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Women with Multiple Sclerosis who Have a Higher BMI are at Higher Risk for Lymphopenia, Studies Show

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Researchers in Germany and Sweden have found that some female patients taking the multiple sclerosis (MS) drug Gilenya (fingolomid) may be at increased risk for lymphopenia, a condition that affects the immune system.

Lymphopenia (also known as lymphocytopenia) is a condition in which a patient has a deficiency of lymphocytes, which play a vital role in supporting immune system function. Gilenya has been known to reduce the level of circulating lymphocytes, and one of the most common side effects of the drug reported by the U.S. Food and Drug Administration (FDA) and the drug’s manufacturer, Novartis Pharma Stein AG, is infections. Lower lymphocyte numbers make the patient more susceptible to infection, according to

According to, researchers concluded that:

-Women with a body mass index (BMI) under 18.5 kg/m2 had a 26 percent increased risk for developing lymphopenia (counts at or lower than 0.2 x 109/L associated with drug use.

-Patients with lymphocyte levels lower than 1.6 x 109/L had a 46 percent greater risk of developing lymphopenia while using Gilenya.

-Use of the drug Copaxone before the start of Gilenya use seemed to help protect against the development of lymphopenia, but researchers were uncertain about the immunologic effect of Copaxone.

For the German study, researchers study data on 418 individuals with relapsing-remitting multiple sclerosis that were enrolled in an open label study in which they took 0.5 mg of Gilenya daily. Blood samples were taken at the beginning of treatment, and at months 1, 4 and 6. In the Swedish study, data from 438 patients were used to validate the findings, reported.

Previous research (phase III trials) found that the timing of meals or other medications, including corticosteroids, had no impact on lymphocyte counts among MS patients who take Gilenya, reported.

The findings of the German and Swedish studies will help provide doctors with more guidelines and background to consider when weighing whether to start patients on Gilenya, such as monitoring of female patients who are underweight and/or patients who have low baseline lymphocyte counts. Gilenya has been associated with other serious side effects such as slow heart rate (bradycardia), which can occur at the onset of treatment; macular edema, which typically appears three to four months after the start of treatment; liver problems, and short ness of breath, according to disclaimer: This article: Women with Multiple Sclerosis who Have a Higher BMI are at Higher Risk for Lymphopenia, Studies Show was posted on Wednesday, December 31st, 2014 at 6:04 pm at and is filed under Defective Drug Lawsuits.

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