Fortunately, the recall is limited to just 3 lots of Infants’ Ibuprofen Concentrated Oral Suspension that were made by Tris Pharma, Inc. and sold under the Equate, CVS Health, and Family Wellness brands and sold at Wal-Mart, CVS, and Family Dollar stores.
If you have the recalled Ibuprofen, don’t use it. Contact Tris Pharma for a refund.
And seek medical attention if you think your child got too much Ibuprofen and is having any symptoms, especially nausea, vomiting, epigastric pain, or more rarely, diarrhea.
Fortunately, getting extra Ibuprofen is not usually as dangerous as getting extra Acetaminophen.
Although, of course, neither is good! Be careful when dosing your kids and be sure they need it first.
Oh, and yes, at least in this case, store brand Ibuprofen at Family Dollar and Wal-Mart is the same as store brand Ibuprofen at CVS…
More on Infants’ Ibuprofen Concentrated Oral Suspension Recall
We continue to get regular updates from the CDC about AFM.
Unfortunately, we aren’t getting the real answer we were looking for – how to stop the outbreak.
Acute Flaccid Myelitis Update
Since the last update, we have learned that:
the case count is up to 201 confirmed cases (up from 196 last week)
an additional 163 cases are under investigation (up from 161 last week)
cases have been reported in 40 states (up from 39 last week – Utah is the new state)
That means that we have clearly exceeded the last record of 149 cases in 2016.
There are also 47 confirmed cases and 29 cases (up 1) under investigation in Canada this year.
In other news:
the CSTE will be issuing issued a new statement on AFM reporting reaffirming that they “are confident state and local health departments are working closely with doctors to ensure suspected cases are reported.”
Although you may just now be hearing about acute flaccid myelitis, it is important to understand that it isn’t new.
It wasn’t even new when we started to see an increased number of cases a few years ago.
What is new, is that we are seeing an increased number of cases.
Acute Flaccid Myelitis Timeline
AFM refers to acute (sudden onset) flaccid (droopy or loose muscles) myelitis (inflammation of the spinal cord) and it is a subtype of acute flaccid paralysis.
If that explanation doesn’t really help you, it might help to understand that paralytic polio, like AFM, is another subtype of acute flaccid paralysis.
“In August 2012, the California Department of Public Health (CDPH) was contacted by a San Francisco Bay area clinician who requested poliovirus testing for an unvaccinated man aged 29 years with acute flaccid paralysis (AFP) associated with anterior myelitis (i.e., evidence of inflammation of the spinal cord involving the grey matter including anterior horn cell bodies) and no history of international travel during the month before symptom onset. Within 2 weeks, CDPH had received reports of two additional cases of AFP with anterior myelitis of unknown etiology.”
Acute Flaccid Paralysis with Anterior Myelitis — California, June 2012–June 2014
That seems to be about when this started, in 2012.
Unfortunately, they didn’t figure out what was causing the paralysis in these three patients, despite extensive testing and more cases followed.
“To identify other cases of AFP with anterior myelitis and elucidate possible common etiologies, CDPH posted alerts in official communications for California local health departments during December 2012, July 2013, and February 2014.”
Among 23 cases, California health officials found that the median age of the patients was 10 years old, only two tested positive for EV-D68, although most did have a recent “an upper respiratory or gastrointestinal prodrome.”
“Acute flaccid paralysis (AFP) with anterior myelitis is not a reportable condition, and baseline rates of disease are unknown but are likely quite low. Data from 1992–1998 on children aged <15 years in California indicated an incidence of 1.4 AFP cases per 100,000 children per year and did not identify a single case of AFP with anterior myelitis.”
California wasn’t the only state with cases.
In 2014, there were at least 12 cases in Colorado and 11 in Utah.
“In response to the CDPH and CHCO reports, the CDC established a case definition for enhanced nationwide surveillance of AFM, which included individuals less than 21 years of age with acute flaccid limb weakness and MRI involvement of predominantly the gray matter of the spinal cord without identified etiology presenting after August 1, 2014.”
Messacar et al on Acute Flaccid Myelitis: A Clinical Review of US Cases 2012–2015
All together though, in 2014, once the CDC began actively investigating cases, at least 120 cases were discovered in 34 states. The cases were associated with a large outbreak of EV-D68-associated respiratory illness, although they weren’t able to conclusively link those respiratory illnesses to the AFM cases.
Is there any evidence that there were a lot of cases before 2012?
Or that the CDC has dropped the ball and hasn’t been doing enough to investigate cases?
CDC activities include… using multiple research methods to further explore the potential association of AFM with possible causes as well as risk factors for AFM. This includes collaborating with experts to review MRI scans of people from the past 10 years to determine how many AFM cases occurred before 2014, updating treatment and management protocols, and engaging with several academic centers to conduct active surveillance simultaneously for both AFM and respiratory viruses.
CDC on the AFM Investigation
And if the first cases in California and Colorado triggered so much attention, isn’t it likely that any cases anywhere else would have done the same thing?
That makes it very unlikely that many cases were missed in earlier years.
EV-D68 first identified as a cause of respiratory tract infections – 1962
the first reports that EV-D68 could cause severe, even fatal respiratory disease – 2008
first AFM cases are discovered in California – August 2012
the Colorado Department of Public Health and Environment notifies the CDC about a cluster of AFM cases at Children’s Hospital Colorado and a joint investigation begins between the CDPH, CDC, and the physicians caring for the patients – September 2014
the CDC issues a health advisory on Acute Neurologic Illness with Focal Limb Weakness of Unknown Etiology in Children and calls on local and state health departments to report patients to the CDC – September 2014
the CDC conducts a conference call on Neurologic Illness with Limb Weakness in Children, so that clinicians could learn about the latest situation, surveillance, and CDC clinical guidance for AFM testing, patient evaluation and case reporting – October 2014
the CDC posts Interim Considerations for Clinical Management – November 2014
120 AFM cases in 34 states – 2014
Council of State and Territorial Epidemiologists AFM case definition adopted – June 2015
33 AFM cases in 16 states, including one death – 2017
CDC Telebriefing on Acute Flaccid Myelitis in the US with Dr. Nancy Messonnier, director of CDC’s National Center for Immunization and Respiratory Diseases – August 2018
158 AFM cases confirmed in 36 states among 311 reported cases that are being investigated – 2018
The other issue that concerns many parents is why a definitive cause hasn’t yet been identified. And why don’t we have treatments or a cure yet?
“To date, no pathogen (germ) has been consistently detected in the patients’ spinal fluid; a pathogen detected in the spinal fluid would be good evidence to indicate the cause of AFM since this condition affects the spinal cord.”
CDC on AFM Investigation
Although enteroviruses can be difficult to detect in spinal fluid, it is important to keep in mind that isn’t the only thing that is keeping experts from declaring the investigation over and naming a cause, such as EV-D68.
“Among 41 patients whose upper respiratory tract samples were available for enterovirus/rhinovirus testing at CDC, 17 (41%) tested positive: eight (20%) for EV-D68 and nine (22%) for eight other enterovirus/rhinovirus types.”
Eyal Leshem on Notes from the Field: Acute Flaccid Myelitis Among Persons Aged ≤21 Years — United States, August 1–November 13, 2014
Another big issue is that EV-D68 has not been detected in every, or even most AMF patients, and many others have been found to have other enteroviral infections, including EV-A71.
Could it be a coincidence that investigators are finding these enteroviruses simply because it is the season for them to appear? That would mean something else is causing these kids to have AFM.
“During September–November 2016, 10 confirmed cases of AFM were reported in Washington. No common etiology or source of exposure was identified. Enterovirus-A71 was detected in one patient and EV-D68 in two patients, one of whom also tested positive for adenovirus.”
Acute Flaccid Myelitis Among Children — Washington, September–November 2016
While the focus is on EV-D68 as a cause and everyone wants an answer, no one wants the CDC or other investigators to be wrong.
That doesn’t mean that they should be overly cautious and waste time or resources once an answer is evident, but just that they should follow sound epidemiological principles, get the right answer, and help stop kids from getting AFM.
What’s Next for AFM?
There are still a lot of unknowns about AFM, but this is likely what we can expect in the coming months:
the CDC will continue to investigate all unconfirmed cases that have occurred this year, which can take about four weeks after a case is reported and all necessary information is sent in. Keep in mind that since we don’t know if the CDC has already received all of the information on the cases they are investigating, we don’t know when they will finish investigating any pending cases.
local or state health departments will likely reach out to treating physicians to get followup about AFM patients about two months after they developed limb weakness and then report this short-term follow-up data to the CDC. In general, the CDC does not seem to contact patients directly.
From the current investigation, information from outbreaks and cases over the previous years, and cases in other countries, we will hopefully get the answers we need soon to prevent and treat AFM.
Maybe some of those answers will come during a Clinician Outreach and Communication Activity (COCA) Call on November 13, when members from the CDC Acute Flaccid Myelitis Surveillance Team discuss the “activities the CDC is conducting as part of its investigation into AFM.”
The fact that the CDC has an Acute Flaccid Myelitis Surveillance Team will be news and is hopefully reassuring to some folks…
This is also probably a good time to remind folks that funding for public health has been declining in recent years, even as we expect our public health officials to respond to more things and react more quickly to keep us all safe and healthy. Let’s make sure we fund our public health programs, including the CDC and NIH, so that they have all of the resources they need to address all of today’s public health challenges.
Many are describing President-elect’s choice of Representative Tom Price as the secretary of health and human services as “scary” and a “radical choice.”
To understand why, you should both understand what he believes and what his job will be.
The HHS Secretary
Surprisingly, few people probably know the name of the current HHS secretary – Sylvia Mathews Burwell.
She succeeded Kathleen Sebelius, who resigned in 2014, mostly over problems with the healthcare.gov website and roll-out of the Affordable Care Act.
What does the HHS Secretary do?
As head of the United States Department of Health and Human Services, the HHS Secretary is a member of the President’s Cabinet and overseas the:
Administration for Children and Families (ACF)
Administration for Community Living (ACL)
Agency for Healthcare Research and Quality (AHRQ)
Agency for Toxic Substances and Disease Registry (ATSDR)
Centers for Disease Control and Prevention (CDC)
Centers for Medicare & Medicaid Services (CMS)
Food and Drug Administration (FDA)
Health Resources and Services Administration (HRSA)
Indian Health Service (IHS)
National Institutes of Health (NIH)
Substance Abuse and Mental Health Services Administration (SAMHSA)
As you probably recognize at least a few of those names, like the FDA, CDC, and NIH, you likely know that these agencies “administer a wide variety of health and human services and conduct life-saving research for the nation, protecting and serving all Americans.”
To Advance the Health, Safety, and Well-Being of the American People
To Ensure Efficiency, Transparency, Accountability, and Effectiveness of HHS Programs
And it can be seen in many of the current problems they are tackling, such as combating the opioid epidemic, lead poisoning hazards, the Zika virus, and continuing to get more people insurance coverage, etc.
Problems with Tom Price as HHS Secretary
So what might be the problem with Rep. Tom Price as HHS Secretary, after all, he is a doctor and has been endorsed by the AMA?
“The Association of American Physicians and Surgeons recommends a policy of Non-Participation to all physicians as the only legal, moral, and ethical means of concretely expressing their complete disapproval of the spirit and philosophy behind these amendments.”
THE PRINCIPLES OF MEDICAL ETHICS OF THE ASSOCIATION OF AMERICAN PHYSICIANS AND SURGEONS
Tom Price is a member of the Association of American Physicians and Surgeons (AAPS), an organization of doctors that was opposed to the establishment of Medicare and Medicaid and which tells its members that it is “legal, moral, and ethical” to not treat patients on Medicare and Medicaid.
The AAPS is also against birth control and pushes a lot of anti-vaccine misinformation that can scare parents away from getting their kids vaccinated and protected against vaccine-preventable diseases!
A Radical Choice
In describing Tom Price as a “radical choice” for HHS Secretary, the New York Times stated that he is “a man intent on systematically weakening, if not demolishing, the nation’s health care safety net.”
In addition to supporting the repeal of Obamacare, Tom Price is a climate change denier, and has been in favor of:
cutting billions of dollars from the Supplemental Nutrition Assistance Program (SNAP or food stamps) as it was converted to a State Flexibility Fund in the 2015 GOP proposed budget
continuing to ban research on gun violence at the CDC as he did not sign a letter with a bipartisan group of 146 other members of Congress, led by Congressman David Price, calling for a lift of the de-facto ban on federal gun violence research
And although his nomination was supported by the AMA, the American Academy of Family Physicians (AAFP), and the Association of American Medical Colleges (AAMC), there are many doctors and medical students who think that “Price’s stances are incompatible with the values of the medical profession and with the stated missions of the above organizations.”
The AAP on the Nomination of Tom Price
What has the American Academy of Pediatrics said about Tom Price’s nomination?
“Above all, HHS should strive to implement an agenda with children at the core and ensure that all children have access to high-quality, affordable health care so they can thrive throughout their lifetimes. All children, regardless of their immigration status, should have affordable health care coverage, insurance with pediatric-appropriate benefits, access to timely and affordable primary and subspecialty pediatric care and mental health services, and receive comprehensive, family-centered care in a medical home.”
AAP’s Blueprint for Children
As is their style, they have not issued a statement, but reviewing the AAP’s Blueprint for Children, it isn’t too hard to figure out what they would say.
The Blueprint, which “presents specific policy recommendations for the federal government to align its activities to promote healthy children, support secure families, build strong communities, and ensure that the United States is a leading nation for children,” states that they:
oppose block grants for Medicaid and other entitlement programs
support federally funded research to build the evidence base for a public health response to violence, including research on gun violence coordinated by the Centers for Disease Control and Prevention (CDC)
And perhaps the thing that is most apparently in conflict with Tom Price’s nomination, the AAP states that they want the HHS secretary and Congress to:
“Support and improve the ACA. The ACA has made important progress for children. Congress should improve upon this progress and enhance pediatric benefits in the marketplaces, allow families that are not eligible for CHIP to purchase CHIP plans in the health insurance marketplaces, improve affordability of plans for families (especially those with children with special health care needs), and strengthen rules to ensure that adequate pediatric networks exist in marketplace plans.”
Tom Price is not going to support and improve the ACA (Obamacare), strengthen CHIP, or improve access to Medicaid services. He is basically against just about everything the American Academy of Pediatrics supports and has been working for.
We don’t need a statement from the AAP to know what that means.
Breaking News – 90 cases of AFM in 27 states have been confirmed so far this year, and are among 252 cases that are under investigation.
Polio has been in the news a lot lately.
Well, not exactly polio.
The term “polio-like” has been in the news.
This follows a large outbreak of enterovirus D68 (EV-D68) respiratory infections in 2014, some of which seemed to be associated with the development of acute flaccid myelitis (AFM).
While there were no reports of EV-D68 infections in 2015, there have been “limited sporadic EV-D68 detections in the U.S. in 2016.”
But after we saw 149 cases in 39 states in 2016, there were only 33 cases in 16 states in 2017.
And there have been about 38 cases in 16 states in 2018, coming out of the peak season for AFM cases – August to October.
Similar to coxsackievirus, which causes hand, foot, and mouth disease, EV-D68 is a non-polio enterovirus. On the other hand, the virus that actually causes polio is just a different type of enterovirus.
Because they are all enteroviruses, some get differentiated as being non-polio.
To make it even more confusing, some non-polio enteroviruses can cause a polio-like syndrome.
And both polio and non-polio enteroviruses can cause acute flaccid myelitis.
It is important to note that only some, but not all, of the kids with AFM have been positive for enterovirus D68. In Colorado this year, 9 of 14 cases were linked to EV-A71 infections.
Acute Flaccid Myelitis
What is acute flaccid myelitis?
AFM is a syndrome characterized by sudden onset of limb weakness, sometimes accompanied by cranial nerve dysfunction (such as facial drooping or difficulty speaking). In many cases, distinctive lesions in the gray matter (nerve cells) of the spinal cord may be seen on neuroimaging.
Acute flaccid myelitis caused by the polio virus can usually be recognized because it is associated with an unvaccinated person who traveled to an area that still has cases of polio and who has “one or more limbs with decreased or absent tendon reflexes in the affected limbs, without other apparent cause, and without sensory or cognitive loss. Paralysis usually begins in the arm or leg on one side of the body (asymmetric) and then moves towards the end of the arm or leg (progresses to involve distal muscle groups).”
Since 2014, at least 350 children have developed acute flaccid myelitis. Most had some improvement in function and a small number had a complete recovery, just as a small number had no improvement.
And of course, none of them had polio. In fact, the last polio outbreak in the United States was in 1979.
So maybe we should stop saying “polio-like,” as it likely just confuses people, few people likely know what “polio-like” symptoms actually are, and these cases have nothing to do with the polio virus.
Unfortunately, “despite extensive testing, CDC does not yet know the cause of the AFM cases.”
Still, the CDC recommends standard precautions to try and avoid AFM, including handwashing, avoiding other people who are sick, getting vaccinated (to avoid polio), and protecting your kids from mosquitoes (West Nile virus can cause AFM too).
The high price of Mylan’s EpiPens is getting a lot of attention lately.
In a way that’s good. Not just so that something will finally be done about high drug prices, but because more people need to know about food allergies and about the importance of having and using EpiPens. That is one thing Mylan got right. Their education and awareness campaigns not only encouraged parents to get EpiPens for their kids, but they strongly encouraged them to use them.
Just a ploy to sell more EpiPens? Not when you realize that many people are afraid to use their EpiPens, even when they are having a severe allergic reaction.
Still, they certainly got greedy with the continued price hikes.
Although we are getting used to hearing about high drug prices, they typically aren’t for drugs that your pediatrician prescribes everyday.
You were likely outraged when Martin Shkreli raised the price of Darapim to $750 a pill, but you probably still have no idea what it is used for. On the other hand, you may have or almost certainly know someone with an EpiPen.
An epinephrine autoinjector is traditionally the only treatment for people having anaphylactic reactions to peanuts, insect bites and stings, or other serious allergic reactions.
Why fuss about the cost of a life-saving drug or device? A product that can save your child’s life in a manner of seconds would be priceless to most people.
Much of the issue is that they went from costing about $100 in 2006 to over $600 today. Even last year, a set of two EpiPens (one dose) cost up to $450. So it would be nice to have that option to save lives and save money. Afterall, the very same EpiPens are much cheaper in most other countries.
Surprisingly, it has been the media and not parents or patients who are doing most of the complaining about the high cost of EpiPens. Most of us have insurance and can use a coupon to waive their copay and effectively get their EpiPens free. Those without insurance may not be able to see a doctor to get a prescription, but if they can, may be eligible for Mylan’s patient assistance program.
So who is paying full price?
Mostly people with high deductible insurance plans, at least until they realize that they might save money going with a more costly insurance plan without a deductible, especially if family members have other medical problems, like asthma.
Have you priced an asthma inhaler lately? Those that you use to prevent asthma can easily cost $300 to $400 each month. A rescue inhaler can cost another $100.
Competition hasn’t helped us get less expensive asthma inhalers. You will need a coupon for that.
Drug coupon use by patients could “come at the cost of higher long-term expenses for themselves and society.” That was a warning in the New England Journal of Medicine editorial “Prescription-Drug Coupons — No Such Thing as a Free Lunch.”
Unfortunately, instead of heeding the warning back in 2013, some companies adopted it as a business model.
Martin Shkreli didn’t do anything original when he bought the rights to the antiparasitic drug pyrimethamine and rebranded it as Darapim, raising the price 5,000%.
For example, although Lupin Pharmaceuticals makes many generic medications, they chose to license Suprax, an expensive antibiotic with a coupon, as a branded generic. So while a similar generic antibiotic, such as cefdinir, might cost about $50, Suprax costs about $250 to $400 for a 10 day course. It will also likely be on the highest and most expensive tier of your insurance, which is why they offer a coupon.
Impax Laboratories, another big maker of generic drugs, takes the cake though. They are selling Emverm for $596 a pill. A chewable pill that is used to treat pinworms, with two doses over two weeks, that means one treatment to stop your child’s butt from itching can cost almost $1200 – unless you use their coupon. An inexpensive generic version of the very same medicine, Vermox, was discontinued in 2011.
It was discontinued by Teva Pharmaceuticals, who then sold the rights to the drug to Amedra Pharmaceuticals, which was then acquired by Impax.
An off-patent, generic drug, Vermox should have been getting cheaper, not having its price soar. The fact that they offer consumers free coupons, meaning they won’t actually pay for the drug, likely explains how they get away with it.
Of course, we all end up paying. There is no free lunch, except maybe when the drug reps for these companies drop off those coupons at your doctor’s office.