The Food and Drug Administration (FDA) has approved Aubagio (teriflunomide) for the treatment of Multiple Sclerosis.  The new drug can help those patients with MS that have reoccurring relapses.  Aubagio should be taken once a day and is made by drug manufacturer Sanofi Aventis. 

 

Russell Katz, M.D. and Director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research recently commented on the new MS drug approval.  “In a clinical trial, the relapse rate for patients using Aubagio was about 30 percent lower than the rate for those taking a placebo.  Multiple Sclerosis can impair movement, sensation, and thinking, so it is important to have a variety of treatment options available to patients,” said Katz. 

 

All medications have some degree of side-effects and the most common side-effects noticed by patients in clinical trials were diarrhea, abnormal liver tests, hair loss, and nausea.  Pharmacy Technicians should also be aware of the boxed warnings associated with Aubagio.  The boxed warnings are as follows: 

 

· Risk of liver problems.  Patients should have a liver function test before starting Aubagio and also have these tests performed periodically while taking the drug. 

 

· Based on animal studies the drug can potentially cause fetal harm.  Pharmacy Technicians should note that the new MS drug carries a Category X Warning.  This warning means that women who are of childbearing age should have a negative pregnancy test and also use effective birth control while using Aubagio. 

 

More information concerning Aubagio can be obtained by going to the drug’s web site at www.aubagio.com. 

 

Sources: 

1. Walsh, Sandy.  “FDA Approves New Multiple Sclerosis Treatment Aubagio.”  FDA.  Web.  19 Sept 2012. 

 

2. Aubagio Web Site.  www.aubagio.com.       

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