Migraine Blog

Migraine Community Concerned for a Speedy Recovery for Senator John Warner

Senate Migraine Healthcare Leader Hospitalized for Serious Heart Condition

Photo courtesy US Government

WASHINGTON, DC—February 26th, 2008; “Yesterday, Senator Warner came to his office, consulted with the Capitol Physician, completed his office appointments and left for a scheduled admission to Inova Fairfax Hospital, where he remains for observation.” According the Senator Warner’s press office. 

In addition it remarked “Last fall, Senator Warner was treated for a common heart condition known as atrial fibrillation. Over the course of the past several months, his heart rhythm and rate have been normal.      
      
Senator Warner recently experienced a return of atrial fibrillation, and in consultation with the Capitol Physician’s Office and his private doctors, is pursuing a re-evaluation and readjustment of medications which require regular monitoring and observation within a hospital environment.”

All of us at MAGNUM, the National Migraine Association wish to send our love and concern to the Senator and his family in hopes that the knowledge that so many care for his well being, that it may somehow help aid and speed his healing process.

         
As health advocates it is always hard to see those in government who have risen to the cause to help improve health care in this country fall ill themselves.  It has an Alice in Wonderland quality to it, if that makes sense?  You find yourself saying, he can’t be in the hospital, that’s not far.  Ironically his belief in our mission and Migraine disease awareness will help protect millions from heart disease, something reflected only recently in studies highlighting the relationship between Migraine and cardiovascular disease.

When MAGNUM began looking for allies on Capitol Hill over a decade and half ago many a door were slammed shut before we got to meet any staff.  Migraine disease and headache disorders in 1994 were just not considered a public health issue until we called it one and backed the rhetoric up with lots of medlines and empirical papers.  But as a Virginians Terri and I felt, well we hoped after months and months of hardship, that our Virginia Senators would not let us down.  So we abandoned our initial game plan of targeting members of the key committees such as health committee types, you know the H.E.L.P. Senators? No really, I’m not kidding, for those readers not following politics or slept through your civics or college classes that would be the Health, Education, Labor, and Pensions committee, so I did not make that up.  It is a very important committee for health advocates, but any Senator with heart can make the committee pay attention to a key overlooked health area.  Which is the beauty of our representative government.    

So we turned to Senator John Warner and Senator Charles Robb, both representing the Commonwealth of Virginia.  Both staffs graciously met with us which was the beginning of an important dialog to educate Congress about the true impact of Migraine the neurological disease as opposed to migraine the headache caused by stress and poor life management.  Senator John Warner’s office was very helpful over the next dozen or so years issuing nearly twenty Migraine disease and headache disorder public health policy letters.  Senator Robb’s office was also very accommodating, in part because both Senators offices talked to each other on these issues that would impact 36 million Americans.  Which is something to think about in a time when government is so partisan each side refuses to help the other.

So as the Senator recovers, we are reminded how fortunate we have been to have had his support over the years when others in Congress ignored the disease impact of Migraine when he did not.  Senator Warner looked at the stunning impact of Migraine disease such as World Health Organization analysis, which noted Migraine alone is responsible for at least one percent of the total US medical disability burden, and severe migraine attacks are as disabling as quadriplegia. 

The US annual direct and indirect economic costs of Migraine disease & headache disorders exceed $31 billion.  Migraine disease & Headache disorders are responsible for nine percent of all US lost labor productivity.

Senator Warner wrote “The severe pain and suffering of migraine inflicts major hardships on the individuals, their families and our American society.  A significant need continues for further research and education to alleviate this serious health problem.” 

These words of wisdom might lead you to think this was written last Fall during Headache On the Hill when sixty-five of the nation’s leading medical experts on Migraine disease & headache disorders can a calling to Capitol Hill, along with hundreds of patient advocates.  (It was a sight to behold by the way.)

No.  Those words above written by Senator Warner where written November 6, 1997 for a policy letter included in an MAGNUM publication for our Third Annual Migraine Awareness Event in Washington, DC.  The man had vision, which is why we ask you say a prayer for him tonight. 

It is ironic that the Senator suffered a condition, but one he is taking very serious.  In 1997 stroke and Migraine where a major concern, but heart damage related to Migraine was not uncovered.  But even with today’s limited Migraine research, a recent study entitled “Migraine and Risk of Cardiovascular Disease in Women” clearly highlighted the link between not only stroke and Migraine, but now we know that there is a clear link between Migraine and Cardiovascular Disease and heart attack.   This large study which was published in JAMA in 2006 (JAMA. 2006;296:283-291), based on a prospective cohort of women, active Migraine with aura was associated with increased risk of major CVD, myocardial infarction, ischemic stroke, and death due to ischemic CVD, as well as with coronary revascularization and angina.   It is obvious with better Migraine research we can hope to protect millions of Migraineurs from possible heart conditions which up until recently research has exposed us to this new Cardiovascular threat.

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REFERENCES

Migraine and Risk of Cardiovascular Disease in Women
Tobias Kurth, MD, ScD; J. Michael Gaziano, MD, MPH; Nancy R. Cook, ScD; Giancarlo Logroscino, MD, PhD; Hans-Christoph Diener, MD, PhD; Julie E. Buring, ScD
JAMA. 2006;296:283-291.

Migraine Plus: Associated Cardiovascular Risks
Roger N. Rosenberg
Arch Neurol. 2006;63(10):1381-1382.

 
Migraine and Cardiovascular Disease
Richard B. Lipton and Marcelo E. Bigal
JAMA. 2006;296(3):332-333.
 
Are We Ignoring the Elephant in the Room?
Jindeel
Arch Intern Med 2007;167:2263-2264.
 

Fighting Pain With Fentanyl Patches?

Generic Maker Actavis Recalls Their Transdermal Version as a Precaution.

Photo courtesy Actavis.

WASHINGTON, DC—February 19th, 2008; Many Migraineurs fight multiple pain disorders in addition to their episodic Migraine neurological disease.  Managing severe pain issues is a very complicated and delicate dance at best.  In addition you can find yourself being frustrated by a society which is very intolerant and judgmental regarding legitimate pain patients in America.  But one of the most important things an intractable head-pain sufferer can tell you is how important it is to not let pain get away from you.  Because if you do it can act as yet another Migraine trigger leaving you even more vulnerable.

To that fact, for those readers who may manage co-morbid pain issues that require low grade constant pain management to improve quality of life and have found Fentanyl patches offer and effect adjunct therapy, be advised one of the popular generic makers, Actavis Incorporated, are recalling their generic product.

There are 14 lots of Fentanyl transdermal system patches being voluntarily recalled from wholesalers and pharmacies as a precaution.  MAGNUM has not had anyone contact us with a report of a product failure so far, but Migraineurs are no strangers to pain disorders and we wanted to get this warning out.

If you use the name brand this warning is not for you.  But like most of us you are you are using a generic, take the time to check the maker and see if it is Actavis.  If you are not sure call your pharmacist today.  The fourteen lots covered by this recall are: 27261 (exp 05/09), 27317 (exp 05/09), 27318 (exp 06/09), 27319 (exp 06/09), 27391 (exp 06/09), 27409 (exp 06/09), 27475 (exp 07/09), 27476 (exp 06/09), 27488 (exp 06/09), 27514 (exp 07/09), 27536 (exp 07/09), 27537 (exp 08/09), 27538 (exp 08/09), 27545 (exp 07/09), covering the following strengths: 25 mcg/hr, 50 mcg/hr, 75 mcg/hr and 100 mcg/hr.

The imperfection appears to be a fold-over defect which could cause the patch to leak allowing the Fentanyl to be absorbed directly by the skin of the patient or the caregiver or family member assisting, which would defeat the time release system of the transdermal system.  Receiving a large amount of a 72 hour supply of gel of this pain medication at one time, regardless of the partial dose would not be good for the person in question.  Hence we have a recall!

We want to commend Actavis Inc. for voluntarily acting before the FDA stepped in.  It is at times such as  this it is good to see the health care system working well.   To so many Migraineurs having access to pain management options is important, but product safety is something we often take for granted, but the two go hand in hand.

For the complete company press release see below:

FOR IMMEDIATE RELEASE -- Morristown, NJ -- February 17, 2008 --

Actavis Inc., the United States manufacturing and marketing division of the international generic pharmaceutical company Actavis Group hf, today announced that 14 lots of Fentanyl transdermal system CII patches sold in the United States by Actavis' subsidiary Actavis South Atlantic LLC are being voluntarily recalled from wholesalers and pharmacies as a precaution.
The recalled patches were manufactured by Corium International Inc., a contract manufacturer for Actavis, and sold nationwide in the United States by Actavis South Atlantic LLC.

MAGNUM Brings Light to CFL Concerns to Migraineurs on ABC TV News

MAGNUM's Terri Miller Burchfield Sheds Light on Compact Fluorescent Lights & Migraines on ABC News TV.

WASHINGTON, DC; FEBRUARY 17, 2008-(Updated)- Tune in Wednesday evening at 5:00EST to ABC News to watch our Legislative Director and Co-Founder Terri Miller Burchfield sit down with ABC News television Reporter Julie Parker as they discuss Compact Fluorescent Light bulbs (CFL) & Migraines.

This interview about the much discussed Compact Fluorescent Light (CFL) bulbs as a Migraine trigger is one of the best broadcasts you will see regarding this public health issue.  Terri is interviewed by ABC TV News reporter Julie Parker, herself a Migraineur, who asked excellent questions.  Although this clip is only a three minute feature with Terri, her daughter Taylor at her side, also a Migraine sufferer, and the reporter it covers many areas not discussed on other TV interviews on CFL's and related concerns of those with disabilities not taken into consideration by the new laws about to take effect.

Dealing With 'Lightbulb Migraines'

   Aired 5:50 pm Wed February 20, 2008 - Washington, DC

Terri (L) looking at Michael John (taking this photo) right before the TV cameras start rolling.  ABC reporter Julie Parker (C) going over her notes before the interview begins, filmed at Terri's house.  Photo © Michael John Coleman 2008

Those new energy-efficient light bulbs may be keeping your electricity bills down, but some people are reporting one unintended side-effect.

About 12 percent of Americans experience migraines. Some of those 36-million people are finding while they want to help save energy, it's becoming a battle with the bulb.

Wild temperature swings are just one of many migraine triggers for Terri Burchfield. Washington's weather often has her reaching for her medication.

"It can be so severe that I literally crawl up into a ball and just can't move," said Burchfield.  

Besides changing weather patterns Burchfield's discovered something else that can spark the severe pain: compact fluorescent bulbs.

I noticed a lot of eye fatigue and eye fatigue for me is a trigger for migraine. It can lead directly into nausea and mixed with other triggers can trigger a very bad migraine," she said.

Burchfield had one of the energy efficient bulbs on her desk at work-and quickly removed it after the light's flickering bothered her.

That's a common complaint according to neurologist Marc Schlosberg.

"Migraine is not just head pain. Migraine is a whole syndrome," said Dr. Schlosberg. "One of the most important parts of this syndrome is sensitivity to light. So it can be sensitivity to glare. It can be sensitivity to flicker. It can be sensitivity to some-certain colors of light," he said."

Migraine experts say people who don't get the severe headaches don't see the flicker. A 60-watt energy-efficient bulb affected Burchfield's eyes while a much brighter 100-watt standard bulb did not.

She says she wants to do her part to save the planet, but not at the cost of her health. "My goal is to mitigate triggers. There's triggers I can control and there's triggers I can't control," said Burchfield."

Burchfield has no control over the U.S. government's new energy reform law. It's scheduled to effectively phase out most incandescent bulbs nationwide within six years. She and thousands of others like her, are wincing, anticipating all those headaches to come.

"It's just really hard to function. It hurts! It hurts everywhere!," she said.

Manufacturers say the newer bulbs have been improved. Sylvania says there is no scientific evidence showing that otherwise healthy people can get migraines from energy-efficient bulbs. Sylvania says it manufactures flicker-free light bulbs.

To view this ABC TV News feature click here or click the photo of Terri looking at you before the interview at the beginning of this text report from WJLA ABC News.

Note from the editor:

MAGNUM has requested ANY such studies Sylvania might have to support that NO such evidence exist that "otherwise healthy people can get migraines from energy-efficient bulbs".  MAGNUM assumes when Sylvania says otherwise healthy people, would that not exclude Migraineurs as they suffer from a pre-existing disease.  Migraine is a complex disorder involving the brain and the blood vessels around the brain and head. A Migraineur's brain may become hyperactive in response to certain environmental triggers such as light or smells for reasons that are not known. The scientific community generally agrees this starts a series of chemical changes that irritate the pain sensing nerves around the head and cause blood vessels to expand and leak chemicals which further irritate the nerves.

In short a Migraineurs brain is wired differently, their brains have low levels of energy, which causes hypersensitivity to things like light or noise. Studies show that people who take more magnesium than they need have fewer Migraines. Magnesium also combats hypersensitivity in the brain, and it has been shown to decrease Migraine pain. By the way riboflavin, otherwise known as Vitiamin B2 gives your brain more energy, which is why it is recommended as a major other-the-counter Migraine preventive treatment.  Ironically health reporters at ABC News did a story on "Alternative Therapies for Migraine Sufferers" which touched on some of this material.

The bottom line is the light bulb industry is eager to shut down incandescent bulb production to increase profits.  Yes we can get away with losing ninety percent of the incandescent bulb production to save energy and help save the planet, but we need to keep a small selection of incandescent bulbs available to save Migraineurs, Lupus sufferers, and other photo-phobic burdened disabled Americans.

New York Times Migraine Blog Fits Right Into Unique Head-Pain Community

The Grey Lady's Op Ed Is A Welcome Port In a Migraineurs Storm!

WASHINGTON, DC—February 15th, 2008; Terri and I opened up the New York Times Op Ed online and what do I find non other than my good friend Klaus Podoll, German national a rather brilliant neurologist and psychiatrist working at the University Clinic Aachen, Germany. In cooperation with the late Derek Robinson, he wrote a book and numerous medical papers on migraine art.

While MAGNUM was had the honor of exhibiting Michael John's artwork in Rome in 2001, Susan Moeller Denny, MAGNUM's Information Services Director and Michael John met Doctor Klaus Podoll at yet another opening of Migraine art after MAGNUM's mid-day opening.  To see Klaus Pololl musings about Migraine and art in the New York Times would be a treat beyond imagination.  But as this month advances we can see there is no end in site to the good fortune for the Migraine, and the non Migraine reading community.

But as any Migraine advocate, an artist advocate no less seeing the elder statesman of Migraine & headache awareness Dr. and writer and artist Oliver Sacks was just and overpowering moment in a time when this disease has struggled to get the respect we all have been working so hard to achieve.  In his article "Patterns" he opens up a ripples effect through the blogisphere, which is just so exciting to see the Grey Lady set such prime editorial real estate aside for the thirty six million Migraineurs looking to take up residence damn the housing bust.

Ongoing Botox Safety Review Continues

Early Communication about an Ongoing Safety Review
Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B)

WASHINGTON, DC—February 8th, 2008; The good news is even though Botox® is not yet approved by the FDA for on label use for Migraine disease, it is still legal to use and for many it is an effective preventive Migraine treatment. In addition, it appears not to be associated with any of the serious systemic adverse reactions that lead to this cautionary tail.

So let us tell you what we have found out from the makers as well as what we have discovered from our good friends at the Food and Drug Administration. 

This information reflects FDA’s current analysis of available data concerning these drugs. Posting this information does not mean that FDA has concluded there is a causal relationship between the drug products and the emerging safety issue.  Nor does it mean that FDA is advising healthcare professionals to discontinue prescribing these products. The FDA is considering, but has not reached a conclusion about whether this information warrants any regulatory action. FDA intends to update this document when additional information or analysis become available.

The FDA has received reports of systemic adverse reactions including respiratory compromise and death following the use of botulinum toxins types A and B for both FDA-approved and unapproved uses. The reactions reported are suggestive of botulism, which occurs when botulinum toxin spreads in the body beyond the site where it was injected. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for cerebral palsy-associated limb spasticity. Use of botulinum toxins for treatment of limb spasticity (severe arm and leg muscle spasms) in children or adults is not an approved use in the U.S.

These serious systemic adverse reactions occurred following treatment of a variety of conditions using a wide range of botulinum toxin doses.  FDA is currently reviewing safety data from clinical studies submitted by the manufacturers of Botox, Botox Cosmetic and Myobloc, as well as post-marketing adverse event reports and the medical literature.

Botox® (botulinum toxin type A) is approved for treatment of conditions such as blepharospasm (spasm of the eyelids), cervical dystonia (severe neck muscle spasms), and severe primary axillary hyperhydrosis (excess sweating).  Botox® Cosmetic, also botulinum toxin Type A, is approved for temporary improvement in the appearance of moderate to severe facial frown lines.

Myobloc (botulinum toxin Type B) is approved for the treatment of adults with cervical dystonia; the safety and effectiveness of Myobloc for cervical dystonia in children have not been established.
   
FDA is aware of the body of literature describing the use of botulinum toxins to treat limb spasticity in children and adults.  The safety, efficacy and dosage of botulinum toxins have not been established for the treatment of limb spasticity of cerebral palsy or for use in any condition in children less than 12 years of age.

The current prescribing information (labeling) for  Botox®,  Botox Cosmetic and Myobloc describes adverse reactions occurring in regions near the site of injection for each product’s approved uses, such as dysphagia (difficulty swallowing) after injections to treat cervical dystonia, or ptosis (drooping eye lids) after injections for glabellar frown lines or for strabismus and blepharospasm.

The Warnings sections of the labeling for both botulinum toxin products note that important systemic adverse effects, including severe difficulty swallowing and difficulty breathing have occurred in patients with neuromuscular disorders after local injection of typical doses of botulinum toxin.  FDA now has evidence that similar, potentially life-threatening systemic toxicity from the use of botulinum toxin products can also result after local injection in patients with other underlying conditions such as those with cerebral palsy associated limb spasticity. Systemic toxicity has been reported in children, several of whom required feeding tubes and/or ventilation (breathing) support.

Until such time that FDA has completed its review, healthcare professionals who use medicinal botulinum toxins should: 
 
• Understand that potency determinations expressed in “Units” or “U” are different among the botulinum toxin products; clinical doses expressed in units are not comparable from one botulinum product to the next
• Be alert to the potential for systemic effects following administration of botulinum toxins such as: dysphagia, dysphonia, weakness, dyspnea or respiratory distress
• Understand that these effects have been reported as early as one day and as late as several weeks after treatment
• Provide patients and caregivers with the information they need to be able to identify the signs and symptoms of systemic effects after receiving an injection of a botulinum toxin
• Tell patients they should receive immediate medical attention if they have worsening or unexpected difficulty swallowing or talking, trouble breathing, or muscle weakness

What does FDA know now about these data?

The FDA has reviewed post-marketing cases from its Adverse Event Reporting System (AERS) database and from the medical literature of pediatric and adult patients diagnosed with botulism following a local injection with a marketed botulinum toxin product.

The pediatric botulism cases occurred in patients less than 16 years old, with reported symptoms ranging from dysphagia to respiratory insufficiency requiring gastric feeding tubes and ventilatory support.  Serious outcomes included hospitalization and death.  The most commonly reported use of botulinum toxin among these cases was treatment of limb muscle spasticity associated with cerebral palsy.  For Botox, doses ranged from 6.25 to 32 Units/kilogram (U/kg) in these cases.  For Myobloc, reported doses were from 388 to 625 U/kg. 

The reports of adult botulism cases described symptoms including patients experiencing difficulty holding up their heads, dysphagia and ptosis.  Some reports described systemic effects that occurred distant from the site of injection and included weakness and numbness of the lower extremities.  Among the adult cases that were serious, including hospitalization, none required intubation or ventilatory support. No deaths were reported.  The doses for Botox ranged from 100 to 700 Units and for Myobloc from 10,000 to 20,000 U.

This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs.  FDA will communicate to the public its conclusions, resulting recommendations, and any regulatory actions after the review of the data are completed.
Report serious adverse events to FDA’s MedWatch reporting system by completing a form on line at http://www.fda.gov/medwatch/report/hcp.htm, by faxing (1-800-FDA-0178), by mail using the postage-paid address form provided online (5600 Fishers Lane, Rockville, MD 20853-9787),
or by telephone (1-800-FDA-1088)