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FDA Requires Manufacturers to Conduct Safety Studies for Long-Acting Beta-Agonists (LABAs)
As a follow up to a June 2010 Drug Safety Communication, the U.S. Food and Drug Administration (FDA) announced its plan to further evaluate the safety of Long-Acting Beta-Agonists (LABAs) when used in combination with inhaled corticosteroids for the treatment of asthma. LABAs are a class of medications used for the treatment of asthma and chronic obstructive pulmonary disease (COPD). Currently available LABAs include arformoterol (Brovana), formoterol (Foradil, Perforomist), and salmeterol (Serevent), as well as LABAs combined with an inhaled corticosteroid in a single inhaler, sold under the names Advair (salmeterol and fluticasone), Dulera (formoterol and mometasone) and Symbicort (formoterol and budesonide).
The FDA is requiring the manufacturers of LABAs to conduct five clinical research studies comparing the addition of LABAs to inhaled corticosteroids versus inhaled corticosteroids alone. The FDA hopes these studies will provide more information about the increased risk of serious asthma outcomes, such as asthma-related death, intubation, or hospitalization that have been linked to LABAs.
For more information, please visit:
http://www.fda.gov/Drugs/DrugSafety/ucm251512.htm
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FDA Continues to Receive Reports of Rare Cancer in Patients Treated With TNF Blockers, Azathioprine, and/or Mercaptopurine
The U.S. Food and Drug Administration (FDA) has announced that it continues to receive reports of a rare cancer of white blood cells known as Hepatosplenic T-Cell Lymphoma or HSTCL, mainly in adolescents and young adults being treated with medicines known as 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 (fast-growing) cancer and is usually fatal. The majority of cases reported were in patients being treated for Crohn’s disease or ulcerative colitis, but also included a patient being treated for psoriasis and two patients being treated for rheumatoid arthritis.
Although most reported cases of HSTCL occurred in patients treated with a combination of medicines known to suppress the immune system, including the TNF blockers, azathioprine, and/or mercaptopurine, there have been cases reported in patients receiving azathioprine or mercaptopurine alone.
TNF blockers suppress the immune system by blocking the activity of TNF, a substance in the body that can cause inflammation and lead to immune-system diseases, such as Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. Azathioprine (also known as Imuran) and mercaptopurine (known as Purinethol) also suppress the immune system. They are commonly used as part of a combination regimen or used alone to treat Crohn’s disease and ulcerative colitis, although they are not approved for those uses. Azathioprine is approved for the prevention of rejection following renal transplantation and for the reduction of signs and symptoms of rheumatoid arthritis. Mercaptopurine is approved to treat acute lymphatic leukemia.
For more information, please visit:
http://www.fda.gov/Drugs/DrugSafety/ucm250913.htm
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