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FDA Black Box Warning - Dangerous Side Effects of Drugs

The Dallas-Fort Worth personal injury lawyers at The Anderson Law Firm represent patients who have suffered injuries from dangerous drugs. If you or a loved one sustained severe, life altering side effects from taking a dangerous prescription, please contact us at 817-294-1900 for a free consultation with an experienced attorney to discuss your case.

What is a black box warning?

The FDAs "black box" warning is the most serious warning label applied to prescription medications in the U.S.  When a medication has a black box warning label, it means that medication could cause serious side effects or possible death.

Why do medications get a black box warning?

Medications that get a black box label are those that:

  • Could possibly cause adverse, life threatening side effects that could cause permanent disabilities.
  • Can cause serious side effects, but only when improperly administered. An example of this would be a medication that's safe when administered to adults, but not safe for children. Or, a medication that is safe for women, but not pregnant women.

How does a medication get a black box warning label by the FDA?

A lot of times, a medication can be prescribed for years before it carries a black box label. Overtime however, if a medication has a large amount of doctor reported serious side effects, the FDA will investigate the medication and then decide whether or not the prescription should carry a black box warning label.

Why does the FDA leave drugs with black box warning labels on the market?

The FDA will leave a medication with a black box warning on the market if the benefits of the drug outweigh the possible risks.

Where can I go to find a list of medications with black box warning labels?

You can see a list of all medications with an FDA black box warning label here.

Before taking any medications, you should always weigh the pros and cons of that medication with your doctor. Your doctor should always explain the side effects of a drug he's prescribing you and if not, ask him! If you're going to a new doctor, always let them know of each and every medication you're on, or use from time to time. Prescription drugs can negatively interact with each other, so it's imperative you let your doctor know what you're taking.

Take advantage of your pharmacist. It you're starting a new drug, ask them for a consultation to explain your new medication. Pharmacists are just as informative as doctors when it comes to prescriptions - and you don't have to have an appointment to see them.

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Dangerous Drug and Devices

Mark A. Anderson
Board Certified Personal Injury Lawyer in Fort Worth, Texas