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Sep 18

FDA Approves MS Drug, Noting Boxed Warnings

On September 12, 2012, the U.S. Food and Drug Administration (“FDA”) announced the approval of the drug Aubagio (teriflunomide). Manufactured by Sanofi Aventis, Aubagio is a once-a-day tablet for the treatment of relapsing forms of multiple sclerosis (“MS”) in adults. The full announcement of the approval may be accessed here.

As noted in the FDA’s announcement, Aubagio contains a Boxed Warning intended to alert prescribers and patients of certain risks, including liver problems and birth defects. Accordingly, prescribers are warned to refrain from prescribing Aubagio to patients who have existing liver problems. In addition, prescribers are required to verify that women of childbearing age are not pregnant prior to starting treatment with the drug and are using an effective birth control method during the pendency of treatment.

Boxed warnings are particularly serious warnings, typically indicating the potential for death or serious bodily injury that FDA regulations require to be used in certain situations. In particular, boxed warnings are commonly used three distinct scenarios. First, boxed warnings are used where a drug is known to have an adverse reaction that is so serious when considered in proportion to the drug’s potential benefit that the adverse reaction must be considered when assessing the risks and benefits of prescribing the drug. Second, a boxed warning is appropriate where a serious adverse event may be prevented or otherwise reduced in frequency by appropriate use of the drug, i.e., only being prescribed to certain types of patients. Finally, boxed warnings are used where the FDA approved the drug with certain restrictions to ensure safe use. Although these warnings may be used in other circumstances, there are considered the most common. More information about boxed warnings and other FDA warnings sections of labeling for prescription drugs may be found here.

FDA Attorney

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