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Early Communication about an Ongoing Safety Review
The FDA has issued an early communication today announcing the ongoing safety review of APROTININ. The communication was issued after the FDA received information from an ongoing clinical trial suggesting that APROTININ may be associated with an increased risk of death compared to other antifibrinolytic drugs. For more information, please visit:
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Updated Prescribing Information Now Available for Inhalers Used for Asthma: Serevent, Foradil, Brovana, and Others
The U.S. Food and Drug Administration (FDA) announced that Long-Acting Beta-Agonists (LABAs), a class of medications used for the treatment of asthma and chronic obstructive pulmonary disease (COPD), now have updated prescribing information. In February 2010, the FDA required manufacturers to revise their drug labels because of an increased risk of severe exacerbation of asthma symptoms in adults and children that could lead to hospitalizations or death. Currently available LABAs include salmeterol (Serevent), formoterol (Foradil, Perforomist), and arformoterol (Brovana) as well as LABAs combined with an inhaled corticosteroid in a single inhaler, sold under the names Advair (salmeterol and fluticasone) and Symbicort (formoterol and budesonide). The new recommendations in the updated prescibing information state: 1) Use of a LABA alone without use of a long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated (absolutely advised against) in the treatment of asthma. Examples of inhaled corticosteroids include beclomethasone (Beclovent, QVAR), budesonide (Pulmicort Flexhaler, Pulmicort Respules), ciclesonide (Alvesco), flunisolide (AeroBid, Aerospan), fluticasone (Flovent), mometasone (Asmanex Twisthaler), and triamcinolone (Azmacort). 2) LABAs should not be used in patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids. 3) LABAs should only be used as additional therapy for patients with asthma who are currently taking but are not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid. 4) Once asthma control is achieved and maintained, patients should be assessed at regular intervals and step down therapy should begin (for example: discontinue LABA), if possible without loss of asthma control, and the patient should continue to be treated with a long-term asthma control medication, such as an inhaled corticosteroid. 5) Pediatric and adolescent patients who require the addition of a LABA to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a LABA, to ensure adherence with both medications. The new recommendations do not apply to the use of LABAs for the treatment of COPD. For more information about the recent FDA MedWatch Alert, please visit: To view the February 2010 iGuard Safety Alert about this issue, please visit:
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Date Published Title Drug Source
2007-10-25 Early Communication about an Ongoing Safety Review FDA
2010-06-03 Updated Prescribing Information Now Available for Inhalers Used for Asthma: Serevent, Foradil, Brovana, and Others Arformoterol FDA
2008-08-14 Weight gain associated with use of antipsychotics Aripiprazole MediGuard CRT
2009-06-08 Antipsychotics Linked With Sudden Cardiac Death Aripiprazole MediGuard CRT
2009-10-28 Newer Antipsychotics Associated with Significant Weight Gain With Short-Term Use in Children and Adolescents Aripiprazole MediGuard CRT
2012-08-17 FDA Warns: Codeine May Be Risky for Some Children FDA
2011-09-01 FDA Warns: Serious Allergic Reactions Reported with the Use of Saphris (Asenapine Maleate) Asenapine FDA
2008-08-13 NSAIDS (Motrin, Advil, Aleve) may reduce the ability of aspirin to prevent a second stroke. Aspirin MediGuard CRT
2008-11-10 Recommendations for Antiplatelet Therapy (Aspirin, Clopidogrel, or Ticlopdipine) Aspirin MediGuard CRT
2009-04-30 FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers Aspirin FDA
2010-01-15 Voluntary Recall of Certain Lots of McNeil Over-the-Counter Products Aspirin Manufacturer
2011-07-19 Bayer Health Recalls Single Lot of Genuine Bayer Aspirin Aspirin FDA
2012-01-18 New Study Raises Concerns about Daily Aspirin Use in People Without a History of Heart Disease Aspirin MediGuard CRT
2013-06-20 One Lot of Rugby Labeled Enteric Coated Aspirin 81 mg Tablets Recalled - May Contain Acetaminophen 500 mg Tablets Aspirin FDA
2014-05-07 FDA Addresses the Question: “Can an Aspirin a Day Help Prevent a Heart Attack?” Aspirin FDA
2009-10-25 Recall of Several Lots of Teva / Ivax Atenolol 25 mg and 50 mg Tablets Atenolol FDA
2012-07-23 Teva Pharmaceuticals USA, Inc. Recalls Several Lots of Atenolol Tablets, 25 mg Atenolol FDA
2011-11-09 FDA Issues Safety Review Update of Medications Used to Treat Attention-Deficit/Hyperactivity Disorder (ADHD) Atomoxetine FDA
2008-08-08 Combination use can lead to rare condition of muscle damage Atorvastatin FDA
2008-11-10 Cholesterol-lowering Medications May Increase Risk of Confusion After Surgery Atorvastatin MediGuard CRT
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