Multiple sclerosis drug Gilenya linked to risk of PML brain infections, according to FDA warning

by Eric Pearson

The Food and Drug Administration has warned that patients with multiple sclerosis who are treated with the drug Gilenya (fingolimod) may be at risk of developing a serious form of brain infection known as progressive multifocal leukoencephalopathy (PML). Gilenya is an immunomodulator that is prescribed to patients with relapsing forms of MS, who may experience occasional periods in which their symptoms become worse.

PML brain infections are caused by exposure to the John Cunningham (JC) virus. Although the JC virus is common and usually harmless in most patients, it can lead to PML in patients with weak or compromised immune systems, including those being treated with immunosuppressants such as Gilenya.

The FDA’s concerns about the link between Gilenya and PML first arose in 2013, when a patient with MS who was being treated with the drug was diagnosed with the brain infection. However, because the patient had also been treated with an immunosuppressant drug that can cause PML—as well as corticosteroids, which can weaken the immune system—doctors could not be certain of the link between Gilenya and brain infections.

The FDA warning about Gilenya was issued after the agency received a report about a second patient who was diagnosed with PML after taking the MS drug. Unlike the first patient, this second individual had not been treated with immunosuppressant drugs prior to being diagnosed with PML.

The FDA has advised patients being treated with Gilenya to talk with their doctor if they experience symptoms which may be a sign of PML. Symptoms of the brain infection may include changes in thinking, eyesight, strength, or balance; weakness that is new or worsens; and trouble moving the arms or legs.

Hurt by side effects from a prescription drug? Our attorneys can help.

Despite the efforts of the FDA and other federal regulators, thousands patients are injured every year as a result of side effects from prescription medications. If you or a loved one has been hurt by complications from prescription drugs or other medical products, you and your family are entitled to have an well-trained and experienced attorney fighting on your behalf.

In order to successfully file a lawsuit against big and well-funded drug companies, you will need a law firm with the financial resources to take your case all the way to trial. Heygood, Orr & Pearson has the experience, expertise, and resources to take on any pharmaceutical liability case. Our attorneys have tried hundreds of cases to verdict and have settled hundreds more.

In just the last few years, our lawyers have collected more than $200 million on behalf of our clients in cases relating to defective pharmaceutical products. The lawyers at Heygood, Orr & Pearson have pursued claims involving injuries linked to a variety of pharmaceutical products, including the fentanyl pain patch, Yasmin, Actos, Avandia, and Pradaxa. We have also filed lawsuits on behalf of patients who were injured by medical devices such as hip and knee replacements.

The lawyers at Heygood, Orr & Pearson are trial attorneys in the truest sense. We are as comfortable before a judge and jury as we are drafting legal briefs. In fact, every one of our attorneys has trial experience, ranging from auto accident cases to commercial fraud cases to pharmaceutical liability cases. We are all committed to bringing the highest standards of ethics and a passion for justice to every client and every case.

If you or a loved one have been injured due to side effects from prescription drugs or other medical products, the first step in taking actions is to speak with an attorney about your case. For a free legal consultation and to find out if you qualify to file a lawsuit, contact the lawyers at Heygood, Orr & Pearson by calling toll-free at 1-877-446-9001. You can also reach us by following the link to our free case evaluation form and answering a few simple questions about your case.