Safety Alerts & Recalls

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FDA Limits Use of 80 mg Simvastatin
The Food and Drug Administration (FDA) is placing limits on the use of medicine containing 80 mg of simvastatin—the highest approved dose of the popular cholesterol-lowering statin—because of the risk of muscle injury. The FDA says this high dose should only be used by patients who currently have been taking simivastatin 80 mg for 12 months or longer and have not experienced any muscle toxicity. Simvastatin 80 mg should not be prescribed to new patients. There are also new contraindications and dose limitations for when simvastatin is taken with certain other medications. All statins, despite their proven benefit in lowering the risk of heart attacks and strokes, carry some risk of an muscle injury called myopathy, which causes symptoms of unexplained muscle tenderness, weakness or pain. A very rare form of myopathy, called rhabdomyolysis, can lead to kidney failure and other serious problems. The risk of myopathy is greater for patients who take the 80 mg dose of simvastatin, especially in the first year of treatment. These muscle problems can also be caused by interactions with other medications and some people have a genetic predisposition toward simvastatin-related myopathy. Simvastatin is sold under the brand name Zocor and as a single-ingredient generic drug. It is also sold in combination with ezetimibe as Vytorin, and niacin as Simcor. The FDA has revised the drug labels for simvastatin, Vytorin, and Simcor products to include the new dose restrictions and to include dosing recommendations when these drugs are used with medicines that can increase the level of simvastatin in the body, thus increasing the risk of myopathy. For more information and to view a list of medicines that interact with simvastatin, please visit: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm257884.htm  and http://www.fda.gov/Drugs/DrugSafety/ucm256581.htm#Simvastatin_Dose_Limitations and http://www.fda.gov/Drugs/DrugSafety/ucm256581.htm
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FDA Issues Drug Safety Communication: Finasteride (Proscar, Propecia), Dutasteride (Avodart, Jalyn) May Increase the Risk of a More Serious Form of Prostate Cancer
The U.S. Food and Drug Administration (FDA) is informing healthcare professionals that the Warnings and Precautions section of the labels for the 5-alpha reductase inhibitor (5-ARI) class of drugs has been revised to include new safety information that these drug products may increase the risk of high-grade prostate cancer. The product labeling will also state that 5-ARIs are not approved for the prevention of prostate cancer. Medicines in the 5-ARI class are primarily used to treat the symptoms of benign prostatic hyperplasia (BPH) and include finasteride, marketed as Proscar and dutasteride, marketed as Avodart and marketed in combination with tamsulosin under the brand name Jalyn. Finasteride is also available under the brand name Propecia. The brand Propecia is only indicated for the treatment of male pattern hair loss in men. The labels of all of these 5-alpha reductase inhibitors are being revised based on FDA's review of two large studies examining whether these medicines reduce the risk of prostate cancer. The studies did find an overall reduction in the risk of lower-grade forms of prostate cancer, but both studies also showed an increased risk of high-grade prostate cancer. High-grade prostate cancer is an aggressive type of prostate cancer, meaning it grows and spreads faster compared to low-grade prostate cancer. High-grade prostate cancer is a serious disease, but accounts for a small portion of all diagnosed prostate cancers. The applicability of the Avodart and Proscar studies to Propecia is currently unknown. While the dose of finasteride in Propecia is lower than the amount of finasteride in Proscar, the active ingredient is the same and the warnings are being added to the Propecia labeling out of caution. The FDA will continue its risk/benefit assessment of using 5-ARIs for the treatment for male pattern hair loss and will update the public when additional information is available. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm258314.htm  and http://www.fda.gov/Drugs/DrugSafety/ucm258358.htm
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Date Published Title Drug Source
2011-06-08 FDA Limits Use of 80 mg Simvastatin Simvastatin FDA
2011-06-09 FDA Issues Drug Safety Communication: Finasteride (Proscar, Propecia), Dutasteride (Avodart, Jalyn) May Increase the Risk of a More Serious Form of Prostate Cancer Finasteride FDA
2011-06-13 Healthcare Providers Reminded About Risks With Victoza Liraglutide FDA
2011-06-14 FDA Issues Warning About Medication Errors Due to Name Confusion Between Risperidone (Risperdal) and Ropinirole (Requip) Risperidone FDA
2011-06-14 Endo Pharmaceuticals Recalls Single Lot of Percocet 10 mg/325 mg Acetaminophen with Oxycodone FDA
2011-06-15 Bristol-Myers Squibb Expands May 2011 Recall: More Tablet Strengths Recalled Warfarin Manufacturer
2011-06-15 FDA Issues Safety Update for Ongoing Safety Review of Actos (Pioglitazone) and Increased Risk of Bladder Cancer Glimepiride and Pioglitazone FDA
2011-06-16 FDA Warns: Chantix (varenicline) May Increase the Risk of Heart Attack, Angina and Other Heart-Related Adverse Events in Patients with Cardiovascular Disease Varenicline FDA
2011-06-18 Ortho-McNeil Voluntarily Recalls Two Lots: Risperdal (Risperidone) 3mg and Risperidone 2mg Risperidone Manufacturer
2011-06-23 New Study Suggests High-Dose Statins May Cause Diabetes Atorvastatin MediGuard CRT
2011-06-24 New Study: Combining Commonly Used Drugs Linked to a Greater Risk of Death and Declining Brain Function Beclomethasone MediGuard CRT
2011-06-24 FDA Modifies Dosing Recommendations for Erythropoiesis-Stimulating Agents Epoetin Alfa FDA
2011-06-27 Rugby Recalls Children's Pain & Fever Concentrated Drops Due To Problems With Child-Resistant Closure Acetaminophen Manufacturer
2011-06-27 Endo Pharmaceuticals Recalls Endocet Bottles With Wrong Pill Sizes Acetaminophen with Oxycodone Manufacturer
2011-06-28 Qualitest Recalls Four Lots of Butalbital, Acetaminophen, and Caffeine Tablets and Four Lots of Hydrocodone Bitartrate and Acetaminophen Tablets Butalbital FDA
2011-06-30 McNeil Recalls Single Lot of Tylenol Extra Strength Caplets, 225 count Acetaminophen Manufacturer
2011-06-30 New Study Suggests High-Dose Statins May Cause Diabetes Simvastatin MediGuard CRT
2011-07-07 Chantix: New Study Links Drug to Heart Problems Varenicline MediGuard CRT
2011-07-12 Fetal Exposure To Valproate Medicine During Pregnancy May Cause Cognitive Delay Divalproex Sodium FDA
2011-07-13 CDC Revises Recommendations for the Use of Birth Control Methods During the Initial Period After Childbirth MediGuard CRT