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FDA MedWatch Alerts

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

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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FLOW-i Anesthesia Systems by Maquet: Class 1 Recall - Dislodged Patient Cassette May

June 30, 2015

[Posted 07/01/2015] AUDIENCE:Risk Manager ISSUE: FDA is providing notification of a Class 1 recall of FLOW-i Anesthesia Systemsby Maquet. The firm has received several complaints where patient cassettes, which are the center of gas flow in the system, have come loose. The patient cassette locking device may accidentally release the patient cassette from its mount when usersperform a change of system. This may...

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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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Potiga (ezogabine): Drug Safety Communication - FDA Determines 2013 Labeling Adequate to Manage Risks of Retinal Abnormalities, Potential Vision Loss, and Skin Discoloration

June 16, 2015

Audience: Neurology, Eye Care, Dermatology. ISSUE: Based on reviews of additional safety reports from patients treated with the anti-seizure drug Potiga (ezogabine), the FDA has determined that the potential risks of vision loss due to pigment changes in the retina and of skin discoloration can be adequately managed by following the current recommendations in the Potiga labeling. To further explore any potential...

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Unintentional Injection of Soft Tissue Filler into Blood Vessels in the Face: FDA Safety Communication - Risk of Serious Patient Injury

May 28, 2015

Audience: Dermotology, Surgery, Neurology, Patient. [Posted 05/28/2015] ISSUE: The FDA has reviewed information that suggests unintentional injection of soft tissue fillers into blood vessels in the face can result in rare, but serious side effects. Unintentional injection can block blood vessels and restrict blood supply to tissues. Sometimes this can result in embolization. This means the filler material has...

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Zerbaxa (ceftolozane and tazobactam): Drug Safety Communication - FDA Cautions about Dose Confusion and Medication Errors

May 19, 2015

Audience: Nursing, Pharmacy, Risk Manager. ISSUE: The U.S. Food and Drug Administration (FDA) is warning health care professionals about the risk for dosing errors with the antibacterial drug Zerbaxa (ceftolozane and tazobactam) due to confusion about the drug strength displayed on the vialand carton labeling. (See the Drug Safety Communication for Label Photos). FDA evaluated seven reported cases of medication...

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SGLT2 inhibitors: Drug Safety Communication - FDA Warns Medicines May Result in a Serious Condition of Too Much Acid in the Blood

May 15, 2015

Audience: Endocrinology, Family Practice. ISSUE: FDA is warning that the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization. FDA is continuing to investigate this safety issue and will determine whether changes are needed in the prescribing...

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Adrucil (fluorouracil Injection, USP) 5 g/100 mL (50 mg/mL): Recall - Particulate Matter

May 5, 2015

Audience: Pharmacy, Oncology, Nursing, Risk Manager. ISSUE: Teva Parenteral Medicines issued a voluntary recall of eight 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. See the press release for a listing of affected lot numbers. Administration...

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Injectable Products by Mylan: Recall - Presence of Particulate Matter

April 24, 2015

Audience: Pharmacy, Oncology, Rheumatology. including certain lots of: Gemcitabine for Injection Carboplatin Injection Methotrexate Injection Cytarabine Injection See the press release for a listing of the product strength, NDC, and lot numbers affected by this recall. Some products may be packaged with a Pfizer Injectables label (see Background below)   [Posted 04/24/2015] ISSUE: Mylan N.V. is...

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Bupivacaine HCl Injection by Hospira: Recall - Iron Oxide Particulate In Glass Vials

April 24, 2015

Audience: Pharmacy, Anesthesiology, Veterinary . ISSUE: Hospira issued a voluntary recall of one lot of Preservative-Free Bupivacaine HCl Injection, USP, 0.5% (5 mg/mL), 30 mL Single-dose (NDC: 0409-1162-02, Lot 38-515-DK, Expiry 1FEB2016) due to one confirmed customer complaint of orange and black, visible particles embedded and free floating within a single-dose glass teartop vial. The particles were identified as...

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Ebola Virus One-Step Test Kits by LuSys Laboratories: Class I Recall - Not Cleared for Marketing

April 22, 2015

[Posted 04/23/2015] AUDIENCE: Infectious Disease, Emergency Medicine ISSUE: The FDA has not cleared or approved the Ebola Virus One-Step Test Kits for use or sale. The results obtained from these test kits have not been demonstrated to be accurate and should not be used as in vitro diagnostic tests for Ebola infection. A false positive result may be life-threatening by potentially placing the patient in an...

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Mucinex Fast-MAX Products: Recall - Incorrect Labeling

April 22, 2015

Audience: Consumer. Including certain lots of Mucinex Fast-MAX Night Time Cold & Flu; Mucinex Fast-MAX Cold & Sinus; Mucinex Fast-MAX Severe Congestion & Cough and Mucinex Fast-MAX Cold, Flu & Sore Throat [Posted 04/22/2015] ISSUE: RB (formerly Reckitt Benckiser) has recalled certain lots of liquid bottles of Mucinex Fast-MAX Night Time Cold & Flu; Mucinex Fast-MAX Cold & Sinus; Mucinex Fast-MAX Severe...

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Flurbiprofen-Containing Topical Pain Medications: FDA Alert - Illnesses and Deaths in Pets Exposed to Prescription Topical Pain Medication

April 17, 2015

Audience: Health Professional, Pharmacy, Consumer, Veterinary. [Posted 04/17/2015] ISSUE: FDA is alerting pet owners, veterinarians, health care providers and pharmacists that pets are at risk of illness and death when exposed to topical pain medications containing the nonsteroidal anti-inflammatory drug (NSAID) flurbiprofen. People using these medications should use care when applying them in a household with...

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Intravenous (IV) Solutions (Select Lots) by Baxter: Recall - Potential Presence of Particulate Matter

April 10, 2015

Audience: Pharmacy, Risk Manager, Nursing. [Posted 04/10/2015] ISSUE:  Baxter International Inc. is voluntarily recalling select lots of intravenous (IV) solutions to the hospital/user level due to the potential presence of particulate matter. Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences. The extent and severity of harm depends on the...

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IV Solutions from Wallcur of San Diego: CDER Statement - FDA Warns Health Care Professionals Not to Inject Patients

April 8, 2015

Audience: Risk Manager, Health Professionals, Pharmacy. UPDATED 04/08/2015. FDA’s laboratory analysis of Wallcur’s simulated Practi-0.9% sodium chloride IV is now complete. FDA sampled 11 of Wallcur’s simulated saline solution bags and identified large amounts of endotoxin and significant bacterial contamination in the samples. These include bacteria (e.g., Bacillus spp., Brevundimonas sp., Pseudomonas...

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Products from Prescription Center Pharmacy in Fayetteville, N.C.: Recall - Lack of Sterility Assurance

April 2, 2015

Audience: Health Professional, Pharmacy, Veterinary, Patient. [Posted 04/02/2015] ISSUE: FDA is joining the North Carolina Board of Pharmacy (NC BOP) to urge health care professionals, including veterinarians, and patients not to use products made and distributed by the Prescription Center pharmacy, located at 915 Hay St., Fayetteville, North Carolina. In an inspection conducted in March by the NC BOP, state...

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Feraheme (ferumoxytol): Drug Safety Communication – Warnings Strengthened and Prescribing Instructions Changed

March 31, 2015

Audience: Hematology, Nephrology, Pharmacy. ISSUE: FDA is strengthening an existing warning that serious, potentially fatal allergic reactions can occur with the anemia drug Feraheme (ferumoxytol). FDA changed the prescribing instructions and approved a Boxed Warning, FDA’s strongest type of warning, regarding these serious risks. Also added is a new Contraindication, a strong recommendation against use of...

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Hepatitis C Treatments Containing Sofosbuvir in Combination With Another Direct Acting Antiviral Drug: Drug Safety Communication - Serious Slowing of Heart Rate When Used With Antiarrhythmic Drug Amiodarone

March 24, 2015

Audience: Cardiology, Infectious Disease, Gastroenterology, Pharmacy. [Posted 03/24/2015] ISSUE: FDA is warning that serious slowing of the heart rate can occur when the antiarrhythmic drug amiodarone is taken together with either the hepatitis C drug Harvoni (ledipasvir/sofosbuvir) or with Sovaldi (sofosbuvir) taken in combination with another direct acting antiviral for the treatment of hepatitis C infection....

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Zyprexa Relprevv (olanzapine pamoate): Drug Safety Communication - FDA Review of Study Sheds Light on Two Deaths Associated with the Injectable Schizophrenia Drug

March 23, 2015

Audience: Psychiatry, Pharmacy, Patient. ISSUE: FDA has concluded a review of a study undertaken to determine the cause of elevated levels of the injectable schizophrenia drug Zyprexa Relprevv (olanzapine pamoate) in two patients who died. The study results were inconclusive. FDA is unable to exclude the possibility that the deaths were caused by rapid, but delayed, entry of the drug into the bloodstream following...

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