Drugs Used Off-Label Often Make Lethal Prescription

Written by HealthyPlace.com Staff Writer

For the last three and a half months she was pregnant, Tammie Snyder had a small medical device strapped to her thigh. It pumped a drug called terbutaline through her body to prevent her from going into labor too soon.

On Sept. 17, 2002, Snyder gave birth to two healthy girls. Within days, however, her lungs filled with fluid, her heart began to fail and she was told she might need a heart transplant. She recovered, but she's been told she can never have a baby again. Her heart wouldn't stand the strain.

Terbutaline is an asthma drug, and the Food and Drug Administration hasn't approved its use to prevent premature labor. The FDA has warned doctors that the treatment is "potentially dangerous" and may not be effective. Snyder said her doctor never told her about the warning or that the FDA had approved terbutaline only to treat asthma.

A six-month Knight Ridder investigation has found that patients nationwide are being injured and killed as doctors routinely prescribe drugs in ways the FDA never certified as safe and effective.

Moreover, these unapproved prescriptions are soaring. Over the past year, 115 million such prescriptions were written, nearly double the number of five years ago, an analysis of prescriptions for the country's top-selling drugs found.

The practice, called off-label prescribing, often is driven by questionable research, aggressive drug-company marketing and cavalier doctors, and condoned by tepid regulators.

Doctors are giving their patients epilepsy drugs for depression and hot flashes and to help them lose weight. They use antidepressants to treat premature ejaculation and pain, and powerful antipsychotics for insomnia and attention deficit disorder. High blood-pressure pills are prescribed for headaches and anxiety; antibiotics are used to treat viruses.

Some drugs, in fact, are sold mostly for unapproved purposes. Eight out of 10 prescriptions for the epilepsy drug Topamax aren't for epilepsy. Thalidomide, the notorious morning-sickness drug that caused horrible birth defects and ushered in today's FDA drug-safety rules, today is on the market, and 99 percent of its prescriptions are off-label.

Knight Ridder reviewed 15 top-selling classes of drugs and found that some, such as cholesterol medicines, rarely are given as unapproved treatments. But three-quarters of anti-seizure medications are prescribed off-label, as are nearly two-thirds of antipsychotics and about one-quarter of antidepressants, the analysis found.

For patients with rare, intractable or fatal illnesses, off-label prescribing is sometimes appropriate. In other cases, there may be gold-standard studies backing an off-label use. But doctors routinely are choosing unapproved therapies that are questionable at best.

The practice is perfectly legal, widely accepted and defended by doctors and the American Medical Association -- and it's taking a toll.

Victims of off-label prescribing whom Knight Ridder interviewed have suffered heart attacks and strokes, had permanent nerve damage or lost their eyesight. Most said they never were told that the FDA hadn't approved their treatments.

Based on the FDA's own data, Knight Ridder estimates that at least 8,000 people became seriously ill last year after taking some of the nation's most popular drugs off-label. The true number is likely to be many times higher.

"Sometimes it may help, sometimes it may do more harm than good and sometimes it may kill people," said Arnold Relman, a former editor of the prestigious New England Journal of Medicine.

Despite the rise in off-label drug use, the FDA has done little to discourage it, and is considering whether to allow drug companies greater leeway in pushing unapproved therapies.

STOLEN TIME

George Murphy's hands, made strong by years of climbing utility poles for Houston Lighting & Power, shake with tremors. His legs, now rigid, shuffle as he pushes his walker through his studio apartment in Deer Park, Texas.

"I wish I didn't have to use this thing," he said as the walker snagged on his recliner while he was showing off his Army dog tags from World War II, a plaque for 40 years of service as a Mason, his Shriner fez and the oil paintings his wife did a few years before she died.

Murphy, now 85, began having the tremors last year after he had a series of stroke-like attacks while taking Risperdal (Risperidone), a powerful antipsychotic drug that the FDA has approved only for treating schizophrenia.

Murphy's family practitioner in Pasadena, Texas, Dr. Dennis Yaworski, prescribed Risperdal for an off-label purpose: "cancer phobia," according to case notes from an office visit on Sept. 9, 2002.

The drug's maker, Johnson & Johnson, has marketed Risperdal heavily to doctors who treat elderly patients.

In 1999 the FDA cited Johnson & Johnson for downplaying the drug's risks to the elderly and making false and misleading claims that it could be used not just to treat schizophrenia, but also "for psychotic symptoms associated with a broad range of disorders."

While doctors are free to prescribe as they wish, the FDA prohibits drug-makers from marketing unapproved treatments.