CHITCHATNINE's Public Groups:

FDA Recalls Group:  http://www.medhelp.org/forums/FDA-Recalls-US-Food-and-Drug-Administration/show/395

Helicopter Moms (Parents) Debate Group - http://www.medhelp.org/forums/Helicopter-Moms-Parents-Debate-Group/show/437

Swine Flu Vaccine Debate Group - http://www.medhelp.org/forums/Swine-H1N1-Flu-Vaccine-Debate-Forum/show/438

MSK (Medullary Sponge Kidney Disease): http://www.medhelp.org/forums/MSK-Medullary-Sponge-Kidney-Disease/show/391

I'm a Moderator on the Interstitial Cystitis (IC), Pelvic Pain Support Forum:  http://www.medhelp.org/forums/Interstitial-Cystitis-IC--Pelvic-Pain-Support-Forum/show/412


Stop by and say hello - All are invited!

To start your own group it is simple as 1-2-3  .. really really easy!
http://www.medhelp.org/user_groups/new


C~

Hi -- found the info on the this info on the Tylenol website as it applies to children's products & is a voluntary recall, so it's not posted on my FDA Recalls Group - ( http://www.medhelp.org/forums/FDA-Recalls-US-Food-and-Drug-Administration/show/395)


TYLENOL VOLUNTARY RECALL:
http://www.tylenol.com/page.jhtml?id=tylenol/news/subpchildinfantnews.inc

Recalled Products - Full List

Lot #  Product Description  

SBM041, SBM067, SCM037, SDM027, SEM109  Children's Tylenol Plus Cold MS Suspension 4 oz. Grape  
SBM042, SCM015, SCM036, SDM034  Children's Tylenol Suspension 4oz. Grape  
SBM043, SBM044, SCM029  Children's Tylenol Suspension 4oz. Bubble Gum  
SBM045, SCM011, SCM030, SDM035  Children's Tylenol Suspension 4oz. Strawberry  
SBM064, SCM033, SDM020  Infant’s Tylenol Grape Suspension Drops 1/4oz.  
SBM065, SCM005, SCM006, SDM032  Infant's Tylenol Suspension 1/2oz. Cherry  
SBM066, SCM068  Children's Dye Free Suspension 4oz. Cherry  
SBM068, SCM035, SCM070, SCM080, SDM005  Children's Tylenol Suspension 4oz. Cherry  
SBM069, SBM070, SCM081, SDM006  Children's Tylenol Plus Cough & Runny Nose 4oz. Cherry  
SCM012, SCM067, SDM007, SDM068  Infant's Tylenol Suspension Drops 1/2oz. Grape  
SCM013, SCM014, SCM069  Children's Tylenol Plus Flu 4oz. Bubble Gum  
SCM016, SFM024  Children's Tylenol Plus Cold Suspension 4oz. Grape  
SCM017  Children's Tylenol Plus Cough/ST Suspension 4oz. Cherry  
SCM082, SDM039, SDM040  Infant's Tylenol Suspension Drops 1oz. Grape  
SCM083, SCM084, SDM008  Infant's Tylenol Dye Free Suspension 1oz. Cherry  
SDM064  Children’s Tylenol Pediatric Suspension 1oz. Cherry  
SDM038, SDM009  Infant's Tylenol Suspension Drops 1oz. Cherry  
SDM033  Children's Tylenol Plus Cold/Allergy 4oz. Bubble Gum  
SDM078  Infant's Tylenol Drops 1oz. Grape  
SCM034  Infant’s Tylenol Grape Suspension Drops H/G 1/2oz.  
SDM028  Children's Tylenol Suspension 4oz. Cherry, Hospital Govt.  

Wanted to mention my new Group about FDA Recalls .. you may want to join.  

http://www.medhelp.org/forums/FDA-Recalls-US-Food-and-Drug-Administration/show/395

We've created / opened a new public FDA Recalls Group - stop by, take a look and please join!   Together we can all be aware of FDA recalls, alerts, safety, press releases, etc.

Everyone's Invited! -

http://www.medhelp.org/forums/FDA-Recalls-US-Food-and-Drug-Administration/show/395

C~

Swine Flu Vaccine Approved by the FDA


http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm182399.htm


FDA NEWS RELEASE
For Immediate Release: Sept. 15, 2009
Media Inquiries: Pat El-Hinnawy, 301-796-4763, patricia.el-***@****; Peper Long, 301-796-4671, mary.***@****
Consumer Inquiries: 1-888-INFO-FDA
FDA Approves Vaccines for 2009 H1N1 Influenza Virus
Approval Provides Important Tool to Fight Pandemic


The U.S. Food and Drug Administration announced today that it has approved four vaccines against the 2009 H1N1 influenza virus. The vaccines will be distributed nationally after the initial lots become available, which is expected within the next four weeks.

“Today's approval is good news for our nation's response to the 2009 H1N1 influenza virus,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “This vaccine will help protect individuals from serious illness and death from influenza.”

The vaccines are made by CSL Limited, MedImmune LLC, Novartis Vaccines and Diagnostics Limited, and sanofi pasteur Inc. All four firms manufacture the H1N1 vaccines using the same processes, which have a long record of producing safe seasonal influenza vaccines.

”The H1N1 vaccines approved today undergo the same rigorous FDA manufacturing oversight, product quality testing and lot release procedures that apply to seasonal influenza vaccines,” said Jesse Goodman, M.D., FDA acting chief scientist.

Based on preliminary data from adults participating in multiple clinical studies, the 2009 H1N1 vaccines induce a robust immune response in most healthy adults eight to 10 days after a single dose, as occurs with the seasonal influenza vaccine.  

Clinical studies under way will provide additional information about the optimal dose in children. The recommendations for dosing will be updated if indicated by findings from those studies. The findings are expected in the near future.
As with the seasonal influenza vaccines, the 2009 H1N1 vaccines are being produced in formulations that contain thimerosal, a mercury-containing preservative, and in formulations that do not contain thimerosal.  

People with severe or life-threatening allergies to chicken eggs, or to any other substance in the vaccine, should not be vaccinated.

In the ongoing clinical studies, the vaccines have been well tolerated. Potential side effects of the H1N1 vaccines are expected to be similar to those of seasonal flu vaccines.

For the injected vaccine, the most common side effect is soreness at the injection site. Other side effects may include mild fever, body aches, and fatigue for a few days after the inoculation. For the nasal spray vaccine, the most common side effects include runny nose or nasal congestion for all ages, sore throats in adults, and -- in children 2 to 6 years old -- fever.

As with any medical product, unexpected or rare serious adverse events may occur. The FDA is working closely with governmental and nongovernmental organizations to enhance the capacity for adverse event monitoring, information sharing and analysis during and after the 2009 H1N1 vaccination program. In the U.S. Department of Health and Human Services, these agencies include the Centers for Disease Control and Prevention.
Vaccines against three seasonal virus strains are already available and should be used (see information on the seasonal flu). However, they do not protect against the 2009 H1N1 virus (see information on H1N1 flu).


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FDA Vaccine Questions & Answers:

http://www.fda.gov/BiologicsBloodVaccines/Vaccines/QuestionsaboutVaccines/ucm182335.htm