新藥和醫療發展更新

新藥(諾華藥廠)Gilenya 口服藥物的回顧檢驗

Health Canada is reviewing a new multiple sclerosis drug that has been linked to 11 deaths.

加拿大衛生局正在檢視和Gilenya代號FTY720 (fingolimod) 口服藥物是否上市,因為此醫藥物目前造成11位MS患者的死亡

There have been no reports of deaths in Canada of people taking the Novartis drug, which is sold under the brand name Gilenya.

Gilenya, also called fingolimod, is taken once a day for people with the relapsing-remitting form of MS. (Novartis)

Health Canada says that of the deaths outside the country, it's not clear whether the drug itself caused them, or whether other factors played a role.

Both the U.S. Food and Drug Administration and the European Medicines Agency had earlier announced that they were undertaking reviews of Gilenya.

包含美國FDA和歐洲藥品局早先都宣布再次檢視此藥物的情形

Gilenya is used for treatment of relapsing-remitting MS to reduce the frequency of attacks and to delay physical disability; it is generally recommended when other MS treatments have not been effective or cannot be tolerated.

At the time the drug was authorized, it was known that certain types of heart rhythm disturbances can be seen with Gilenya use and the Canadian labelling contains several warnings to this effect.

But Health Canada says it felt the drug's benefits outweighed its risks.

Of the 11 reported deaths, four involved serious heart-related events — three were heart attacks and another a disturbance of the heart rhythm. The seven other deaths are unexplained, including one from the United States involving a person who died within 24 hours of his or her first dose of Gilenya.

這11位死亡的案例中有4位和心臟相關 (3位心臟病1位心率不整) 其他7位未明(其中一位第一次服用後24小時內就死亡)

Health Canada says people taking the drug should not discontinue it without consulting their doctor. But anyone on the drug who is feeling symptoms of heart disease — including chest pain, slow or irregular heartbeat, or dizziness — should seek medical care.

The department says doctors should monitor patients on the drug closely. Blood pressure should be checked regularly as the drug is known to increase blood pressure.

看來目前只有Ampyra還較為安全（通用名稱dalfampridine，以前稱為fampridine），是第一個臨床治療是口服和第一個同類接受FDA的批准。其目的是幫助人們與任何類型的MS提高步行速度。該藥物的研製藥廠為 : Biogen Idec

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醫療發展更新

Application closes for MS Liberation treatment study in New York

日前有關於加拿大Saskatchewan和美國共同進行靜脈擴張術研究的申請名額已經額滿,加拿大共接到682患者参與實驗研究

For hundreds Multiple Sclerosis patients in Saskatchewan the next few months will be spent waiting.

On Friday, February 24 the deadline closed for the provincially funded MS Liberation Treatment trial in Albany, New York. The government received 682 applications to be part of the trial

Lori Lumax is one of the many people hoping to be chosen for the double-blind study and she is happy to see the government taking a step in the right direction.

“I’m really happy that this is going and there’s more studies coming out all the time so Canada is getting on top of it finally,” Lumax said.

The 46-year-old from Regina was diagnosed in 2003 and most of the time she only feels tired and dizzy. About once a year she has a relapse of symptoms which affect her cognitive functions causing her to lose feeling in her hands and feet and her balance.

Lumax said she is very excited for the study because all of the data will be documented to see if the controversial liberation treatment really works.

“If I’m not chosen for this trial – well, I’ll be looking at other trials coming up,” she said, explaining that she doesn’t want to wait for two years to see if the treatment will be offered here.

Lumax added that she is not willing to go overseas for treatment because she wants to know that there will be after-care in place.

Saskatchewan has one of the highest rates of MS with 3,500 people suffering from the disease. Starting in March the provincial government will send 86 patients to participate in the study in New York.

3月開始將會有86名Ms患者至紐約進行實驗手術研究

新藥和醫療發展更新