FDA Wants Tysabri Warning Revised
FDA Wants Tysabri Warning Revised
Prescribing instructions for Biogen Idec and Elan's drug Tysabri should be revised to note cases of a serious brain disorder in patients who were using it as their sole treatment for multiple sclerosis, the FDA said yesterday. The FDA said it was working to amend the Tysabri label after two cases of the brain disorder, progressive multifocal leukoencephalopathy, were reported in Europe.
FDA Wants Biogen, Elan Drug Warning Revised
Reuters Health - Aug. 25, 2008
WASHINGTON (Reuters) - Prescribing instructions for Biogen Idec and Elan Corp's drug Tysabri should be revised to note cases of a serious brain disorder in patients who were using it as their sole treatment for multiple sclerosis, U.S. health regulators said on Monday.
The Food and Drug Administration said it was working to amend the Tysabri label after two cases of the brain disorder, progressive multifocal leukoencephalopathy (PML), were reported in Europe.
"While the two patients who developed PML were on monotherapy, the FDA still believes that Tysabri monotherapy may confer a lower risk of PML than when Tysabri is used together with other immunomodulatory medications," the FDA said in a statement on its website.
(Reporting by Lisa Richwine; Editing by Braden Reddall)
FDA seeks changes on labelling for Tysabri
The US Food and Drug Administration has issued an alert saying it is working with Biogen Idec and Elan Corp to change the product labelling for Tysabri
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In This Issue
The FDA has approved changes to Tysabri package inserts following two new cases of the potentially deadly brain infection progressive multifocal leukoencephalopathy (PML) in people taking the drug in the European Union.
The changes update Tysabri’s label to include information about the two new cases, as well as to indicate that the cases occurred in people who were taking the drug as a monotherapy. Previous cases of PML occurred in people who were taking Tysabri in combination with another immunomodulatory drug.
Tysabri’s packaging now states that the connection between the duration of treatment and PML is unknown, but that most cases of the infection have been seen in people taking the drug for more than one year.
Both people who were diagnosed with PML in the EU have now undergone plasma washing to remove Tysabri from their systems. No further update on their condition is available at this time.
The FDA-approved changes also make clearer who is a candidate for Tysabri, saying that the drug generally is recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate MS therapy. Previously, the packaging indicated Tysabri was for use in people who had tried several other failed therapies. The change may assist people taking Tysabri in getting coverage of the drug from their insurance company.
Despite the recent cases, the FDA has said it still believes there is a lower risk of PML when Tysabri is taken as a monotherapy.
The updated prescribing information and patient medication guide for Tysabri can be viewed at www.tysabri.com.
Those taking Rebif may be eligible to enroll in a 12-week trial of a new injection device, RebiSmart.
RebiSmart is being tested to see if it is suitable for injection of the updated formulation of Rebif, as well as to measure any side effects or issues experienced during use.
The device is loaded with three doses of Rebif that are administered by a battery-powered electromechanical injector triggered by pressing a button. It can be adjusted for injection depth, insertion speed, medication injection speed and the amount of time the needle stays in the skin.
Eligible people must currently be using Rebiject to take 44 mcg doses of Rebif.
For more information, call (888) 275-7376 or visit http://www.clinicaltrials.gov/ct2/show/NCT00735007?term=NCT00735007&rank=1
Those treating their MS with Novatrone should be aware of recently re-issued recommendations regarding heart health from the FDA.
Since 2005, the agency has recommended that people taking Novatrone (mitoxantrone) be evaluated for a heart condition called left ventricular ejection fraction (LVEF) both before their first treatment and prior to each subsequent infusion.
LVEF and congestive heart failure have been associated with people whose cumulative dose of Novatrone was less than 100 mg/m2. The maximum lifetime cumulative dose for Novatrone for people with MS is 140 mg/m2, or eight to 12 doses in two to three years.
Those people who have finished treatment with Novatrone also should be evaluated yearly to detect cardiac problems.
For more information on the FDA’s advisory, visit http://www.fda.gov/MedWatch/safety/2005/Novantrone_ptinfomay24.pdf
Researchers at the Cleveland Clinic Lerner Research Institute found evidence that neurons may regrow in brain lesions caused by MS, although it is not clear how much function those neurons would have.
The scientists looked at nine people with MS and four people with no known health conditions, finding that while neurons in the brain’s white matter were destroyed during the demylination process, in a small percentage of old lesions neurons in the white matter had increased by 72 percent, compared to normal brain tissue.
The research, which scientists said may influence future MS therapies, was published in the medical journal Brain.
A small study by Italian researchers found that other than slightly lowered birth weight, there appeared to be no negative effects for babies exposed to interferon beta in utero.
The retrospective study looked at 38 women, including those who had never taken drugs for MS, those who had been treated with interferon beta but discontinued use before conception, and those who took interferon beta after their pregnancy began.
Researchers examined the health of the babies through their 18th month of life, finding no developmental problems and that the lower birth weight of children who were exposed to beta interferon during pregnancy was not statistically significant.
Much remains unknown, however, about the effect of disease-modifying drugs on a developing fetus and no MS drug has been approved for use during pregnancy. Women in the US are advised to discontinue use of DMD prior to conception; those who become pregnant while taking MS drugs may enroll in registries established to help determine any potential negative effects.
For more information on pregnancy registries for MS drugs, visit http://www.fda.gov/womens/registries/registries.html.
Recent research has found that some drugs developed for erectile dysfunction in men may have helpful side effects, or be beneficial for women.
In two separate studies, scientists found that men with enlarged prostates who took Cialis (tadafil) had fewer UTI symptoms, while women with sexual problems linked to antidepressant use reported improvements in their sex life after taking Viagra.
The study, financed by Viagra-maker Pfizer, looked at 98 women who experienced at least a month of sexual troubles triggered by antidepressant use. After eight weeks, 72 percent of the women who took the drug saw improvements in arousal, sexual enjoyment and orgasm, though the women did report a higher rate of headaches and indigestion than the placebo group. Previous studies had shown Viagra did not work for women.
The study of Cialis looked at more than 1,000 men in five countries who took either placebo or 2.5, 5, 10 or 20 mg doses of the drug daily. It found that Cialis at any dose was an improvement over placebo, helping with UTI symptoms such as urination frequency, weak urine stream and straining.
The research will be published in an upcoming issue of The Journal of Urology.
Premiums for Medicare Part D prescription drug plans will rise by an average of three dollars a month in 2009, an increase of about 12 percent over this year’s rates.
Individual premiums vary by plan and location. About 24.4 million Americans are enrolled in Part D plans nationwide.
The increase, announced by Medicare officials in August, is in part caused by the rising cost of prescription drugs. Despite the rise, the average annual costs of a Part D plan remains 37 percent lower than originally anticipated when the coverage was first conceived in 2003.
Those who pay an additional premium will be able to cover gaps in their coverage, commonly known as the “donut hole,” through enhanced plans. People on limited incomes may be eligible to get extra assistance or have the premiums waived through the Low Income Subsidy.
Those enrolled in Medicare plans will receive their annual handbook, Medicare & You 2009 in October. Annual enrollment for Part D begins Nov. 15.
For more information on your Medicare plan, visit http://www.medicare.gov or call 1-800-MEDICARE (1-800-633-4227).
While no one food provides the perfect energy boost, simple steps are important to keep your body running.
- Eat breakfast – Blending carbohydrates and protein is best, even when you are on the go. Quick breakfasts include a whole grain bagel with cream cheese or whole grain toast with peanut butter and a piece of fruit.
- Drink water – Use water to quench your thirst, instead of sugary drinks or soda. Carry a water bottle with you during the day and treat yourself to a fruity ice-pop for desert.
- Eat often – Three large meals a day might not be what works best for your body. Try splitting up your calories into six smaller meals for sustained energy.
- Be wary quick fixes – Sugar and caffeine provide a rapid energy boost, followed by a crash. Caffeine in drinks also can dehydrate your body.
For more tips, check out http://www.webmd.com/solutions/fight_fatigue.
Journals, magazines, books and papers included in the United Kingdom’s Multiple Sclerosis Society library are now open to the public online.
The collection, which is searchable, has documents for people with MS, their doctors and children. Some medical journals will allow access to full text articles; abstracts will be provided for other publications with the full article on request.
For more information, or to search for articles, visit http://www.mssociety.org/uk/library
The Tortoise and the Chair: Living with Multiple Sclerosis
By Sally Rickert, Xlibris 2008
This gem of a book is filled with poetry, first-person narratives, and short stories that address some facet of the physical or emotional fallout associated with MS. If you’ve ever adjusted to using a cane or wheelchair, have allowed the fear associated with incontinence to shrink your world, or have watched your loving partner become your primary caregiver, Sally Rickert’s deft phrases (like “dry-pants people”) will resonate with you.
Sally previously has been featured in MSFocus. Formerly a Registered Nurse, she was diagnosed with MS in 1996. The Tortoise and the Chair is available through the MSF Lending Library. Purchase it by calling 1-888-795-4274, ext. 7876, or visiting major online booksellers.
Have you ever wondered exactly what happens on the MSF Cruise for a Cause? Check out footage of the 2008 trip to find out more at http://www.msfocus.org/programs_cruise.php.
The MSF’s 2009 Cruise for a Cause departs February 8, 2009 from Miami, Florida, making stops in San Juan, Puerto Rico, Charlotte Amalie, St. Thomas and Philipsburg, St. Maarten.
The program, “MS Center at Sea: The Benefits of a Comprehensive Healthcare Team,” promises to be empowering and educational, with a multidisciplinary team of speakers from the MS Institute at Shepherd Center.
Topics will include insurance issues, cognitive impairment and the benefits of occupational therapy for fatigue, as well as sessions on speech and swallowing, and bladder and bowel symptoms. Among our esteemed scheduled speakers are: neuropsychologist Robert Godsall, PhD; Emily Cade, a case manager specializing in vocational and disability issues for individuals with chronic illnesses; occupational therapist Melinda Hodgson; speech language pathologist Bonnie Schaude; physical therapist Candy Tefertiller; certified personal trainer Jeff Segal and nurse practitioner Tracy Walker; MSF Medical Advisor Ben Thrower and pediatrician Dr. Karen Thrower.
Cruise rates range from $655 to $1140 per person, based on double occupancy. Taxes and gratuities as well as fuel and port charges are additional.
For questions about the MSF Cruise for a Cause, please call our Program Development Department at 800-225-6495. To book your cabin, call Fun Cruise and Travel at 888-826-9660.
If a relative, child, partner or friend is making a difference in your life, honor them this November during National Family Caregivers Month. Nominations will be accepted until September 15 for the MSF’s 7th annual Caregiver’s Night Out contest.
Tell us your story for a chance to win dinner for two at a restaurant of your choice. Winning essays will be published in the Fall, 2008 issue of MSFocus.
To enter, send us your name, address, phone number and email address, along with 100 words or fewer about what makes your caregiver special.
Email your information to firstname.lastname@example.org or download an application at http://www.msfocus.org/PDF/Caregiver_application.pdf and send it to Caregivers’ Night Out Contest, Multiple Sclerosis Foundation, 6350 N. Andrews Ave., Ft. Lauderdale, FL 33309.
Applications for the MSF Brighter Tomorrow Grant Program will be accepted through October 1.
The Brighter Tomorrow Grant is a wish-based program and is not based solely on financial need. Its goal is to provide people with MS goods or services that will enhance their safety, self-sufficiency, comfort, or well-being. Previous grant recipients are ineligible.
Requests must be for specific goods or services. Applicants provide basic personal and financial information, along with a brief essay of 100 words or less describing their need and how the grant will help them have a brighter tomorrow. Applications are confidential and are reviewed by our grant committee.
Applications are available at http://www.msfocus.org/programs_grants_bwmg_app.php. For additional applications, call 1-888-MSFOCUS (673-6287).
Settle into your stance and hit a long drive for the MSF this fall. Two golf fundraisers are in the works on the East Coast to raise money for the Foundation’s programs and services.
In September, the fourth annual MS Busters Golf Tournament in Davidsonville, Maryland is scheduled for Friday, September 19 at Renditions Golf Course. Players will have a chance to win a 1999 Ferrari Spider worth $115,000 while helping the MSF. For the third consecutive year, the tournament’s hole-in-one prize will be a car donated by http://www.b-dperformance.com/
For more information about the MS Busters, visit
www.ms-busters.com. To register or reserve a sponsorship opportunity for the golf tournament, call (410) 693-9302 or (301) 412-0409.
Then, in November, MSF’s Fifth Annual PAR for the Cause Golf Tournament will take place in Florida, the “Golf Capital of the World.” Presented by Toshiba Business Solutions and scheduled for Friday, November 21 at the Woodlands Country Club in Tamarac, Florida, the Par for the Cause will start with registration at 7:45 a.m., followed by breakfast at 8 a.m. and a 9 a.m. tee time.
To register for the Fifth Annual PAR for the Cause Golf Tournament, or for more information, call Annette Woods at (954) 776-6805 ext. 121.
from Julie Stachowiak, Ph.D.
Okay, I'm upset. I get mail all the time from readers who say that their neurologist says that certain physical complaints couldn't possibly have anything to do with their MS. It might or it might not, but it seems that neurologists are awfully quick to dismiss things that go beyond tingling, tremor and walking difficulties. I am highlighting three things that can definitely be linked to MS, but don't automatically come to mind when one thinks of MS symptoms. Hope this helps. Take care of yourselves, my friends.
In the Spotlight
Headache as a Symptom of MS
I know that everyone gets headaches, constipation and the occasional cough. However, for those of us with multiple sclerosis (MS), these common ailments may be caused (or made worse) by our MS.
If you are bothered by any of these problems, mention them to your neurologist. If he/she seems dismissive, stand your ground and insist on help. We already battle so many little and big problems that we need relief from anything that can be treated - and all of these can.
Read the full article: Headaches as a Symptom of MS
Constipation as a Symptom of MS
While this can definitely be a symptom of MS, the things that we have to do to prevent and treat constipation are pretty much the same as everybody else: fiber, water, exercise...
Read the full article: Constipation as a Symptom of MS
Respiratory Problems and Coughing as a Symptom of MS
I always wondered why my colds turned into bronchitis, characterized by coughing fits that would leave me desperately gasping for air. Now I know that I just don't cough as efficiently and have to treat these coughs quickly and seriously to get relief.
Read the full article: Respiratory Problems and Coughing as a Symptom of MS
- Basic Multiple Sclerosis Information
- Multiple Sclerosis Symptoms and Signs
- Treatments for Multiple Sclerosis
- Information for Patients Newly Diagnosed with Multiple Scler
- How to Live Well with Multiple Sclerosis
- Diagnosis of MS
- Treatment of MS
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