Thursday, October 21, 2010

FDA in Rare Reversal of Approval of Medical Device

http://www.allgov.com/Controversies/ViewNews/FDA_in_Rare_Reversal_of_Approval_of_Medical_Device_101017

Lobbying while on duty for the state of New Jersey?
Hey they're supposed to do that AFTER they leave office
Heree's your government America
What was approved in your medicine cabinet and who got bought off put it there?
Do you ever listen to those drug ads on TV and the side effects that have been reported for that particular drug of the ad?
My favorite one is Advair, my husband and I laugh and laugh every time it comes on.
Here's why:
If you have any of these other conditions, you may need a dose adjustment or special tests to safely use Advair:

a food or drug allergy;

heart disease or high blood pressure;

epilepsy or other seizure disorder;

an infection of any kind;

a weak immune system;

diabetes;

glaucoma;

tuberculosis;

osteoporosis;

a thyroid disorder; or

liver disease.
FDA pregnancy category C. It is not known whether Advair is harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether fluticasone and salmeterol passes into breast milk or if it could harm a nursing baby. Do not use Advair without telling your doctor if you are breast-feeding a baby.

See also: Pregnancy and breastfeeding warnings in more detail

Advair can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.

Do not give this medication to a child younger than 4 years old.

Long-term use of steroids may lead to bone loss (osteoporosis), especially if you smoke, if you do not exercise, if you do not get enough vitamin D or calcium in your diet, or if you have a family history of osteoporosis.




Read more: http://www.drugs.com/advair.html#ixzz1312xrFa7

Well now you know how it got to be for sale.


The Food and Drug Administration has changed its mind about a patch for injured knees, and withdrawn its approval for the product that was originally allowed on the market after four politicians from New Jersey pressured regulators into making their decision.

The about-face on Menaflex was a first in many ways for the FDA.

According to The New York Times, the agency “had never before admitted that it approved a drug or device mistakenly, never rescinded such an approval without citing new information about the product, never admitted that a regulatory decision was influenced by politics, and never accused a former commissioner of questionable conduct.”

FDA scientists said they did not recommend Menaflex for approval. But higher-ups overruled the expert opinions after four Democrats from New Jersey—Senators Robert Menendez and Frank R. Lautenberg and Representatives Frank Pallone Jr. and Steven R. Rothman—lobbied the FDA on the company’s behalf, and it was approved in December 2008