Do You Know What to Do with Black Box Drugs?

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Do You Know What to Do with Black Box Drugs?

Black box drugs sound rather ominous. However, you would be surprised to know just how many of these drugs are on the market and being used by patients. You could be taking a black box drug yourself. What is a black box drug and what should you do if you are taking one?

What is a Black Box Drug?

The name comes from the warning on a medication’s box and materials that is required by the U.S. Food and Drug Administration (FDA). It is no mystery or secret that prescription medications have side effects. If you read the materials provided with your medications and the warnings on over-the-counter medications, you will see the list of potential side effects and warnings.

Many side effects are discovered during the trial phase and research stage for a drug’s approval. However, some adverse health events and side effects are not discovered until a drug is marketed and prescribed to thousands of patients. When a serious risk is identified, the FDA can require the drug manufacturer to issue what is referred to as a “black box warning.” The black box warning is the highest and most severe warning required by the FDA.

The warning is exactly as it sounds. On the medication guide, promotional materials, and the box (for over-the-counter medications), a thick black line forms a “box” around the text that describes the potential risks, dangers and side effects that can cause adverse health conditions. The black box warning is intended to call specific attention to this information.

The FDA’s Adverse Event Reporting System

The FDA relies on voluntary reporting of adverse events by healthcare professionals and consumers to help it determine if a drug is safe and effective or if a drug requires a black box warning. The FDA’s Adverse Event Reporting System (FAERS) allows consumers, pharmacists, doctors, and other industry professionals to file reports with the FDA about a drug’s side effect or adverse health event. The reports are voluntary for consumers, but physicians and other professionals are mandatory reporters.

After an event is reported through FAERS, the report is reviewed by the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER).  Depending on what is found, further investigation can be ordered. The FDA uses the information from the investigation to determine if it needs to take any regulatory actions, such as issuing additional restrictions for when the drug can be used, requiring a black box warning, or reversing FDA approval for a medication.

What Should I Do If I Am Taking a Black Box Drug?

If you have been prescribed a drug with a black box warning, there are steps you can take to protect yourself.

  • Ask your doctor what is meant by the black box warning. Review each item in the black box warning with your doctor to ensure you understand all risks associated with the use of the drug.
  • Discuss why your doctor prescribed this specific medication to you, including why your doctor believes the medication is safe for you to use. Depending on your specific medical condition and overall health, the doctor may feel the drug is appropriate, but you should know why he feels this way.
  • Ask about other drugs that the doctor could prescribe instead of the black box drug. Are the other drugs as effective? Do other drugs have more risks? What are the risk and benefits of this drug compared to other similar drugs?
  • Discuss your doctor’s policy for drug representatives. Does your doctor’s office work closely with the drug representative for this particular medication? Could this have influenced the doctor’s decision to use this medication?
  • Tell your doctor about all medications and dietary supplements you are taking. Using the same pharmacy for all medications can also help reduce the risk of taking medications that can be harmful together.

If in doubt, you can seek a second opinion from another physician. However, you need to be aware of the risks of delaying when you begin a medication. The best thing you can do is to continue to ask questions until you feel you have all relevant information to make an informed decision about a black box drug.

Nationwide Defective Medication Attorneys

Some drugs with black box warnings have been shown to cause serious, life-threatening injuries and deaths. The pharmaceutical lawsuit attorneys at The Fox Law Firm, P.C. work with clients across the country to file claims for damages caused by dangerous drugs. Our lawyers are dedicated to fighting large drug companies for clients who have suffered terrible injuries because of a defective drug.

For a free consultation and free case review, call 1-866-FOX-FIRM or 1-866-369-3476 today.