November 16, 2011

Baxter Healthcare Corporation has sent a notice of a labeling error affecting the expiration date of the Sterile Water for Injection that is packaged as a diluent with RECOMBINATE [Antihemophilic Factor (Recombinant)]. The Sterile Water for Injection label indicates that the shelf life is longer than what was actually approved by the FDA.

Please continue to use the RECOMBINATE product as labeled on the kit. There is no impact to the safety or efficacy of Recombinate if the Sterile Water for Injection diluent is used before the expiration date of the RECOMBINATE.

Read the rest of this entry »

Practical advice to help plan airplane trips

By Elizabeth Thompson Beckley | 06.24.2010
Originally Published January 2007 | Updated June 2010

Hopping a plane can be stressful nowadays, as you deal with long check-in lines, baggage fees and enhanced security. But for people with hemophilia and other bleeding disorders, the biggest concern is often how to transport their factor products and supplies safely to their destination. Here’s what you need to know about traveling with medication.

After the discovery of a 2006 London terrorist plot involving liquid explosives, airlines limited the amount of liquids, aerosols and gels travelers can carry on board airplanes. This regulation particularly affects passengers who need to keep medical supplies with them. This includes clotting factor products, needles, syringes and other supplies required for treatment of bleeding disorders. Being prepared with complete information about your medications, and packing them properly, will go a long way toward smoothing the security screening process.

Read the rest of this entry »

Medical Advisory #414
October 26, 2011

WARNING ABOUT USE OF NON-STERILE ALCOHOL WIPES

In January 2011, NHF issued a Medical Advisory (#412) about a recall of non-sterile alcohol wipes produced by one company, Triad. In April, the FDA forced this company to close. Now, additional infections have occurred in patients using non-sterile alcohol wipes manufactured by another company, Pacific Disposables International (PDI). This company has also been required by the FDA to recall their products. Both of these companies package their products under their own label and under other companies’ labels.

At this time, it appears prudent to recommend that all individuals who have alcohol wipes or other prep pads/swabs in their home examine the individual packages to see if they contain the word “Sterile.” This includes wipes that are packaged with factor or other IV preparation kits. If the word “sterile” does not appear on the package, there is no way to determine if they are in fact sterile or not. Therefore, individuals should discontinue use of any wipes that do not state “sterile” and request replacement with sterile wipes from their clotting factor distributor.

Nurses should also check their supply of alcohol wipes to ensure that they are only using sterile wipes. This is particularly important for patients with indwelling venous access devices (catheters or ports) and for patients with compromised immune systems, but should be standard of care for all patients.

By JoNel Aleccia
Health writer

msnbc.com
updated 10/10/2011 8:46:40 AM ET 2011-10-10T12:46:40

A massive recall of potentially contaminated alcohol prep products by a second manufacturer is raising sharp questions about an entire category of medical supplies: non-sterile pads and swabs, infection experts say.

“Is there any place for a non-sterile alcohol prep pad in a hospital setting?” said Dr. Christine Nyquist, a Colorado infection control director who blew the whistle on dangerous bacteria in alcohol wipes last fall. “We believe there isn’t.”

Nyquist and other microbiology experts say a debate is brewing about whether the non-sterile pads and wipes routinely used in hospitals, clinics and private homes to clean skin before shots and other procedures should be curtailed — or perhaps banned —
because of the potential for infection. While sterile pads have had problems, too, non-sterile products may raise alarms from the start.

Read the rest of this entry »

By Melanie Padgett Powers | 09.15.2011

Originally Published September 2011

Children and adults with bleeding disorders can and should receive the recommended immunizations for their age group. These vaccinations are often given by their primary care physician.

Most vaccinations can be given subcutaneously, or under the skin, instead of intramuscularly, or into the muscle, to reduce the risk of a muscle bleed. However, some healthcare providers may prefer to give intramuscular injections using a smaller needle in a larger muscle, like the thigh, according to “Caring for Your Child,” published by the National Hemophilia Foundation.

Read the rest of this entry »

September 5, 2011

A University of Central Florida and University of Florida collaboration has landed $5.6 million in National Institutes of Health grants for hemophilia research.

The first grant, $3.6 million over five years, is aimed at determining whether a green technique pioneered at UCF will help make treatment of hemophilia A more effective. The second grant, $2 million for four years, covers similar research for hemophilia B. The grants were awarded to UCF and UF, which applied for funding jointly thanks to a long-time collaboration between scientists at both institutions. Duke University also is a partner for the research on hemophilia A.

Read the rest of this entry »

Biogen Idec and Swedish Orphan Biovitrum Present Data on Long-Lasting Recombinant Factor VIII Therapy at International Society on Thrombosis and Haemostasis Meeting

–Results Show Potential to Significantly Reduce the Burden of Treatment for People with Hemophilia A–

KYOTO, Japan, Jul 26, 2011 (BUSINESS WIRE) –

Biogen Idec (NASDAQ: BIIB) and Swedish Orphan Biovitrum (STO: SOBI) today announced Phase 1/2a trial data showing that the companies’ long-lasting fully-recombinant factor VIII Fc fusion protein (rFVIIIFc) was well tolerated and demonstrated an approximately 1.7-fold increase in half-life compared with Advate(R) (antihemophilic factor recombinant, plasma/albumin-free method, rFVIII), a commercially-available factor VIII product, in 16 previously-treated patients with severe hemophilia A. The findings, which were seen consistently across all patients and dose levels, are being presented today at the XXIIIrd Congress of the International Society on Thrombosis and Haemostasis in Kyoto, Japan.

Read the rest of this entry »

Initiated by : Baxter Healthcare
Event Id : 146
Event Date : 07-27-2011

Therapy Recombinate rAHF
NDC Number Lot Number Size Packaging Expiration Date
0944283310TRA09834AB10 mL- 01-28-2012

Reason Baxter is voluntarily recalling one (1) lot of RECOMBINATE [Antihemophilic Factor (Recombinant)], product code 1501594, NDC Number 0944-2833-10, lot number TRA09834AB, with an expiry date of January 28, 2012.

This action is being taken as a precautionary measure after a retrospective review of manufacturing processes revealed a potential breach in aseptic processing may have occurred during the manufacture of this lot. It is important to note that this lot met all in-process and final container specifications, including sterility and pyrogenicity. There have been no reports of adverse events associated with this lot; however, in an abundance of caution, Baxter has decided to recall this particular lot of RECOMBINATE. The Food and Drug Administration has been notified of this action.
Action 1) Please check all product labels against affected lot number.
2) Do not take this product. Return affected recalled lots to the point of purchase to receive replacement product.
3) Contact your physician if you have medical questions.
Other Information If you need assistance, please call the Stericycle, Inc. at 1-888-UPDATE-U.

A memo from Patient Services Incorporated regarding the ruling by the 6th Circuit Court of Appeals which upholds the Individual Mandate in the Affordable Care Act as constitutional.

Bipartisan appeals panel upholds federal mandate that everyone buy health insurance

A three-judge panel for the Sixth U.S. Circuit Court of Appeals in Ohio became the first federal appellate court today to uphold the constitutionality of the Affordable Care Act mandate that all Americans purchase health insurance coverage.

Read the rest of this entry »

By NICHOLAS WADE
Published: June 27, 2011

Researchers using a new technique for editing the genome of living cells have shown that they can cure hemophilia in mice, at least in principle, with a couple of injections that carry out the “cut” and “paste” operations needed to insert a corrective gene.

This is the first time this genome-editing technique has succeeded in a live animal. Along with other applications, like two AIDS treatments in preliminary stages, the new technique could be the decisive improvement that gives credibility to the long-struggling field of gene therapy.

“This may well revolutionize the field, but it won’t do so overnight,” said Dr. Katherine A. High of the Children’s Hospital of Philadelphia, the research team leader. “Any novel kind of therapeutic takes time to develop.”

Read the rest of this entry »