Tuesday, February 28, 2012

MS Society of Canada - Living with MS - MS Updates

Gilenya (fingolimod) under Health Canada review

MS Update

February 28, 2012

Health Canada has announced an ongoing safety review of Gilenya (fingolimod) following the reports of serious adverse events, including 11 deaths internationally. At this time, it is not clear whether the deaths were caused by Gilenya or whether other factors may have played a role. There have been no deaths in Canada.
Health Canada’s review was initiated following reports earlier this year that 11 deaths have occurred among people being treated with Gilenya, including the report of an American who died within 24 hours of receiving a first dose of Gilenya in December 2011.

At the time of approval in March 2011, it was known that Gilenya could be associated with certain types of heart rhythm disturbances. The Health Canada labeling for Gilenya includes several important warnings related to these risks however, provided Gilenya is used as recommended in the authorized Health Canada drug label, the benefits of Gilenya are considered to outweigh the risks at this time.

Health Canada is advising healthcare professionals to continue to follow the labeling instructions closely, particularly with respect to patient monitoring. Specifically, the label recommends that physicians:
  • Obtain an ECG (electrocardiogram) before the first dose if one is not available in the last 6 months
  • Observe patients for signs and symptoms of bradyarrhythmia (slow heart rate), including periodic assessment of heart rate, for at least six hours after the first dose (or if more than two weeks have passed since the previous dose).
  • Initiate appropriate treatment if clinically important heart-related symptoms occur. Symptoms include bradyarrhythmia or atrioventricular block (a problem with the conduction of electricity in the heart). Continue to manage and monitor patients until symptoms have resolved.
  • Measure blood pressure regularly as Gilenya is known to increase blood pressure.
read more here http://mssociety.ca/en/help/msupdates/msupdate_20120228.htm

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Saturday, February 25, 2012

English: Saskatchewan Province within Canada. ...Image via Wikipedia
Saskatchewan MS sufferers wait for the call
REGINA -- Saskatchewan MS patients hoping to take part in a clinical trial of a controversial treatment may soon get a call from the ministry of health.
Only 10 per cent of those who applied will get that call.
Deb Jordan, a ministry spokeswoman, said 670 people had signed up as of Thursday. The deadline to apply for the two-year, double-blind trial of liberation therapy was midnight Friday.
Jordan said names will be randomly drawn starting next week to determine who will fill 86 spots in the test taking place in Albany, N.Y. A successful candidate must be a Saskatchewan resident, under the age of 60 and not had liberation treatment.
"Once we verify that information, then the applicant will be forwarded to the folks who are involved in the clinical trial," said Jordan. "I want to also emphasize that the fact that a patient may be drawn does not necessarily mean that they will move on to the clinical trial.
"There's the medical assessment that has to take place by the team and it is the... clinical team that is operating the clinical trial that will ultimately make the decisions about the patients who will be participating in the trial."
Jordan said the process could take several months.
The treatment is based on a hypothesis by Italian vascular surgeon Dr. Paolo Zamboni that a condition he dubbed chronic cerebrospinal venous insufficiency, or CCSVI, may be linked to multiple sclerosis. The theory suggests narrowed neck veins create a backup of blood that can lead to lesions in the brain and inflammation. Liberation therapy involves opening up blocked neck veins.
The idea has divided the medical community.
Some patients have reported improvement after the therapy. Other studies have raised doubts about its effectiveness and questioned the benefits when weighed against the risks.The procedure is not offered in Canada and some patients have travelled around the world to seek it out. At least two Canadians have died after having the treatment.
Saskatchewan has some of the highest rates of MS in the country. Canada's rate of MS is among the highest in the world at 240 per 100,000 people. On the Prairies, the rate is 340 per 100,000 people.

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Tuesday, February 7, 2012

CBC -The Nature of Things with David Suzuki - Episode - MS Wars: Hope, Science and the Internet

MS Wars is a one hour documentary that delves into the science, controversy and human drama around Liberation Therapy. It is a tale that explores how the Internet has spurred a social network movement that is changing the doctor/patient relationship and the repercussions for physician and institutions.


MS Wars: Hope, Science and the Internet

Thursday, February 9, 2012 8:00 PM on CBC-TV
Thursday February 15 at 10 pm ET/PT on CBC News Network

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