The manufacturers of Etanercept (Enbrel), an injectable drug used to treat arthritis and psoriasis, announced that the drug is now required to carry a black box warning about the risk of infections, including tuberculosis (TB), in the drugs U.S. prescribing information. A black box warning is the strongest type of warning that the U.S. Food and Drug Administration (FDA) can require in a drug’s prescribing information. The U.S. FDA has an equivalent function to the Saudi Food and Drug Authority.

TB is caused by Mycobacterium tuberculosis and usually infects the lungs, but may also infect other organs. TB spreads through the air when a person with TB of the lungs or throat coughs, sneezes or talks.

Symptoms of TB in the lungs may include:

- A bad cough that lasts 3 weeks or longer.

- Weight loss.

- Coughing up blood or mucus.

- Weakness or fatigue.

- Fever and chills.

- Night sweats.

The etanercept announcement can be found on the manufacturer’s Web site at: .

The update prescribing information with the new black box warning is available on the Internet at: .

Actions that Healthcare Professionals and Public Should Follow:

• Physicians and pharmacists should instruct patients being treated with etanercept who develop the signs of infection to seek immediate medical attention.
• Patients should be instructed on the symptoms of TB involving the lung as listed above and told to seek immediate medical attention should these symptoms develop.

REPORT ADVERSE DRUG REACTIONS TO THE SFDA:

The public and health professionals are encouraged to report adverse drug reactions the National Pharmacovigilance Center on the Internet at:

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