FDA warns health care professionals not to inject patients with IV solutions from Wallcur, of San Diego

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FDA warns health care professionals not to inject patients with IV solutions from Wallcur, of San Diego

The U.S. Food and Drug Administration is alerting health care professionals not to use Wallcur, LLC, simulated intravenous (IV) products in human or animal patients. These products are for training purposes only.

Before administering IV solutions to patients, health care providers should carefully check the labels to ensure that the products are not training products, such as Practi IV Solution Bags marketed by Wallcur. Wallcur’s training products, which may bear the words “for clinical simulation,” are not to be administered to patients.

FDA has become aware that some Wallcur training IV products have been distributed to health care facilities and administered to patients. There have been reports of serious adverse events associated with the use of certain of these products – i.e., Practi IV Solution Bags.
If you suspect that any Wallcur training IV products may have been administered to a patient, whether or not the incident has resulted in an adverse event, please report the incident to FDA’s MedWatch Adverse Event Reporting program by:

Adverse events associated with Wallcur training IV products
FDA will continue to investigate and monitor this issue. The agency is also working with the Centers for Disease Control and Prevention to inform health care professionals and state health departments.

To view the FDA alert: http://www.fda.gov/Drugs/DrugSafety/ucm428431.htm

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CDC News: Immunization Works! Newsletter Update

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You are subscribed to CDC’s Immunization Works! Newsletter email subscription service. The current issue is now available.

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CDC Registry (IIS): CVX – Vaccines Administered (HL7 Standard Code Set) Update

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You are subscribed to Registry (IIS): CVX – Vaccines Administered (HL7 Standard Code Set) for Centers for Disease Control and Prevention (CDC). This information has recently been updated and is now available.

Two new vaccines were added to the CVX, vaccine group and trade name tables. These vaccines are HPV9 and influenza, intradermal, quadrivalent.

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CDC’s IIS: Clinical Decision Support for Immunization (CDSi) Update

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You are subscribed to CDC’s IIS Clinical Decision Support for Immunization (CDSi) email subscription service. This information has recently been updated and is now available.

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CDC’s Vaccine Conversations with Parents

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CDC has added two new parent-friendly resources to their Provider Resources for Vaccine Conversations with Parents suite of materials:

  • Vaccines When Your Child is Sick was developed in response to parents’ questions about vaccinating sick children. This fact sheet helps parents understand when their sick child should and should not get vaccinated.
  • Combination Vaccines focuses on combination vaccines, providing information about why they are used and their safety.

See these new resources, along with several other parent-focused materials, at Vaccine Resources to Share with Parents.

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New Study Finds No Safety Concerns in HPV Vaccine During Pregnancy

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New Study Finds No Safety Concerns in HPV Vaccine During Pregnancy

A new CDC study looking at human papillomavirus (HPV) vaccination during pregnancy was published in the journal Vaccine this week.
vaccinesafety-HPV Researchers reviewed reports to the Vaccine Adverse Event Reporting System (VAERS) about women who received the HPV vaccine Gardasil® while they were pregnant. Gardasil® is not currently recommended for pregnant women, given the limited available safety data in pregnancy. However, because catchup vaccination is recommended for women through age 26, there is a possibility that some women will receive the vaccine before realizing that they are pregnant. This study found no patterns of safety concerns for pregnant woman who received Gardasil®, or for their babies.
This study adds to the literature on the safety of HPV vaccination during pregnancy. Gardasil®’s manufacturer, Merck, maintained a Gardasil® Pregnancy Registry from 2006 to 2012. No safety concerns were noted in this registry.

For more information on HPV vaccine safety, see: http://www.cdc.gov/vaccinesafety/Vaccines/HPV/Index.html

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CDC National Infant Immunization Week 2015 Update

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You are subscribed to CDC’s National Infant Immunization Week (NIIW) email subscription service.

The website has been updated with information and materials for NIIW 2015.

Start planning your 2015 NIIW activities now. Visit the National Infant Immunization Week website.

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