Earlier this month the FDA announced that it intends remove nearly 500 unapproved prescription cough, cold and allergy medicines from the U.S. market.
The products were never tested by the FDA. See the full list here.
In effect, these drugs were grandfathered into legality… Most companies are expected to stop manufacturing these products within 90 days and stop shipping them within 180 days. Some are expected to stop manufacturing and shipping them immediately.
Many of these drugs have been sold for 50 years or more. A 1962 law requiring FDA approval of new drugs allowed existing drugs to continue to be sold. In effect, these drugs were grandfathered into legality. The idea was that these drugs would be submitted for FDA review someday. For many of them, this never happened.
The FDA has numerous concerns regarding these medicines. Some double up on active ingredients such as antihistamines. Some are marketed as "time-release" but may release their ingredients too quickly, too slowly or inconsistently. Other products are inappropriately labeled for use by young children and infants. And there are questions about the purity of ingredients in some medicines.
Most of these drugs are not common household names. And while no serious side effects have been linked to any of them, they have never been reviewed by the FDA, so the FDA will not vouch for their safety and effectiveness.
Nearly all of these medicines contain active ingredients commonly found in other prescription and over-the-counter medicines, such as the decongestant pseudoephedrine, the cough suppressant dextromethorphan or various antihistamines. A multitude of substitutes exist, both prescription and non-prescription (most over-the-counter medications do not require FDA approval).
According to the FDA, many doctors have prescribed these medicines for years, assuming that because they've been on the market for so long, they are safe. Some are even approved by insurance company drug plans.
Anyone who has been taking any of these medicines should consult with their doctor about alternatives, of which there should be plenty.
The FDA explains the reasons for the removal in a consumer update on their website. The consumer update also contains links to questions and answers on the removal and other related material.
