FDA to Withdraw Unapproved Cold & Cough Medicines

On 2 March, 2011 the Food and Drug Administration (FDA) of the United State has declared to withdraw the unapproved cold and cough medicines from the market shelves. They have planned to take away approximately 500 ineffective cold and allergy medications which are untested by FDA and not match with the standards of it for the safety, quality and effectiveness.

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FDA is the organization of the US Department of Health and Human Services and it is also associated with examining the quality and content of prescription and over-the-counter pharmaceutical drugs as well as medicines. The medicines which are not evaluated by the FDA are more likely to cause the unwanted effects to the users, especially at the time of availability of other FDA-approved and standardized or over-the-counter drugs for the cough, cold and allergy. As per the FDA, listed companies for the unapproved medicines have to discontinue the manufacturing of products in 90 days and also have to stop shipping in 180 days. And companies which are not listed for products in this category are anticipated to end production and shipping of their products as early as possible.

According to the FDA officials, they have many reasons for this action; some present medicines in the market contain risky blend of the active ingredients and on the other side some medicines are traded as the “timed-release” but they may release the active constituent very slowly, much faster or unpredictably. FDA has also got the information for the some kind of products which have the name which appears or sound like the other products and may likely to put medication error.

The director of agency's Office of Compliance at the Center for Drug Evaluation and Research, Deborah M. Autor said, "This action is necessary to protect consumers from the potential risks posed by unapproved drugs, because we don't know what's in them, whether they work properly or how they are made."

They also found few medicines, incorrectly marked for the consumption by infants and kids. In 2008, the action was taken against the use of OTC cough and cold medicines for infants and children under age 2 by the FDA due to some serious side effects. Many doctors do not know whether the drug he prescribing is FDA approved or not and because just listed in the Physicians' Desk Reference (PDR), they prescribe these products. FDA focused mainly on the pills offering unproven mixture of decongestant and cough-suppressing compounds. Manufacturing companies are also needed to register all new prescription drugs for scientific examination before they are released in the market.

If you want to check the whether the medicine you are taking for the cough or cold is approved by the FDA or not, enter the name of your medicine in the FDA sources given below:

Drugs@FDA (contains most FDA-approved drug products): www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

The Orange Book List of Approved Drug Products: www.accessdata.fda.gov/scripts/cder/ob/default.cfm

The National Drug Code (NDC) Directory of prescription drugs and insulin products: www.accessdata.fda.gov/scripts/cder/ndc/default.cfm