Update on Gilenya use in Pregnancy: multiple sclerosis medicine

Multiple sclerosis: Multiple sclerosis (MS) is a potentially disabling disease of the brain and spinal cord (central nervous system).

In MS, the immune system attacks the protective sheath (myelin) that covers nerve fibers and causes communication problems between your brain and the rest of your body. Eventually, the disease can cause permanent damage or deterioration of the nerves.

Signs and symptoms of MS vary widely and depend on the amount of nerve damage and which nerves are affected. Some people with severe MS may lose the ability to walk independently or at all, while others may experience long periods of remission without any new symptoms.

People with multiple sclerosis may also develop:

• Muscle stiffness or spasms
• Paralysis, typically in the legs
• Problems with bladder, bowel or sexual function
• Mental changes, such as forgetfulness or mood swings
• Depression
• Epilepsy

Treatment: 

There’s no cure for multiple sclerosis. However, treatments can help speed recovery from attacks, modify the course of the disease and manage symptoms. Some people have such mild symptoms that no treatment is necessary.

Gilenya is one of most effective treatment option for highly active relapsing-remitting Multiple sclerosis which is ‘disease-modifying therapy’ that is used to treat adults and children over 10 years of age. Gilenya is used when the disease remains active despite appropriate treatment with at least one other disease-modifying therapy, or is severe and getting worse rapidly. Gilenya contains the active substance fingolimod. 

Till now there was no restriction for this medicine to use in pregnancy and breast feeding. Now EMA has recommended that the multiple sclerosis medicine Gilenya (fingolimod) must not be used in pregnant women and in women able to have children who are not using effective contraception.

If a woman becomes pregnant while using Gilenya, the medicine must be stopped and the pregnancy will have to be closely monitored. This is because the active substance in Gilenya, fingolimod, can harm the unborn baby and may cause birth defects. The most frequently reported birth defects in infants exposed to Gilenya were those affecting the heart, kidneys, bones and muscles.