Earlier this month, the FDA ordered a product recall of nearly 500 prescription medications used for treating colds, coughs, and allergies from the United States market. The reason, according to the Food and Drug Administration (FDA), is that the drugs contain ingredients that have not been approved by federal regulators. These products had not been formally evaluated by federal regulators and is being referred to as the latest in a series of actions by the FDA to stop the sale of products sold without government authorization. The FDA stated that the agency was unsure if the drugs were safe or effective and believe that their existence on the market poses an untenable risk to US consumers. Hence, removing these unapproved products will reduce potential risks to consumers.
The unapproved drugs have been linked to some minor problems, such as drowsiness and irritability. However, the agency is concerned that medical problems associated with the drugs may be significantly underreported. Some of the products are labeled as suitable for children, but contain ingredients covered by a 2008 FDA advisory that warned against over-the-counter medications in children under the age of 2. Some of the drugs combine two varieties of the same ingredient that could cause excessive drowsiness. Agency officials do not know how many patients are taking the drugs that would be removed from the market. Over-the-counter medications, which are used more frequently than prescription drugs, are not affected by the FDA’s order. Many questioned whether physicians were aware that they prescribed a drug that was never approved by the FDA.
Visit the New York Times to read more about the FDA cold drug product recall.