http://www.hhs.gov/news/press/2011pres/03/20110331c.html

News Release

BARDA funds advanced development of new influenza antiviral

A contract has been awarded to develop a long-acting single-dose antiviral drug for use in the United States, the U.S. Biomedical Advanced Research and Development Authority (BARDA) announced today.

The drug, CS-8958, is currently marketed in Japan under the name Inavir and is in the same class of drugs as the currently approved influenza antiviral drugs Tamiflu and Relenza. CS-8958 requires only a single dose for full treatment, as opposed to the five days of twice daily dosing required for Tamiflu and Relenza. CS-8958 also may be effective against influenza viruses known to be resistant to Tamiflu.

The advanced development contract for was issued to Biota Scientific Management Pty, Ltd., of Melbourne, Australia, for $231 million over five years.

“This award represents another critical step forward in ensuring that safe and effective antiviral drugs are available for the treatment of influenza,” said BARDA Director Dr. Robin Robinson. “The ability to treat influenza by delivering a single dose of medicine would provide real advantages to doctors and patients during an emergency and would be an important addition to our pandemic influenza arsenal.”

CS-8958 is a long-acting neuraminidase inhibitor, which prevents the flu virus from spreading in the body’s cells. The drug is delivered using a dry powder inhaler.

Under the contract, the company will establish U.S. manufacturing of the drug, optimize its manufacturing processes, and conduct clinical trials for safety and efficacy in adult and pediatric populations. These studies are needed to apply for U.S. Food and Drug Administration approval of the drug.

The contract is part of BARDA’s implementation of the national pandemic influenza preparedness strategy, which includes accelerating the advanced development of new antiviral drugs.

BARDA, an agency within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, provides a comprehensive, integrated, portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing infrastructure for vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear threats, pandemic influenza, and emerging infectious diseases.

For more information about BARDA and the national influenza preparedness strategy, visit www.phe.gov. Information about the flu is available at www.flu.gov.

http://www.fda.gov/Safety/Recalls/ucm249068.htm

Recall — State / Local Press Release

FDA posts press releases and other notices of recalls and safety alerts from states as a service to consumers, the media, and other interested parties. FDA is not responsible for the content of these notices.

CDC And ADPH Investigate Outbreak At Alabama Hospitals; Products Recalled

Contact:
Alabama Department of Public Health
Phone: 334-206-5300
Fax: 334-206-5520
www.adph.org ¹

FOR IMMEDIATE RELEASE – March 29, 2011 – The Alabama Department of Public Health today is announcing an ongoing investigation of an outbreak of Serratia marcescens bacteremia in six Alabama hospitals. On March 16, ADPH was notified that an outbreak had occurred in two of these hospitals among patients receiving TPN (total parenteral nutrition).

TPN is liquid nutrition fed through an IV using a catheter. Use of contaminated products may lead to bacterial infection of the blood.

ADPH requested assistance from the Centers for Disease Control and Prevention. CDC’s initial investigation identified TPN produced by a single pharmacy, Meds IV, as a potential common source and has determined that these hospitals received TPN from this pharmacy. Affected hospitals are Baptist Princeton, Baptist Shelby, Baptist Prattville, Medical West, Cooper Green Mercy and Select Specialty Hospital in Birmingham.

Meds IV was notified and informed its customers of the possibility of contamination. ADPH has been informed that impacted hospitals immediately stopped using TPN received from this pharmacy and that the pharmacy discontinued all production. On March 24, Meds IV recalled all of its IV compounded products. The U.S. Food and Drug Administration is aware of the voluntary recall. The pharmacy and the hospitals are cooperating with the investigation.

At this time, ADPH is aware of 19 cases in these six hospitals of Serratia marcescens bacteremia related to this outbreak.

ADPH will provide updates as more information becomes available.

Product List

• Bronch Procedure Kit
• Bupivacaine Epidural Bag
• Cardioplegia Solutions
• Cefazolin 2 gm Syringe
• Dialysate Solution
• Fentanyl /Ropivacaine Epidural Bag
• Fentanyl/ Bupivacaine Epidural Bag
• Folic Acid 1mg/0.2ml Syringe
• Glycopyrrolate 0.2mg/ml 1ml in 3ml Syringe
• Heparin IV Bags
• Hydromorphone Intravia Bag
• Hydromorphone PCA Syringe
• Ketamine Syringe
• Labetalol syringe
• Lorazepam 2mg/ml syr
• Meperidine 10mg/100ml NS(Intravia Bag)
• Morphine 1mg/ml PCA 100ml Intravia Bag
• Neostigmine 3mg Syringe
• Nitroglycerin IV Bag
• Nitroglycerin Syringe
• Norepinehrine IV Bag
• Oxytocin Bags
• Sodium Chl 23.4% (4meq/ml) 10ml Syr
• Succinylcholine 20mg/ml 5ml Syringe
• TPN Solution
• Vancomycin IV Bag

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm249099.htm

Meds IV Pharmacy, IV Compounded Products Recall: Outbreak of Serratia Marcescens Bacteremia in Alabama Hospitals

[Posted 03/30/2011]

AUDIENCE: Risk Manager, Pharmacy

ISSUE: The Alabama Department of Public Health announced an ongoing investigation of an outbreak of Serratia marcescens bacteremia in six Alabama hospitals. On March 16, ADPH was notified that an outbreak had occurred in two of these hospitals among patients receiving TPN (total parenteral nutrition). ADPH is aware of 19 cases in these six hospitals of Serratia marcescens bacteremia related to this outbreak.

BACKGROUND: CDC’s initial investigation identified TPN produced by a single pharmacy, Meds IV, as a potential common source and has determined that these hospitals received TPN from this pharmacy. At this time, Meds IV recalled all of its IV compounded products.

RECOMMENDATION: Remove the recalled products from Meds IV Pharmacy from shelves. Refer to the Press Release for a complete list of affected products.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm¹
• Download form² or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

http://www.fda.gov/Safety/Recalls/ucm248548.htm

Recall — Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Candy Dynamics Recalls Toxic Waste® Short Circuits™ Bubble Gum
Net wt. 3.2 oz. (90g) Package — Lot # 15070SC12

Contact:
Eileen O’Neal
317-228-5012


FOR IMMEDIATE RELEASE – March 26, 2011 – Circle City Marketing and Distributing, doing business as Candy Dynamics, Indianapolis, IN, is issuing a voluntary recall of Toxic Waste® Short Circuits™ Bubble Gum, 3.2 oz (90 g) size, Lot #15070SC12. The product is imported from Pakistan.

A recent test performed by the U.S. Food and Drug Administration (FDA) has indicated that Lot #15070SC12 of the 3.2 oz. (90 g) size of the above-listed product contains elevated levels of lead (0.189 parts per million; the FDA tolerance is 0.1 ppm) that potentially could cause health problems, particularly for infants, small children, and pregnant women.

Out of abundance of caution, the company has determined to recall Lot #15070SC12, which was distributed from January 4, 2011 until March 18, 2011.

The product is identified as: Toxic Waste® Short Circuits™ Bubble Gum, (UPC 0 89894 31001 3), 3.2 oz (90 g) size, Lot #15070SC12 (the Lot # is located along the left side of the bag).

No other “Toxic Waste®” brand product or “Short Circuits™ Bubble Gum”, besides Lot #15070SC12 is affected by this recall.

No illnesses have been reported to date in connection with this problem.

The recalled Short Circuits™ Bubble Gum product was distributed nationwide in retail stores and through mail orders. The product was also distributed in limited quantities into Canada and Switzerland.

The company will continue to sell Short Circuits™ Bubble Gum products in the U.S.

Candy Dynamics is sending recall notices to its direct customers. Anyone in possession of the recalled product should telephone the company for information on destruction of the product. Please call Eileen O’Neal at 317-228-5012 (Monday – Friday 9am – 5pm EST) for further information.

Reducing Admissions Utilizing the Boston Syncope Criteria
Published online: 23 March 2011
Shamai A. Grossman, Jessica Bar, Christopher Fischer, Lewis A. Lipsitz, Lawrence
Mottley, Kenneth Sands, Peter Zimetbaum, Nathan I. Shapiro
DOI: 10.1016/j.jemermed.2011.01.021
Journal of Emergency Medicine

http://www.jem-journal.com/article/S0736-4679%2811%2900191-0/abstract

Incidence and Impact of Physician and Nurse Disruptive Behaviors in the
Emergency Department
Published online: 23 March 2011
Alan H. Rosenstein, Bruce Naylor
DOI: 10.1016/j.jemermed.2011.01.019
Journal of Emergency Medicine

http://www.jem-journal.com/article/S0736-4679%2811%2900189-2/abstract

Pseudoaneurysm in the Hand of a Three-year-old Boy: A Case Report
Published online: 24 March 2011
Christopher D. Hughes, Christopher Binette, Alan Babigian
DOI: 10.1016/j.jemermed.2010.11.049
Journal of Emergency Medicine, The, http://www.jem-journal.com/article/S0736-4679%2811%2900200-9/abstract

http://www.cdc.gov/features/dsColorectalCancer/?source=govdelivery

CDC

Colorectal (Colon) Cancer Incidence Rates

Screening saves lives: all men and women aged 50 years or older should be screened regularly for colorectal cancer.

Of cancers affecting both men and women, colorectal cancer (cancer of the colon and rectum) is the second leading cancer killer in the United States. In 2007 (the most recent year for which statistics are available), 142,672 Americans were diagnosed with colorectal cancer, including 72,755 men and 69,917 women.

“Incidence rate” means how many people out of a given number get the disease in a year. The graph shows how many people out of 100,000 got colorectal cancer in 2007. The colorectal cancer incidence rate is grouped by race, ethnicity, and gender.

Men and women had significantly different incidence rates. Among men, black men the highest rates; 62.0 out of every 100,000 black men were diagnosed with colorectal cancer in 2007. White men were second with a rate of 51.5 per 100,000, followed by Hispanic men (44.8), Asian/Pacific Islander men (39.7), and American Indian/Alaska Native men (33.5).

Among women, black women were the most likely to be diagnosed with colorectal cancer in 2007, at a rate of 47.1 per 100,000. White women were second at 38.5, followed by Hispanic women at 32.6, Asian/Pacific Islander women at 31.1, and American Indian/Alaska Native women at 28.8.

†Hispanics are not mutually exclusive from whites, blacks, Asians/Pacific Islanders, and American Indians/Alaska Natives.

Reducing Risk

Colorectal cancer screening saves lives. However, many people who are at risk for colorectal cancer are not being screened according to national guidelines. It is estimated that as many as 60% of colorectal cancer deaths could be prevented if all men and women aged 50 years or older were screened routinely.

Data source:

U.S. Cancer Statistics Working Group. United States Cancer Statistics: 1999–2007 Incidence and Mortality Web-based Report. Atlanta (GA): Department of Health and Human Services, Centers for Disease Control and Prevention, and National Cancer Institute; 2010.

More Information

• Colorectal (Colon) Cancer
• Cáncer colorrectal
• Colorectal Cancer Statistics
• Colorectal Cancer Research
• Screen for Life Print Materials
• Colorectal Cancer Control Program

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60310-3/abstract

Helicopters Improve Survival in Seriously Injured Patients Requiring Interfacility Transfer for Definitive Care

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm213206.htm

Safety Announcement 

Additional Information for Patients and Consumers 

Additional Information for Healthcare Professionals 

Data Summary 

Table of epidemiological studies evaluating fracture risk with proton pump inhibitors 

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm248390.htm

FDA NEWS RELEASE

For Immediate Release: March 24, 2011
Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA approves Zostavax vaccine to prevent shingles in individuals 50 to 59 years of age

The Food and Drug Administration (FDA) today approved the use of Zostavax, a live attenuated virus vaccine, for the prevention of shingles in individuals 50 to 59 years of age. Zostavax is already approved for use in individuals 60 years of age and older. 

In the United States shingles affects approximately 200,000 healthy people between the ages of 50 and 59, per year. It is a disease caused by the varicella-zoster virus, which is a virus in the herpes family and the same virus that causes chickenpox. After an attack of chickenpox, the virus lies dormant in certain nerves in the body. For reasons that are not fully understood, the virus can reappear in the form of shingles, more commonly in people with weakened immune systems and with aging. 

“The likelihood of shingles increases with age. The availability of Zostavax to a younger age group provides an additional opportunity to prevent this often painful and debilitating disease” said Karen Midthun, M.D., director of FDA’s Center for Biologics Evaluation and Research.

Shingles is characterized by a rash of blisters, which generally develop in a band on one side of the body and can cause severe pain that may last for weeks, and in some people, for months or years after the episode.

Approval was based on a multicenter study conducted in the United States and four other countries in approximately 22,000 people who were 50-59 years of age. Half received Zostavax and half received a placebo. Study participants were then monitored for at least one year to see if they developed shingles. Compared with placebo, Zostavax reduced the risk of developing shingles by approximately 70 percent.

The most common side effects observed in the study were redness, pain and swelling at the site of injection, and headache. 

Zostavax was originally approved on May 26, 2006, for the prevention of shingles in individuals 60 years of age and older.

Zostavax is manufactured by Merck & Co. Inc., of Whitehouse Station, New Jersey.

For more information:
Zostavax Product Page¹

http://consumer.healthday.com/Article.asp?AID=651091

HealthDay

Severe Blood Clots Should be Treated Aggressively: Heart Docs

Heart association releases new guidelines on worst-case deep vein thrombosis, complications

By Steven Reinberg
HealthDay Reporter

MONDAY, March 21 (HealthDay News) — “The American Heart Association is urging doctors to treat the worst cases of potentially life-threatening blood clots that form in the legs’ deep veins more aggressively……Noting that many patients with the most severe blood clots and related complications need more than blood thinners, the heart association is recommending aggressive treatment with clot-busting drugs. In addition, the group recommends inserting catheters in blood vessels to open them up.  For certain patients, the heart association also recommends surgery to remove clots and the insertion of filters in the vein to prevent new clots from traveling to the lungs……..”

http://www.fda.gov/Safety/Recalls/ucm247596.htm

Recall — Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Lilly Announces Important Action Regarding Recall
of Alcohol Prep Pads Made by Triad Group Included in Forteo Starter Kits
This Recall Does Not Affect or Involve Forteo Delivery Device

Contact:
Tamara Hull
(317) 651-9116
 

FOR IMMEDIATE RELEASE – March 17, 2011 – INDIANAPOLIS, March 17, 2011 – Eli Lilly and Company (NYSE: LLY) announced today that patients should not use the alcohol prep pads made by the Triad Group that are contained in the black starter kits for Forteo® [teriparatide (rDNA origin) injection] in the United States. The Tri-ad Group is recalling the alcohol prep pads due to potential contamination with the bacteria, Ba-cillus cereus, which could result in life threatening infections, especially in at-risk populations, including immune suppressed and surgical patients. It is important to note that this recall does not affect or involve the Forteo Delivery Device. The starter kits did not contain the Forteo Delivery Device.

Some Forteo starter kits distributed by Eli Lilly and Company between March 2008 and June 2009 may have contained Triad Group alcohol prep pads. The Triad alcohol prep pads should not be used. The Forteo starter kits that contained the Triad alcohol prep pads were black bags and were discontinued in June 2009. The Forteo starter kits have been updated since June 2009. The bags are now blue, do not include Triad alcohol prep pads, nor any other alcohol prep pad.

Lilly has requested that physicians and their staff examine their inventory of Forteo starter kits and remove and appropriately discard the Triad Group alcohol prep pads in the black bags. Lil-ly has also requested that physicians inform any patients who may have received Forteo starter kits containing Triad Group alcohol prep pads to discontinue use of the pads.

Further information about this recall can be found at http://www.fda.gov/Safety/Recalls/ucm239219.htm¹. For questions pertaining to the recall, consumers may contact Triad Group at 262-538-2900.

Adverse reactions or quality problems experienced with the use of the Triad alcohol prep pads 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.htm²
• Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm³
• Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: 1-800-FDA-0178

http://www.fda.gov/Safety/Recalls/ucm247526.htm

Recall — Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

American Regent Initiates Voluntary Nationwide Recall of Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Single Dose Vials; 5 mL and 30 mL Multiple Dose Vials

Contact:
Walter Tozzi, R.Ph., M.S., M.B.A.
Sr. Director of Professional Services
631-924-4000
 

FOR IMMEDIATE RELEASE – March 16, 2011 – American Regent is conducting a nationwide voluntary recall of the following:

Dexamethasone Sodium Phosphate Injection, 4 mg/mL, 1 mL Single Dose Vials
NDC # 0517-4901-25;
and
Dexamethasone Sodium Phosphate Injection, 4 mg/mL, 5 mL Multiple Dose Vials
NDC # 0517-4905-25;
and
Dexamethasone Sodium Phosphate Injection, 4 mg/mL, 30 mL Multiple Dose Vials
NDC # 0517-4930-25

PLEASE NOTE: This voluntary recall, initiated on March 16, 2011 to the User Level, is for ALL unexpired lots of all 3 sizes of Dexamethasone Sodium Phosphate Injection, USP. See attached Appendix for Lot #s, Expiration Dates and Dates of First Distribution.

This voluntary recall was initiated because some vials of these lots either contain particulates or have the potential to form particulates prior to their respective expiration dates. Potential adverse events after intravenous administration of solutions containing particulates, may include disruption of blood flow within small blood vessels in the lung, localized inflammation (swelling and redness due to accumulation of inflammatory cells), and granuloma formation. Intramuscular administration could result in foreign body inflammatory response, with local pain, swelling and possible long term granuloma formation. American Regent is undertaking this recall in consideration of the potential for safety issues, if these lots of product are administered to patients.

Dexamethasone Sodium Phosphate Injection, USP, is a synthetic adrenocortical steroid used to treat a variety of inflammatory and allergic conditions. See the Full Prescribing Information at www.americanregent.com¹ for a complete listing of indications and uses.

The product was distributed to wholesalers and distributors nationwide.

Hospitals, emergency rooms, infusion centers, clinics, physician offices and other healthcare providers and facilities should not use American Regent Inc., Dexamethasone Sodium Phosphate Injection, USP 4mg/mL, 1mL Single Dose Vials, 5mL and 30 mL Multiple Dose Vials with the lot #s listed in the attached Appendix for patient care and should immediately quarantine any product for return.

While American Regent continues to investigate this issue, the company is taking precautionary action and initiated this voluntary nationwide recall. American Regent has informed the FDA of its actions and is maintaining ongoing discussions with the agency.

As is standard practice, and as stated in the Dexamethasone Sodium Phosphate Injection, USP Product Package Insert, “Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.”

American Regent will credit accounts for all returned product with these lot #’s. Those with product to return may do so by accessing our recall website at www.americanregent.com/recall/adx². If you have questions about the return or recall process, please contact our Customer Service Department at 1-877-788-3232: Monday thru Friday from 8:30AM to 7:00PM ET or by email at recall@americanregent.com.

Hospitals, emergency rooms, infusion centers, clinics, physician offices and other healthcare providers, or patients with product quality complaints, medical or other questions concerning the use of the product or reasons for this recall should contact the Professional Services Department at 1-877-788-3232.

Any adverse reactions experienced with the use of this product should be reported to American Regent, Inc. via email at pv@luitpold.com, by fax to (610) 650-7781 or (610) 650-0170 or by phone at 1-800-734-9236. TO EXPEDITE HANDLING PLEASE DO NOT REPORT ANYTHING OTHER THAN SPECIFIC ADVERSE EVENTS TO THIS EMAIL ADDRESS OR FAX OR PHONE.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program online, or regular mail or by fax.

• Online: www.fda.gov/medwatch/report.htm³
• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at:
  www.fda.gov/MedWatch/getforms.htm⁴. Mail to address on the pre-addressed form.
• Fax: 1-800-FDA-0178

Dexamethasone Sodium Phosphate Injection, USP is manufactured by Luitpold Pharmaceuticals, Inc. and is distributed by American Regent, Inc. (Shirley, NY).
 

Source: Luitpold Pharmaceuticals, Inc.

APPENDIX

American Regent Recall Lots of
Dexamethasone Sodium Phosphate Injection, USP

Dexamethasone Sodium Phosphate Injection, USP
4 mg/mL, 1 mL Single Dose Vial

NDC # 0517-4901-25

Dexamethasone Sodium Phosphate Injection, USP
4 mg/mL, 5 mL Multiple Dose Vial

NDC # 0517-4905-25

Dexamethasone Sodium Phosphate Injection, USP
4 mg/mL, 30 mL Multiple Dose Vial

NDC # 0517-4930-25