Safety Alerts & Recalls

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FDA Issues Statement on Possible Increased Risk of Rare Bone Fractures with Long-Term Bisphosphonate Use
The American Society of Bone and Mineral Research's (ASBMR's) expert Task Force recently released a report that recommended changes to product labels alerting healthcare professionals and patients to the possibility of rare fractures of the thigh bone with long-term use of bisphosphonates, a class medicines most commonly used to treat and prevent osteoporosis. Bisphosphonates include alendronate (Fosamax, Fosamax Plus D), ibandronate (Boniva), risedronate (Actonel, Actonel with Calcium), tiludronic acid (Skelid) and zoledronic acid (Reclast). The FDA first announced an ongoing safety review of the bisphosphonates and the risk of unusual thigh fractures in March 2010. The FDA review process has included working closely with outside experts such as the ASBMR Task Force. Since the initial report of unusual thigh fractures with bisphosphonates was published, the FDA has been reviewing all data available on the products and is considering revisions to the prescribing information. The FDA will update the public when more information on this safety issue is available. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm225681.htm
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FDA Announces Safety Review of Actos (Pioglitazone) for Cancer Risk
The U.S. Food and Drug Administration (FDA) is conducting a review of results from an ongoing, ten-year study designed to determine if Actos (pioglitazone) is associated with an increased risk of bladder cancer. Findings from studies in animals and humans suggest this potential safety risk needs further study. The FDA has not concluded that Actos increases the risk of bladder cancer. The FDA's review of this safety concern is ongoing and the FDA will update the public when more information is available. Actos contains the active ingredient pioglitazone and is used in the treatment of type 2 diabetes. Pioglitazone is also sold in combination with other diabetes medicines under the brand names Duetact, Actosplus Met, and Actosplus Met XR. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm226214.htm
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Date Published Title Drug Source
2010-09-19 FDA Issues Statement on Possible Increased Risk of Rare Bone Fractures with Long-Term Bisphosphonate Use Ibandronate Sodium FDA
2010-09-17 FDA Announces Safety Review of Actos (Pioglitazone) for Cancer Risk Glimepiride and Pioglitazone FDA
2010-09-16 FDA Announces New Pediatric Dosing Guidelines for Valcyte Valganciclovir FDA
2010-09-11 FDA Sends Warning Letters to Makers of Electronic Cigarettes FDA
2010-08-20 FDA: Ongoing Safety Review of Stalevo and Possible Increased Risk of Heart Attack and Stroke Entacapone FDA
2010-08-17 Companies Failed To Prove Benefits of Midodrine (ProAmantine) Midodrine Hydrochloride FDA
2010-08-16 Proctor & Gambles Recalls Select Lots of Vicks Sinex Nasal Spray Oxymetazoline FDA
2010-08-15 Single Lot of ShopKo Cold/Flu Relief Multi Symptom Night Time Original Recalled Acetaminophen with Dextromethorphan and Doxylamine FDA
2010-08-15 Allergan Recalls Acuvail Eye Drops Ketorolac FDA
2010-08-12 FDA: Aseptic Meningitis Risk with Use of Seizure Drug Lamictal Lamotrigine FDA
2010-08-11 Teva Recalls Select Lots of Amoxicillin for Oral Suspension, 400 mg/5 mL Amoxicillin FDA
2010-08-11 Wellbutrin XL 150 mg: Single Lot Recalled Bupropion FDA
2010-08-11 2010-2011 Flu Vaccine: What Consumers Should Know Influenza Vaccine FDA
2010-08-05 Delay in Results From FDA's Ongoing Safety Review of Stimulant Medications used in Children with ADHD Lisdexamfetamine FDA
2010-08-05 FDA Warns: Nimodipine Is for Oral or Feeding Tube Use Only Nimodipine FDA
2010-07-30 Apotex Corp.Recalls Single Lot of Carbamazepine Tablets 200 mg Carbamazepine FDA
2010-07-30 Paddock Laboratories, Inc. Recalls Single Lot of LiothyronineTablets Liothyronine FDA
2010-07-30 McNeil Healthcare Recalls Additional Lot of Motrin IB Ibuprofen FDA
2010-07-30 Vintage Pharmaceuticals LLC Recalls Single Lot of Ibudone, 5 mg/200 mg tablets Hydrocodone Bitartrate with Ibuprofen FDA
2010-07-29 The FDA Announces Ongoing Safety Review of Evamist and Reports of Unintended Exposure of Children and Pets Estradiol FDA
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