Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine

Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine

The following statement is attributed to Dr. Anne Schuchat, Principal Deputy Director of the CDC and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research

 

 

As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen ) vaccine have been administered in the U.S. CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine. In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination. Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.

 

CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.

 

Right now, these adverse events appear to be extremely rare. COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously. People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider. Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System at Caution-https://vaers.hhs.gov/reportevent.html < Caution-https://vaers.hhs.gov/reportevent.html > .

 

CDC and FDA will provide additional information and answer questions later today at a media briefing. A recording of that media call will be available on the FDA’s YouTube channel.

 

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U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES < Caution-http://www.hhs.gov/ > 

 

CDC works 24/7 protecting America’s health, safety and security. Whether diseases start at home or abroad, are curable or preventable, chronic or acute, or from human activity or deliberate attack, CDC responds to America’s most pressing health threats. CDC is headquartered in Atlanta and has experts located throughout the United States and the world.

 

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DRUG RECALLS

Amneal Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Ranitidine Tablets, USP, 150mg and 300mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-voluntary-nationwide-recall-ranitidine-tablets-usp-150mg-and-300mg

Apotex Corp. Issues Voluntary Nationwide Recall of Ranitidine Tablets 75mg and 150mg (All pack sizes and Formats) due to the potential for Detection of an Amount of Unexpected Impurity,N-nitrosodimethylamine (NDMA) Impurity in the product

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/apotex-corp-issues-voluntary-nationwide-recall-ranitidine-tablets-75mg-and-150mg-all-pack-sizes-and

Sandoz Inc. Issues Voluntary Recall of Ranitidine Hydrochloride Capsules 150mg and 300mg Due to An Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA), in the Product

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sandoz-inc-issues-voluntary-recall-ranitidine-hydrochloride-capsules-150mg-and-300mg-due-elevated

Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium / Hydrochlorothiazide Tablets, USP

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/updated-torrent-pharmaceuticals-limited-expands-voluntary-nationwide-recall-losartan-potassium-0

MONROE HEALTH CENTER Celebrates National Health Center Week 2019

National Campaign Celebrates Health Centers Rooted in Communities

 

MONROE HEALTH CENTER will celebrate this week at our Union, Peterstown, AND Forest Hill, WV locations and our Craig County Health & Dental Centers in New Castle, VA to mark National Health Center Week 2019 from August 4th-10th. We will celebrate one day this week at each site as part of a national campaign to increase awareness of the ways health centers are providing affordable health care in communities. A host of NHCW events that celebrate  the ways that health centers are “Rooted in Communities” are scheduled across the country, including health fairs, visits by Members of Congress and state officials to local health centers, press conferences, back-to-school drives, community breakfasts, patient appreciation events, free health screenings and much more.

MONROE HEALTH CENTER is part of a nationwide network of locally-run health centers that serve more than 28 million people nationwide. They are on the front lines of national public health challenges – whether caring for veterans, providing opioid treatment, or responding to natural disasters. They are also a lifeline in remote and underserved communities where the nearest doctor or hospital can be as far as 50 miles or more away. Nearly half of health centers (44 percent) are located in rural communities.

Highlights of health center accomplishments include:

  • Reducing unnecessary hospitalizations and unnecessary visits to the emergency room;
  • Treating patients for a fraction of the average cost of one emergency room visit;
  • Serving more than one in six Medicaid beneficiaries for less than two percent of the national Medicaid budget;
  • Lowering the cost of children’s primary care by approximately 35 percent;
  • Treating 65,000 patients with Medication Assisted Therapy for opioid use disorder in 2017; and,
  • Serving over 355,000 veterans throughout the country.

 

This year’s NHCW 2019 will highlight how health centers are at the forefront of a nationwide shift in addressing environmental and social factors as an integral part of primary care, reaching beyond the walls of conventional medicine to address the factors that may cause sickness, such as lack of nutrition, mental illness, homelessness and substance use disorders.  Community Health Centers’ success in managing chronic disease in medically vulnerable communities has helped reduce health care costs for American taxpayers.

Each day of NHCW 2019 is dedicated to a particular focus area.  To learn more and view a listing of events please visit: www.healthcenterweek.org.

 

 

Pfizer, Inc. Issues A Voluntary Nationwide Recall Of One Lot Of Children’s Advil® Suspension Bubble Gum Flavored 4 FL OZ Bottle. Visit the site below for more Info

https://www.fda.gov/Safety/Recalls/ucm618675.htm

MONROE HEALTH CENTER BOARD OF TRUSTEE MEETINGS:
4TH Wednesday of Every month (subject to change due to inclement weather, etc.)
Time – 6:00 p.m. Location – Learning Resource Center @ Monroe Health Center – 200 Health Center Drive, Union, WV For a copy of the Board Agenda please call 304-772-3064

Monroe Health Center

To help us serve you quickly and efficiently,

we respectfully request that you visit us for NURSING SERVICES between

8:30am – 11:30am

And

1:00pm – 4:00pm

Monday through Friday.

These services would include:

Immunizations*, Depo-Provera, B-12, Allergy injections, Family Planning, and Lab testing.

*Must present a copy of immunization record(s).

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Tuberculin Skin Tests (“TB” Tests or “PPD’s”) will only be given on Monday, Tuesday & Friday

8:30 am – 11:30 am

AND

1:00 pm – 4:00 pm

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Thank you, Administration