Unapproved drugs are those drugs that don’t have the required FDA approval. The US Food & Drug agency has several issues with the drugs that are marketed without FDA approval, as it cannot certify whether these drugs will meet the standards for effectiveness, safety, labeling and quality as of FDA approved drugs.
Few things to know about unapproved drugs
Here is a list of things that you must know about unapproved drugs:
#1. Is it true that unapproved drugs are being sold in the U.S.?
Yes, it is true. Most of the drugs available in the U.S. market are approved by the FDA. However, there are some medications that are not approved by the FDA. These unapproved drugs are the older ones that were being sold before the FDA approval process began approx. 50 years ago. The manufacturers of these unapproved drugs never applied for FDA approval, and these drugs are still available in the market today. But FDA is encouraging these manufacturers to provide complete information to get the FDA approval.
#2. Why FDA approval of drugs is important?
The FDA approval process helps to make sure that drugs are both safe and effective, before they are available to the public. The drugs are tested on both humans and animals before getting approved by the FDA. These studies help to know the FDA whether a drug is safe and actually works. The proper dose of the drug and side effects to expect are also determined.
The FDA also makes sure that drugs are manufactured properly, and the drugs label contains all the information healthcare providers and patients need to know to use the drugs safely.
#3. What is FDA doing about unapproved drugs still on the market?
- The main goal of the FDA is to make sure that all the drugs available in the market are safe and effective.
- The second is to remove the unapproved drugs from the market that are not safe and ineffective.
FDA has already removed some drugs from the market that are not safe. For example, unapproved quinine has been taken off the market. Quinine is recommended for people suffering from leg cramps. Many patients that were using quinine experienced serious side effects like severe bleeding and heart problems. Due to which it was taken off the market.
FDA is also encouraging the makers of unapproved drugs to submit the information needed for FDA approval. Many of these drugs are effective and safe to use.
#4. How do I know if a drug is FDA approved or not?
You can ask your pharmacist whether your drug is approved by FDA or not. Your pharmacist can do a thorough check for you.
#5. Should I stop taking my medicine if it is not approved by the FDA?
No. Consult with your health care provider if you are concerned about whether your medication is safe or not. Your healthcare provider will recommend an alternative for that drug, if it’s unsafe for you.