Canadian regulators indicate that side effects of Gilenya during pregnancy could increase the risk of congenital malformations among newborns, resulting in new label warnings for users and doctors outside the U.S.
The Gilenya warning was issued by Health Canada on December 19, indicating that prenatal exposure to the immunosuppressive drug has been linked to reports of major congenital malformations.
The countries drug regulatory agency has contraindicated Gilenya for pregnant women those of childbearing potential who are not using effective contraception.
Gilenya (fingolimod) was introduced by Novartis for treatment of multiple sclerosis in 2010, and it is widely used to reduce flare-ups and delay the onset of physical disability caused by the disease. An estimated 70,000 people throughout the world currently using Gilenya, which is one of several medications approved to treat a form of the disease known as relapsing MS. This includes periods of time when MS symptoms get worse.
Health Canada warned that data indicates it has been linked to congenital heart disease, like atrial septal defects, and renal and musculoskeletal abnormalities. The agency recommended doctors discuss the risks, the need for a negative pregnancy test, and the need to use effective contraception during Gilenya therapy and for two months after stopping Gilenya treatment. It also recommended doctors warn women to stop using Gilenya at least two months before planning a pregnancy.
The FDA has not announced similar warnings about the potential Gilenya birth defect risk in the U.S.
Gilenya Brain Infection Concerns
In addition to concerns about the potential link between Gilenya and birth defects, warnings have been issued by the FDA in recent years about reports of a rare, but potentially deadly, brain infection that has developed among users of the drug, known as Progressive multifocal leukoencephalopathy (PML). This has resulted in some questions in the U.S. about whether the drug may have been approved too fast, without sufficient research.
PML brain infections have been linked to a number of similar medications, and is believed to be caused by the John Cunningham (JC) virus, which is usually a harmless virus, but can cause the serious brain infection among people who have a weakened immune system.
In August 2015, the FDA required new warnings about the link between Gilenya and progressive multifocal leukoencephalopathy (PML), indicating that patients and medical providers should be aware of potential symptoms, which may include mood changes, confusion, memory loss, weakness on one side of the body and problems walking.
According to a report published by the Journal of the American Medical Association (JAMA) in 2014, Gilenya was cited as an example of a medication that may have been approved too fast. Researchers indicated that at least seven major safety issues were identified during Gilenya clinical trials, including heart problems, liver toxicity, increased risk of infection, reduced pulmonary function, teratogenicity, macular edema and a potentially risk of cancer. Clinical trials involving doses of 5mg and 2.5mg were halted due to safety reasons, leading the FDA to approve Gilenya at the lowest dose possible of 0.5mg.
In May 2012, the FDA added new Gilenya warnings about the risk of heart problems after a patient died within 24 hours after taking the drug. Doctors were advised not to prescribe Gilenya to patients who have a history of heart problems or who take drugs that lower their heart rates. When the drug is given to patients with heart problems, health regulators indicated that they should be monitored by ECG before the first dose and continuously for six hours afterwards.
Despite concerns over the safety of Gilenya when it was reviewed, the FDA agreed to fast-track the drug’s approval with only minimal testing, because the drug was identified as a crucial medication that addressed needs that were not met by other treatments.