From Medscape: http://www.medscape.com/viewarticle/725038
The rheumatoid arthritis drug leflunomide (Arava; sanofi-aventis) has received a boxed warning about the risk for severe liver injury, the US Food and Drug Administration (FDA) announced today.
The FDA added a boldface warning about severe liver injury to the drug's label in 2003 but decided to escalate it in light of an agency review this year of adverse event reports associated with leflunomide. The FDA identified 49 cases of severe liver injury associated with the drug, including 14 cases of fatal liver failure, between August 2002 and May 2009, according to an alert sent today from MedWatch, the FDA's safety information and adverse event reporting program.
"In this review, the greatest risk for liver injury was seen in patients taking other drugs known to cause liver injury, and patients with pre-existing liver disease," the FDA stated.
The drug label already features a boxed warning stating that leflunomide is contraindicated for pregnant women and for women of childbearing potential not using reliable contraception.
The boxed warning will now include the following information on severe liver injury:
The rheumatoid arthritis drug leflunomide (Arava; sanofi-aventis) has received a boxed warning about the risk for severe liver injury, the US Food and Drug Administration (FDA) announced today.
The FDA added a boldface warning about severe liver injury to the drug's label in 2003 but decided to escalate it in light of an agency review this year of adverse event reports associated with leflunomide. The FDA identified 49 cases of severe liver injury associated with the drug, including 14 cases of fatal liver failure, between August 2002 and May 2009, according to an alert sent today from MedWatch, the FDA's safety information and adverse event reporting program.
"In this review, the greatest risk for liver injury was seen in patients taking other drugs known to cause liver injury, and patients with pre-existing liver disease," the FDA stated.
The drug label already features a boxed warning stating that leflunomide is contraindicated for pregnant women and for women of childbearing potential not using reliable contraception.
The boxed warning will now include the following information on severe liver injury:
- Leflunomide should not be given to patients with preexisting liver disease or elevated liver enzymes (alanine transaminase [ALT] > 2 times the upper limit of normal).
- Clinicians should be cautious with patients who are taking other drugs that can injure the liver.
- After patients begin leflunomide therapy, their liver enzyme levels should be monitored at least monthly for 3 months, and then at least quarterly thereafter.
- If the ALT rises to greater than 2 times the upper limit of normal while the patient is taking the drug, leflunomide treatment should be stopped and cholestryamine washout should commence to speed up the removal of leflunomide from the body. Clinicians should order follow-up liver function tests at least weekly until the ALT value is within normal range.