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Novartis Provides Important Information about Tekturna and Aliskiren-Based Products
In a recent "Dear Doctor Letter," Novartis has informed healthcare professionals about important new safety information for aliskiren (Tekturna) following a recent review of the results from the ongoing study Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE). The ALTITUDE study is a study of diabetic patients taking both aliskiren and an angiotensin converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB). The study showed patients treated with both aliskiren and an ACE or an ARB were unlikely to benefit from aliskiren and were at a higher than expected risk for non-fatal stroke, kidney complications, high blood potassium levels, and low blood pressure. The review of the study data is ongoing. However, as a precautionary measure, Novartis is recommending that aliskiren or aliskiren-containing fixed combination products should not be used in combination with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARB) in patients with diabetes. Aliskiren (Rasilez), ACE inhibitors and ARBs are all used in the treatment of high blood pressure. Aliskiren is sold under the brand name Tekturna and as the combination product Amturnide, Tekamlo, Tekturna HCT, and Valturna. Examples of ACE inhibitors and ACE inhibitor combinations available in the US are: Benazepril (Lotensin, and the combinations Lotrel, Lotensin HCT), Captopril (Capoten, and the combination Capozide), Enalapril (Vasotec and the combination Vasoretic), Fosinopril, Lisinopril (Prinivil, Zestril and the combinations Prinzide, Zestoretic), Moexipril (Univasc and the combination Uniretic), Perindopril (Aceon), Quinapril (Accupril and the combinations Accuretic, Quinaretic), Ramipril (Altace), and Trandolapril (Mavik and the combination Tarka). Examples of ARBs and ARB combinations available in the US are: Candesartan (Atacand and the combitation Atacand HCT), Eprosartan (Teveten and the combination Teveten HCT), Irbesartan (Avapro and the combination Avalide), Losartan (Cozaar and the combination Hyzaar), Olmesartan (Benicar, and the combinations Azor, Benicar HCT, Tribenzor), Telmisartan (Micardis and the combinations Micardis HCT, Twynsta), and Valsartan (Diovan and the combinations Diovan HCT, Exforge HCT, Valturna). For more information, please visit: http://www.pharma.us.novartis.com/assets/pdf/TKT-1118923%20Dear_HCP_Letter_email_with%20Tek-Val%20PIs_vf.pdf and http://www.pharma.us.novartis.com/assets/pdf/ALTITUDE-US-FAQ.pdf
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Possible Supply Shortage and Rare Tablet Mix-up For Opioid Pain Medications from Endo Pharmaceuticals
The U.S. Food and Drug Administration (FDA) and Endo Pharmaceuticals are advising patients and healthcare professionals of a potential safety risk associated with opioid pain medicines manufactured for Endo Pharmaceuticals by Novartis Consumer Health. The FDA’s inspection of the Novartis manufacturing facility found a packaging problem that may result in a pill, tablet or caplet getting mixed in with a bottle of another product. The likelihood of this occurring in medication dispensed to patients is estimated to be low. Endo Pharmaceuticals reports that they are aware of only three product mix-ups with respect to these products since 2009. At this time, no products are being recalled, however, to ensure patient safety and continued access to needed pain medicines, patients and healthcare professionals are being asked to examine the tablets in their prescriptions to identify whether there is a wrong pill in a medication bottle. The FDA is working with Novartis and Endo to resolve the packaging problem. Production of certain Endo products has been temporarily stopped in order to implement manufacturing process improvements. As a result, Endo expects that there may be a short-term shortage in the supply of these products to patients. Opioids are potent medications used to alleviate pain and are available only by prescription. The following Endo Pharmaceutical products may be affected by the packaging problem: - Opana ER (oxymorphone hydrochloride) Extended-Release Tablets - Opana (oxymorphone hydrochloride) Tablets - Oxymorphone hydrochloride Tablets - Percocet (oxycodone hydrochloride and acetaminophen USP) Tablets - Percodan (oxycodone hydrochloride and aspirin, USP) Tablets - Endocet (oxycodone hydrochloride and acetaminophen USP) Tablets - Endodan (oxycodone hydrochloride and aspirin, USP) Tablets - Morphine Sulfate Extended-Release Tablets - Zydone(hydrocodone bitartrate/acetaminophen tablets, USP) To view a visual guide to verify the appearance of these products, please visit: http://endo.com/pdf/Supply_disruption/Visual_Guide.pdf This public health advisory applies only to tablets manufactured for Endo Pharmaceuticals by Novartis Consumer Health. Liquid and powder form medicines, and blister packaged products manufactured for Endo Pharmaceuticals by Novartis Consumer Health are not included in this alert. Also several of these products are manufactured by other companies under other brand or generic names; products from other companies are not affected by this alert. For more information, please visit: http://endo.com/Supply_disruption.aspx http://www.fda.gov/Drugs/DrugSafety/ucm286226.htm
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Date Published Title Drug Source
2012-01-09 Novartis Provides Important Information about Tekturna and Aliskiren-Based Products Aliskiren Manufacturer
2012-01-09 Possible Supply Shortage and Rare Tablet Mix-up For Opioid Pain Medications from Endo Pharmaceuticals Acetaminophen with Oxycodone FDA
2012-01-13 New Study Study Finds Small Increased Risk of Heart Attack in Patients Treated with Pradaxa Dabigatran MediGuard CRT
2012-01-16 New Boxed Warning for Progressive Multifocal Leukoencephalopathy (PML) and Contraindication for Adcetris (Brentuximab vedotin) Brentuximab Vedotin FDA
2012-01-18 New Study Raises Concerns about Daily Aspirin Use in People Without a History of Heart Disease Aspirin MediGuard CRT
2012-01-18 Rexall, Inc Issues Allergy Alert and Recall of Single Lot of Calcium 1200mg plus Vitamin D 1000 IU Softgels FDA
2012-01-24 FDA Announces New Risk Factor for Progressive Multifocal Leukoencephalopathy (PML) Associated with Tysabri (Natalizumab) Natalizumab FDA
2012-01-26 FDA Makes Changes to Risk Evaluation and Mitigation Strategies (REMS) Program for Nplate (Romiplostim) and Promacta (Eltrombopag) Romiplostim FDA
2012-01-30 Treanda (bendamustine HCL) Recall - Particles Found in Vial Bendamustine FDA
2012-02-01 Pfizer Announces Voluntary Nationwide Recall Of Lo/Ovral-28 And Norgestrel/Ethinyl Estradiol Tablets Due To Tablet Mix-Up Ethinyl Estradiol with Norgestrel Manufacturer
2012-02-02 Sandoz Inc. Recalls Single Lot of Fluoxetine Capsules 10 mg Fluoxetine FDA
2012-02-02 Taro Pharmaceuticals USA, Inc. Recalls Several Lots of Fluocinonide, Ointment USP, 0.05% Fluocinonide FDA
2012-02-02 Warner Chilcott Company Recalls Several Lots of Ovcon 50 Tablets Norethindrone with Ethinyl Estradiol FDA
2012-02-02 Paddock Laboratories, Inc. Recalls Select Lots of Ciclopirox Gel 0.77% Ciclopirox FDA
2012-02-02 Glenmark Generics Inc. Recalls Single Lot of Glenmark Clotrimazole Cream Clotrimazole FDA
2012-02-02 Sanofi-aventis US, Inc. Recalls Several Lots of Lantus Insulin Glargine FDA
2012-02-02 Teva Pharmaceuticals USA, Inc Recalls Select Lots of Tetracycline Capsules 500 mg Tetracycline FDA
2012-02-08 FDA Issues Safety Announcement: Proton Pump Inhibitors (PPIs) Possibly Associated with Clostridium Difficile-Associated Diarrhea (CDAD) Dexlansoprazole FDA
2012-02-13 FDA Issues Warning about Important Drug Interactions Between Victrelis (boceprevir) and Ritonavir-boosted Human Immunodeficiency Virus (HIV) Protease Inhibitors Lopinavir with Ritonavir FDA
2012-02-16 FDA and Manufacturers Warn about Conterfeit Avastin (Bevacizumab) Bevacizumab FDA