Showing posts with label United States Food Drug and Comestic Secretary Jodi Foster. Show all posts

Saturday, May 7, 2011

CDC What's New on the Influenza Site

Guy Ralph Perea Sr President of The United States
http://columbiabroadcast.spaces.live.com
ptusss@aol.com
United States Secret Service Director Patty Martinez President Pro Tempro
5 USCS section 5301 (c) "The President's Pay Agent" New in Caution to 'settlement of payment cards" ~ VOUCHERS ~ electronic 26 USCS section 6050W returns 12/31/2010; Travel and Subsistence Expenses; mileage allowance 5 USCS section 5701 without pay or $1.00 a year authorize employment. Confidentality Notice: This E-mail transmission may contain confidential or legally privileged information that is intended only for the individual or entity named in the E-mail address. If you are not the intended recipient, you are hereby notified that any disclosure, copying, distribution, or reliance upon the contents of this E-mail is strictly prohibited. If you have received this E-mail transmission in Error, please reply to the sender, so arrangements can be made for proper delivery, and then delete the message from your system. Please consider the environment before printing this email. Notice of Removal of office of Defendant Article IV General Provisions Section 2 (Supreme Law of The Land) The Constitution of The United States. "Any Thing in The Constitution or Laws of any State to the Contrary Notwithstanding" Contrary to Law (of an Act or Omission) Illegal; In Notwithstanding "Dispite;in spite of The government is current Executive Branch violating Notice of Removal, The Notice of Removal on the Obama Administration in personam including Goods (including tea, i.e. Leslie in like); within 30 days after the defendant Barak Obama is served with process in suit (case 641210) 28 USCS section 1446; Murphy Bros., Inc Vs. Michetti Pipe Stringing Inc., 119 S.Ct 1322 (1999). In responce to Housekeeper statment of Court Process of Subject Matter California Inn in Notice of Removal. Create a new office Federal Districts Modesto City Schools Districts and Turlock Irrigation District Division 3; United States Department of Education, Director Ross Carkeet United States Department of Education, Federal Bureau of Investigation Youth Authorty Director Guy Perea, Jr., Federal Bureau of Investigation Youth Authority Director Shopie Perea, and Director United States District Court Western Washington Clean Water United States Navy.

Subject: CDC What's New on the Influenza Site
Date: Fri, 6 May 2011 14:34:46 -0500
To: guyperea@live.com
From: cdc@service.govdelivery.com

You are subscribed to What's New on the Influenza Site for Centers for Disease Control and Prevention (CDC). This information has recently been updated, and is now available.
The updates are as follows:

Situation Update: Summary of Weekly FluView
FluView - Weekly Influenza Surveillance Report
Flu Information for Travelers
CDC influenza prevention recommendations for travelers.
2011-2012 Flu Season
Information about flu activity during this season.
Questions and Answers: Vaccine Selection for the 2011–2012 Influenza Season
Seasonal Flu: International Situation Update
This report is a summary of key influenza-related updates created from regional World Health Organization (WHO) reports, country reports, CDC field staff updates, and other sources. Updates are listed by region.

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FDA MedWatch - Needleless Pre-filled Glass Syringes: Drug Safety Communication - Compatibility Problems with Needleless Intravenous Access Systems

Date: Fri, 6 May 2011 14:27:19 -0500
From: fda@service.govdelivery.com
Subject: FDA MedWatch - Needleless Pre-filled Glass Syringes: Drug Safety Communication - Compatibility Problems with Needleless Intravenous Access Systems
To: guyperea@live.com

Needleless Pre-filled Glass Syringes: Drug Safety Communication - Compatibility Problems with Needleless Intravenous Access Systems

Reports Received on Adenosine and Amiodarone Products

[UPDATED 05/06/2011] FDA recommends that, to reduce the potential risks to patients, healthcare professionals and risk managers stock crash carts, ambulances, and emergency rooms with adenosine and amiodarone supplied in vials or pre-filled plastic syringes, if possible. The use of needleless pre-filled glass syringes in emergency situations should be avoided.
Refer to the May 2011 FDA Drug Safety Communication, featuring photos, a list of affected adenosine and amiodarone products, and IV access systems known to be incompatible with adenosine and amiodarone pre-filled glass syringes.

[Posted 11/17/2010]

AUDIENCE: Critical Care Medicine, Emergency Medicine, Cardiology, Risk Manager
ISSUE: FDA is notifying healthcare professionals, especially those working in emergency and critical care settings, of reports of compatibility problems when certain needleless pre-filled glass syringes are used with some needleless intravenous (IV) access systems. These syringes may malfunction, break, or become clogged during the process of attempting to connect to needleless IV access systems. Most of the reports have been related to pre-filled needleless glass syringes that contain adenosine, often when attempting to connect to some pin activated needleless IV access systems. Adenosine is a cardiac drug that is administered when a patient has a rapid or irregular heart rhythm in an attempt to return their heart rhythm to normal. Adenosine must be injected rapidly into the blood stream in emergency situations and this failure could delay treatment.
In some cases where an attempt is made to connect to pin activated needleless IV access systems, the syringe may cause the pin to break thus clogging the syringe, or damaging the IV tubing and/or the needleless connector and requiring reestablishment of a new intravenous access. These failures can cause a delay in administration of the medication, which could potentially result in serious harm to patients.
BACKGROUND: Adenosine pre-filled glass syringes are marketed by Teva, Sagent, Baxter, and Wockhardt. FDA has also received reports of problems related to certain pre-filled needleless glass syringes containing the cardiac drug amiodarone. See the FDA letter for a list of affected adenosine and amiodarone products.
RECOMMENDATION: Healthcare professionals, risk managers, and staff who purchase, stock, or administer emergency crash cart medications, operating room medications, emergency drug boxes, or types of emergency drug caches should be alerted to this incompatibility problem and potential for damage or blockage of the IV line and delay in administering the medication. Healthcare organizations currently using glass prefilled syringes should consider stocking adenosine supplied in vials or pre-filled plastic syringes as a back up measure.
FDA has expanded the scope of its review to include all currently marketed pre-filled needleless glass syringes intended for use with needleless intravenous access systems, where delay in administration could potentially result in a life threatening event. FDA is working with manufacturers to correct the problem and identify additional mitigation strategies.
Healthcare professionals and healthcare organization managers are encouraged to report adverse events or problems experienced with the use of needleless pre-filled glass syringes to the FDA's MedWatch Safety Information and Adverse Event Reporting Program. FDA is interested in receiving information on the type, manufacturer and NDC numbers of the prefilled syringes and type and manufacturer of needleless IV access devices. FDA is especially interested in any description of the nature of the syringe failure, any adverse patient outcomes, and any mitigation strategies that have been identified or implemented by users of these products.

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 Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm234219.htm

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Friday, May 6, 2011

U.S. Drug Enforcement Administration Dateline DEA Update

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Guy Ralph Perea Sr President of The United States

http://www.myspace.com/guypereasrpresidentusa

Confidentality Notice: This E-mail transmission may contain confidential or legally privileged information that is intended only for the individual or entity named in the E-mail address. If you are not the intended recipient, you are hereby notified that any disclosure, copying, distribution, or reliance upon the contents of this E-mail is strictly prohibited. If you have received this E-mail transmission in error, please reply to the sender, so arrangements can be made for proper delivery, and then delete the message from your system. Please consider the enviroment before printing this email. Notice of Removal of office of Defendant Article IV General Provisions Section 2 (Supreme Law of The Land) The Constitution of The United States "Any Thing in The Constitution or Laws of any State to the Contrary Notwithstanding" Contrary to Law (of an act or omission) illegal; In Notwithstanding "Despite; in spite of the government is current Executive Branch violating Notice of Removal The Notice of Removal on The Obama Administration, In personam including Goods (including Tea, i.e. Leslie in like). Within 30 days after the defendant Barak Obama is served with process in The Suit (case 641210). 28 USCS section 1446; Murphy Bros. Inc. V. Michetti Pipe Stringing Inc., 119 S Ct 1322 (1999). In responce to Housekeeper statment of Court process of Subject Matter California Inn in Notice of Removal. New office created out of removal Federal Districts Modesto City Schools District and Turlock Irrigation District Director Division 3, United States Department of Education, Director Ross Carkeet United States Department of Education, Federal Bureau of Investigation Youth Authorty Guy Perea, Jr., Federal Bureau of Investigation Youth Authorty Director Shopie Perea, United States District Court Western Washington Director Clean Water United States Navy.

--- On Fri, 5/6/11, U.S. Drug Enforcement Administration <dea@govdelivery.com> wrote:

From: U.S. Drug Enforcement Administration <dea@govdelivery.com>
Subject: U.S. Drug Enforcement Administration Dateline DEA Update
To: guyperea@rocketmail.com
Date: Friday, May 6, 2011, 4:33 PM

Dateline DEA
DEA's Biweekly E-mail Informant
May 6, 2011
Top Stories from the Drug Enforcement Administration, April 23 to May 6, 2011 __________________________________________________________________________
Alleged Leader of Mexican Drug Cartel Benjamin Arellano-Felix Extradited To U.S.
On April 29 Alberto Benjamin Arellano-Felix, an alleged leader of the Arellano-Felix Organization (AFO), was extradited by the Mexican government to the United States to face racketeering, money laundering, and narcotics trafficking charges. Arellano-Felix was taken into custody by Mexican authorities in 2002. Long-reputed to be one of the most notorious drug trafficking organizations, AFO controlled massive flows of cocaine, marijuana, and other drugs through the Mexican border cities of Tijuana and Mexicali into the United States. In addition, Arellano-Felix is charged with negotiating directly with Colombian cocaine trafficking organizations, purchasing multi-ton shipments of cocaine, receiving those shipments in Mexico, and arranging for the cocaine to be smuggled and distributed into the United States, with the proceeds smuggled back into Mexico. The indictment also alleges that AFO recruited, trained and armed groups of bodyguards and assassins and for conducting assassinations of rival drug traffickers, suspected cooperators, uncooperative Mexican law enforcement and military personnel, and members of the Mexican news media.
Click Here to Read the DEA Press Release

Puerto Rican Drug Lord, Brother Convicted on Drug Charges
On April 26 Ángel Ayala-Vázquez, aka "El Negro," and his brother Luis X. Cruz-Vázquez, aka "El Mono," were found guilty of conspiracy to possess with intent to distribute heroin, crack, cocaine, marijuana, Percocet, and Xanax. For the past 15 years, Ayala-Vázquez was the notorious leader of a violent and pervasive drug trafficking organization responsible for the importation of thousands of kilograms of narcotics to Puerto Rico; the transshipment of narcotics from Puerto Rico to several eastern seaboard states, including New York, New Jersey, Pennsylvania and Florida; the distribution of kilogram quantities of narcotics to other drug trafficking organizations operating in Puerto Rico; and the street level distribution of the drugs in Bayamón, Puerto Rico.
Members of this drug trafficking organization employed violence and even murder to maintain control of their drug trafficking activities, and to eliminate rival organizations. Cruz-Vázquez was an administrator who was tasked with supervising the day-to-day operations of the various narcotics distribution points throughout Puerto Rico. Included in the indictment are forfeiture allegations for a $100 million money judgment.
Click Here to Read the DEA Press Release

Former Medellin Cartel Associate Pleads Guilty to Drug Trafficking Conspiracy
On May 3 in Miami, Florida, Sigifredo Maya of Medellin, Colombia, pled guilty to a conspiracy to possess with intent to distribute large quantities of cocaine. In 1994 Maya was indicted with his three brothers on charges related to drug trafficking on behalf of the late Pablo Escobar and the now-defunct Medellin cocaine cartel. On March 18, 2011, Maya was detained by Panamanian authorities while attempting to travel to Mexico, and then flown to Miami, Florida, where he was arrested by DEA.
Court records indicate that between 1979 and 1994, Maya and his brothers, under the instruction of Pablo Escobar, were dispatched to Miami to direct the Medellin cartel's efforts in the importation and distribution of multiple-thousand ton shipments of cocaine throughout the United States. The Maya brothers also served as enforcers for Pablo Escobar in the United States. This was demonstrated in December 1988 when an associate who was tasked with guarding a warehouse in Miami that contained more than 500 kilograms of cocaine claimed the shipment was stolen by a rival drug gang. The Maya brothers interrogated this associate and then promptly sent him back to Medellin to personally explain the loss to Pablo Escobar.
Click Here to Read the DEA Press Release

10 Arrested on Major Drug, Weapons, Money Laundering Charges in San Diego
On April 25 the arrest and unsealing of a five count indictment against 10 individuals was made on federal narcotics, firearms, and money laundering violations. According to count one of the indictment, the 10 individuals were charged with conspiracy to distribute five kilograms and more of cocaine. Counts two through four are federal firearm charges, including the illegal transportation and importation of two AR-15 assault rifles, one AK-47-style assault rifle, and one 9-mm pistol which were then sold to DEA undercover agents, and the possession by a felon of firearms, including two AR-15 assault rifles, one AK-47-style assault rifle, a 9-mm pistol, and a .22 caliber pistol equipped with a screw-in silencer. The fifth count of the indictment contains allegations that would result in the forfeiture of firearms and any other assets obtained, directly or indirectly, through proceeds derived from the cocaine conspiracy. The charges stem from an investigation conducted by the DEA, the Bureau of Alcohol, Tobacco, Firearms and Explosives, the Naval Criminal Investigative Service, and the Internal Revenue Service.
Click Here to Read the DEA Press Release
_______________________________________________________________________________________
DID YOU KNOW?
All too frequently criminals pose at DEA Special Agents on the phone or via the internet in an attempt to illegally scam innocent individuals. DEA Special Agents will never demand money or any other form of payment over the phone or the internet. Those who engage in these criminal acts are violating federal law, and there are severe penalties for impersonating a federal law enforcement officer. If you are contacted on the phone or via the internet by an individual who claims to be a DEA Special Agent and demands money, do not send it to them—instead, call our extortion scam hotline at 1-877-792-2873, or click here to find out more information.
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Monday, February 7, 2011

FDA MedWatch - Hydrocodone Bitartrate And Acetaminophen Tablets, Phenobarbital Tablets by Qualitest: Recall - Incorrect Package Labeling

Guy Ralph Perea Sr President of The United States
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http://columbiabroadcast.spaces.live.com
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United States Secret Service Director Patty Martinez President Pro Tempro
5 USCS section 5301 (c) "The President's Pay Agent" New in Caution to 'settlement of payment cards" ~ VOUCHERS ~ electronic 26 USCS section 6050W returns 12/31/2010; Travel and Subsistence Expenses; mileage allowance 5 USCS section 5701 without pay or $1.00 a year authorize employment. Confidentality Notice: This E-mail transmission may contain confidential or legally privileged information that is intended only for the individual or entity named in the E-mail address. If you are not the intended recipient, you are hereby notified that any disclosure, copying, distribution, or reliance upon the contents of this E-mail is strictly prohibited. If you have received this E-mail transmission in Error, please reply to the sender, so arrangements can be made for proper delivery, and then delete the message from your system. Please consider the environment before printing this email. Notice of Removal of office of Defendant Article IV General Provisions Section 2 (Supreme Law of The Land) The Constitution of The United States. "Any Thing in The Constitution or Laws of any State to the Contrary Notwithstanding" Contrary to Law (of an Act or Omission) Illegal; In Notwithstanding "Dispite;in spite of The government is current Executive Branch violating Notice of Removal, The Notice of Removal on the Obama Administration in personam including Goods (including tea, i.e. Leslie in like); within 30 days after the defendant Barak Obama is served with process in suit (case 641210) 28 USCS section 1446; Murphy Bros., Inc Vs. Michetti Pipe Stringing Inc., 119 S.Ct 1322 (1999). In responce to Housekeeper statment of Court Process of Subject Matter California Inn in Notice of Removal. Create a new office Federal Districts Modesto City Schools Districts and Turlock Irrigation District Division 3; United States Department of Education, Director Ross Carkeet United States Department of Education, Federal Bureau of Investigation Youth Authorty Director Guy Perea, Jr., Federal Bureau of Investigation Youth Authority Director Shopie Perea, and Director United States District Court Western Washington Clean Water United States Navy.

Date: Mon, 7 Feb 2011 13:00:54 -0600
From: fda@service.govdelivery.com
Subject: FDA MedWatch - Hydrocodone Bitartrate And Acetaminophen Tablets, Phenobarbital Tablets by Qualitest: Recall - Incorrect Package Labeling
To: guyperea@live.com

Hydrocodone Bitartrate And Acetaminophen Tablets, Phenobarbital Tablets by Qualitest: Recall - Incorrect Package Labeling

AUDIENCE: Pharmacy, Patient
ISSUE: An individual bottle of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count was found incorrectly labeled with a Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count label, printed with Lot Number T150G10B. Both products are manufactured by Qualitest Pharmaceuticals.
As a result of this mix-up, patients may unintentionally take Hydrocodone and acetaminophen tablets, instead of the intended dose of Phenobarbital. Unintentional administration of Hydrocodone can lead to serious adverse events including respiratory depression, CNS depression, coma and death, especially in opioid naïve patients and patients on other CNS depressants. Unintentional administration of acetaminophen may result in liver toxicity in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day. Additionally, missing doses of Phenobarbital could result in loss of seizure control.
BACKGROUND: The recall includes the following products:

Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count, Lot Numbers T150G10B, T120J10E and T023M10A
Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count, Lot Numbers T150G10B, T120J10E and T023M10A

Recalled lots were distributed between Sept. 21, 2010 and Dec. 29, 2010 to wholesale and retail pharmacies nationwide (including Puerto Rico).
RECOMMENDATION: Consumers who have affected product should stop using the product and contact Qualitest at 1-800-444-4011 for reimbursement. Lot numbers can be found on the side of the bottle.

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 company press release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm242527.htm

Tell us how we are doing:
http://survey.foreseeresults.com/survey/display?cid=d509U9xg0gZVxkMRcoMsQg==&sid=link&cpp[date]=02_07_2011_1355&cpp[type]=S

You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
Follow MedWatch on Twitter

U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420

FDA MedWatch - American Regent Injectable Products: Recall - Visible Particulates in Products

Date: Sat, 5 Feb 2011 09:51:49 -0600
From: fda@service.govdelivery.com
Subject: FDA MedWatch - American Regent Injectable Products: Recall - Visible Particulates in Products
To: guyperea@live.com

American Regent Injectable Products: Recall - Visible Particulates in Products

Sodium Thiosulfate Injection USP 10%
Potassium Phosphates Injection, USP

AUDIENCE: Pharmacy
ISSUE: Recall initiated because some vials exhibit translucent visible particles consistent with glass delamination. Potential adverse events after intravenous administration include damage to blood vessels in the lung, localized swelling, and granuloma formation.
BACKGROUND: Glass delamination can occur with high pH solutions when the surface glass from the vial separates into thin layers, resulting in glass particles with a flaky appearance.
RECOMMENDATION: Hospitals, Home Health Care Agencies, Emergency Rooms, Infusion Centers, Clinics and other healthcare facilities should not use the recalled American Regent products. Recalled products should be immediately quarantined for return. Refer to Press Releases for specific lot numbers recalled.
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, incljuding links to the company press releases, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm242365.htm

Tell us how we are doing:
http://survey.foreseeresults.com/survey/display?cid=d509U9xg0gZVxkMRcoMsQg==&sid=link&cpp[date]=02_05_2011_1042&cpp[type]=S

You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
Follow MedWatch on Twitter

U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420

CVM Updates - FDA Announces Upcoming Shortage of Vetsulin for Dogs and Cats in the Critical Need Program

Guy Ralph Perea Sr President of The United States
http://ad.trwv.net/t.pl/54991/261038
http://groups.google.com/group/weatherdata1046am0426
http://columbiabroadcast.spaces.live.com/
http://ptusss.blogspot.com/
ptusss@aol.com
https://www.paypal.com/cgi-bin/webscr?cmd=_donations&business=guyperea@gmail.com&lc=US&item_name=President of The United States&item_number=14112769481&currency_code=USD&bn=PP-DonationsBF:btn_donateCC_LG.gif:NonHosted
United States Secret Service Director Patty Martinez President Pro Tempro
5 USCS section 5301 (c) "The President's Pay Agent" New in Caution to 'settlement of payment cards" ~ VOUCHERS ~ electronic 26 USCS section 6050W returns 12/31/2010; Travel and Subsistence Expenses; mileage allowance 5 USCS section 5701 without pay or $1.00 a year authorize employment. Confidentality Notice: This E-mail transmission may contain confidential or legally privileged information that is intended only for the individual or entity named in the E-mail address. If you are not the intended recipient, you are hereby notified that any disclosure, copying, distribution, or reliance upon the contents of this E-mail is strictly prohibited. If you have received this E-mail transmission in Error, please reply to the sender, so arrangements can be made for proper delivery, and then delete the message from your system. Please consider the environment before printing this email. Notice of Removal of office of Defendant Article IV General Provisions Section 2 (Supreme Law of The Land) The Constitution of The United States. "Any Thing in The Constitution or Laws of any State to the Contrary Notwithstanding" Contrary to Law (of an Act or Omission) Illegal; In Notwithstanding "Dispite;in spite of The government is current Executive Branch violating Notice of Removal, The Notice of Removal on the Obama Administration in personam including Goods (including tea, i.e. Leslie in like); within 30 days after the defendant Barak Obama is served with process in suit (case 641210) 28 USCS section 1446; Murphy Bros., Inc Vs. Michetti Pipe Stringing Inc., 119 S.Ct 1322 (1999). In responce to Housekeeper statment of Court Process of Subject Matter California Inn in Notice of Removal. Create a new office Federal Districts Modesto City Schools Districts and Turlock Irrigation District Division 3; United States Department of Education, Director Ross Carkeet United States Department of Education, Federal Bureau of Investigation Youth Authorty Director Guy Perea, Jr., Federal Bureau of Investigation Youth Authority Director Shopie Perea, and Director United States District Court Western Washington Clean Water United States Navy.

Date: Fri, 4 Feb 2011 17:04:13 -0600
From: fda@service.govdelivery.com
Subject: CVM Updates - FDA Announces Upcoming Shortage of Vetsulin for Dogs and Cats in the Critical Need Program
To: guyperea@live.com

You are subscribed to CVM Updates from the U.S. Food & Drug Administration's (FDA) Center of Veterinary Medicine (CVM). CVM Updates are brief news releases issued on developments of interest to our stakeholders and the public. This information has recently been updated, and is now available.

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U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420

FDA MedWatch - Merit Prelude Short Sheath Catheter Introducer: Class I Recall - Tip May Detach During Use

Date: Fri, 4 Feb 2011 17:22:47 -0600
From: fda@service.govdelivery.com
Subject: FDA MedWatch - Merit Prelude Short Sheath Catheter Introducer: Class I Recall - Tip May Detach During Use
To: guyperea@live.com

Merit Prelude Short Sheath Catheter Introducer: Class I Recall - Tip May Detach During Use

AUDIENCE: Cardiology, Nephrology, Risk Manager
ISSUE: Introducer tip may detach during use, causing arterial injury, hemorrhaging, or other serious events, while introducer tip material may enter into the bloodstream, causing blood clots (thrombosis).
BACKGROUND: The Merit Prelude Short Sheath Catheter Introducer is used to provide access and facilitate the introduction of other medical devices into veins or arteries while maintaining hemostasis for a variety of procedures.
RECOMMENDATION: Merit Medical Systems, Inc. is advising customers to immediately discontinue use of any affected product, examine their inventory, and quarantine all affected 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, includinbg a link to the Class I recall notice, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm242343.htm

Tell us how we are doing:
http://survey.foreseeresults.com/survey/display?cid=d509U9xg0gZVxkMRcoMsQg==&sid=link&cpp[date]=02_04_2011_1821&cpp[type]=S

You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
Follow MedWatch on Twitter

U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420

FDA Data Standards Update - SPL Web Page Update

Guy Ralph Perea Sr President of The United States
http://ad.trwv.net/t.pl/54991/261038
http://groups.google.com/group/weatherdata1046am0426
http://columbiabroadcast.spaces.live.com/
http://ptusss.blogspot.com/
ptusss@aol.com
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United States Secret Service Director Patty Martinez President Pro Tempro
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Date: Fri, 4 Feb 2011 13:54:17 -0600
From: fda@service.govdelivery.com
Subject: FDA Data Standards Update - SPL Web Page Update
To: guyperea@live.com

Greetings,

The FDA Data Standards Council's website was updated Friday, February 4, 2011, to replace the hyperlink located in the Download Labels subsection on the SPL web page: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm.

Lonnie Smith

Policy Analyst

FDA Data Standards Council

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Drug Information Update - Gardasil approved to prevent anal cancer

Guy Ralph Perea Sr President of The United States
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Date: Fri, 4 Feb 2011 12:32:11 -0600
From: fda@service.govdelivery.com
Subject: Drug Information Update - Gardasil approved to prevent anal cancer
To: guyperea@live.com

FDA/CDER/Division of Drug Information (DDI)

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

The U.S. Food and Drug Administration today approved the vaccine Gardasil for the prevention of anal cancer and associated precancerous lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18 in people ages 9 through 26 years.
Gardasil is already approved for the same age population for the prevention of cervical, vulvar, and vaginal cancer and the associated precancerous lesions caused by HPV types 6, 11, 16, and 18 in females. It is also approved for the prevention of genital warts caused by types 6 and 11 in both males and females.
Although anal cancer is uncommon in the general population, the incidence is increasing. HPV is associated with approximately 90 percent of anal cancer. The American Cancer Society estimates that about 5,300 people are diagnosed with anal cancer each year in the United States, with more women diagnosed than men.
Gardasil's ability to prevent anal cancer and the associated precancerous lesions [anal intraepithelial neoplasia (AIN) grades 1, 2, and 3] caused by anal HPV-16/18 infection was studied in a randomized, controlled trial of men who self-identified as having sex with men (MSM). This population was studied because it has the highest incidence of anal cancer. At the end of the study period, Gardasil was shown to be 78 percent effective in the prevention of HPV 16- and 18-related AIN. Because anal cancer is the same disease in both males and females, the effectiveness data was used to support the indication in females as well.
Gardasil will not prevent the development of anal precancerous lesions associated with HPV infections already present at the time of vaccination. For all of the indications for use approved by the FDA, Gardasil's full potential for benefit is obtained by those who are vaccinated prior to becoming infected with the HPV strains contained in the vaccine.
For more information, please visit: Gardasil

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