Safety Alerts & Recalls

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FDA Cautions About Using Testosterone Products for Low Testosterone Due to Aging; Possible Increased Risk of Heart Attack and Stroke
The Food and Drug Administration (FDA) has issued a Drug Safety Communication to caution that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions. Examples of such conditions include failure of the testicles to produce testosterone due to genetic problems or chemotherapy, as well as problems with brain structures (the hypothalamus and pituitary) that control the production of testosterone by the testicles. The FDA has become aware that testosterone is being used extensively to relieve symptoms in men who have low testosterone for no apparent reason other than aging. The benefits and safety of testosterone have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone. Testosterone levels can decrease naturally with age, and sometimes can become lower than the normal range seen in young healthy men. Older men can experience decreases in energy levels and problems with sexual function. It is uncertain whether these symptoms are caused by low testosterone levels or due to normal aging; therefore, the need to replace testosterone in these older men is unclear. Also, based on a review of the available evidence from published studies and input from experts, the FDA has concluded that there might be an increased risk of heart attack and stroke associated with testosterone use. These studies included older men treated with testosterone. Some studies reported an increased risk of heart attack, stroke, or death associated with testosterone treatment, while others did not. The FDA will require makers of prescription testosterone products to clarify the approved uses on the product label and include information about the possible increased risk for heart attack and stroke with use of these products. Some brand names of testosterone products are Androderm, AndroGel, Android, Axiron, Aveed, Delatestryl, Depo-Testosterone, Ditate-DS, Fortesta, Metandren, Natesto, Oreton, Striant, Testim, Testoderm, Testopel, Testred, Virilon, and Vogelxo. For more information, please visit: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm436280.htm
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FDA Warns Ziprasidone (Geodon) May Cause Rare but Serious Skin Reactions
The US Food and Drug Administration (FDA) is warning that the medicine ziprasidone (marketed under the brand name, Geodon) is associated with a rare but serious skin reaction known as DRESS (which stands for Drug Reaction with Eosinophilia and Systemic Symptoms). A warning has been added to the Geodon prescribing information to describe this serious condition. DRESS may start as a rash that can spread to all parts of the body. It can include fever, swollen lymph nodes, and inflammation of the liver, kidney, lungs, heart, or pancreas. DRESS also causes a higher-than-normal number of a certain white blood cells in the blood. DRESS can lead to death. Patients who have a fever with a rash and/or swollen lymph glands should seek immediate medical care. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm426391.htm
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Date Published Title Drug Source
2015-03-05 FDA Cautions About Using Testosterone Products for Low Testosterone Due to Aging; Possible Increased Risk of Heart Attack and Stroke Methyltestosterone FDA
2014-12-11 FDA Warns Ziprasidone (Geodon) May Cause Rare but Serious Skin Reactions Ziprasidone FDA
2014-11-26 FDA Warns About Case of Progressive Multifocal Leukoencephalopathy (PML) With MS Drug Tecfidera (Dimethyl Fumarate) Dimethyl Fumarate FDA
2014-11-25 Empty Gabapentin 300 mg Capsules From Aurobindo Pharma Prompt Recall Gabapentin FDA
2014-11-17 FDA Reviews Recently Published Study Data for Long-term Antiplatelet Therapy Clopidogrel (Plavix) or Prasugrel (Effient) Prasugrel FDA
2014-11-17 FDA Reviews Recently Published Study Data for Long-term Antiplatelet Therapy Clopidogrel (Plavix) or Prasugrel (Effient) Prasugrel FDA
2014-11-14 FDA Raises Concern About Generic Extended-Release Methylphenidate Hydrochloride Tablets (generic Concerta) made by Mallinckrodt and Kudco Methylphenidate FDA
2014-07-03 Oral Lidocaine for Teething Pain May Cause Harm Lidocaine FDA
2014-06-30 FDA Warns That Over-the-Counter Topical Acne Medicines May Cause Serious Allergic Reactions Benzoyl Peroxide FDA
2014-06-26 FDA Warns: Docetaxel May Cause Alcohol Intoxication Docetaxel FDA
2014-06-24 FDA Adds Blood Clot Warning to Testosterone Products Methyltestosterone FDA
2014-06-13 Diabetic Supply of Suncoast, Inc. Recalls Advocate Redi-Code+ BMB-BA006A Blood Glucose Test Strips Manufacturer
2014-06-13 Diabetic Supply of Suncoast, Inc. Recalls Advocate Redi-Code+ BMB-BA006A Blood Glucose Test Strips Tolazamide Manufacturer
2014-05-21 FDA Requests Seizure of Unapproved Drugs Marketed by Ascend Laboratories of Montvale, NJ Hydrocortisone with Pramoxine FDA
2014-05-19 FDA Requires Lower Starting Dose of Lunesta (eszopiclone) to Reduce Risk of Next-Day Impairment Eszopiclone FDA
2014-05-14 FDA Completes Study Reviewing Efficacy and Safety of Pradaxa® (dabigatran) Dabigatran FDA
2014-05-08 Alere Recalls Alere INRatio®2 PT/INR Professional Test Strips Warfarin FDA
2014-05-07 FDA Addresses the Question: “Can an Aspirin a Day Help Prevent a Heart Attack?” Aspirin FDA
2014-05-01 FDA Issues Reminder Warning for Combination Medicines Containing Acetaminophen Acetaminophen with Oxycodone FDA
2014-05-01 FDA Warns: Stop Using GenStrip™ Blood Glucose Test Strips FDA