Safety Alerts & Recalls

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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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Date Published Title Drug Source
2011-04-19 FDA Requires Manufacturers to Conduct Safety Studies for Long-Acting Beta-Agonists (LABAs) Mometasone and Formoterol FDA
2011-04-15 FDA Continues to Receive Reports of Rare Cancer in Patients Treated With TNF Blockers, Azathioprine, and/or Mercaptopurine Etanercept FDA
2011-04-14 Ortho-McNeil Voluntarily Recalls Two Lots of Topamax 100 mg Topiramate Manufacturer
2011-04-08 FDA Warns Consumers About Serious Side Effect Linked To the Use of Benzocaine Found in Over-the Counter Anbesol, Hurricaine, Orajel, Baby Orajel, Orabase, and Other Store Brands FDA
2011-03-31 McNeil Recalls 10 Lots of OTC Products, Including Tylenol 8 Hour, Tylenol Arthritis Pain, Tylenol Sinus, Benadryl and Sudafed PE Products Acetaminophen with Pseudoephedrine Manufacturer
2011-03-31 McNeil Recalls Single Lot of Tylenol 8 Hour Extended Release Caplet - 150 count Acetaminophen Manufacturer
2011-03-30 APP Pharmaceuticals, Inc. Recalls Select Lots of Irinotecan Vials Due to Contamination Irinotecan FDA
2011-03-30 FDA Issues Safety Alert: Special Storage and Handling Requirements Must Be Followed for Pradaxa (Dabigatran Etexilate Mesylate) Capsules Dabigatran FDA
2011-03-28 Possible Label Switch Prompts Recall of Generic Citalopram 10mg and Finasteride 5mg Citalopram FDA
2011-03-24 FDA Issues Update for Proton Pump Inhibitors and Risk of Fractures Dexlansoprazole FDA
2011-03-18 Lilly Informs Customers of Important Information About Alcohol Prep Pads in Forteo Starter Kits Teriparatide Manufacturer
2011-03-17 Primatene Mist With Chlorofluorocarbons No Longer Available After Dec. 31, 2011 Epinephrine FDA
2011-03-14 King Pharmaceuticals Inc. Recalls Embeda Morphine and Naltrexone Manufacturer
2011-03-10 New Study: Mothers Taking Opioid Pain Medicines May Place Infants At Increased Risk for Birth Defects MediGuard CRT
2011-03-08 Animas Insulin Pump 2.0 mL Cartridge Recalled Insulin Manufacturer
2011-03-08 FDA Warns About Serious Health Problems Seen in Premature Babies Given Kaletra Oral Solution Lopinavir with Ritonavir FDA
2011-03-05 Marlex Pharmaceuticals and Cispharma Inc. Recall Select Lots of Acetaminophen Tablets, 325mg Acetaminophen FDA
2011-03-05 Glenmark Generics Inc. Recalls Several Lots of Alclometasone Dipropionate Ointment USP, 0.05% Alclometasone FDA
2011-03-05 Teva Pharmaceuticals Recalls Several Lots of Nifediac CC (nifedipine), Extended Release Tablets, 30 mg, 60 mg and 90 mg Nifedipine FDA
2011-03-05 FDA Warns About Risk of Oral Birth Defects in Children Born to Mothers Taking Topiramate Topiramate FDA