbirth Education Classes Start February 13th

Stork

STORK is coming to Spring Valley Pediatrics! Check out their website for upcoming class dates. For all of our expectant parents, don’t forget to sign up for Stork’s Childbirth Education class offered at our office on Monday, February 13th, 2017. Stork teaches a variety of classes for expecting, new and even experienced parents.

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Dr. McDowell announces his retirement

We wish Dr. McDowell well as he sets forth on this next chapter, beginning March 31. 2017. We will care for his patients with the same expertise and dedication that he showed them each and every day. Please call us if you have any questions about your child’s medical care.

 

Dr. McDowellTo my patients and their families-

It is with mixed feelings that I write to inform you that, after forty two years in the practice of pediatrics, I will be retiring from Spring Valley Pediatrics on March 31, 2017.

I very much look forward to a somewhat slower pace of life, time to really enjoy my many other interests and activities outside of medicine and spending more time with my wonderful family. At the same time, I will unquestionably miss those treasured daily encounters with you and your children that have been so meaningful to me over the last forty years. I hope that I have at times been of help to you in the many and varied challenges of parenthood. I know that I have daily learned from each of you and will always remain impressed with the commitment, diligence and perseverance of parents in helping their children reach their potential, especially the willing self-sacrifice of young parents in the first days and months of new parenthood. It has truly been a privilege each and every day to get to know you and your children and to guide you through the inevitable ups and downs of raising a child. I will remain part of the Bethesda- DC community and hope to see you episodically as we all go about our daily lives. Thank you for the confidence you have shown in me in allowing me to be your pediatrician over the years. That confidence I always viewed as a sacred trust, which I took very much to heart. I will miss each and every one of you and will treasure our shared experiences for many years to come. The other doctors at Spring Valley Pediatrics will very willingly and seamlessly continue your child’s medical care. All of my partners are excellent doctors in whom you can have confidence. I am happy to discuss your choice of new physician if you have questions.

Robert-L-McDowell-MD

Warmest regards,
Robert L. McDowell, Jr., M.D.

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We are pleased to welcome Dr. Nicolas Cuttriss pediatric endocrinologist

“We are pleased to welcome Dr. Nicolas Cuttriss, pediatric endocrinologist, to Spring Valley Pediatrics. Please call 202-740-8597 to schedule an appointment with Dr. Cuttriss. For more information please visit his website at www.endodw.com

 

Dr-CuttrissDR. NICOLAS CUTTRISS
MD, MPH, FAAP
PEDIATRIC ENDOCRINOLOGIST

Trained as a pediatric endocrinologist and public health professional, Dr. Cuttriss has a unique dedication to improving the quality of life of people living with diabetes and chronic pediatric endocrine conditions.

Dr. Cuttriss is a Washington, DC native, and during his freshman year of high school at Georgetown Day School, he co-founded AYUDA (American Youth Understanding Diabetes Abroad). AYUDA empowers youth to serve as agents of change in communities abroad by recruiting students to support and enhance local diabetes educational and empowerment programs. Dr. Cuttriss has supported diabetes projects in Bermuda, Bolivia, Belize, Chile, Croatia, Dominican Republic, Haiti, Ecuador, Mexico, and Peru. He has published peer-reviewed articles and authored peer-reviewed books that were disseminated by Pan American Health Organization. Dr. Cuttriss continues to help guide and direct AYUDA by serving as its Chairman of the Board.

Dr. Cuttriss received his bachelor’s degree in International Relations from the University of Pennsylvania and his medical and public health degrees from the George Washington University School of Medicine. He completed his pediatric residency at Harbor-UCLA Medical Center and his fellowship in pediatric endocrinology at the Jackson Memorial Hospital-University of Miami Miller School of Medicine Program. Dr. Cuttriss continues to serves on faculty in public health sciences at the University of Miami Miller School of Medicine.

Dr. Cuttriss is a board certified pediatrician and a fellow of the American Academy of Pediatrics. Dr. Cuttriss is a frequent speaker at international and national professional meetings, and he serves on several boards and advisory committees, including the American Diabetes Association Youth Strategies Committee.

Dr. Cuttriss founded ENDO Diabetes & Wellness in order to provide a more practical and efficient model of delivery of care and empowerment to children and their families who are dealing with chronic pediatric endocrine conditions.

The Storks are coming to Spring Valley Pediatrics

the-storksThe Storks found a new home. Classes coming at Spring Valley Pediatrics, PLLC in 2017!

Stork has a class that will fit any couple’s needs. The mission of Stork is to provide new parents with excellent education about the birthing, breastfeeding and infant care process in order to alleviate concerns regarding their upcoming childbirth. We aim to make parents comfortable in the delivery setting. We have expert teachers present in each class to answer all parent’s questions prior to birth.

Learn more at storkdc.com

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Giving peanut-based foods to babies early prevents allergies

A child holds a bag of peanut snacks in her pediatrician’s office at age nine-months, in Columbus, Ohio.

Most babies should start eating peanut-containing foods well before their first birthday, say guidelines released Thursday that aim to protect high-risk tots and other youngsters, too, from developing the dangerous food allergy.

The new guidelines from the National Institutes of Health mark a shift in dietary advice, based on landmark research that found early exposure dramatically lowers a baby’s chances of becoming allergic.

The recommendations spell out exactly how to introduce infants to peanut-based foods and when — for some, as early as 4 to 6 months of age — depending on whether they’re at high, moderate or low risk of developing one of the most troublesome food allergies.

“We’re on the cusp of hopefully being able to prevent a large number of cases of peanut allergy,” said Dr. Matthew Greenhawt of the American College of Allergy, Asthma and Immunology, a member of the NIH-appointed panel that wrote the guidelines.

Babies at high risk — because they have a severe form of the skin rash eczema or egg allergies — need a check-up before any peanut exposure, and might get their first taste in the doctor’s office.

For other tots, most parents can start adding peanut-containing foods to the diet much like they already introduced oatmeal or mushed peas.

No, babies don’t get whole peanuts or a big glob of peanut butter — those are choking hazards. Instead, the guidelines include options like watered-down peanut butter or easy-to-gum peanut-flavored “puff” snacks.

“It’s an important step forward,” said Dr. Anthony Fauci, director of NIH’s National Institute of Allergy and Infectious Diseases, which appointed experts to turn the research findings into user-friendly guidelines. “When you do desensitize them from an early age, you have a very positive effect.”

Peanut allergy is a growing problem, affecting about 2 percent of U.S. children who must avoid the wide array of peanut-containing foods or risk severe, even life-threatening, reactions.

Happy New Year!

Happy New Year! Wishing all of our patients and their families a Healthy 2017!

Giving Tree

 

We are so proud to continue our tradition of collecting gifts for children in need. Thanks to our nurse Jennifer Miller for spear-heading the effort this year.

News Around The Office

We now offer comprehensive Travel Consults. Please call to schedule an appointment and let us know where and when you will be traveling. When you come for your consult, we will discuss your plans and administer any vaccinations that you may need (including the Yellow Fever Vaccine).

The HPV vaccine, Influenza, and all other vaccines are now available on weekends. Please call for an appointment.