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About the FDA's 'Black Box' Warning for Prescription Drugs

The Law Offices of Tyler & Peery

The black-box warning is that big, bold warning seen on the packaging or instruction sheet of drugs like the blood thinner Pradaxa (dabigatran) and the diabetes drug Actos (pioglitazone), both of which are known to cause serious side effects in some patients.

The Food and Drug Administration's black-box warning - which is the strongest warning for any prescription drug - has been around for awhile, but has only recently won the attention of media outlets with the rise in popularity of certain prescription drugs.

But the presence of a black box warning doesn't necessarily mean that a doctor won't hesitate to prescribe the drug to a patient. It's up to the doctor to weigh the pros and cons of taking any medication, in light of the patient's health history and medical diagnosis.

For instance, the FDA has a black-box warning for the blood thinner Pradaxa (used to treat patients with cardiac arrhythmia) because it has been known to cause irreversible and life-threatening bleeding. At the same time, however, the FDA advises that you consult your doctor first before deciding to stop taking the medication, as Pradaxa may help to prevent blood clots and strokes.

If the drug you've been prescribed has a black box warning, be sure to discuss with your doctor the risks of adverse side effects.

Source: FDA Black Box Warnings


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