I’ve heard that unapproved drugs are being sold in the U.S. Is this true?
Yes, it is true. Most drugs on the U.S. market have been approved by the FDA; however, some medications, mostly older ones, have not. These unapproved drugs were being sold BEFORE the current FDA approval process began about 50 years ago. Manufacturers of these older drugs never applied for FDA approval, and the drugs are still on the market today.
Why is FDA approval of drugs important?
The FDA approval process helps make sure that drugs are both safe and effective, before they are available to the public. Before a drug is approved by FDA, it is studied in both animals and humans. From these studies FDA can tell if a drug is safe and if it actually works. The proper dose of the drug and side effects to expect are also determined. FDA also makes sure that drugs are manufactured properly, and that the product labeling includes the information healthcare providers and patients need to use the drugs safely. It should be pointed out that dietary supplements (e.g., vitamins, herbals, etc) are NEVER evaluated by the FDA for safety, effectiveness, or purity.
What is FDA doing about unapproved drugs still on the market?
The FDA’s goal is to make sure all drugs on the market are safe and effective. Unapproved drugs that are not safe or effective are their first priority. Some unapproved drugs that are not safe or effective have already been removed from the market; for example, unapproved quinine used for leg cramps was taken off the market. Many patients were using quinine and swore by it, but there were downsides. For a small number of people, quinine caused serious side effects like severe bleeding and heart problems. Unfortunately, no one can predict who will have a problem with quinine. FDA decided that the risks of taking quinine for leg cramps outweighed the benefits. One approved quinine product is available, but it is NOT approved for treatment of leg cramps. FDA is encouraging the makers of unapproved drugs to submit the information needed for FDA approval. Many of these drugs are effective and safe. If the right information and paperwork are provided to FDA, it’s possible that they could receive FDA approval and stay on the market.
How do I know if a drug is approved by FDA?
Ask your pharmacist. He or she can do a thorough check for you.
Should I stop taking my medicine if it is not approved by the FDA?
No. If you are concerned about whether or not your medicine is safe, check with your healthcare provider. If a drug that you are taking is unapproved and removed from the market, your healthcare provider will find an alternative medication that is proven to be safe and effective.
Content taken from Pharmacist’s Letter.