“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,” said Deborah Autor, director of the agency’s Office of Compliance at the Center for Drug Evaluation and Research.
Unapproved time-release drugs are among the most worrisome because those particular drugs are especially complicated to manufacture and may not release the medication in a timely or safe manner.
The FDA is also concerned about unapproved cough, cold and allergy medications labeled for use by children under the age of 2 because of potentially serious, life-threatening side effects.
It is required for all prescription drugs to be evaluated by the FDA before they can be sold, but some manufactors simply saw a “business opportunity” and bypassed the guidelines, said Autor.
What’s worse is, some have been on the market for years and are prescribed by doctors because the doctors are not aware they have not been approved. Many of the illegal drugs are listed in the Physicians’ Desk Reference (PDR), which doctors often use as a guide for prescribing drugs.
FDA officials are requiring companies who manufacture illegal drugs to stop making them within 90 days and to stop shipping them within 180 days. There are many other approved drugs on the market, so the FDA does not expect any kind of shortage in prescription and OTC cough, cold, and allergy medications.