FDA Pulls Unapproved Cold, Cough, Allergy Drugs From Market

[Horse with no Name]

www.medscape.com (must register)

>>>snip
March 2, 2011 — The US Food and Drug Administration (FDA) is taking action against companies that manufacture, distribute, or market oral agents that are not approved by the FDA. The drugs are prescribed for the treatment of coughs, colds, and allergies in the United States.

According to the FDA, companies that have previously listed products subject to today's action are required to stop manufacturing the products within 90 days and to stop shipping the products within 180 days. Companies that have not previously listed products subject to today's action with FDA are expected to stop manufacturing and shipping their products immediately.

"Many health care providers are unaware of the unapproved status of drugs and have continued to unknowingly prescribe them because the drugs' labels do not disclose that they lack FDA approval," according to an FDA news release.

During an FDA press conference today, officials said there has been limited reporting of adverse events related to these products, but that these adverse events are probably significantly underreported, and this has the spurred the FDA to take action.

Here is the list:

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm245106.htm

[derby378]

1. Can't say I've heard of any of these meds...

...let alone taken them. Is this a list of dollar-store compounds or something?

[Horse with no Name]

2. Prescriptions mostly.

We have several in our cabinet. I am going to have to get a list and start throwing away stuff.

[derby378]

5. Are you KIDDING me? PRESCRIPTIONS?

The very drugs the FDA is supposed to regulate, and they aren't even doing that?

Y'know, we just had eight years of this doofus in the White House who probably had something to do with this malaise... :mad:

[customerserviceguy]

3. I didn't notice any famous brand names on the list

Just stuff that was probably made by manufacturers that don't pay huge sums to the FDA for "approval", yet are the same stuff that the big name brands have as active ingredients. Of course, the excessive advertising campaigns for the top shelf stuff makes it cost twice as much, but the FDA doesn't care about that.

[MedicalAdmin]

4. I love the IDEA of the FDA.

I hate the revolving door between them and the same corporations they are supposed to be a watch dog over. The obvious conflicts of interest inherint in this practice weakens their authority and validity.

And I'm a fan of what they are SUPPOSED to be doing.

[Trekologer]

6. It seems to be not just the ingredients but their combination and labeling

The MSNBC article has a little more information: http://www.msnbc.msn.com/id/41869370/ns/health-cold_and_flu/

Many of the listed drugs have unapproved labeling or ingredients which were not tested together in the ratio being sold.