Tagged Articles

ulcerative colitis 5 articles

FDA panel questions whether bowel disease drug increases risk of deadly brain infection

A Food and Drug Administration (FDA) advisory panel is questioning the safety of Takeda Pharmaceutical’s inflammatory bowel disease drug candidate vedolizumab, claiming the drug could cause patients to develop a rare but deadly brain infection. The panel is set to rule on Dec. 9 whether to recommend the drug be approved for marketing in the United States. The medication fared well in clinical trials as a treatment for ulcerative colitis and Crohn’s disease, but experts say the drug carries the risk of progressive multifocal leukoencephalopathy (PML), a life threatening brain disease that affects immune deficient patients. No patients in clinical ... Read More

Labels on TNFa blockers get stronger warning

The black box warning for a class of immunosuppressant drugs known as Tumor Necrosis Factor-alpha (TNFa) blockers is being updated to include the risk of potentially deadly infections from two bacterial pathogens, Legionella and Listeria. TNFa blockers are biologic products that include Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol), and Simponi (golmumab). TNFa blockers are drugs used to treat Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and/or juvenile idiopathic arthritis. Since TNFs blockers are immunosuprresants, patients who take these drugs are at increased risk of serious, including fatal, infections. These infections can involve ... Read More

Chron’s, colitis drug linked to deadly cancer

A fast-growing and deadly type of cancer has been reported in patients – in particular, adolescents and young adults – who are taking a type of medication used to treat Crohn’s disease and ulcerative colitis. The Food and Drug Administration (FDA) alerted doctors that a rare cancer of white blood cells known as Hepatosplenic T-Cell Lymphoma or HSTCL has been linked to medicines called tumor necrosis factors (TNF) blockers, as well as with azathioprine and/or mercaptopurine. TNF blockers include Remicade (infliximab), Enbrel (etancercept), Humira (adalimumab), Cimzia (certolizumab pegol) and Simponi (golimumab). HSTCL is an aggressive cancer that is usually fatal. ... Read More

IBD treatment’s label warns of birth defect risk

The safety label of Asacol and Asacol HD, a prescription treatment for mildly to moderately active ulcerative colitis (UC), is being updated to include precautions that the medication should not be used during pregnancy because of birth defects in unborn children. UC is a type of inflammatory bowel disease (IBD) that affects the large intestine (colon) and rectum. IBD is characterized by a dysfunction of motility and sensation in the bowel. Symptoms include rectal bleeding, abdominal pain and cramping, an urgent need to go to the bathroom, and diarrhea. About eight new cases of UC per 100,000 people are diagnosed ... Read More

Accutane linked to bowel problem, serious skin condition

A new study on the side effects of Accutane published in the American Journal of Gastroenterology suggest that the acne drug may increase the risk of developing bowel problems. The findings come just weeks after a New Jersey jury awarded an Alabama man $25.16 million because they believed Roche’s Accutane caused the man to develop inflammatory bowel disease (IBD), a group of digestive disorders that includes ulcerative colitis and Crohn’s disease. Researchers looked at data from 87 health insurance providers and found more than 8,000 people had been diagnosed with IBD. The data also showed that people taking Accutane were ... Read More