FDA Pulls 500 Cold Medicines From the Market
March 3, 2011 by admin
Filed under News Stories
March 3rd, 2011
WebMD
By: Denise Mann
The FDA today announced steps to remove more than 500 prescription cold, cough, and allergy products from the market because of potential safety concerns.
The FDA asked companies to stop manufacturing the 500 products within 90 days and stop shipping them within 180 days. Some manufacturers must stop making and shipping their products immediately, the FDA warns.
There are no data on how often these now-banned medications are prescribed today, but many doctors may be unaware that they contain unapproved ingredients because these drugs are listed in the Physicians’ Desk Reference and may be advertised in medical journals.
Questions on Drug Safety
The FDA does not know if these prescription drugs are safe or not largely because they were grandfathered in before changes to the FDA’s drug approval process were enacted.
“We don’t know what they are, whether they work properly, or how they are made,” said Deborah M. Autor, director of the FDA’s Office of Compliance at the Center for Drug Evaluation and Research (CDER) in Silver Spring, Md., during a teleconference. “The problem is that we don’t know what the problem is.”
For example, some of these cough, cold, and allergy drugs are labeled as “time-release.” These are complicated to manufacture, and the FDA has not reviewed whether the active ingredient is released in a consistent matter over a period of time, she says. “They may be released too slowly, too quickly, or not at all.”
Kids Under Age 2
Others contain an “irrational” combination of the same types of products, such as two or more antihistamines, and some are inappropriately labeled for use by infants and young children, she says. Many contain the same ingredients as the over-the-counter cough and cold products that are no longer supposed to be used in kids under 2.
Yolandra Hancock, MD, a pediatrician at Children’s National Medical Center in Washington, D.C., praises the FDA’s move.
“The new FDA decision supports modern-day pediatric practice to avoid cough syrups in children under 2 because they do more harm than good,” she says. Some may slow down breathing, and others decrease cough and allow mucus to sit in the chest, where it can cause other problems such as lung infection, she says.
“I fully support the FDA’s move in controlling access to these medications in children; it is highly appropriate and long overdue,” she says.
As to the risks these drugs pose, “for the most part, [these adverse reactions] are not serious,” says Charles E. Lee, MD, medical officer of the division of new drugs and labeling compliance at the CDER.
After the FDA crackdown on the use of over-the-counter cough and cold medicine in children younger than 2, the number of emergency room visits for adverse events decreased by 50%, he says.
“We also know that 15% of these events came from prescription cough, cold, and allergy products and included sedation/drowsiness and irritability,” Lee says.
I get at least 20 emails daily with offers for prescription medication from other places including a prescription over the internet. The only thing they really car for is to get you drugged up and to lower your vibration. I have not taken any kind of medication for more than 10 years and plan on keeping it this way. Thank you and keep up the good work. The CD’s CD’s Your Wish is Your Command is a masterpiece. I am listening to them over and over again.
Thank you, thank you, thank you!!!
Thanks Kevin for all the info. I agree the pills are wrong and I stopped using them. Having had a spondylartrhitis (on the lower and upper back!) since 1985 I eventually discovered EFT in January 2009 and cured it in Nov. 2009! No pills ! Great show. thanks.
Kevin, I’ve loved you for years. I first became aware of you through your Natural Cures books. They always resonated with me. Now I am a GIN member and follow you on your radio show. All I know is I always feel you are telling the truth about the way “things” are…and I’m not a gullible type. I really see it the way you call it. I definitely feel I’m with my people or as you call it…like minded people. I’m anxious to grow with GIN and to be a part of “KT world”. Personally, I get a real kick out of your radio show and think you’re hysterical, even when your discussing serious issues, you bring some levity to the topics…probably the Italian in you…I’m an Italian mommy so I feel connected in a weird way and I get good chuckles. Keep doing what you do. We need more people like you to make huge changes.
I have known about the dangerous cold medicines for years; however, it makes since that it would take the FDA years to remove them. My brother was one of the kids at school who got put on Ritalin at a very young age. Since then he has never been the same. The Ritalin made he ADHD. Kevin does the Government really pay $500 dollars a month for every child put on Ritalin? To me that seems like to much.
Thank you, thank you, and thank you for this wealth of information. This is all the more reason why I stopped taking pain medication for headaches (I completely stopped after listening to the ‘Your Wish Is Your Command’ series for the first time last year in August). I’d rather deal with my health the natural way than take ANY type of over-the-counter drug with all of these hard-to-pronounce names of chemicals that don’t belong in us. Mono-gluteo-phoso-hydro-oxidal-huh??? If you can’t even pronounce it, DON’T TAKE IT! lol
In college I did a study regarding the correlation between pseudo-ephedrine availability and meth production. Without pseudo-ephedrine there is no Meth. I tied into the report the idea that if the FDA was to simple take pseudo-ephedrine off the market Meth would disappear completely. We’ve learned through the natural remedies that Kevin teaches, the cold medications that use pseudo-ephedrine are now completely unnecessary.
So why doesn’t the FDA remove the deadly chemical? Because they know they make hundreds of millions of dollars through the legal and illegal sales of pseudo-ephedrine every year. Even though they know they can erase Meth from existence and potentially save thousands of lives, they don’t because of their goals to protect the profits of the drug companies.
So let me get this straight, because there are people that will take a material (pseudo-ephedrin) and spin it down into Met that means ephedrin is a deadly chemical?