Safety Alerts & Recalls

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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: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm213836.htm To view the February 2010 iGuard Safety Alert about this issue, please visit: https://www.iguard.org/alerts/alert/814.html
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All Lots of Four Select PediaCare Products Recalled
Blacksmith Brands, Inc., in consultation with the U.S. Food and Drug Administration (FDA), is voluntarily recalling all lots of four children's products in the PediaCare line. The four PediaCare items involved in the recall are: 1. PediaCare Multi-Symptom Cold 4oz. UPC # 3 0045-0556-05 9 (contains dextromethorphan and phenylephrine) 2. PediaCare Long Acting Cough 4oz. UPC# 3 0045-0465-04 7 (contains dextromethorphan) 3. PediaCare Decongestant 4oz. UPC# 3 0045-0554-04 8 (contains phenylephrine) 4. PediaCare Allergy and Cold 4oz. UPC# 3 0045-0552-04 4 (contains diphenhydramine and phenylephrine) Blacksmith Brands has issued this recall as a precautionary step because the products were made at the McNeil Consumer Healthcare Fort Washington, Pennsylvania plant that has been temporarily shut down. A recent FDA inspection at that facility found serious problems in meeting the FDA's current good manufacturing practice requirements and led to a recall of several McNeil Consumer Healthcare products. Items NOT involved in this recall are PediaCare Allergy 4oz., PediaCare Gentle Vapors Plug in Units, and PediaCare Gentle Vapors refills, all of which are produced in other facilities. For more information, please visit: http://www.fda.gov/Safety/Recalls/ucm214005.htm To view Pediacare Recall Frequently Asked Questions webpage, please visit: http://pediacare.com/recall-faq
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Date Published Title Drug Source
2010-06-03 Updated Prescribing Information Now Available for Inhalers Used for Asthma: Serevent, Foradil, Brovana, and Others Arformoterol FDA
2010-06-01 All Lots of Four Select PediaCare Products Recalled Dextromethorphan Manufacturer
2010-06-01 All Lots of Four Select PediaCare Products Recalled Manufacturer
2010-05-27 FDA Completes Safety Review of Xenical/Alli (Orlistat) and Severe Liver Injury Orlistat FDA
2010-05-26 FDA Updates Prescribing Information for Proton Pump Inhibitors to Warn About Increased Risk of Fractures Dexlansoprazole FDA
2010-05-25 Ultram and Ultracet Prescribing Information Updated Tramadol FDA
2010-05-12 Serious Side Effects from Swallowing Topical Benadryl Product Diphenhydramine FDA
2010-05-12 Nycomed Recalls Several Different Eye Ointments Maxitrol FDA
2010-05-12 Diflorasone Cream: Nycomed Recalls Two Lots Diflorasone FDA
2010-05-12 Proton Pump Inhibitors (PPIs) May Be Linked to Bone Fractures and Bacterial Infections Omeprazole MediGuard CRT
2010-05-10 Voluntary Recall of Certain Lots of Claritin Eye Drops Ketotifen Manufacturer
2010-05-06 What Consumers Need to Know About Recalled Liquid Products for Children Cetirizine Manufacturer
2010-05-04 Medication Guide Reviews Risks of Vivitrol Naltrexone Manufacturer
2010-05-03 FDA Announces Ongoing Safety Review of Gonadotropin-Releasing Hormone (GnRH) Agonists Lupron FDA
2010-05-03 Voluntary Recall of Certain Liquid Children's and Infants' Tylenol Motrin, Zyrtec, and Benadryl Products Cetirizine Manufacturer
2010-04-26 Metoprolol: Ipca Laboratories Recalls Single Lot of Metoprolol Tartrate 50 mg Tablets Metoprolol FDA
2010-04-26 DIgoxin: West-ward Recalls Single Lot of Digoxin 125 mcg (0.125 mg) Tablets Digoxin FDA
2010-04-21 Propylthiouracil: FDA Requires Addition of Boxed Warning About Reports of Severe Liver Injury Propylthiouracil FDA
2010-04-20 Triclosan: FDA Publishes Questions and Answers Guide Triclosan FDA
2010-04-20 Risperidone: Dr. Reddy's Recalls Several Lots Risperidone FDA