Aubagio, whose active ingredient is teriflunomide, is a medication prescribed primarily for treating relapsing forms of multiple sclerosis (MS). The FDA warnings on Aubagio highlight several important safety concerns and potential adverse effects that patients and healthcare providers must carefully consider before and during treatment.
One of the most serious FDA warnings involves the risk of **liver damage**. Teriflunomide can cause elevated liver enzymes, hepatitis, jaundice, and in rare cases, severe liver injury including hepatic failure and acute hepatic necrosis. Because of this, liver function tests must be monitored regularly before starting Aubagio and throughout the treatment period. Patients should immediately report symptoms such as yellowing of the skin or eyes, dark urine, severe fatigue, or abdominal pain, which may indicate liver problems.
Another critical warning concerns **serious infections**. Aubagio suppresses the immune system by inhibiting the proliferation of certain immune cells, which can increase susceptibility to infections. Patients must be monitored for signs of infection such as fever, chills, cough, or unusual tiredness. In some cases, infections can become severe or life-threatening, so prompt medical attention is necessary if symptoms develop.
Aubagio also carries a boxed warning about **teratogenicity and fetal harm**. Teriflunomide can cause birth defects and miscarriage, so it is contraindicated in pregnant women. Women of childbearing potential must use effective contraception during treatment and for a prolonged period after stopping the drug, as teriflunomide remains in the body for months. Men are also advised to use contraception to avoid fathering a child during and after treatment. If pregnancy occurs, an accelerated elimination procedure to remove the drug from the body should be initiated immediately.
**Severe skin reactions** are another serious concern. Rare but potentially life-threatening conditions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported. Patients should watch for symptoms like widespread rash, blistering, peeling skin, or mucous membrane involvement and seek urgent medical care if these occur.
Common side effects that warrant attention include **gastrointestinal issues** such as diarrhea and nausea, which can be persistent and affect quality of life. Some patients experience **hair thinning or hair loss**, which, while usually mild and temporary, can be distressing. Other frequent symptoms include headache, fatigue, muscle or joint pain, and respiratory symptoms like cough or sore throat.
Less common but serious side effects include **blood abnormalities** such as decreased white blood cells or platelets, which can increase the risk of bleeding or infection. Patients may experience unusual bruising, bleeding, or signs of anemia like pale skin and weakness. Regular blood counts are recommended to detect these changes early.
Cardiovascular warnings include reports of **irregular heartbeat, palpitations, and rapid pulse**. Patients with pre-existing heart conditions should be closely monitored, and any new cardiac symptoms should be promptly evaluated.
Because Aubagio affects the immune system, it may also cause **allergic reactions** ranging from mild skin rash to severe anaphylaxis. Any signs of swelling, difficulty breathing, or severe rash require immediate medical attention.
Due to the drug’s long half-life and persistence in the body, any adverse effects may take time to resolve after stopping treatment. In cases of severe toxicity or pregnancy, an elimination procedure using cholestyramine or activated charcoal can accelerate drug removal.
In summary, the FDA warnings on Aubagio emphasize the importance of careful patient selection, regular monitoring of liver function and blood counts, vigilance for infections and skin reactions, and strict pregnancy prevention measures. Patients should be educated about the signs and symptoms of serious side effects and maintain close communication with their healthcare providers throughout treatment to ensure safe use of this medication.
