Pharmacovigilance Russia (EAEU)

FDA MedWatch Drug Alerts

• FDA Updates on Valsartan Recalls Октябрь 16, 2018
  Audience: Consumer, Health Professional, Pharmacy Investigation ongoing – This page to be updated as more information is available FDA releases additional NDMA/NDEA detection methodUpdate [10/16/2018] FDA is posting a gas...
• FDA Alerts Consumers and Pet Owners of Silver Star Brand’s Voluntary Recall of Homeopathic Drug Products Октябрь 4, 2018
  Audience: Consumers, Pet Owners The Food and Drug Administration is alerting consumers and pet owners about a voluntary recall of certain lots of eight products – six products for humans, including four Native Remedies and two Healthful Naturals,...
• Caution When Using Pen Needles to Inject Medicines: FDA Safety Communication Сентябрь 27, 2018
  Audience: Consumer, Health Professional, Pharmacy Audience: Patients and caregivers who use or are considering using pen injectors with pen needles to inject prescription medicines. Health care providers who treat patients, or who train...
• FDA Alerts Consumers of BioLyte Laboratories Voluntary Recall of NeoRelief Сентябрь 14, 2018
  Audience: Consumer [9/14/2018] The Food and Drug Administration is alerting consumers and health care professionals about a voluntary recall of certain lots (1138, 1139, 1146, and 1160) of NeoRelief distributed by BioLyte Laboratories (Grand Rapids,...
• Beaumont Bio Med, Inc. Issues Voluntary Nationwide Recall of all their Homeopathic Aqueous/Alcohol-Based Medicines due to the Nationwide Recall by the Contract Manufacturer, King Bio, of all their Aqueous-Based Products due to Possible Microbial Contamination Сентябрь 5, 2018
  Audience: Consumer, Health Professional, Pharmacy Beaumont Bio Med, Inc. is voluntarily recalling its entire aqueous/alcohol-based product line for human use, within expiry, to the consumer level. All products manufactured by the contract...
• SGLT2 (sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area Август 29, 2018
  Audience: Patient, Endocrinology, Health Professional, Pharmacy ISSUE: FDA is warning that cases of a rare but serious infection of the genitals and area around the genitals have been reported with the class of type 2 diabetes medicines called...
• Zithromax, Zmax (azithromycin): FDA Warning - Increased Risk of Cancer Relapse With Long-Term Use After Donor Stem Cell Transplant Август 3, 2018
  Audience: Patient, Health Professional, Oncology ISSUE: The antibiotic Zithromax, Zmax (azithromycin) should not be given long-term to prevent a certain inflammatory lung condition in patients with cancers of the blood or lymph nodes who undergo a...
• Valsartan-Containing Products: Update Health Professional and Consumer on Recent Recalled Products Июль 19, 2018
  Audience: Consumer, Health Professional, Pharmacy ISSUE: The investigation into valsartan-containing products is ongoing and the following list may change. We will update this statement as we have more information. There are currently three...
• Fluoroquinolone Antibiotics: FDA Requires Labeling Changes Due to Low Blood Sugar Levels and Mental Health Side Effects Июль 10, 2018
  Audience: Patient, Health Professional, Pharmacy ISSUE: FDA is strengthening the current warnings in the prescribing information that fluoroquinolone antibiotics may cause significant decreases in blood sugar and certain mental health side...
• Kratom (mitragyna speciosa) powder products by Gaia Ethnobotanical: Recall - Due to Potential Salmonella Contamination Июнь 22, 2018
  Audience: Consumer, Health Professional ISSUE: The products have been found by the FDA via sample testing and finding to have salmonella contamination. In lieu of such FDA findings the company has implemented standard operating procedures and...