Novartis Product Recall
Novartis Consumer Health Inc. (NCH) informed customers, that it is voluntarily recalling all lots of select bottle packaging configurations from retailers of Excedrin® and NoDoz® products with expiry dates of December 20, 2014 or earlier as well as Bufferin® and Gas-X Prevention® products with expiry dates of December 20, 2013 or earlier, in the United States. NCH is taking this action as a precautionary measure, because the products may contain stray tablets, capsules, or caplets from other Novartis products, or contain broken or chipped tablets.
Click Here for More Information.
Gene therapy breakthrough treats hemophilia B
Researchers have treated hemophilia B with gene therapy, a first for a well-known disease, according to this article. The scientists used a virus called adeno-associated virus-8 to deliver a good version of the gene for clotting agent Factor IX to six patients. A single injection allowed four of the patients to stop the usual therapy, injections of concentrated Factor IX. Researchers in Memphis, Tenn., London and Philadelphia collaborated on the project, and they plan to treat 20 more patients to determine the best dosage.
(Source: The New York Times)
Warning about use of Nonsterile Alcohol Wipes
FYI - Although the only time you need a "sterile" alcohol wipe is when you have the central venous access. Cleansing the skin before a vena-puncture does not require a "sterile" wipe according to the Infusion Nurses Society Standards of care.
In January 2011, NHF issued a Medical Advisory (#412) about a recall of nonsterile alcohol wipes produced by one company, Triad Group, Inc. In April, the FDA forced this company to close. Now, additional infections have occurred in patients using nonsterile alcohol wipes manufactured by another company, Professional Disposables International (PDI). This company has also been required by the FDA to recall its 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 on the label that they are “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.
PHYSICIANS: Please distribute this information to all providers in your area who treat patients with hemophilia.
CHAPTERS: Please distribute this information to your membership.
Please sign up for the Patient Notification System (PNS) to be notified directly about the latest recall or withdrawal of recombinant and plasma products. The system is confidential and time sensitive. It is administered by an independent third-party organization and is free of charge. To enroll in the PNS, please call (888) UPDATE-U or go online at http://www.patientnotificationsystem.org/
This material is provided for your general information only. NHF does not give medical advice or engage in the practice of medicine. NHF under no circumstances recommends treatment for specific individuals and in all cases recommends that you consult your physician or local hemophilia treatment center before pursuing any course of treatment.
(Source: hemophilia.org)
FDA approves BeneFIX Enhanced Room Temperature Storage
Pfizer received approval from the FDA for BeneFIX enhanced room temperature storage. BeneFIX can now be stored at room temp for up to 2 years, as opposed to 6 mos. with their current product. The product formulation has not changed, only the storage condition.
H&P Industries, Inc. Issues a Voluntary Nationwide Recall of All Lots of Povidine Iodine Prep Pads Due to Potential Microbial Contamination
Hartland, Wisconsin, H&P industries, Inc., a manufacturer of over-the-counter products has initiated a voluntary product recall of ALL LOTS of POVIDINE PREP PADS manufactured by H&P Industries, Inc. but which are private labeled for many accounts. This recall has been initiated due to results of the FDA’s ongoing investigation and sampling efforts, and H&P Industries, Inc. internal investigation.
The Povidine Iodine Prep Pads are non-sterile and contain some of the same raw material as the recalled Alcohol Prep pads, and were therefore investigated by FDA and by H&P Industries for potential contamination with objectionable organisms. However, analytical testing showed the presence of objectionable organisms, namely Elizabethkingia meningoseptica.
We are therefore taking immediate action to voluntarily recall the Povidine Iodine Prep Pads. Use of contaminated Povidine Prep Pads could lead to life-threatening infections, especially in at risk populations, including neonates, immune suppressed patients, and surgical patients. Treatment options are limited for Elizabethkingia meningoseptica infections. To date we have not received any reports of adverse events.
Povidine Iodine Prep Pads are used to prevent infection in minor cuts, scrapes and burns and are labeled as an antiseptic for preparation of the skin prior to surgery. They were distributed nationwide to healthcare customers and are packaged in individual packets and sold in a box of 100 packets. The affected Povidine Iodine Prep Pads can be identified by the names listed below in their packaging:
These products were distributed in the United States. Specific customers distributing the product and selling it at the wholesale and hospital level are being notified by certified mail with instructions on how to return the product. If a consumer has any of these types of products in their possession, they should not use the product and should return it to the place it was purchased for a full refund or call H&P Industries, Inc. Customer Service Monday through Friday between the hours of 8:30 a.m. and 4:00 p.m. Central Time: 262.538.2900.
DO NOT RETURN THE PRODUCT ON YOUR OWN, simply call H&P Industries, Inc. Customer Service listed below and we will issue you a return authorization number and make all return arrangements.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Online:www.fda.gov/medwatch/report.htm
Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm2. Mail to address on the pre-addressed form.
Fax: 1-800-FDA-0178
(Source: www.fda.com)
FDA approves product to prevent bleeding in people with rare genetic defect
Corifact is 1st treatment for congenital Factor XIII Deficiency
The U.S. Food and Drug Administration today approved Corifact, the first product intended to prevent bleeding in people with the rare genetic defect congenital Factor XIII deficiency.
Patients with congenital Factor XIII deficiency don’t make enough Factor XIII, a substance that circulates in the blood and is important for normal clotting. Without treatment, people with the condition are at risk for life-threatening bleeding.
Congenital Factor XIII deficiency is rare and affects 1 out of every 3 million to 5 million people in the United States. The deficiency may lead to soft tissue bruising, mucosal bleeding and fatal intracranial bleeding. Newborns with Factor XIII deficiency may have umbilical cord bleeding.
“This product helps fill an important need,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research.
Corifact received orphan-drug designation by the FDA because it is intended for use in a rare disease or condition. It was approved for marketing under the FDA's accelerated approval regulations that require an on-going study to demonstrate that patients actually receive the clinical benefit predicted by the data obtained so far.
The FDA approved Corifact based on results of a clinical study of 14 people, including children, with congenital Factor XIII deficiency. The most common side effects observed were hypersensitivity reactions (allergy, rash, pruritus, and erythema), chills, fever, arthralgia, headache, elevated thrombin-antithrombin levels, and an increase in liver (hepatic) enzymes.
Corifact is made from the pooled plasma of healthy donors. People receiving Corifact may develop antibodies against Factor XIII that may make the product ineffective. It potentially can cause adverse events from abnormal clotting if doses higher than the labeled dose are given to patients.
Corifact is manufactured by CSL Behring of Marburg, Germany.
(Source: www.fda.gov)
Tainted Alcohol Pads Recalled
All lots of isopropyl alcohol prep pads, swabs, and swabsticks made by Triad Group have been recalled because of possible contamination by Bacillus cereus bacteria.
The products were all manufactured by Triad Group but have been marketed in the U.S., Canada, and Europe under a number of different labels, including:
- Cardinal Health
- PSS Select
- VersaPro
- Boca/Ultilet
- Moore Medical
- Walgreens
- CVS
- Conzellin
The recall was initiated following a report of a non-life threatening skin infection, according to a statement from Triad Group.
The products are sold at wholesale, hospital, and retail pharmacies. Consumers can purchase them in retail pharmacies in boxes of 100.
Instructions for how to return the recalled products are available by calling the Wisconsin-based company at 262-538-2900.
(Source: MedPage Today)
Swedish Orphan Biovitrum's Hemophilia A Therapy Gets Orphan Drug Designation
Swedish Orphan Biovitrum Thursday said that the U.S. Food and Drug Administration or FDA has granted orphan drug designation to its long-lasting, fully-recombinant Factor VIII Fc fusion protein or rFVIIIFc for the treatment of hemophilia A. rFVIIIFc is being developed in partnership with Biogen Idec.
A global registrational trial of rFVIIIFc is ongoing. The phase II/III trial is an open-label, multicenter clinical trial designed to evaluate the safety, pharmacokinetics and efficacy of rFVIIIFc in the prevention and treatment of bleeding in previously-treated patients with severe hemophilia A.
Peter Edman, Ph.D., Chief Scientific Officer of Swedish Orphan Biovitrum said " The orphan drug designation or ODD for rFVIIIFc is an important step in our efforts to bring an important new, valuable and needed treatment to hemophilia A patients. An ODD gives advantages in FDA assistance, user-fee benefits and, after orphan drug registration, seven years of market exclusivity."
(Source: RTTNews)
Ed Burke Appointed to Blood Safety Committee
The Advisory Committee on Blood Safety and Availability is meeting November 4-5, 2010. The first order of business for today's session was the swearing in of new members.
NCHS is proud to announce that Ed Burke, Director of Advocacy and Outreach/Interstate Sales for Ethical Factor, a division of NCHS, has been appointed to a four year term on the committee. When discussing his appointment, Ed remarked "I understand how important this appointment is and plan to work very hard." Ed has a long history of advocating for the safety of America's blood supply. He has severe hemophilia A so he is very sensitive to the dangers that the blood supply can create.
We applaud Ed's appointment and congratulate him on this important achievement.
Below is a photo of Ed after his swearing in ceremony.
PSI Terminates the Sole Member Relationship with Positudes, Inc. Pharmacy
Midlothian, Virginia, October 28, 2010 — Patient Services, Inc. (PSI), a leading patient assistance non-profit terminated its sole member relationship with Positudes, Inc. a non-profit pharmacy located in Merrick, N.Y. in an amicable decision by PSI’s Board of Directors.
The Positudes, Inc. pharmacy will revert back to its original business model prior to the sole membership agreement. The venture known as the “PSI-PI Pharmacy” ceased to exist as of October 28, 2010 by a decision of the PSI Board of Directors.
This decision will provide Positudes, Inc. the opportunity to pursue independent avenues of non-profit pharmacy business. “We are saddened that the sole membership could not continue due to the economic challenges caused by our present economy and because of the delay in our Medicare Part D initiative due to Health Care Reform,” said PSI President and Founder Dana Kuhn. PSI parts this relationship in an amicable way.
For additional information about the termination of this relationship, please contact Mandy Herbert, Communications and Marketing Manager, by phone at (804) 744-3813, or by email at maherbert@uneedpsi.org.Shortage of DDAVP IV
The Food and Drug Administration has issued a notice that there is currently a shortage of Desmopressin Acetate (DDAVP), Intravenous Formulation, due to increased demand and manufacturing delays. Three pharmaceutical companies currently distribute and market this product in the US. Hospira reports that it will not have product available until early December 2010, Sanofi-Aventis projects availability in mid-November 2010, and Teva Pharmaceuticals estimates availability in January 2011.
This shortage only affects the intravenous form of DDAVP and does not affect the nasal spray formulation of DDAVP (Stimate), which is distributed by CSL Behring.
For more information regarding supply you can contact Hospira at 877-946-7747 or www.hospira.com, Sanofi Aventis at 800-981-2491 or www.sanofi-aventis.us, and Teva Pharmaceuticals at 800-545-8800 or www.tevausa.com/.
PHYSICIANS: Please distribute this information to all providers in your area who treat patients with hemophilia.
CHAPTERS: Please distribute this information to your membership.
Please sign up for the Patient Notification System (PNS) to be notified directly about the latest recall or withdrawal of recombinant and plasma products. The system is confidential and time sensitive. It is administered by an independent third-party organization and is free of charge. To enroll in the PNS online, please go to: www.patientnotificationsystem.org
This material is provided for your general information only. NHF does not give medical advice or engage in the practice of medicine. NHF under no circumstances recommends treatment for specific individuals and in all cases recommend that you consult your physician or local hemophilia treatment center before pursuing any course of treatment.
(Source: hemophilia.org)
Pfizer's Xyntha-administering syringe gets FDA approval
By Alaric DeArment
NEW YORK (Aug. 16) The Food and Drug Administration has approved a prefilled dual-chamber syringe made by Pfizer for treating hemophilia, Pfizer said.
The FDA approved the syringe for administering the drug Xyntha (antihemophilic factor [recombinant]) for hemophilia A. The drug is used to prevent and control bleeding episodes in patients.
"The approval of the pre-filled dual-chamber syringe is an important milestone for hemophilia patients due to its innovative, convenient reconstitution system that eliminates the transfer step," Pfizer VP marketing for specialty biologics Emil Andrusko said.
FDA Approves Wilate
HOBOKEN, N.J., Aug. 2 /PRNewswire/ -- Octapharma USA has received confirmation of orphan drug exclusivity from the U.S. Food and Drug Administration (FDA) for wilate® (von Willebrand Factor/Factor VIII Concentrate, Human), the replacement therapy developed specifically for von Willebrand Disease (VWD). The approval comes from the FDA Office of Orphan Products Development, which helps to advance the development of products that demonstrate promise for the treatment of rare diseases."In awarding orphan drug exclusivity, the FDA Office determined that wilate® offers greater viral safety than Humate-P," said Flemming Nielsen, President of Octapharma USA, the rapidly growing U.S. division of Octapharma AG, one of the world's largest human protein products manufacturers. "wilate® has received seven years of marketing exclusivity as a result of the evidence suggesting wilate® is as efficacious and safer than Humate P."
The FDA has approved wilate® for the treatment of spontaneous or trauma-induced bleeding episodes in patients with severe VWD as well as in patients with mild or moderate forms of the illness in whom the use of desmopressin is known or suspected to be ineffective or contraindicated.
wilate® is the first double virus inactivated VWF/FVIII (von Willebrand Factor / Factor FVIII), high-purity concentrate, utilizing the solvent/detergent (S/D) process and a special terminal dry-heating (TDH) step. The selected purification processes isolates the VWF/FVIII complex under highly protein-protecting conditions, resulting in a 1:1 ratio of VWF:RCo (ristocetin cofactor) to FVIII activity that is similar to normal plasma. No albumin is added as a stabilizer. wilate® is exclusively derived from large pools of human plasma collected in U.S. FDA approved plasma donation centers. wilate® contains a VWF triplet structure and VWF mulitmeric distribution similar to normal human plasma.
According to the National Institutes of Health, VWD is the most common inherited bleeding disorder and occurs in about 1 out of every 100 to 1,000 people. "The FDA orphan drug exclusivity approval for wilate® confirms Octapharma's decision to focus exclusively on the treatment of von Willebrand patients and further demonstrates Octapharma's commitment to the continued advancement of human protein therapies," said Nielsen.
For more information on wilate®, please visit www.wilateusa.com.
About the Octapharma Group
Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein products manufacturers in the world and has been committed to patient care and medical innovation for over 27 years. Octapharma's core business is the development, production and sale of high quality human protein therapies from both human plasma and human cell-lines, including immune globulin intravenous (IGIV). In the U.S., Octapharma's IGIV product, octagam® (immune globulin intravenous [human] 5%), is used to treat disorders of the immune system, and Octapharma's albumin (Human) is indicated for the restoration and maintenance of circulating blood volume. Octapharma's wilate® received orphan drug exclusivity from the U.S. Food and Drug Administration (FDA) for the treatment of von Willebrand disease (VWD). Octapharma employs over 4,000 people and has biopharmaceutical experience in 80 countries worldwide, including the United States, where Octapharma USA is located in Hoboken, N.J. Octapharma operates two state-of-the-art production sites licensed by the FDA, providing a high level of production flexibility. For more information, please visit www.octapharma.com.
Forward-looking statements
This news release contains forward-looking statements, which include known and unknown risks, uncertainties and other factors not under the company's control. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. These factors include results of current or pending research and development activities and actions by the FDA or other regulatory authorities.
SOURCE Octapharma USA
