FDA Actions

The FDA is requiring new boxed warnings on TNF-blockers regarding the risk of lymphoma and other malignancies in children and adolescents who have received the drugs. The new labeling will include warnings regarding cases of leukemia in adults, adolescents, and children, as well as new onset psoriasis. The labeling will also include a revised Medication Guide to reflect the safety information. Products subject to the new boxed warning are infliximab (Remicade®), etanercept (Enbrel®), adalimumab (Humira®), and the recently approved agents certolizumab pegol (Cimzia®) and golimumab (Simponi™). These TNF-blockers are used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, Crohn's disease, and ankylosing spondylitis. The warning is based on reports of nearly 50 cases of various cancers associated with the drugs, of which half were lymphomas.

The FDA has approved a new dipeptidyl peptidase-4 (DPP-4) inhibitor for the treatment of type 2 diabetes. Bristol-Myers Squibb and AstraZeneca's saxagliptin (Onglyza™) is the second DPP inhibitor approved after sitagliptin (Januvia®). It is the first drug approved since the FDA changed its standards for diabetes drug approvals, requiring evidence of cardiovascular safety. While saxigliptin has not shown evidence of higher rates of cardiovascular disease, the FDA is requiring post-marketing studies to specifically look at cardiovascular safety in high-risk populations. Saxigliptin is dosed once daily and is approved as monotherapy or in combination with metformin, sulfonylureas, or thiazolidinediones.

The FDA has announced that it is reviewing adverse event reports of liver injury in patients taking the weight-loss drug orlistat, marketed as the prescription drug Xenical® and over the counter as Alli®. The agency has received 32 reports of serious liver injury in patients taking the drug in the last 10 years. Of these, 6 resulted in liver failure. Almost all of the reports are from outside the United States. The FDA is not recommending patients discontinue the drug, but is suggesting that those who have used orlistat should consult a health care professional if they develop jaundice, fever, fatigue, brown urine, or other symptoms of liver injury.