Safety Alerts & Recalls

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Updated information on drug interactions for Victrelis (boceprevir)
In February 2012, the Food and Drug Administration (FDA) issued a Drug Safety Communication (DSC) regarding a drug-drug interaction study, which showed that taking Victrelis (boceprevir), a hepatitis C virus (HCV) protease inhibitor, and any one of the three ritonavir-boosted HIV protease inhibitors could reduce the desired blood levels of both medicines. Because lower blood levels could lead to less effective treatment of HCV and HIV infections, the FDA recommended that healthcare professionals closely monitor the treatment response of patients who might be taking these drugs in combination. While there is limited information on the effectiveness of Victrelis and ritonavir-boosted HIV protease inhibitors when they are used together in patients co-infected with HIV and HCV, the FDA has updated the Victrelis prescribing information as a precaution. The new labeling states that the use of Victrelis along with certain ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors is not recommended at this time because of the possibility of reducing the effectiveness of the medicines, permitting the amount of HCV or HIV virus in the blood (viral load) to increase. Ritonavir-boosted HIV protease inhibitors include ritonavir-boosted Reyataz (atazanavir), ritonavir-boosted Prezista (darunavir), and Kaletra (lopinavir/ritonavir). A larger clinical trial is planned that will evaluate HCV treatment with Victrelis and peginterferon/ribavirin in patients infected with both HCV and HIV who are also receiving ritonavir-boosted HIV protease inhibitors. The FDA will communicate any important new information about use of these drugs together in co-infected patients when it becomes available. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm301616.htm
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FDA Announces New Warning and Contraindications for Aliskiren-containing Medications
The Food and Drug Administration (FDA) has notified healthcare professionals of possible risks when using blood pressure medicines containing aliskiren (known by the brand name Tekturna) with other drugs called angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) in patients with diabetes or poor kidney function: - The combination of aliskiren with ARBs or ACEIs should not be used (is contraindicated) in patients with diabetes. - The use of aliskiren with ARBs or ACEIs should be avoided in patients with moderate to severe kidney impairment. The labels for the aliskiren medicines are being updated based on preliminary data from a clinical trial, “Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE).” The manufacturer of Tekturna issued these warnings for diabetic patients earlier this year as described in a MediGuard Safety Alert in January 2012: https://www.mediguard.org/alerts/alert/1796.html Aliskiren is a renin inhibitor used to treat high blood pressure (hypertension). The following medicines contain aliskiren alone or in combination with other medicines: Amturnide, Tekturna, Tekturna HCT, Tekamlo, and Valturna. Please note, Novartis (the manufacturer of aliskiren-containing products) has decided to stop marketing Valturna, a combination drug product containing aliskiren and the ARB drug valsartan, but will ensure that Valturna is available until July 2012 so that heathcare professionals can change patients to other therapy. Examples of ACE inhibitors and ACE inhibitor combinations available in the United States 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.fda.gov/Drugs/DrugSafety/ucm300889.htm
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Date Published Title Drug Source
2012-04-27 Updated information on drug interactions for Victrelis (boceprevir) Boceprevir FDA
2012-04-23 FDA Announces New Warning and Contraindications for Aliskiren-containing Medications Aliskiren FDA
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
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