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New from FDA: Drug Safety Newsletter now Available

FDA is announcing a new quarterly publication for healthcare professionals called the Drug Safety Newsletter. Every year, FDA receives more than 400,000 reports of adverse events associated with the use of drugs marketed in the U.S. FDA continu...

Recalls and Safety Alerts: Caution on Viracept in Children and Pregnant Women

Pfizer is advising healthcare professionals to avoid treating certain children and pregnant women with the antiretroviral drug Viracept (nelfinavir mesylate). The company says that patients taking Viracept have the potential to be exposed to an...

Recalls and Safety Alerts: Warning on Unapproved Antitussives Containing Hydrocodone

FDA is taking action against companies that market unapproved drugs containing hydrocodone, a controlled substance. Hydrocodone is a narcotic widely used as an analgesic in approved products such as Vicodin. It is also used as a cough suppressant. ...

Recalls and Safety Alerts: Preventing Meningitis in Children with Cochlear Implants

FDA is reminding healthcare practitioners about the importance of vaccinating children with cochlear implants against bacterial meningitis caused by Streptococcus pneumoniae. Two deaths from meningitis have been reported over the past year in childr...

Recalls and Safety Alerts: Possible Link between Bisphosphonates and Atrial Fibrillation

FDA has issued an early communication to healthcare professionals about a possible association between bisphosphonate drugs, which are used to treat osteoporosis, and atrial fibrillation. This issuance is part of FDA's commitment to keep the public ...

Recalls and Safety Alerts: Severe Adverse Events with Ultrasound Micro-bubble Contrast Agents

FDA is alerting healthcare professionals about serious cardiopulmonary reactions from the ultrasound micro-bubble contrast agents Definity or Optison. These products are used during echocardiography to enhance a cardiac image. Eleven deaths and...

Recalls and Safety Alerts: Possibility of Pancreatitis in Patients Taking Byetta

FDA is alerting healthcare professionals that Byetta (exenatide) may be associated with acute pancreatitis in some patients. Byetta is administered subcutaneously to treat type 2 diabetes. FDA has reviewed 30 reports of acute pancreatitis in pat...

Recalls and Safety Alerts: Recall of Sprint Fidelis Cardiac Leads

Medtronic Inc. has stopped distributing Sprint Fidelis defibrillation leads because of the possibility that these leads could fracture in a small percentage of patients. Although the leads continue to function properly in the vast majority of pat...

New Medical Products: First Rapid Test for Bacterial Contamination in Platelets

FDA recently cleared for marketing the first rapid test to detect bacterial contamination in blood platelets before transfusion. The test, called the Platelet Pan Genera Detection (PGD) Test System, was developed by Verax Biomedical Inc. Bacter...

UMC Unveils Plans to Build Diamond Children’s Medical Center

University Medical Center unveiled plans to build Tucson’s first children’s hospital – Diamond Children’s Medical Center.

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