MULTIPLE SCLEROSIS MEDICATION LINKED TO SEVERE SIDE EFFECTS
Gilenya (fingolimod) is a pharmaceutical drug prescribed to treat patients with relapsing forms of multiple sclerosis (MS). The drug reduces the frequency of clinical exacerbation and to delay the accumulation of physical disability caused by MS. Manufactured and marketed by Novartis, Gilenya was approved by the U.S. Food and Drug Administration (FDA) in 2010.
Minor adverse reactions caused by Gilenya include:
- Liver enzyme elevation
- Back pain
- Abdominal pain
- Extremity pain
In the phase III clinical trials compared with a placebo drug, Gilenya was linked to several serious side effects. Compared to the placebo, patients taking fingolimod experienced a higher incidence of bradycardia, basal-cell carcinoma, lower respiratory tract infections, macular edema, and cancer.
RARE BRAIN INFECTION FOUND IN TWO GILENYA PATIENTS
In 2015, the FDA warned the public of two incidents of a rare brain infection occurring in patients taking Gilenya for MS treatment. Progressive multifocal leukoencephalopathy (PML) is a serious brain infection that could cause severe disability and death. Symptoms of this potentially fatal condition include:
- Weakness on one side of the body
- Vision problems
- Changes in thinking, memory, orientation, and personality
Information regarding this deadly brain condition have been added to Gilenya’s warning label.
GILENYA CAN SLOW HEART RATE, CAUSE BRADYCARDIA OR ARRHYTHMIA
Fingolimod can cause heart rates to slow down, especially after taking the first dose. Observation is required to monitor heart activity for the first few hours after being administered the drug by a healthcare provider. Most often caused by problems in the heart, metabolic problems, or damage from a heart attack or heart disease, bradycardia is a heart rate of less than 60 beats per minute. Bradycardia, when left untreated, can cause heart failure, loss of consciousness, chest pain, hypertension or hypotension. In some extreme cases, cardiac arrest can occur.
CONTACT AN EXPERIENCED DANGEROUS DRUG LITIGATION ATTORNEY
People take pharmaceutical drugs to improve their quality life and treat conditions. When these dangerous medications instead cause harm, pharmaceutical companies need to be brought to justice. Drugs like Gilenya can cause life-altering and fatal injuries. If you or a loved one have suffered an injury after taking Gilenya, contact Thomas J. Henry. Our experienced team of drug injury lawyers are available to evaluate your claim and provide you with a free case review.