New Birth Injury and Side Effect Warnings for MS Drug Gilenya after FDA Review
by
Michael F. Becker on Jul. 16, 2012
Accident & Injury Medical Malpractice Accident & Injury Personal Injury Accident & Injury Malpractice
Summary: Those suffering from MS and considering taking Gilenya to help with symptoms need to know of the new warnings from the U.S. Food and Drug Administration (FDA). The side effects of the initial dose of Gilenya can lead to death, so the FDA recommends monitoring for at least the first 6 hours.
If you suffer from multiple sclerosis (MS), you know how painful and frustrating it can be to live with this condition. When there is a medication on the market that can make your life much easier, you’ll most likely jump at the chance to take it.; however, it is always good to know the risks of taking such effective drugs, as the side effects may outweigh the risks of it. If prescription or over-the-counter drugs have injured you or your child, consult a Cleveland birth injury lawyer.
FDA Warning for MS Drug Gilenya
FDA Warning for MS Drug Gilenya
Gilenya is a medication for people suffering from MS. The medication is effective in reducing flare-ups, and it decreases the development of physical disabilities for adults with the condition.
While the medication can bring much relief to MS patients, it comes with risk. The United States Food and Drug Administration (FDA) recently conducted an investigation on Gilenya after someone died from taking the first dose. They also considered other reports of people taking the medication and then dying from cardiovascular or unknown causes.
The FDA concluded that they can’t show a direct relationship between Gilenya and the deaths, but they did warn people of the cardiovascular effects of the drug. Gilenya slows down heart rate, with the slowest heart rate occurring at 20 hours after the first dose.
Those most at risk of death may have a recent history of:
• class III/IV heart failure;
• stroke;
• transient ischemic attack;
• unstable angina;
• myocardial infarction; and
• other heart conditions.
According to the FDA, people with a history of Mobitx type II or antrioventricular block also have a higher chance of suffering serious effects from Gilenya, as well as those with a QTc baseline interval of 500 ms or more.
Drug interactions with class la or class III antiarrhythmic drugs also lead to increased cardiovascular effects.
To decrease the risk of death in patients taking Gilenya, the FDA recommends 6 hours of monitoring after the initial dose, especially those at higher risk. Patients should be advised of these warnings and the need for monitoring by their doctor.
Gilenya and Pregnancy
Women with MS may believe taking Gilenya during pregnancy may outweigh the risks of MS symptoms to a developing fetus; however, the drug has its own risks that could lead to birth defects or even fetal death.
The FDA categorized Gilenya as a Category C drug. Category C drugs may not be safe during human pregnancy. In animal studies, this drug has caused miscarriage and birth defects.
Doctors should warn women to avoid pregnancy while taking Gilenya. If conception occurs, women should contact their doctor immediately. The doctor can advise how best to stop the medication, as stopping it suddenly could result in serious withdrawal effects.
If a woman wants to conceive, she must wait at least 2 months to ensure the drug has completely left her body so that it does not have an effect on the fetus.
Contact a Cleveland, Ohio Birth Injury Lawyer
If your doctor did not advise you of the adverse effects of Gilenya before you became pregnant, you could have a medical malpractice case. Many people have been able to receive compensation for fetal death or their baby’s birth injury.
Becker Law Firm specializes in birth injury medical malpractice cases. They are committed to seeking retribution for the pain and suffering that you and your baby endure. Contact a birth injury lawyer today at 1-877-863-6219 for a free case evaluation.
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