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FDA MedWatch Alerts

FDA Label Changes are now available online and in our monthly newsletter update.

AVEA Ventilator by CareFusion: Class I Recall - Electrical Issue May Cause Unexpected Shutdown

July 28, 2016

Audience: Risk Manager, Nursing, Critical Care Medicine. [Posted 07/28/2016] ISSUE: CareFusion is recalling the AVEA Ventilator because of a faulty fuse on the ventilators’ alarm board, which may cause the ventilator to unexpectedly shut down. If the ventilator shuts down, a patient may not receive necessary oxygen. The use of affected product may cause serious adverse health consequences, including d...

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Fluoroquinolone Antibacterial Drugs for Systemic Use: Drug Safety Communication - Warnings Updated Due to Disabling Side Effects

July 26, 2016

Audience: Family Practice, Infectious Disease, Neurology, Pharmacy, Patient. ISSUE: FDA approved changes to the labels of fluoroquinolone antibacterial drugs for systemic use (i.e., taken by mouth or by injection). Includes the following currently available fluoroquinolones: Avelox (moxifloxacin) Cipro (ciprofloxacin) Cipro extended-release (ciprofloxacin extended-release) Factive (gemifloxacin) Levaquin...

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HCG and Sermorelin by Talon Compounding Pharmacy: Recall - Lack of Sterility Assurance

July 22, 2016

Audience: Patient, Pharmacy. ISSUE: Talon Compounding Pharmacy (TCP) voluntarily recalled all lots of lyophilized HCG and sermorelin aseptically compounded and packaged by TCP and that remain within expiry due to FDA concern over a lack of sterility assurance. Administration of a sterile drug product intended to be sterile that is compromised can result in health hazards including risk of serious infection or other...

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Oral Liquid Docusate Sodium by PharmaTech : Recall - Contaminated with B. cepacia

July 16, 2016

Audience: Health Professional. ISSUE: The FDA is alerting health care professionals that PharmaTech LLC, Davie, Florida, is voluntarily recalling all non-expired lots of Diocto Liquid, a docusate sodium solution distributed by Rugby Laboratories, Livonia, Michigan. The agency confirmed the product has been contaminated with Burkholderia cepacia, a bacteria linked to an outbreak in five states. In addition, FDA has...

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Canagliflozin (Invokana, Invokamet) and Dapagliflozin (Farxiga, Xigduo XR): Drug Safety Communication - Strengthened Kidney Warnings

June 14, 2016

Audience: Endocrinology, Internal Medicine, Nephrology, Pharmacy. ISSUE: FDA has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR).  Based on recent reports, we have revised the warnings in the drug labels to include information about acute kidney injury and added recommendations to ...

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Nature Made (Various Products) by Pharmavite LLC: Recall - Possible Health Risk

June 8, 2016

Audience: Consumer. [Posted 06/08/2016] ISSUE: Pharmavite LLC is recalling specific lots of Nature Made products due to possible Salmonella or Staphylococcus aureus contamination. Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever,...

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Step 2 60 Gold by The Body Shot Bar: Recall - Undeclared Drug Ingredients

June 7, 2016

Audience: Consumer. [Posted 06/07/2016] ISSUE: The Body Shot Bar is voluntarily recalling all lots distributed March 1- May 6 2016 of Step 2 60 gold capsule (350MG per) capsules to the consumer level. Step 2 has been found positive for Sibutramine after FDA sampling and testing. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010. Sibutramine is known to substantially...

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Loperamide (Imodium): Drug Safety Communication - Serious Heart Problems With High Doses From Abuse and Misuse

June 7, 2016

Audience: Pharmacy, Cardiology, Internal Medicine, Pain Management, Consumer. ISSUE: FDA is warning that taking higher than recommended doses of the common over-the-counter (OTC) and prescription diarrhea medicine loperamide (Imodium), including through abuse or misuse of the product, can cause serious heart problems that can lead to death. The risk of these serious heart problems, including abnormal heart rhythms,...

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Over-the-Counter Antacid Products Containing Aspirin: FDA Drug Safety Communication - Serious Bleeding Risk

June 6, 2016

Audience: Consumer. ISSUE: The FDA is warning consumers about the risk of serious bleeding when using nonprescription, also known as over-the-counter or OTC, aspirin-containing antacid products to treat heartburn, sour stomach, acid indigestion, or upset stomach. Many other products for these conditions are available that do not contain aspirin. These widely used products already contain warnings about this...

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Zecuity (sumatriptan) Migraine Patch: Drug Safety Communication - FDA Evaluating Risk of Burns and Scars

June 2, 2016

Audience: Internal Medicine, Pain Management, Neurology, Pharmacy. ISSUE: FDA is investigating the risk of serious burns and potential permanent scarring with the use of Zecuity (sumatriptan iontophoretic transdermal system) patch for migraine headaches. Since marketing of the Zecuity patch began in September 2015, a large number of patients have reported they experienced burns or scars on the skin where the patch...

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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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