Last week I focused on the AGS Beers Criteria® that provides a comprehensive list of medications that should be used with caution in adults 65 and older. Something else you should be aware of when you’re prescribed a new medication is Black Box Warnings.

All medications carry a long list of possible side effects and potentially serious adverse reactions when taken alone or in combination with other medications.

A “black box warning” is the strictest warning given by the Food and Drug Administration (FDA) and indicates that medication has the potential to cause serious or life-threatening risks. This typically occurs when a medication has been approved by the FDA but is then determined to cause serious reactions.

After confirmation of a serious or life-threatening risk, a black box warning is given.

A black boxed warning doesn’t mean that the drug shouldn’t be prescribed… but it does alert healthcare providers and patients that there is potential for a serious risk when using this medication.

Important Black Box Warnings Include:

  • The combination of cigarette smoking and oral contraceptives. Cigarette smoking increases the risk of serious heart and blood vessel disorders when combined with oral contraceptives. This warning is particularly important for women who smoke and are over the age of 35.
  • Fluoroquinolones such as Levaquin (levofloxacin) and Cipro (ciprofloxacin). These antibiotics have been associated with a higher risk of tendon rupture, most frequently involving the Achilles tendon. Other tendon ruptures of the rotator cuff, hand, and upper arm have also been reported. These medications should be immediately discontinued if the patient experiences any pain, swelling, or inflammation of the tendon.
  • Actos/pioglitazone. This medication is used in patients with Type II diabetes. Actos has been shown to cause or worsen fluid retention leading to congestive heart failure. All patients should be closely monitored for signs of fluid retention or symptoms of heart failure after starting Actos.  
  • Atypical Antipsychotics. The use of antipsychotic medications such as Seroquel (quetiapine), Zyprexa (olanzapine), and Risperdal (risperidone) in patients with dementia-related psychosis should be used with caution to avoid the risk of death from cardiovascular or infectious disease causes.
  • Antidepressants. Younger adults between the ages of 18 and 24 have a higher risk of suicidal ideations and behaviors after starting antidepressants. All patients who are started on antidepressants should be monitored closely for worsening suicidal thoughts and behaviors.

It’s important to know if you are being prescribed a medication with a black box warning and to become more familiar with the potential risks and side-effects of that medication. Take the time to speak with your healthcare provider or pharmacist for guidance when taking any medications with a black box warning.

As a Health Advocate, I always encourage my clients to ask questions and to become better informed about the choices they make in their healthcare. Your life could depend upon it!