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FDA MedWatch Alerts

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Nizoral (ketoconazole) Oral Tablets: Drug Safety Communication - Prescribing for Unapproved Uses including Skin and Nail Infections Continues; Linked to Patient Death

May 19, 2016

Audience: Dermatology, Family Practice, Pharmacy, Patient. ISSUE: FDA is warning health care professionals to avoid prescribing the antifungal medicine ketoconazole oral tablets to treat skin and nail fungal infections. Use of this medication carries the risk of serious liver damage, adrenal gland problems, and harmful interactions with other medicines that outweigh its benefit in treating these conditions, which...

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Well Care Compounding Pharmacy Sterile Compounded Products: Recall - Lack Of Sterility Assurance

May 18, 2016

Audience: Pharmacy, Veterinary Medicine. [Posted 05/18/2016] ISSUE: Well Care Compounding Pharmacy is performing a voluntary statewide recall in Nevada on all unexpired sterile compounded products due to FDA concern over lack of sterility assurance. The recall impacts all sterile compounded products distributed between 01/01/2016-04/29/2016. Well Care Compounding Pharmacy is conducting this recall after an FDA...

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Canagliflozin (Invokana, Invokamet): Drug Safety Communication - Clinical Trial Results Find Increased Risk of Leg and Foot Amputations

May 18, 2016

Audience: Internal Medicine, Family Practice, Pharmacy, Patient. ISSUE: FDA is alerting the public about interim safety results from an ongoing clinical trial that found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the diabetes medicine canagliflozin (Invokana, Invokamet). FDA has not determined whether canagliflozin increases the risk of leg and foot amputations. FDA...

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SOS Telecom Products: Recall - Undeclared Drug Ingredient

May 13, 2016

Audience: Consumer. [Posted 05/13/2016] ISSUE: SOS Telecom, Inc. is voluntarily recalling all lots of the following products to the consumer level because these products were tested by the FDA and found to contain Sildenafil, and analogs of Sildenafil.  Sildenafil is a PDE-5 Inhibitor which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED), making these products tainted dietary ...

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BiCNU (carmustine for injection): FDA Alert - Counterfeit Product Discovered in Some Foreign Countries

May 13, 2016

Audience: Health Professional, Pharmacy, Oncology. ISSUE: FDA is informing health care professionals that a counterfeit version of the FDA approved cancer drug, BiCNU (carmustine for injection) 100 mg, has been detected in some foreign countries. There is no indication at this time that counterfeit BiCNU has entered the legitimate U.S. drug supply chain and no indication that any U.S. patients have received...

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Fluoroquinolone Antibacterial Drugs: Drug Safety Communication - FDA Advises Restricting Use for Certain Uncomplicated Infections

May 12, 2016

Audience: Internal Medicine, Family Practice, Pharmacy, Patient. ISSUE: FDA is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolones should be reserved for those who do not have ...

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Olanzapine: Drug Safety Communication - FDA Warns About Rare But Serious Skin Reactions

May 10, 2016

Audience: Psychiatry, Dermatology, Patient. ISSUE: FDA is warning that the antipsychotic medicine olanzapine can cause a rare but serious skin reaction that can progress to affect other parts of the body. FDA is adding a new warning to the drug labels for all olanzapine-containing products that describes this severe condition known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). A search of the...

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PharMEDium Sterile Preparations Compounded With a Single Recalled Lot of Fresenius Kabi Sensorcaine-MPF (bupivacaine HCl): Recall - Presence of Glass Particulate Matter

May 9, 2016

Audience: Pharmacy, Risk Manager ISSUE: PharMEDium Services, LLC is voluntarily recalling the codes/lots of sterile preparations compounded with a single recalled lot of Fresenius Kabi Sensorcaine-MPF (bupivacaine HCl) to the hospital level. Fresenius Kabi recalled the specific lot at issue due to identification of particulate matter, characterized as glass, during reserve sample inspection. The list of affected...

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Aripiprazole (Abilify, Abilify Maintena, Aristada): Drug Safety Communication - FDA Warns About New Impulse-control Problems

May 3, 2016

Audience: Psychiatry, Internal Medicine, Patient. ISSUE: FDA is warning that compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with the use of the antipsychotic drug aripiprazole (Abilify, Abilify Maintena, Aristada, and generics). These uncontrollable urges were reported to have stopped when the medicine was discontinued or the dose was reduced. These impulse-control...

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Brintellix (vortioxetine): Drug Safety Communication - Brand Name Change to Trintellix, to Avoid Confusion With Antiplatelet Drug Brilinta (ticagrelor)

May 2, 2016

Audience: Psychiatry, Internal Medicine, Pharmacy. ISSUE:  FDA has approved a brand name change for the antidepressant Brintellix (vortioxetine) to decrease the risk of prescribing and dispensing errors resulting from name confusion with the blood-thinning medicine Brilinta (ticagrelor). The new brand name of the drug will be Trintellix, and it is expected to be available starting in June 2016. No other changes will ...

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Making It A Lifestyle, L.L.C. Supplements 3rd Degree, Black Gold X Advanced, and Black Label X: Recall - Undeclared Drug Ingredients

May 2, 2016

Audience: Consumer. [Posted 05/02/2016] ISSUE: Making It A Lifestyle, L.L.C. is voluntarily recalling all lots of 3rd Degree, Black Gold X Advanced and Black Label X capsule form supplements to the consumer level. The products have been found to contain undeclared sibutramine and sildenafil. These undeclared ingredients make these products an unapproved new drug for which safety and efficacy have not been...

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Sensorcaine-MPF (bupivacaine HCl) by Fresenius Kabi: Recall - Presence of Particulate Matter

April 26, 2016

Audience: Surgery, Dentistry, OBGYN, Nursing, Pharmacy. ISSUE: Fresenius Kabi USA announced today it is voluntarily recalling a single lot (Lot Number 6111504; Product Code 470237) of Sensorcaine®-MPF (bupivacaine HCl) Injection, USP, 0.75%, 7.5 mg/mL, 30 mL fill in a 30 mL vial. The recall is being performed to the user level due to visible particulate matter characterized as glass observed by the company during ...

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Fluconazole (Diflucan): Drug Safety Communication - FDA Evaluating Study Examining Use of Oral Fluconazole (Diflucan) in Pregnancy

April 26, 2016

Audience: Internal Medicine, Family Medicine, OB/GYN. ISSUE: FDA is evaluating the results of a Danish study that concludes there is a possible increased risk of miscarriage with the use of oral fluconazole (Diflucan) for yeast infections. FDA is also reviewing additional data and will communicate final conclusions and recommendations when the review is complete. The current FDA drug label states that data...

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Sterile Drug Products from Pharmakon Pharmaceuticals, Inc: CDER Statement - FDA alerts health care professionals not to use due to a lack of sterility assurance and other quality issues

April 16, 2016

Audience: Pharmacy, Nursing, Health Professional ISSUE: FDA is alerting health care professionals not to use any drug products that are intended to be sterile and are produced and distributed nationwide by Pharmakon Pharmaceuticals Inc., in Noblesville, Indiana, due to a lack of sterility assurance and other quality issues. BACKGROUND: FDA recently inspected Pharmakon’s facility following the company’s voluntary re...

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50 Percent Magnesium Sulfate Injection, USP by Hospira: Recall - Presence Of Particulate Matter

April 14, 2016

Audience: Pharmacy, Nursing, OB/GYN. [Posted 04/14/2016] ISSUE: Hospira, Inc. is voluntarily recalling one lot of 50% Magnesium Sulfate Injection, USP, 10 g/20 mL (0.5 g/ml), 20 mL Single-dose vials, Lot 50-343-DK, Expiration 01FEB2017, NDC 0409-2168-02, to the hospital level due to a confirmed customer complaint for the presence of particulate matter, within one single-dose fliptop vial. A recall was previously...

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Super Herbs Capsules: Recall - Undeclared Drug Ingredients

April 12, 2016

Audience: Consumer. [Posted 04/12/2016] ISSUE: Super Herbs is voluntarily recalling all bottles of SUPER HERBS, light green and dark green capsules to the consumer level after FDA laboratory testing found SUPER HERBS to contain sibutramine, desmethylsibutramine, and/or phenolphthalein. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010. Desmethylsibutramine is an...

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Metformin-containing Drugs: Drug Safety Communication - Revised Warnings for Certain Patients With Reduced Kidney Function

April 8, 2016

Audience: Pharmacy, Nephrology, Internal Medicine, Patient. ISSUE: FDA is requiring labeling changes regarding the recommendations for metformin-containing medicines for diabetes to expand metformin’s use in certain patients with reduced kidney function. The current labeling strongly recommends against use of metformin in some patients whose kidneys do not work normally. FDA was asked to review numerous medical s...

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Diabetes Medications Containing Saxagliptin and Alogliptin: Drug Safety Communication - Risk of Heart Failure

April 5, 2016

Audience: Pharmacy, Internal Medicine, Patient, Endocrinology. ISSUE: An FDA safety review has found that type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure, particularly in patients who already have heart or kidney disease. As a result, FDA is adding new warnings to the drug labels about this safety issue. Medicines containing saxagliptin and alogliptin...

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Continuum Labs LGD-4033 by Invisiblu International: Recall - Investigational Drug Not Approved for Use

April 5, 2016

Audience: Consumer. ISSUE: Invisiblu International LLC is voluntarily recalling one lot of Continuum Labs LGD-Xtreme, 3 mg to the retail and consumer level. The product has been found to contain LGD-4033 Ligandrol, an investigational drug not approved for use. The risks of using this product are unknown. The affected LGD-Xtreme lot numbers are 21511166 with expiration dates of 11/2018. BACKGROUND: LGD-Xtreme is...

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Sterile Drug Products by Medaus Pharmacy: FDA Alert - Lack of Sterility Assurance

April 1, 2016

Audience: Pharmacy, Nursing, Health Professional. [Posted 04/01/2016] ISSUE: FDA is alerting health care professionals and patients not to use unexpired drug products that are intended to be sterile that were produced by Medaus Pharmacy in Birmingham, Alabama, due to lack of sterility assurance. Medaus’ products were distributed nationwide and internationally. BACKGROUND: During FDA’s recent inspection of Med...

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