Market Withdrawal: Are Our Drugs Really Safe?

Kimberly Andrews, PharmD/MBA Candidate 2009
Medical University of South Carolina, College of Pharmacy
Prepared during Consumer Health Information Corporation Clerkship
McLean, VA

“Anticholesterol Drug Pulled After Link With 31 Deaths”

“Pill Linked to 63 Liver-Poisoning Deaths”

“Increased Blood Clot Risk with Birth Control Patch”

These headlines have recently been creating quite a buzz about the approval process of prescription drugs. Many consumers are asking “Why would the FDA approve these drugs in the beginning if they were thought to be unsafe?” A better understanding of how and why drugs are removed from the market helps to answer this question.

How Drugs Get Approved
Drugs are tested in 3,000 to 10,000 people before they are approved for use in the general public. The people that are tested in the trials only represent a small fraction of the millions of people who will use the drug after it becomes available on the market. After the drug hits the market, there may be some rare side effects that show up. This is one of the reasons why the FDA continues to monitor the safety of drugs after they have been released to the market.

New information is collected about drugs after they have been approved for use. This period is called the post marketing phase.  During this time, the FDA gathers more detailed information about the drug’s side effects and use in the general public. The FDA may discover that the drug has greater health risks that were previously unknown.  In this case, the FDA can add the new risks to the warning label on the medication. In a few cases, post marketing research may show that the drugs may be unsafe to use at all and the drugs are taken off the market.

Why Drugs are Removed from the Market
Here is a closer look at some of the reasons why the FDA would decide to remove a drug from the market.

Rare side effects
Our bodies are not all alike. We respond differently to medications.  Our genes, the foods we eat, and other drugs we may take can all affect the way we respond to drugs. It is hard to predict which people will have a negative effect from drugs. Some side effects are not seen until it is used in millions of people after it is approved.

Safer Alternatives
When the FDA decides that drugs are safe for most people, it does not mean they are harmless. Every prescription drug has risks. The FDA is willing to accept those risks if they are outweighed by the drugs’ benefits. However, those risks may not be as acceptable when new drugs that have the same benefits but fewer risks become available. The FDA may decide to remove a drug from the market if there is a safer alternative for patients to choose.

Improper Use
Drugs are approved to be used a certain way by patients. If the drugs are not taken as prescribed, the patient may experience some unwanted and sometimes deadly side effects. This does not mean that the drug was unsafe. Sometimes the directions on the medication may not be clear to patients. The patients may take too much of the drug and have bad side effects.

How Consumers Can Help
The FDA makes sure that the drugs that are used to save lives are safe. We can also take small steps to make sure that the drugs we take are safe for us to use.

• Clinical Trials
  Volunteer for a clinical trial that relates to your medical condition. A clinical trial can be more useful it if contains more volunteers and people of different races and backgrounds. This is because more information can be gained from these trials and be applied to different types of people before it hits the market. Not only will you benefit, but so will others who are seeking treatment for their medical condition. Speak to your doctor about the risks and benefits of volunteering for a clinical trial.

• Report side effects
  The FDA needs to know what side effects are happening so that an accurate study can be done. Reporting these side effects can prevent harm to other patients that may take the medication. Harmful side effects can be reported to your healthcare provider or directly to the FDA MedWatch Program at www.fda.gov/medwatch or 1-888-INFO-FDA. You can submit your report online.  You will need to provide information about the drug, the person who took the drug, and the effects that happened. Instructions on how to submit the form are found on the website.

• Use as directed
  Medications must be used properly in order to get the most benefit. You can get the most benefit from your medication and reduce your chance of having a bad side effect from the medication if you use it as directed. If you are unclear on how to use your medication, ask your pharmacist or doctor for help.

The next time you read an article about a new health risk associated with a medication, do not think that the FDA is ignoring the safety of our medication in the approval process. Actually, the opposite is true. The FDA continues to monitor drugs after they are approved to make sure they are safe. Sometimes, keeping us safe means taking a drug off the market.

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