January 31, 2006 --

Ben Swann -KFOX Morning News Anchor/Reporter

How safe are prescription drugs and how carefully are they monitored by the Food and Drug Administration? Consumer Reports has identified a dozen prescription drug types that it says you should take with caution, and in most cases only as a last resort.

"These prescription drugs have legitimate medical uses, but there's also evidence that they carry serious risks. And those risks were underestimated or undetected when the FDA approved them," said Joel Gurin of Consumer Reports.

The drugs and drug types with undetected or underestimated risks at the time of approval are sold under many names and include:

With most of these drugs, Consumer Reports says the risks are rare, and a few are not conclusively proven, but they point to weaknesses in the nation's drug-safety system.

"The FDA is short-staffed and has tight deadlines to approve new drugs. And then once a drug is on the market, the FDA has only limited power to monitor it for safety," said Gurin.

If you have been prescribed a drug mentioned in this report, Consumer Reports says don't stop taking it on your own. It might be right for you. But be sure to talk to your doctor about the risks and whether there are better options.

Here again is a list of the drugs and their possible side effects that Consumer Reports has identified:

Celecoxib (Celebrex)

USED FOR

Pain and inflammation.

(MAY CAUSE)

Increased risk of heart attack and stroke. (Other NSAIDs may have similar risks, but current evidence appears stronger for Celebrex.)

(RECOMMENDATION)

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)

USED FOR

Menopausal symptoms and postmenopausal osteoporosis.

(MAY CAUSE)

Increased risk of breast cancer, heart disease, stroke, and blood clots.

(RECOMMENDATION)

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)

USED FOR

Severe nodular acne.

(MAY CAUSE)

Birth defects, depression, psychosis, and suicidal tendencies.

(RECOMMENDATION)

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)

USED FOR

Head lice.

(MAY CAUSE)

Flammability of hair and neurotoxicity.

(RECOMMENDATION)

Use only if other insecticides (Nix, Rid) don't help.

Medroxy-progesterone injections (Depo-Provera)

USED FOR

Contraception.

(MAY CAUSE)

Irreversible bone loss.

(RECOMMENDATION)

Don't use if you've had blood-clotting disorder or unusual vaginal bleeding. Discuss alternatives with your doctor: condoms, for example, or oral contraceptives, which pose little or no bone risk but similar blood-clot risk.

Mefloquine (Lariam)

USED FOR

Malaria prevention for travelers.

(MAY CAUSE)

Disorientation, severe anxiety, paranoia, hallucinations, and depression.

(RECOMMENDATION)

People who've had psychological problems should use alternative: doxycycline or atovaquone/proguanil (Malarone).

Rosuvastatin (Crestor)

USED FOR

Elevated cholesterol levels.

(MAY CAUSE)

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.

(RECOMMENDATION)

Use only if other statin drugs with longer safety records don't help.

Salmeterol (Serevent)

USED FOR

Asthma.

(MAY CAUSE)

Increased asthma-related deaths; risk may be higher in African-Americans.

(RECOMMENDATION)

Use only with adequate doses of an inhaled corticosteroid, and only for prevention.

Sibutramine (Meridia)

USED FOR

Weight loss.

(MAY CAUSE)

Increased blood pressure and heart rate; heart-rhythm abnormalities, heart attack, cardiac arrest, memory problems.

(RECOMMENDATION)

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)

USED FOR

Anxiety and depression.

(MAY CAUSE)

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.

(RECOMMENDATION)

Monitor mood closely during the first few months and after dosage changes.

Tegaserod (Zelnorm)

USED FOR

Irritable bowel syndrome with constipation.

(MAY CAUSE)

Potentially dangerous diarrhea, other intestinal problems.

(RECOMMENDATION)

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)

USED FOR

Eczema.

(MAY CAUSE)

Increased cancer risk.

(RECOMMENDATION)

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.

For helpful consumer information, visit Consumer Reports on the web.

http://www.consumerreports.org/

Consumer Reports is a fee-based Web site. Many of the articles require a subscription.