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FDA MedWatch Alerts

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

DPP-4 Inhibitors for Type 2 Diabetes: Drug Safety Communication - May Cause Severe Joint Pain

August 28, 2015

Audience: Patient, Endocrinology, Family Practice, Internal Medicine. ISSUE: The U.S. Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines sitagliptin, saxagliptin, linagliptin, and alogliptin may cause joint pain that can be severe and disabling. FDA has added a new Warning and Precaution about this risk to the labels of all medicines in this drug class, called dipeptidyl peptidase-4...

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OmniPod (Pod) Insulin Management System by Insulet Corporation: Recall - Possibility of a Higher Rate of Failure

August 28, 2015

Audience: Risk Manager, Patient, Internal Medicine. [Posted 08/28/2015] ISSUE: Insulet Corporation initiated a lot-specific voluntary recall of 40,846 boxes (10 Pods per box) of the OmniPod (Pod) Insulin Management System. This field corrective action is due to the possibility that some of the Pods from these lots may have a higher rate of failure than Insulet's current manufacturing standards. This recall does not...

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Refresh Lacri-Lube, Refresh P.M., FML 0.1 Percent and Blephamide 10 Percent/0.2 Percent by Allergan: Recall - Particulate Matter

August 24, 2015

Audience: Consumer, Eye Care, Health Professional, Patient. ISSUE: Allergan announced that it is conducting a voluntary recall down to consumer level of specific lots of its Refresh Lacri-Lube 3.5g and 7g for dry eye, Refresh PM 3.5g for dry eye, FML (fluorometholone ophthalmic ointment) 0.1% (sterile ophthalmic ointment topical anti-inflammatory agent for ophthalmic use, 3.5g), and Blephamide (sulfacetamide sodium...

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Picato (ingenol mebutate) Gel: Drug Safety Communication - FDA Warns of Severe Adverse Events, Requires Label Changes

August 21, 2015

Audience: Dermatology, Pharmacy, Patient. ISSUE: FDA is warning about reports of severe allergic reactions and herpes zoster (shingles) associated with the use of Picato gel (ingenol mebutate). FDA received reports of cases involving severe eye injuries and skin reactions associated with the application of Picato gel. Some cases were associated with Picato gel not being used according to the instructions for use on...

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Prolotherapy with Phenol by Hartley Medical: Recall - Non-sterility Concerns

August 18, 2015

Audience: Nursing, Pharmacy, Pain Management, Risk Manager, Compounding. ISSUE: Hartley Medical is recalling three lots of Prolotherapy with Phenol, Injectable to the hospital/user level due to non-sterility concerns. This recall is a voluntary measure taken following a recent inspection with issues on Hartley's sterility methods and testing procedures specifically for this preparation. Parenteral administration of...

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Compounded Drugs Stored in Becton-Dickinson (BD) 3 ml and 5 ml Syringes: FDA Warning - Do Not Use

August 17, 2015

Audience: Pharmacy, Compounding, Nursing, Risk Manager. ISSUE: FDA is alerting health care professionals not to administer to patients compounded or repackaged drugs that have been stored in 3 milliliter (ml) and 5ml syringes manufactured by Becton-Dickinson (BD) unless there is no suitable alternative available. Preliminary information indicates that drugs stored in these syringes may lose potency over a period of...

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Gilenya (fingolimod): Drug Safety Communication - FDA Warns About Cases of Rare Brain Infection

August 4, 2015

Audience: Neurology, Pharmacy. ISSUE: FDA is warning that a case of definite progressive multifocal leukoencephalopathy (PML) and a case of probable PML have been reported in patients taking Gilenya (fingolimod) for multiple sclerosis (MS). These are the first cases of PML reported in patients taking Gilenya who had not been previously treated with an immunosuppressant drug for MS or any other medical condition. As...

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Hydrochlorothiazide Tablets by Unichem Pharmaceuticals (USA), Inc: Recall - Potential Presence of Foreign Tablets Contamination

July 31, 2015

Audience: Pharmacy, Patients. ISSUE: Unichem Pharmaceuticals (USA), Inc. (Unichem) is voluntarily recalling one lot of Hydrochlorothiazide Tablets 25 mg 1000-count bottle to the consumer level. This recall has been initiated as a precautionary measure due to the identification of a Clopidogrel tablet found in a bottle of the product. The risk associated with mistakenly taking a Clopidogrel tablet instead of a...

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0.9 Percent Sodium Chloride Injection, USP (AUTO-C) by Baxter International: Recall - Potential For Leaking Containers, Particulate Matter and Missing Port

July 31, 2015

Audience: Pharmacy, Risk Manager. ISSUE:  Baxter International Inc. announced a voluntarily recall of one lot of intravenous (IV) solution to the hospital/user level due to the potential for leaking containers, particulate matter and missing port protectors. Leaking containers, particulate matter and missing port protectors could result in contamination of the solution. If not detected, this could lead to a...

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Brintellix (vortioxetine) and Brilinta (ticagrelor): Drug Safety Communication - Name Confusion

July 30, 2015

Audience: Pharmacy, Cardiology, Psychiatry. ISSUE: FDA is warning health care professionals and patients that reports of confusion between the antidepressant Brintellix and anti-blood clotting medication Brilinta have resulted in the wrong medication being prescribed or dispensed. FDA determined that the main reason for the confusion between these two medications is the similarity of their brand (proprietary) names....

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Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) by Teva Parenteral Medicines: Recall - Particulate Matter

July 27, 2015

Audience: Risk Manager, Oncology. [Posted 07/27/2015] ISSUE: Teva Parenteral Medicines announced a voluntary recall of six lots of Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) due to the potential presence of particulate matter identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals. Administration of an intravenous product with particulate matter has the...

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Gadolinium-based Contrast Agents for Magnetic Resonance Imaging (MRI): Drug Safety Communication - FDA Evaluating the Risk of Brain Deposits With Repeated Use

July 27, 2015

Audience: Radiology. ISSUE: FDA is investigating the risk of brain deposits following repeated use of gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI). Recent publications in the medical literature have reported that deposits of GBCAs remain in the brains of some patients who undergo four or more contrast MRI scans, long after the last administration. It is unknown whether these...

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Sterile Human and Veterinary Compounded Drugs by Moses Lake Professional Pharmacy: Recall - Lack of Sterility Assurance

July 24, 2015

Audience: Health Professional, Pharmacy, Veterinary, Patient. [Posted 07/24/2015] ISSUE: Moses Lake Professional Pharmacy is voluntarily recalling human and veterinary sterile compounded drugs which are unexpired to the consumer level due to lack of sterility assurance.The company has not received any reports of product contamination or adverse events to date, and is issuing this voluntary recall out of an...

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0.9 Percent Sodium Chloride Injection, USP, 50mL and 100mL by Baxter: Recall - Particulate Matter

July 19, 2015

Audience: Risk Manager, Pharmacy, Nursing. ISSUE: Baxter International Inc. announced it is voluntarily recalling two lots of intravenous (IV) solutions to the hospital/user level due to the potential presence of particulate matter. The particulate matter in each case was determined to be an insect and was identified as a result of a customer complaint. The matter was identified prior to patient administration and...

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Proglycem (diazoxide): Drug Safety Communication - Reports of Pulmonary Hypertension in Infants and Newborns

July 16, 2015

Audience: Pulmonology, Pediatrics, Nursing, Critical Care Medicine. [Posted 07/16/2015] ISSUE: FDA is warning that a serious lung condition called pulmonary hypertension, which is high pressure in the blood vessels leading to the lungs, has been reported in infants and newborns treated with Proglycem (diazoxide) for low blood sugar. In all cases, the pulmonary hypertension resolved or improved after Proglycem...

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Calcium Chloride Intravenous Infusion 10% w/v 10mL Prefilled Syringe by Mylan: Market Withdrawal - Difficulties in Administration

July 13, 2015

Audience: Critical Care Medicine, Nursing. ISSUE: In April 2015, Mylan Institutional conducted a voluntary market withdrawal of 14 lots of Calcium Chloride Intravenous Infusion 10% w/v, packaged in 10 mL prefilled syringes. In June 2015, Mylan Institutional issued a second notification of the market withdrawal. FDA has recently become aware that some units of this drug may still be on the market. Please check your...

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Non-aspirin Nonsteroidal Anti-inflammatory Drugs (NSAIDs): Drug Safety Communication - FDA Strengthens Warning of Increased Chance of Heart Attack or Stroke

July 9, 2015

Audience: Health Professional, Consumer. [Posted 07/09/2015] ISSUE:  FDA is strengthening an existing label warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke. Based on FDAs comprehensive review of new safety information, FDA is requiring updates to the drug labels of all prescription NSAIDs. As is the case with current prescription NSAID...

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Unapproved Prescription Ear Drop (Otic) Products: Not FDA Evaluated for Safety, Effectiveness and Quality

July 1, 2015

Audience: Family Practice, Consumer, Pediatrics. ISSUE: FDA announced its intention to take enforcement action against companies that manufacture and/or distribute certain unapproved prescription ear drop products (known as otic products) labeled to relieve ear pain, infection, and inflammation. The unapproved prescription ear drops contain active ingredients such as benzocaine and hydrocortisone, and have not been...

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Codeine Cough-and-Cold Medicines in Children: Drug Safety Communication - FDA Evaluating Potential Risk of Serious Side Effects

July 1, 2015

Audience: Family Practice, Pediatrics, Surgery, Patient. ISSUE: FDA is investigating the safety of using codeine-containing medicines to treat coughs and colds in children under 18 years because of the potential for serious side effects, including slowed or difficult breathing. Children, especially those who already have breathing problems, may be more susceptible to these serious side effects. In 2013, FDA...

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Daytrana Patch (methylphenidate transdermal system): Drug Safety Communication - Permanent Skin Color Changes

June 24, 2015

Audience: Dermatology, Psychiatry, Pharmacy. ISSUE: FDA is warning that permanent loss of skin color may occur with use of the Daytrana patch (methylphenidate transdermal system) for Attention Deficit Hyperactivity Disorder (ADHD). FDA added a new warning to the drug label to describe this skin condition, which is known as chemical leukoderma. See the FDA Drug Safety Communication for photos of chemical...

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