Drug and Device Safety

Keep up to date with recent drug alerts and through the FDA drug alert system and Vaccine Adverse Event Reporting System (VAERS)

Recent Drug Alerts

Learn more about recent FDA drug safety alerts and communications that may impact your patients.

Zyprexa Relprevv® (olanzapine pamoate)
On March 23, 2015, the FDA issued a drug safety communication on Zyprexa Relprevv® (olanzapine pamoate). The FDA concluded a review of a study undertaken to determine the cause of elevated levels of injectable Zyprexa Relprevv in two patient who died. The study results were inconclusive. Read the full Drug Safety Communication.
Activase® (alteplase)

Genentech has recently updated prescribing information for Activase® (alteplase) to align with the 2006 FDA regulations on the "Physician Labeling Rule (PLR)".  

Changes were made to:

  • Section 4 – Contraindications - For Acute Ischemic Stroke (AIS) treatment should only be initiated within 3 hours after the onset of stroke symptoms, and after exclusion of intracranial hemorrhage by a cranial computerized tomography (CT) scan or other diagnostic imaging method sensitive for the presence of hemorrhage. [See CONTRAINDICATIONS in the full prescribing information]. 
  • Section 5 – Warnings and Precautions.  For AIS treatment of patients with minor neurological deficit or with rapidly improving symptoms is not recommended [See WARNINGS in the full prescribing information].

Read the full prescribing information here.

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Vaccine Adverse Event Reporting System

The Vaccine Adverse Event Reporting System (VAERS) is a national passive surveillance system that monitors the safety of all vaccines licensed for use in the United States. VAERS reports are available through CDC WONDER. All personal identifying information is removed prior to posting the public data. 


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