Events

Safety Alert for Piperacilin - Tazobactam

According to Health Ministry (Panama), this safety alert involved a device in Panama that was produced by Pharmayect SA, Laboratorio Libra SA, Laboratorio Richet SA, Aurobindo Pharma Ltd.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2017-08-24
  • Event Date Posted
    2017-09-01
  • Event Country
    Panama
  • Event Source
    HMP
  • Event Source URL
    http://www.minsa.gob.pa/informacion-salud/alertas-y-comunicados?title=&field_decree_date_value%5Bvalue%5D%5Byear%5D=2017&page=4
  • Notes / Alerts
    Panamanian data is current through January 2019. All of the data comes from the Health Ministry (Panama), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Panama.
  • Extra notes in the data
  • Reason
    The drug regulatory authority of canada, health canada, conducted a safety review to assess the possible link between the combination of antimicrobial drugs piperacillin and tazobactam or piperacillin alone and the drug reaction with eosinophilia and systemic symptom or dress syndrome by its acronym in english (drug reaction with eosinophilia and systemic symptom) after published cases of dress associated with the combination of these drugs. dress syndrome describes a group of rare but serious and life-threatening adverse reactions to medications, such as fever, severe skin rash with swollen or bare skin on large areas of the body, etc. these reactions usually occur two weeks to two months after starting a medication. .

Device

Piperacilin - Tazobactam
  • Model / Serial
  • Product Description
    Piperacillin is an extended spectrum beta-lactam antibiotic that belongs to the ureidopenicillin class. The pair is usually co-administered with the beta-lactamase tazobactam inhibitor, leading to increased activity including Gram positive and Gram negative pathogens, and aerobic organisms such as Pseudomonas aeruginosa. Piperacillin is used for the treatment of infections susceptible to strains of microorganisms such as staphylococcus, streptococcus and klebsiella genus. It is indicated for pulmonary, intra-abdominal infections, complicated urinary tract infections and others.
  • Manufacturer
    Pharmayect SA, Laboratorio Libra SA, Laboratorio Richet SA, Aurobindo Pharma Ltd

Manufacturer

Pharmayect SA, Laboratorio Libra SA, Laboratorio Richet SA, Aurobindo Pharma Ltd
  • Source
    HMP