Arava: Risk of Severe Liver Injury

[Guest guest]

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm221628.htm#Arava

Arava: Risk of Severe Liver Injury

FDA is requiring a “boxed warning” on the label of the rheumatoid arthritis drug

Arava to highlight the risk of severe liver injury.

A boxed warning appears prominently at the top of a drug label and is required

for certain prescription drugs. The warning calls attention to serious or

life-threatening risks.

The risk: FDA has received reports of severe liver injury, including death from

liver failure. 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.

Recommendations

Be aware that severe liver injury is a rare, but serious, side effect of Arava.

Contact your health care professional right away if you develop itching, yellow

eyes or skin, dark urine, loss of appetite, or light-colored stools. These may

be signs of liver injury.

Talk to your health care professional about any concerns you have with this

medication.

For More Information

FDA Drug Safety Communication12

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsan\

dProviders/ucm218679.htm

[Guest guest]

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm221628.htm#Arava

Arava: Risk of Severe Liver Injury

FDA is requiring a “boxed warning” on the label of the rheumatoid arthritis drug

Arava to highlight the risk of severe liver injury.

A boxed warning appears prominently at the top of a drug label and is required

for certain prescription drugs. The warning calls attention to serious or

life-threatening risks.

The risk: FDA has received reports of severe liver injury, including death from

liver failure. 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.

Recommendations

Be aware that severe liver injury is a rare, but serious, side effect of Arava.

Contact your health care professional right away if you develop itching, yellow

eyes or skin, dark urine, loss of appetite, or light-colored stools. These may

be signs of liver injury.

Talk to your health care professional about any concerns you have with this

medication.

For More Information

FDA Drug Safety Communication12

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsan\

dProviders/ucm218679.htm