Find Information About:

Drugs & Supplements

Get information and reviews on prescription drugs, over-the-counter medications, vitamins, and supplements. Search by name or medical condition.

Pill Identifier

Pill Identifier

Having trouble identifying your pills?

Enter the shape, color, or imprint of your prescription or OTC drug. Our pill identification tool will display pictures that you can compare to your pill.

Get Started

My Medicine

Save your medicine, check interactions, sign up for FDA alerts, create family profiles and more.

Get Started

WebMD Health Experts and Community

Talk to health experts and other people like you in WebMD's Communities. It's a safe forum where you can create or participate in support groups and discussions about health topics that interest you.

  • Second Opinion

    Second Opinion

    Read expert perspectives on popular health topics.

  • Community


    Connect with people like you, and get expert guidance on living a healthy life.

Got a health question? Get answers provided by leading organizations, doctors, and experts.

Get Answers

Sign up to receive WebMD's award-winning content delivered to your inbox.

Sign Up

Multiple Sclerosis Health Center

Font Size

New Warnings for MS Drug Gilenya After FDA Review

Heart Risk Safety Concerns Added to Multiple Sclerosis Drug's Label
By Cari Nierenberg
WebMD Health News
Reviewed by Laura J. Martin, MD

April 20, 2012 -- Novartis, the maker of the drug Gilenya (fingolimod), a once-daily oral capsule taken for multiple sclerosis, has added stronger warnings to labels and prescription information about the drug's possible heart risks, according to a company statement.

Labels will now recommend that all patients have an electrocardiogram (ECG) before taking their first dose of the MS drug. In addition, those starting treatment with Gilenya are also advised to get a second ECG six hours after their first dose of the medication.

New patients are advised to take the drug for the first time in their doctor's office with hourly blood pressure and heart rate checks during a six-hour monitoring period.

The revised label information will not affect people currently taking the drug. But it may apply to them if they stop taking Gilenya for more than two weeks and need to restart the treatment. They would need to repeat the ECGs as well as the six-hour monitoring period.

These changes follow an FDA report in December 2011 of an MS patient who died within 24 hours of taking the first dose of Gilenya. The agency is still looking into whether the drug was responsible for the patient's death.

Heart Concerns

The drug is known to slow heart rate, especially in the first 30 days of its use. It may also leave some people feeling dizzy or tired, or they may feel heart palpitations or chest pain that usually improves within the first 24 hours of treatment.

In the U.S., labels will also recommend that people with certain heart conditions or those taking certain medications for these heart problems would need to be monitored overnight by a health professional after taking their first dose of this MS drug.

According to the National Multiple Sclerosis Society, about 400,000 Americans have MS. The autoimmune disease affects the brain and spinal cord, which can result in weakness in one or more limbs, balance problems, and numbness.

Risks vs. Benefits

Gilenya is taken once a day by mouth to reduce the number of MS flares in people with relapsing types of MS. It was approved for use by the FDA in September 2010.

Today on WebMD

nerve damage
Learn how this disease affects the nervous system.
woman applying lotion
Ideas on how to boost your mood and self-esteem.
woman pondering
Get personalized treatment options.
man with hand over eye
Be on the lookout for these symptoms.
brain scan
worried woman
neural fiber
white blood cells
sunlight in hands
marijuana plant
muscle spasm