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date: 5/16/2005
Grave warnings on a growing number of medicines
Reading the "black box" warnings on prescription drug labels could save your life.
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Some prescription-drug warnings are so critical that they're displayed in black-bordered boxes on package inserts. 2004 and 2005 were big years for such "black box" warnings: The Food and Drug Administration required that serious step for over 90 medications, including all antidepressants and prescription nonsteroidal anti-inflammatory painkillers.

It's important for consumers to be aware of the potential dangers and side effects of any medications they are taking. 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. If you're taking any of the other top-selling "black box" drugs listed below, don't stop taking it on your own, but do discuss options with your physician.

FDA Black Box Warnings
Drug name Used for Increases risk for?
Adalimumab (Humira) and infliximab (Remicade) Rheumatoid arthritis Tuberculosis. Test and treat for tuberculosis before starting either drug.
Antidepressants (all), including tricyclics such as amitriptyline (Elavil) and bupropion (Wellbutrin), as well as SSRIs such as citalopram (Celexa) and paroxetine (Paxil). Depression Suicidal thinking and behavior in children and adolescents. Anyone considering use of an antidepressant in a child or adolescent must balance this risk with the clinical need. Anyone started on therapy should be closely observed for worsening depression, suicidal thoughts or actions, and unusual changes in behavior.
Estrogens, including pills (Premarin, Femhrt) and patches (Estraderm, Combipatch) Menopausal symptoms and prevention of osteoporosis. Endometrial cancer, heart attack, stroke, invasive breast cancer, pulmonary emboli, deep vein thrombosis and dementia in postmenopausal women. Should be prescribed at the lowest effective dose for the shortest time.
Fentanyl (Duragesic) Moderate to severe chronic pain Life-threatening breathing problems. Use only in patients who can tolerate opioid drugs.
Fluticasone/Salmeterol (Advair Diskus) Asthma Asthma-related deaths. Risk may be greater in African Americans compared with Caucasians.
Levothyroxine (Synthroid) Hypothyroidism and pituitary suppression in people with goiters Serious or life-threatening toxicity. Not for obesity or weight loss.
Medroxyprogesterone injections (Depo-Provera) Contraception Severe bone loss, with prolonged use. Use for longer than two years only if other forms of contraceptive are unacceptable.
Methylphenidate (Concerta) Attention deficit hyperactivity disorder Addiction, psychotic behavior and, during withdrawal, severe depression.
Nonsteroidal anti-inflammatories (NSAIDs) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), and celecoxib (Celebrex) Arthritis and chronic pain. Heart attack, stroke, and gastrointestinal bleeding. Applies only to prescription-strength products.
Progesterone (Prometrium) Hormone replacement therapy Dementia, heart attack, stroke, breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women.
Oxycodone (OxyContin) Moderate to severe pain Drug abuse and fatal reaction. Use with caution in people who've never used an opiod; don't crush, break, or chew.
Pimecrolimus (Elidel) and tacrolimus (Protopic) Eczema Skin cancer and lymphoma. Use only if other treatments fail.
Promethazine (Phenergan) Allergies and cough. Depressed and interrupted breathing, especially in children under two years old. Don't use in children under that age, and use with caution in all others.
Tamoxifen (Nolvadex) Breast cancer Stroke, pulmonary embolism, and uterine cancer. Benefits clearly outweigh risks in women with history of breast cancer, but possibly not others.


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