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September 2004
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‘Black-box' drug warnings

Some prescription-drug warnings are so grave that they're displayed in black-bordered boxes on package inserts. If you're taking one of the top-selling “black box” drugs, listed below, don't stop taking it on your own, but do discuss options with your physician. In one study, doctors ignored a black-box warning in two-thirds of patients who were given the drug. In another study, they failed more than half the time to heed cautions to monitor patients.



Drug Use Boxed Warning (excerpts)
Estrogens
(Premarin)

Menopausal symptoms and prevention of postmenopausal osteoporosis

Increased risk of certain cancers, cardiovascular disease; dementia in some patients when taken with medroxyprogesterone. Should be prescribed at the lowest effective dose for the shortest time.

Fentanyl
(Duragesic)

Moderate to severe chronic pain

Only for patients who are tolerant to opioid drugs. Safety not established in children under 2 years old. Life-threatening breathing problems can occur in certain situations.

Fluticasone/
salmeterol
(Advair Diskus)

Asthma

Increase in asthma-related deaths, a placebo-controlled study shows. Risk may be greater in African Americans compared with Caucasians.

Levothyroxine
 (Synthroid)

Hypothyroidism and pituitary suppression in people with goiters

Not for obesity or weight loss. Certain doses may produce serious or life-threatening toxicity.
Methylphenidate
(Concerta)

Attention deficit hyperactivity disorder

Risk of drug dependence; abuse can lead to psychotic behavior. Risk of severe depression during withdrawal from abusive use.
Oxycodone
(OxyContin)

Moderate to severe pain

May be fatal to people who have never before taken opioid drugs or if crushed, broken, or chewed. Risk of drug abuse.
Source: FDA-approved package inserts.