Fwd: U.S. Food & Drug Administration (FDA) Weekly Digest Bulletin
Hussein Alsayiegh
Begin forwarded message:
From: "U.S. Food & Drug Administration (FDA)" <f...@service.govdelivery.com>
Date: May 20, 2012 10:23:09 PM GMT+03:00
To: das...@hotmail.com
Subject: U.S. Food & Drug Administration (FDA) Weekly Digest Bulletin
Message 1
From: U.S. Food & Drug Administration (FDA) <f...@service.govdelivery.com>
Date: 05/14/2012
Subject: Celebrate National Women's Health Week
FDA for Women
eblast from the FDA Office of Women's Health
May 14, 2012
Celebrate Women's Health
During National Women's Health Week, the FDA Office of Women's Health encourages you to look to FDA for women's health resources.FDA Voice Blog features Women's Health
Throughout its 100-year history, FDA has played a leading role in advancing women’s health. In FDA’s latest blog, OWH Director Marsha Henderson highlights some of the Agency’s women’s health milestones.National Women's Health Week Twitter Chat
May 15, 2012, 3-4 p.m. ESTFollow @FDAWomen and use the hashtag #NWHWchat to discuss National Women's Health Week with FDA and our federal sister agencies/offices including CDC, HRSA, NIH, OMH and OPA.Resources for Women's Check-Up Day
May 14th is National Women’s Check Day – a day when women are encouraged to get or schedule health screenings. Don’t forget to schedule a mammogram. Mammography screening is the best tool we have to detect breast cancer early. Did you know that mammography facilities in the U.S. must be certified by FDA.Take Time to Care about Your Health
The Take Time to Care program provides women with health information they can use to make better health decisions for themselves and their families.Other FDA Resources
Tobbaco Resources for MomsTake some time to sit down with your kids to talk about the very real risks and dangers of tobacco use. Visit the FDA Tobacco website for information about youth and tobacco use.Food FactsWant to know how to avoid certain food-related illnesses? Download FDA fact sheets on safe food handling, food allergies, food safety during pregnancy, and more.CosmeticsIf you’ve had a negative reaction to a beauty, personal hygiene, or makeup product, the FDA wants to hear from you. Learn how to report a problem with cosmetics.
Message 2
From: FDA MedWatch <f...@service.govdelivery.com>
Date: 05/14/2012
Subject: FDA MedWatch - Hydromorphone Hydrochloride Injection 1 MG/ML, (C-II) 1 ML Fill In 2.5 ML Carpuject: Recall - May Contain More Than the Intended Fill VolumeHydromorphone Hydrochloride Injection 1 MG/ML, (C-II) 1 ML Fill In 2.5 ML Carpuject: Recall - May Contain More Than the Intended Fill Volume
AUDIENCE: Risk Manager, Consumer
ISSUE: Hospira, Inc. notified healthcare professionals of a recall of one lot of Hydromorphone Hydrochloride Injection 1 MG/ML, due to reports of a single Carpuject containing more than the 1 mL labeled fill volume. Opioid pain medications such as Hydromorphone have life-threatening consequences if overdosed, including respiratory depression (slowed breathing or suspension of breathing), low blood pressure, and reduced heart rate including circulatory collapse.
The affected lot number is 07547LL, with an expiration date of July 1, 2013. The affected lot was distributed in September – October 2011. It was initially distributed to wholesalers and a limited number of hospitals in Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Indiana, Louisiana, Maryland, Massachusetts, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Washington, and Wisconsin.
BACKGROUND: The affected product is a prefilled glass cartridge for use with the Carpuject Syringe system.
RECOMMENDATION: Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-888-912-7093 to arrange for the return of the product. Replacement product from other lots is available. Customers can send their DEA 222 form to Hospira, 1635 Stone Ridge Drive, Stone Mountain, GA 30083 to order replacement product.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
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.htm
- Download form 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
Read the MeDWatch safety alert, including a link to the updated Drug Safety Communication, at:
Message 3
From: FDA MedWatch <f...@service.govdelivery.com>
Date: 05/14/2012
Subject: FDA MedWatch - Monthly Safety Labeling Changes includes 43 products with revisions to Prescribing Information
The MedWatch April 2012 Safety Labeling Changes posting includes 43 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT.
The "Summary Page" provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm302285.htm
The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and WARNINGS sections:
Aceon (Perindopril Erbumine)
Altace (Ramipril)
Atacand (Candesartan Cilexetil)
Sporanox (Itraconazole)
Zortress (Everolimus)
Advicor (Niacin Extended-release/Lovastatin)
Altoprev (Lovastatin Extended-release)
Amturnide (Aliskiren, Amlodipine and Hydrochlorothiazide)
Premarin (Conjugated Estrogens,USP)
Tekamlo (Aliskiren and Amlodipine)
Tekturna (Aliskiren)
Tekturna HCT (Aliskiren and Hydrochlorothiazide)
Vagifem (Estradiol)
Valturna (Aliskiren and Valsartan)
Viracept (nelfinavir mesylate)
Beyaz (Drospirenone and Ethinyl Estradiol and Levomefolate Calcium)
Cimzia (Certolizumab Pegol)
Krystexxa (Pegloticase)
Levaquin (Levofloxacin)
Levemir (Insulin Detemir [rDNA origin])
Neupro (Rotigotine)
Nutropin (Somatropin [rDNA origin])
Prandimet (Repaglinide and Metformin HCL)
Safyral (Drospirenone and Ethinyl Estradiol and Levomefolate Calcium)
Sutent (Sunitinib Malate)
Synagis (palivizumab)
Tarceva (Erlotinib)
Victoza (liraglutide [rDNA])
Votrient (Pazopanib)
Xgeva (Denosumab)
Yasmin (Drospirenone and Ethinyl Estradiol)
Yaz (Drospirinenone and Ethinyl Estradiol)
Zegerid (Omeprazole and Sodium Bicarbonate)
Message 4
From: U.S. Food & Drug Administration (FDA) <f...@service.govdelivery.com>
Date: 05/16/2012
Subject: Free Healthy Women's Action Kit Featured in Dear AbbyFor National Women’s Health Week, the U.S. Food and Drug Administration's Office of Women's Health created the Healthy Women's Action Kit. This kit provides the information you need to:
- Manage your cholesterol, blood pressure and risk for diabetes
- Stay safe using cosmetics and getting tattoos
- Recognize and avoid online health scams
- Confidently talk to your doctor about menopause and hormones
- Find the stop-smoking method that can work for you
- And more!
Get a free kit for yourself and for the women in your life.
You can also read the publications online, download them to your computer and print them.
Message 5
From: FDA MedWatch <f...@service.govdelivery.com>
Date: 05/17/2012
Subject: FDA MedWatch - Zithromax (azithromycin): FDA Statement on risk of cardiovascular death
Zithromax (azithromycin): FDA Statement on risk of cardiovascular death
Read the MedWatch safety alert, including a link to the Drug Safety Communication at:
Audience: Primary Care, Pharmacy
ISSUE: FDA notified healthcare professionals that it is aware of the study published in the New England Journal of Medicine May 17, 2012 reporting a small increase in cardiovascular deaths, and in the risk of death from any cause, in persons treated with a 5-day course of azithromycin (Zithromax) compared to persons treated with amoxicillin, ciprofloxacin, or no drug. FDA is reviewing the results from this study and will communicate any new information on azithromycin and this study or the potential risk of QT interval prolongation after the agency has completed its review.
BACKGROUND: Azithromycin belongs to a class of antibacterial drugs called macrolides, which have been associated with cardiovascular effects; specifically, prolongation of the QT interval. In 2011, FDA reviewed macrolide drug labeling information related to QT interval prolongation and TdP. The WARNINGS AND PRECAUTIONS section of the Zmax drug label (azithromycin extended release for oral suspension) was revised in March 2012 to include new information regarding risk for QT interval prolongation, which appears to be low. The drug labels for clarithromycin and erythromycin also contain information about QT interval prolongation in the WARNINGS section. FDA is in the process of updating risk information in the drug labels for additional macrolide antibacterial drugs.
RECOMMENDATION: Patients taking azithromycin should not stop taking their medicine without talking to their healthcare professional. Healthcare professionals should be aware of the potential for QT interval prolongation and heart arrhythmias when prescribing or administering macrolides.
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.htm
- Download form 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
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