FDA Taking Unapproved Drugs Off The Market
By: Stephanie Jackson, KARK 4 News
Updated: September 28, 2007
The FDA announced Friday, they are taking action to get about 200 unapproved drugs containing hydrocodone off the market. The FDA says the prescription drugs have never been proven safe or effective in children, yet some contain label instructions for children as young as two. It's received reports of adverse reactions and even deaths due to medication errors associated with these drugs.
Click here to find out if the drug you or your child is taking has been approved. When visiting the FDA website, type in the drug you are taking into the search box to see if it is FDA-approved.
The FDA says some of the unapproved drugs are on the market because they were available before the current FDA rules were implemented. FDA officials say others are there simply because manufacturers thought they could get away with it. The FDA believes up to 2% of all marketed drugs have not gone through their approval process.
They are requiring manufacturers that market hydrocodone products to children to stop production and distribution by October 31. Those marketing other hydrocodone products must stop by December 31.
There are seven approved cough suppressants that contain hydrocodone and this ruling does not affect analgesic uses of hydrocodone.
Click here to find out if the drug you or your child is taking has been approved. When visiting the FDA website, type in the drug you are taking into the search box to see if it is FDA-approved.
The FDA says some of the unapproved drugs are on the market because they were available before the current FDA rules were implemented. FDA officials say others are there simply because manufacturers thought they could get away with it. The FDA believes up to 2% of all marketed drugs have not gone through their approval process.
They are requiring manufacturers that market hydrocodone products to children to stop production and distribution by October 31. Those marketing other hydrocodone products must stop by December 31.
There are seven approved cough suppressants that contain hydrocodone and this ruling does not affect analgesic uses of hydrocodone.
