Tofacitinib (Xeljanz) dose-related risk of blood clots and death – New boxed warning
New warning draws attention to the increased risk of blood clots and death associated with higher doses of tofacitinib.... Read More
Pharmacy Services Alerts
Alerts
Multiple Ophthalmic Products by Altaire Pharmaceuticals, Inc. Recall – Potential For Nonsterility
Altaire issued the retail level recall over quality concerns at their manufacturing facility.... Read More
Losartan and Losartan-containing Products Recall - Raw Ingredient May Contain a Potential Carcinogen - UPDATED
Voluntarily recalled tablets of losartan potassium co-formulated with hydrochlorothiazide.... Read More
Fecal Microbiota Transplant (FMT) and Risk of Multi-Drug Resistant Organism Transmission
FDA issued a warning about the risk of transmitting multidrug resistant organisms (MRDOs) via fecal microbiota transplant (FMT).... Read More
Amikacin Sulfate and Prochlorperazine Edisylate Recall Due to Possible Microbial Contamination
Heritage Pharmaceuticals issued a voluntary recall of specific lots of amikacin sulfate and prochlorperazine edisylate injections on May 28, 2019, due to possible lack of sterility.... Read More
Eszopiclone (Lunesta), Zaleplon (Sonata), and Zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist) May Cause Serious Injuries From Complex Sleep Behaviors – New Boxed Warning and Contraindication
Use of certain insomnia medications has caused complex sleep behaviors resulting in serious harm or death.... Read More
Sudden Discontinuation of Opioid Pain Medications May Cause Serious Harm to Patients
Sudden discontinuation or rapid dose reduction of prescription opioids in patients who are physically dependent on these medications can cause serious harm including psychological distress, serious withdrawal symptoms, suicide, and uncontrolled pain.... Read More
Irbesartan and Irbesartan-containing Products Recall - Raw Ingredient May Contain a Potential Carcinogen – Updated
Prinston Pharmaceutical Inc. recalled tablets of irbesartan and irbesartan co-formulated with hydrochlorothiazide. The recall affects 1 lot of irbesartan and 7 lots of irbesartan-hydrochlorothiazide. One of the raw ingredients, irbesartan, USP, made by Zhejiang Huahai Pharmaceutical Co. contains the contaminant N-nitrosodiethylamine (NDEA). ... Read More
Valsartan and Valsartan-containing Products Recall - Raw Ingredient May Contain a Potential Carcinogen - UPDATED
More manufacturers have recently recalled their valsartan products.... Read More
Tofacitinib (Xeljanz, Xeljanz XR) may increase the risk of pulmonary embolism in patients with rheumatoid arthritis
FDA issued a warning that tofacitinib (Xeljanz, Xeljanz XR) may increase the risk of pulmonary embolism in patients with rheumatoid arthritis.... Read More
Febuxostat (Uloric) Increases Risk of Cardiovascular Death and All-Cause Mortality - UPDATE
FDA is strengthening warnings in the febuxostat (Uloric) product labeling and has added a Medication Guide requirement because of an increased risk of cardiovascular death and all-cause mortality.... Read More
Drospirenone and Ethinyl Estradiol Product Recall - Missing/Incorrect Tablet Arrangement
Apotex Corp. voluntarily recalled drospirenone and ethinyl estradiol tablets.... Read More
Levetiracetam in 0.54% Sodium Chloride Injection Mislabeling Recall - Incorrect Concentration
The FDA is notifying the public that Dr. Reddy’s Laboratories Ltd. is voluntarily recalling levetiracetam injection bags due to mislabeling.... Read More
Fluoroquinolones Can Increase the Risk of Aortic Ruptures or Tears
Fluoroquinolones administered orally or intravenously may increase the risk of ruptures or tears in the main artery of the body, also known as the aorta, in certain patients.... Read More
Losartan and Losartan-containing Products Recall – Raw Ingredient May Contain a Potential Carcinogen – UPDATED
Sandoz Inc. voluntarily recalled tablets of losartan potassium co-formulated with hydrochlorothiazide.... Read More
Symptoms of differentiation syndrome caused by enasidenib (Idhifa) are not being recognized and treated
Symptoms of differentiation syndrome are not being recognized in patients receiving enasidenib for the treatment of acute myeloid leukemia (AML).... Read More
Alemtuzumab (Lemtrada) May Increase Risk of Stroke and Arterial Wall Tears
Alemtuzumab (Lemtrada) administered in patients with multiple sclerosis (MS) can increase the risk of hemorrhagic and ischemic stroke and tearing of the arterial vessel walls in the head and neck.... Read More
Discontinuing Fingolimod May Increase the Risk of Severe Disability in Patients with Multiple Sclerosis
Discontinuing fingolimod (Gilenya) may worsen multiple sclerosis (MS) disease severity compared to pretreatment baseline or while on the medication.... Read More
EpiPen® and Generic Alternative Auto-Injectors May Stick to Carrier Tube
FDA released a safety alert regarding EpiPen® auto-injectors, and their generic alternatives, sticking to their carrier tubes which could delay or prevent administration.... Read More
Irbesartan Recall - Raw Ingredient May Contain a Potential Carcinogen
Sciegen Pharmaceuticals voluntarily recalled several unexpired lots of irbesartan tablets labeled for Westminster Pharmaceuticals and Golden State Medical Supply, Inc (GSMS).... Read More
Roche CoaguChek XS PT Test Strips - Recall Due to Inaccurate International Normalized Ratio (INR) Test Results
Roche Diagnostics has recalled 43 lots of CoaguChek XS PT test strips to the patient level (Class I recall).... Read More
SGLT2 Inhibitors May Increase Risk of Rare Perineal Infection in Diabetes Patients
On August 29, 2018, FDA issued a warning that sodium-glucose cotransporter-2 (SGLT2) inhibitors are linked to a rare but serious infection of the genital area, known as necrotizing fasciitis of the perineum.... Read More
Montelukast 10 mg Tablets Recall: Bottle May Contain Losartan 50 mg tablets
The FDA is notifying the public that Camber Pharmaceuticals, Inc is voluntarily recalling montelukast tablets due to mislabeling concerns.... Read More
Azithromycin (Zithromax, Zmax) - Potential for Increased Risk of Cancer Relapse and Death with Long-term Prophylactic Use after Donor Stem Cell Transplant
FDA issued a warning to not prescribe the antibiotic, azithromycin, to patients for long-term prophylactic use post stem cell transplant due to a potential increased risk of cancer relapse and death.... Read More
Systemic Fluoroquinolones - Updated Labeling for Blood Sugar and Mental Health Effects
FDA is strengthening the warnings in the product labeling and Medication Guides for systemic (oral or injectable) fluoroquinolones regarding blood sugar and mental health effects.... Read More
Benzocaine Over-the-Counter Products Can Increase the Risk of Serious or Life-threatening Methemoglobinemia
Over-the-counter (OTC) benzocaine products can cause methemoglobinemia. Methemoglobinemia is a rare condition that reduces the amount of oxygen carried in the blood.... Read More
Synthetic Cannabinoids May Cause Potential Life-Threatening Coagulopathies
Synthetic cannabinoid use is linked to multiple cases of severe bleeding, including several deaths.... Read More
Dolutegravir - Risk for neural tube birth defects
Dolutegravir use may carry a potential risk for neural tube birth defects in women using the drug at the time of conception or in early pregnancy.... Read More
Lamotrigine (Lamictal) - Risk for a Serious Immune System Reaction
FDA is requiring a new warning be added to the labeling of lamotrigine, which is used to treat seizures and bipolar disorders in patients 2 years of age or older.... Read More
Methylprednisolone Sodium Succinate for Injection (40 mg, 125 mg, 1 g) Recall – Vials May Contain High Amounts of Impurities
Sagent Pharmaceuticals is voluntarily recalling 10 lots of methylprednisolone sodium succinate for injection 40 mg, 125 mg, and 1 g vials.... Read More
Acyclovir 400 mg Tablets Mislabeling Recall - Bottle May Contain Torsemide
Apace Packaging LLC is voluntarily recalling acyclovir (Zovirax) tablets due to mislabeling concerns.... Read More
Clarithromycin (Biaxin): Potential Increased Risk of Heart Problems or Death in Patients with Heart Disease
FDA has added a warning to the product labeling of clarithromycin about increased risk of delayed heart disease or death in patients with heart disease.... Read More
Obeticholic Acid (Ocaliva) May Cause Fatal Liver Injury when Incorrectly Dosed in Patient with Liver Impairment - UPDATED
This includes a new black-box warning to highlight the importance of proper dosing based upon hepatic function, as well as a new Medication Guide requirement for patient education.... Read More
Clopidogrel 75 mg Tablets Mislabeling Recall - Bottle May Contain Simvastatin
International Laboratories LLC is voluntarily recalling clopidogrel 75 mg tablets due to mislabeling concerns.... Read More
Senna Laxative Tablets Mislabeling Recall - Bottle Contains Naproxen
Magno-Humphries Laboratories Inc is voluntarily recalling Basic Drugs Brand Senna Laxative tablets due to mislabeling concerns.... Read More
Tramadol, Codeine, and Opioid-Containing Cough and Cold Medicines - New Contraindications and Warnings Regarding Risk of Serious Breathing Problems and Death in Pediatric Patients - UPDATED
The FDA is now requiring new information in the labeling of these products describing the risks of use in children or breastfeeding women.... Read More
Rolapitant (Varubi) Injectable Emulsion: Risk of Anaphylaxis and Other Serious Hypersensitivity Reactions
The manufacturer, Tesaro, recommends that healthcare providers watch for hypersensitivity or anaphylaxis during and following rolapitant administration.... Read More
Gadolinium-based contrast agents: updated warning concerning prolonged retention in the body
Gadolinium-based contrast agents (GBCAs) can remain in patients’ bodies for months to years after administration.... Read More
Limbrel May Cause Drug-Induced Liver Injury and Hypersensitivity Pneumonitis
FDA issued a MedWatch alert concerning the use of Limbrel and risk of drug-induced liver injury and hypersensitivity pneumonitis.... Read More
Biotin (Vitamin B7) May Interfere with Laboratory Test Results Leading to Inaccurate Interpretation
FDA issued a MedWatch alert regarding the interference of biotin (vitamin B7) with laboratory test results.... Read More
Midazolam Injection 2 mg/2 mL Prefilled Syringe Mislabeling
Fresenius Kabi USA is recalling midazolam injection 2 mg/2 mL prefilled syringes due to mislabeling concerns.... Read More
Buprenorphine and Methadone - Appropriate Medication Management with Concomitant Benzodiazepine or CNS Depressants
The FDA issued a communication detailing an approach to possibly continue benzodiazepines or CNS depressants with opioid addiction medications, buprenorphine or methadone.... Read More
Compounded Triamcinolone, Moxifloxacin, and Vancomycin (TMV) Intraocular Injections - Risk of Hemorrhagic Occlusive Retinal Vasculitis
The FDA published an alert describing hemorrhagic occlusive retinal vasculitis (HORV) associated with compounded triamcinolone, moxifloxacin, and vancomycin (TMV) intraocular injection from Imprimis Pharmaceuticals, Inc.... Read More
Sodium Polystyrene Sulfonate (Kayexalate) Should be Dosed Separately From Other Oral Medications
Sodium polystyrene sulfonate, known by the brand name Kayexalate, binds to commonly used oral medications, decreasing their absorption and potentially their effectiveness.... Read More
Pembrolizumab (Keytruda) Increases Risk of Death in Patients with Multiple Myeloma
Pembrolizumab (Keytruda) in combination with dexamethasone and either lenalidomide or pomalidomide increased the risk of death in patients with multiple myeloma based on interim analyses from 2 phase 3 clinical trials.... Read More
PharmaTech Liquid Products – Potential contamination with Burkholderia cepacia - UPDATED
The PharmaTech recall of oral liquid docusate products has been expanded. FDA now recommends not using any liquid products manufactured by PharmaTech. ... Read More
Balguti Kesaria Ayurvedic Medicine – Contains High Levels of Lead
The FDA is warning of high levels of lead in the supplement, Balguti Kesaria Ayurvedic.... Read More
Lorazepam Oral Concentrate – Recall due to Misprinted Dosing Droppers
Amneal is voluntarily recalling certain lots of lorazepam 2 mg/mL oral concentrate (NDC 65162-0687-84), which contain misprinted dosing droppers.... Read More
Pravastatin 40 mg Tablets Mislabeling Recall – Tablets Contain Bupropion
International Laboratories, LLC is voluntarily recalling pravastatin 40 mg tablets due to mislabeling concerns.... Read More
Cyclobenzaprine and Amantadine 50-Count Unit Dose Boxes Recall
Apace Packaging LLC is voluntarily recalling one lot each of cyclobenzaprine and amantadine 50-count unit dose boxes due to mislabeling concerns.... Read More
Recall of Novopen Echo Insulin Delivery Device by Novo Nordisk
The device cartridge may break or crack if exposed to chemicals or cleaning agents.... Read More
Recall of Ticagrelor (Brilinta) Physician Sample Bottles
AstraZeneca is voluntarily recalling ticagrelor (Brilinta) 90 mg physician sample bottles because they may also contain lesinurad (Zurampic) 200 mg tablets, another AstraZeneca product.... Read More
Mibelas 24 Fe Chewable Tablets Packaging Error and Recall
Lupin Pharmaceuticals Inc. recalled lot L600518, expiry 05/18 of Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol 1 mg/0.02 mg and ferrous fumarate 75 mg) chewable tablets.... Read More
Canagliflozin Products (Invokana and Invokamet) Cause Increased Risk of Lower Limb Amputations
A new black-box warning for risk of leg and foot amputations is required for canagliflozin-containing products.... Read More
GEC Laxoplex Dietary Supplement by Genetic Edge Compounds Recall
Genetic Edge Compounds is voluntarily recalling GEC Laxoplex due to FDA concerns regarding the presence of anabolic steroids and other steroid-like substances.... Read More
Hospira 25% Dextrose Injection, USP (Infant) pre-filled syringe – Recall Due to Particulate Matter
Hospira Inc., is voluntarily recalling one lot (NDC 0408-1775-10, Lot # 58382EV) of 25% Dextrose Injection, USP (Infant) prefilled syringes.... Read More
General Anesthetic and Sedation Drugs: New Warnings for Young Children and Pregnant Women – Updated
FDA approved a new warning in the product labeling reflecting this risk.... Read More
Illegal Cancer Products - Fraudulent Claims of Cancer Prevention, Diagnosis, Treatment, or Cure
FDA is warning consumers and health care professionals that several companies have sold products illegally claiming to prevent, diagnose, treat, or cure cancer.... Read More
Epoetin alfa, Darbepoetin alfa: Discontinuation of the Apprise Risk Management Program (REMS)
The FDA has discontinued the Risk Evaluation Mitigation Strategy (REMS) program for the erythropoiesis-stimulating agents (ESAs).... Read More
Homeopathic Teething Tablets and Gels - Potential Risk of Harm to Infants and Children - Updated
FDA issued a warning about the risk of adverse effects from all homeopathic teething tablets and gels. The company has agreed to conduct a recall of their belladonna homeopathic teething products as of April 2017.... Read More
Eluxadoline (Viberzi®) May Cause Serious Pancreatitis in Patients Without a Gallbladder
Eluxadoline (Viberzi®) may cause serious, life-threatening pancreatitis in patients without a gallbladder.... Read More
Well Balance Xanthium & Siler Combo (Bi Yan Pian) by Kingsway Trading Inc.
Kingsway Trading Inc. is recalling its dietary supplement Well Balance Xanthium & Siler Combo (Bi Yan Pian) due to the presence of ephedra herba (ma huang) in the product.... Read More
Chlorhexidine Gluconate – Anaphylaxis Warning Added to Over-the-Counter Drug Facts Label
Due to increases in reports of anaphylaxis, a warning is now being added to the OTC Drug Facts labels.... Read More
Implantable Infusion Pump Safety Concerns – Caution in Magnetic Resonance (MR) Environments
FDA is informing patients and health care professionals that magnetic resonance (MR) environments can cause implantable infusion pump errors resulting in patient harm and death.... Read More
Vascu-Guard Patch Risk of Severe Bleeding Complications
FDA received a cluster of bleeding event reports in 2016 associated with the Vascu-Guard Peripheral Vascular Patch from Baxter International. ... Read More
Opioid Use with Benzodiazepines – New Boxed Warning for Risks of Concomitant Use
FDA is adding a new boxed warning to all opioid medications and benzodiazepines about the risk of serious adverse effects with concomitant use. FDA reviewed 6 studies regarding opioid use with benzodiazepines.... Read More