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Drug risks the system missed

January 2006

Drug risks the system missed

This table lists the relatively common drugs we’ve identified as having known or suspected serious risks that were undetected or underestimated when the FDA approved them. Note that the list is not all-inclusive.

All the drugs listed below can be useful in some cases; most of the risks are uncommon or rare, and a few are not conclusively proved. But they’re sufficiently serious that until more is known, these drugs should be prescribed only when other options have failed, be avoided by people whose medical conditions make them especially vulnerable to harmful reactions, and used only with careful monitoring for adverse reactions.

 Our medical consultants recommend asking your doctor whether the risks outweigh the benefits in your case, and whether there are better options. It’s particularly important with these drugs that your doctor prescribe the lowest effective dose. The recommendations in the table are for general guidance and may not apply to you.

In general, do not stop taking any of these medications on your own. Also, see our vital information to help you weigh medical treatments–both benefits and risks.

Celecoxib (Celebrex) Pain and inflammation. Increased risk of heart attack and stroke. (Other NSAIDs may have similar risks, but current evidence appears stronger for Celebrex.) Use only if other pain relievers don’t help. Avoid it, especially at higher doses, if you have elevated risk of heart disease.
Estrogen alone (Premarin and others) or with progestin (Prempro and others) Menopausal symptoms and postmenopausal osteoporosis. Increased risk of
breast cancer, heart disease, stroke, and blood clots.
For menopausal discomfort, use only for short-term relief of severe symptoms if other steps, such as exercise and relaxation, don’t help. For osteoporosis, use only as last resort.
Isotretinoin (Accutane) Severe nodular acne. Birth defects, depression, psychosis, and suicidal tendencies. Use only if less aggressive treatments don’t help. Don’t use if you are pregnant or may become pregnant. Have moods monitored closely by doctor.
Malathion (Ovide) Head lice. Flammability of
hair and neurotoxicity.
Use only if other insecticides (Nix, Rid)
don’t help.
Medroxy-progesterone injections (Depo-Provera) Contraception. Irreversible bone loss. Don’t use if you’ve had blood-clotting disorder or unusual vaginal bleeding. Discuss alternatives with your doctor.
Mefloquine (Lariam) Malaria prevention for
Disorientation, severe anxiety, paranoia, hallucinations, and depression. People who’ve had psychological problems should use alternative: doxycycline or atovaquone/proguanil (Malarone).
Rosuvastatin (Crestor) Elevated cholesterol levels. Muscle breakdown, kidney damage. (Other statins may have similar risks, but current evidence appears stronger for Crestor, especially at high doses and in Asian-Americans.) Use only if other statin drugs with longer safety records don’t help.
Salmeterol (Serevent) Asthma. Increased asthma-related
deaths; risk may be higher in African-Americans.
Use only with adequate doses of an inhaled corticosteroid, and only for prevention.
Sibutramine (Meridia) Weight loss. Increased blood pressure and heart rate; heart-rhythm abnormalities, heart attack, cardiac arrest, memory problems. Don’t use if you have heart disease, hypertension, or other significant coronary risk factors.
SSRIs such as sertraline (Zoloft), and other antidepressants such as venlafaxine (Effexor) Anxiety and depression. Increased suicidal tendencies initially or after dosage changes, particularly in children and teens but possibly in adults as well. All antidepressants may have similar
risks, but current evidence appears stronger for SSRIs.
Monitor mood closely
during the first few months and after dosage changes.
Tegaserod (Zelnorm) Irritable bowel syndrome with constipation. Potentially dangerous diarrhea, other intestinal problems. Use only if safer options don’t help: Boost fluid and fiber intake, limit foods that trigger symptoms, exercise, and reduce stress.
Topical immuno-suppressants pimecrolimus (Elidel), tacrolimus (Protopic) Eczema. Increased cancer risk. Use only if first-line therapies, such as topical corticosteroids, don’t help.

 Lists of major adverse effects are not necessarily all-inclusive. Sources: Medical
literature, FDA alerts, drug labels, and drug-safety consultants.

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