FDA Approves Gattex to Treat Short Bowel Syndrome

The US Food and Drug Administration today approved Gattex (teduglutide) to treat adults with short bowel syndrome (SBS) who need additional nutrition from intravenous feeding (parenteral nutrition).

FDA Safety Communication: Pradaxa

The US Food and Drug Administration (FDA) is informing healthcare professionals and the public that the blood thinner (anticoagulant) Pradaxa ( dabigatran etexilate mesylate ) should not be used to prevent stroke or blood clots (major thromboembolic events) in patients with mechanical heart valves, also known as mechanical prosthetic heart valves.

FDA Drug Safety Communication: Xyrem

The US Food and Drug Administration (FDA) is reminding healthcare professionals and patients that the combined use of Xyrem (sodium oxybate ) with alcohol or central nervous system (CNS) depressant drugs can markedly impair consciousness and may lead to severe breathing problems (respiratory depression).

FDA approves Signifor, a drug for Cushing’s disease

The US Food and Drug Administration today approved Signifor (pasireotide diaspartate) injection for the treatment of Cushing’s disease patients who cannot be helped through surgery.

FDA Approves Raxibacumab to Treat Inhalational Anthrax

The US Food and Drug Administration today approved raxibacumab injection to treat inhalational anthrax, a form of the infectious disease caused by breathing in the spores of the bacterium Bacillus anthracis.

FDA approves Iclusig to treat two rare types of leukemia

The US Food and Drug Administration today approved Iclusig (ponatinib) to treat adults with chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), two rare blood and bone marrow diseases.

FDA Drug Safety Communication: Chantix Heart Risk

The US Food and Drug Administration (FDA) is notifying the public that the smoking cessation aid Chantix (varenicline) may be associated with a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease.

FDA Expands Zytiga’s use for Late-Stage Prostate Cancer

The US Food and Drug Administration today expanded the approved use of Zytiga (abiraterone acetate) to treat men with late-stage (metastatic) castration-resistant prostate cancer prior to receiving chemotherapy.

FDA Drug Safety Communication: Updated information on intravenous Zofran

The US Food and Drug Administration (FDA) is notifying healthcare professionals that the 32 mg, single intravenous (IV) dose of the anti-nausea drug Zofran ( ondansetron hydrochloride) will no longer be marketed because of the potential for serious cardiac risks.

FDA Drug Safety Communication: Important Change to Heparin Container Labels

The US Food and Drug Administration (FDA) is notifying healthcare professionals, caregivers, and patients about a change to the container and carton labels for heparin products, which are blood-thinning agents that prevent the formation of blood clots.