Safety Alerts & Recalls

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Important Information for the Safe Use of Fentanyl Patches
The Food and Drug Administration (FDA) issued a reminder to patients, caregivers, and healthcare professionals of the importance of appropriate storage, use, application, and disposal of fentanyl patches to prevent potential life-threatening harm from accidental exposure to the active ingredient, fentanyl. Fentanyl is sold under the brand name Duragesic and under the generic name fentanyl. Recently, the FDA evaluated a series of 26 cases of where young children were accidentally exposed to fentanyl patches. Of these 26 cases reported over the past 15 years, ten resulted in death and 12 in hospitalization. Sixteen of the 26 cases occurred in children two years old or younger. The FDA also previously alerted the public to the appropriate use and disposal of fentanyl patches following the receipt of reports of death and life-threatening adverse events related to fentanyl overdose. In these advisories, the FDA reminded patients, caregivers, and physicians about the appropriate use and disposal of patches. To view the FDA Safety Update on the proper use of fentanyl patches, please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm051257.htm For more information about the FDA's recent alert about case reports of accidental exposure to fentanyl in young children, please visit: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm300803.htm?source=govdelivery
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Novartis Issues Safety Information Update Gilenya (fingolimod)
Novartis has been informed of a progressive multifocal leukoencephalopathy (PML) diagnosis in a JCV antibody positive multiple sclerosis (MS) patient who had previously been treated with Tysabri (natalizumab) for approximately three and a half years prior to initiating treatment with Gilenya (fingolimod). PML is a rare but serious brain infection. The John Cunningham Virus (JCV) is a common virus that many people have been exposed to at some point in their lives, and is generally harmless. However, people with weakened immune systems have an increased chance of developing PML from JCV. There is a known risk of PML associated with Tysabri treatment, especially in patients who are JCV antibody positive and have been treated with Tysabri for more than two years. The current assessment is that Tysabri is the drug most likely associated with this case of PML. However, it is unknown if Gilenya contributed to the development of this case of PML. This is the first reported PML case in approximately 36,000 Gilenya-treated patients, of whom approximately 2,400 were treated for more than two years and approximately 500 were treated for more than four years. There is currently no confirmed case of PML reported to Novartis in a Gilenya-treated patient without previous Tysabri treatment. Novartis is currently gathering all available details on this case report and the details have been submitted to the FDA and other health authorities. For more information, please visit: http://www.novartis.com/downloads/newsroom/product-related-info-center/statement-PML.pdf and http://online.wsj.com/article/SB10001424052702304444604577341490361751420.html
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Date Published Title Drug Source
2012-04-19 Important Information for the Safe Use of Fentanyl Patches Fentanyl FDA
2012-04-16 Novartis Issues Safety Information Update Gilenya (fingolimod) Fingolimod Manufacturer
2012-04-13 FDA Updates Prescribing Information for Finasteride (Propecia, Proscar) Finasteride FDA
2012-04-11 FDA Completes Safety Review of Drospirenone-Containing Birth Control Pills - Yaz (generics – Gianvi and Loryna), Yasmin (generics – Ocella, Syeda, and Zarah), Beyaz, and Safyral Drospirenone with Ethinyl Estradiol FDA
2012-04-04 FDA Warns about Counterfeit Altuzan (bevacizumab), a Cancer Medicine Bevacizumab FDA
2012-04-01 Sandoz Inc Recalls Select Lots of Enoxaparin Sodium Injection, 100 mg/mL and 30 mg/mL Lovenox FDA
2012-03-28 FDA Revises Recommendations for Citalopram (Celexa) Related to a Potential Risk of Abnormal Heart Rhythms Citalopram FDA
2012-03-27 Procter & Gamble Co. Recalls Several Lots of Pepto Bismol Original, Cherry Flavor, and Max Strength Bismuth FDA
2012-03-27 Mylan Technologies, Inc. Recalls Single Lot of Clonidine Transdermal System, 0.2 mg/day Clonidine FDA
2012-03-27 Sandoz, Inc. Recalls Single Lot of Midodrine Tablets, 5mg Midodrine Hydrochloride FDA
2012-03-27 Golden State Medical Supply Inc. Recalls Several Lots of Ropinirole 0.25 mg, 0.5 mg, 1 mg and 2 mg tablets Ropinirole FDA
2012-03-19 Noven Pharmaceuticals, Inc Recalls Several Lots of Daytrana (methylphenidate) Patch, 20 mg and 30 mg Methylphenidate FDA
2012-03-19 Hi-Tech Pharmacal Co. Recalls Single Lot of Valproic Acid Oral Solution 250 mg/5 mL Divalproex Sodium FDA
2012-03-19 Johnson & Johnson Recalls Single Lot of Aveeno Baby Calming Comfort Lotion FDA
2012-03-19 Teva Pharmaceuticals Recalls Single Lot of Flutamide Capsules 125 mg Flutamide FDA
2012-03-19 Bausch & Lomb Recalls Single Lot of Brimonidine Tartrate Ophthalmic Solution 0.2% Brimonidine FDA
2012-03-08 FDA Warns that Skin Lightening and Anti-Aging Products Found to Contain Mercury Royal Jelly FDA
2012-03-07 Sun Pharmaceutical Industries Recalls Several Lots of Azelastine Hydrochloride Ophthalmic Solution, 0.05% Azelastine FDA
2012-03-07 GlaxoSmithKline Inc. Recalls Several Lots of Ventolin HFA (Albuterol Sulfate) 90 mcg Albuterol FDA
2012-03-07 Sandoz Inc. Recalls Select Lots of Cefprozil Powder for Oral Suspension, USP 125 mg/5 mL and 250 mg/5 mL Cefprozil FDA