500 Unapproved Prescription Cough and Cold Medications Banned by FDA

Our Maryland-based prescription drug error attorneys have been following the U.S. Food and Drug Administration’s recent announcement, ordering the makers of around 500 prescription cold, cough and allergy medications to take the drugs off the pharmacy shelves, as they have not been proven to be safe and effective.

According to the FDA, the prescription drugs in question have not been linked to any major problems or drug-related injuries, but the FDA is still concerned that the medical problems associated with the drugs could be seriously under reported.

The agency claims that the drugs have not been evaluated by the FDA, and taking them may be more of a risk to the consumer than taking over-the-counter (OTC) medications to treat the same symptoms, that have been approved. The FDA also claimed that the action is necessary to protect consumers from any health and safety risks posed by these unapproved drugs, as the agency does not know how they are made, whether they are effective, or what is in them.

One of the problems that the agency found was with time-release drugs, which are reportedly hard to manufacture, and can release too slowly or not at all if quality controls in the manufacturing of the drug are inadequate. The FDA also made a move against unapproved products that contain drug combinations that could be considered dangerous, like combining two antihistamines, which could react in oversedation.

Another concern was with drugs that are labeled for use by children under the age of two. In 2008 the FDA issued a warning against OTC cold and cough medications for children under that age of two, because of serious side effects that could be life threatening.

The drugs are not reportedly household names, with names like Cardec, Lodrane24D and Pediahist—many of which are already off the market. According to the Los Angeles Times, many the drugs on the list came on the drug market before a 1962 law was passed, requiring pharmaceutical companies to prove their effectiveness.

Since 2006, the FDA has embarked on the Unapproved Drugs Initiative, which is the agency’s risk-based enforcement approach to rationally and efficiently bring all drugs that are currently unapproved into the approval process, and to reduce patient harm or injury from exposure to drugs that have not been proven to be safe, effective and of the highest quality.

FDA prompts removal of unapproved drugs from the market, U.S. Food and Drug Administration, March 2, 2011
FDA orders 500 cough and cold drugs off the market, The Los Angeles Times, March 2, 2011
FDA Bans Unapproved Prescription Cough Cold and Allergy Meds, Bloomberg Businessweek, March 02, 2011

Related Web Resources:

U.S. Food and Drug Administration: Medication Error Reports

Institute for Safe Medication Practices, (ISMP)

Related Blog Posts:

FDA Reports on Fatal Morphine Oral Solutions Medication Errors, Pharmacy Error Injury Lawyer Blog, January 26, 2011

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