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Dangerous Drugs and Safer Alternatives

Dec 23, 2004

Dangerous Drugs and Safer Alternatives

Karen Elizabeth Lasser, MD, MPH
Harvard Medical School
Larry Sasich, PharmD, MPH
Public Citizen's Health Research Group

Special from Bottom Line/Health

A study recently published in the Journal of the American Medical Association examined all drugs approved by the FDA from 1975 to 1999. One drug in five was withdrawn from the market or required to have a black-box warning on the package insert about serious risks.

During just one year of the study period, about 20 million Americans were given drugs that were later withdrawn. The most common risks of the drugs were damage to the liver, heart and bone marrow and a variety of problems for pregnant women.

Self-defense: As long as other effective treatments are available, avoid any drug until it's been on the market for at least seven years. About half of all problems with toxicity are discovered within that period.

For advice on common drugs to avoid -- and better alternatives -- Bottom Line/Health interviewed two leading experts in drug safety, Karen Elizabeth Lasser, MD, MPH, and Larry Sasich, PharmD, MPH...

ALLERGY

Desloratadine (Clarinex). Introduced in 2002, this antihistamine is essentially the same as the older drug loratadine (Claritin). When you take loratadine, the drug is broken down in the body into desloratadine. The manufacturer simply got a patent for the chemical by-product. The two antihistamines are basically the same.

Drawbacks: Not only is there no evidence that desloratadine is clinically different from loratadine, neither drug is a particularly effective antihistamine.

In fact, when the manufacturer submitted four clinical trials to the FDA comparing doses of desloratadine with a placebo, only two of the studies found the drug to be effective.

Better choice: Over-the-counter (OTC) antihistamines, such as chlorpheniramine (Chlor-Trimeton) or diphenhydramine (Benadryl). They're less expensive and usually more effective.

As an alternative to OTC drugs, ask your doctor about prescription nasal steroids, such as flunisolide (Nasalide) or beclomethasone (Vancenase). They quickly ease congestion without the grogginess that's sometimes caused by antihistamines.

CHOLESTEROL

Rosuvastatin (Crestor). Introduced in 2003, rosuvastatin is the newest cholesterol-lowering statin, and the most potent. It lowers LDL "bad" cholesterol 40% to 50% at the starting dose of 10 mg, and 50% to 60% at the 40-mg dose.

Drawbacks: Unlike other statins, rosuvastatin has been linked to kidney toxicity. FDA documents report two cases of kidney failure and one case of kidney insufficiency in patients taking the drug.

Better choice: Statins, such as lovastatin (Mevacor), pravastatin (Pravachol) or simvastatin (Zocor). They have better, proven safety records -- and have been scientifically shown to prevent heart attack and stroke.

HEARTBURN

Esomeprazole (Nexium). Introduced in 2001, esomeprazole is the fifth member of the proton pump inhibitor class of drugs used for gastroesophageal reflux disease (heartburn) and for duodenal ulcers that don't respond to antacids or H-2 blockers, such as cimetidine (Tagamet).

Drawbacks: An FDA evaluation suggests that esomeprazole is no better than omeprazole (Prilosec), an older OTC proton pump inhibitor that has a known safety record.

Better choice: Heartburn patients can choose among many drugs -- Prilosec, Tagamet, antacids, etc. -- that have been on the market a long time and are known to be safe.

Non-drug treatments, such as not lying down after meals and avoiding chocolate or other foods known to cause heartburn, are often all that's needed.

INSOMNIA

Zaleplon (Sonata). Introduced in 1999, zaleplon was designed to help insomnia patients fall asleep without the residual grogginess that's so common with other sleeping pills. Zaleplon is quickly eliminated from the body, so you can potentially take it late at night or early in the morning and still be fully alert when you get up.

Drawbacks: It's less potent than the older benzodiazepine sleeping pills, such as triazolam (Halcion), temazepam (Restoril) and flurazepam (Dalmane). Compared with a placebo, it decreases the time it takes to fall asleep by only eight to 20 minutes.

Zaleplon has a high risk for addiction when taken for more than several weeks. It also has potentially serious interactions, such as excessive drowsiness, when taken with other drugs, including antihistamines and anti-ulcer medications.

Better choice: Behavioral and lifestyle changes, such as reducing caffeine intake and practicing yoga or other relaxation techniques, are much safer for treating insomnia. For patients who need extra help for a few nights to two weeks, an older drug, such as oxazepam (Serax) or zolpidem (Ambien), is effective.

JOINT PAIN

Valdecoxib (Bextra). Introduced in 2001, valdecoxib is a new nonsteroidal anti-inflammatory drug (NSAID) that targets the COX-2 enzyme, which plays a major role in causing arthritis pain and inflammation. It's used to treat chronic joint pain due to such conditions as rheumatoid arthritis or osteoarthritis, as well as painful menstrual periods.

Drawbacks: Valdecoxib is an overpriced product that's no safer -- and perhaps even less effective -- than older over-the-counter NSAIDs.

Warning: Valdecoxib may cause allergic reactions in patients who have allergic-type reactions to sulfonamides, a family of antibiotics used to treat urinary tract infections and traveler's diarrhea. Sulfonamides include trimethoprim (Proloprim) and sulfamethoxazole (Gantanol).

Better choice: Patients with chronic pain will probably get better relief with an older NSAID, such as ibuprofen (Motrin) or naproxen (Naprosyn). To prevent gastrointestinal problems, take these drugs on a full stomach.
First Printed: August 1, 2004
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Bottom Line/Health interviewed Karen Elizabeth Lasser, MD, MPH, and Larry Sasich, PharmD, MPH. Dr. Lasser is an instructor of medicine at Harvard Medical School in Boston and Cambridge Health Alliance in Cambridge, Massachusetts. She is the lead author of a study on the safety of new drugs published in the Journal of the American Medical Association. Dr. Sasich is a research analyst at Public Citizen's Health Research Group in Washington, DC, and coauthor of Worst Pills,