Health Team

Pharmacist reacts to FDA recall of cold, allergy meds

Posted March 14, 2011

The Food and Drug Administration plans to remove roughly 500 unapproved cold and allergy medication from the market as part of an ongoing campaign cracking down on ineffective prescription medications.

The agency, which made the announcement last week, said manufactures of the unapproved drugs will have 90 days to cease production.

The FDA requires companies to submit all new prescription drugs for scientific review before they are launched. However, thousands of drugs actually predate the FDA's drug regulations, which were put in place in 1962. Those drugs were supposed to be evaluated over time, but many have escaped scrutiny.

"None of these drugs are recalled because there was a problem with the drug," said Mike James, a pharmacist at Person Street Pharmacy in Raleigh.

James said generic forms of the drugs made them cheaper for consumers but might have caused manufacturers not to invest in the costs of satisfying FDA regulations.

The FDA recall does not affect some of the commonly used brand-name, over-the-counter cough and cold medications. It does affect some prescription medications like Iophen DM, which is used to suppress coughing. 

"It's got Guaifenesin in it and it's been a good product and it's been used over the years," James said. 

Other drugs on the FDA list combine two varieties of the same ingredient, such as the allergy-reliever antihistamine. Regulators called such combinations "irrational," and warned that they could cause excessive drowsiness.

Doctors may not realize they are prescribing unapproved drugs because the products are often labeled just like FDA-approved products, according to the agency.

Many of the older drugs cited by the FDA are manufactured by multiple companies, often using different ingredients and dosages. For instance, a dozen companies market a drug called Rondec, according to the FDA's website.

"That's what makes them so dangerous: they have these shared names but different ingredients and different doses, so it's very easy for medication errors to occur," said Patti Gasdek Manolakis, a pharmacist and consultant who has researched unapproved drugs in the U.S.

Pharmacist reacts to FDA recall of cold meds Pharmacist reacts to FDA recall of cold meds

The FDA began its latest crackdown on unapproved drugs in 2006 and has taken action against 17 types of medications and dozens of companies. Typically, the agency orders manufacturers to stop making and shipping drugs, and it also has seized millions of dollars' worth of medications. But federal law does not call for fines for selling unapproved drugs, and criminal prosecutions are rare.

James said the recall doesn't mean all of the medications will go away. Some might return, repackaged by another company, but offered at a much higher price.


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  • seankelly15 Mar 21, 2011

    whatelseisnew - "You apparently have zero appreciation of Freedom."

    And you have zero comprehension. This is not about 'freedom' it is about companies having to PROVE that a compound that they produce is SAFE and EFFECTIVE.

  • seankelly15 Mar 21, 2011

    illegals--GO HOME - "Hey.......this is the "change" everyone wanted. Lots of you people voted for the id, iot getting the so-called "free" healthcare for all!! So, now live with it and his "change"."

    Where in the article does it refer to healthcare? Where in the article does it refer to 'free healthcare'?

  • whatelseisnew Mar 21, 2011


    AH yes good for you. People like you need and love to be controlled. Tell ya what. Join the Military, they will teach you to learn to love Freedom. You apparently have zero appreciation of Freedom.

  • pmck Mar 21, 2011

    Bigal - Most people know Beck & Limbaugh are nothing close to being a "leader" of any sort. They're nothing but a mouthpiece for a news corporation. Then again, I can say the same thing about another "news" corporation that spouts nothing but socialist agenda. If the FDA wasn't owned by big pharma, more people would trust them. Open your eyes.

  • hppyhourhero Mar 17, 2011

    This is TRUE, I learned about this in physiology class.
    If you have a cold and take drugs to treat that cold the body will respond and heal, usually within the course of about 7 days.

    However, if you have a cold and treat it by staying home, resting, drinking plenty of fluids and do not use any drugs, it will take you about a week to get over your cold.

  • bigal02282 Mar 16, 2011

    Typical are the comments about government regulations. If the minority of the most vocal Republicant crybabies ever quit whining about everything under the sun, the earth would quit spinning. But then again, look at their "leaders" Boehner (crybaby) Limbaugh (whining hypocrite) Beck (whining and insane). So it's no wonder the brainless followers of these do nothing but whine and complain and cry. I know not every Republicant is like that, but then again, the smart ones don't post here.

  • Viewer Mar 16, 2011

    The rules have been in place since 1962. Why haven't the companies proved by now the drugs were really OK? So much for business and self regulation.

  • webberx101 Mar 16, 2011

    Someone needed some "busy work" ... and guess who's going to pay?!

  • bilge53 Mar 15, 2011

    Job security in the FDA. Headcolds and coughs for everyone else.

  • illegals--GO HOME Mar 15, 2011

    Hey.......this is the "change" everyone wanted. Lots of you people voted for the id, iot getting the so-called "free" healthcare for all!! So, now live with it and his "change".