PATIENT BEWARE: THE DANGERS OF OFF-LABEL DRUG USE
In the megahit movie Black Panther, much of the plot revolves around the struggle to control the world’s supply of vibranium, an incredibly rare and versatile substance that’s the secret to the Black Panther’s powers. Vibranium is strong enough to cut through any metal, yet also can absorb sound and serve as body armor; in herb form, it can heal the mortally wounded and endow the user with superhuman strength and agility
Sadly, vibranium is entirely fictional. Outside of superhero movies and fantasy novels, there is no magic pill or potion that can fix everything. Most of the new drugs developed by major pharmaceutical companies are designed to target a specific ailment or condition, and are approved by the Food and Drug Administration for a narrow range of uses only after years of carefully monitored clinical trials.
Yet increasingly, physicians are prescribing certain drugs for uses not approved by the FDA. Repurposing a drug for an “off-label” use is permitted in most circumstances — and might even be advisable, if there’s a track record of success in using the drug to treat serious or even terminal conditions after other, more conventional courses of treatment have been ineffective. But the practice has also generated controversy, investigations, and lawsuits, all stemming from the health risks that can result from using a drug for purposes beyond those for which it was designed, tested, and approved.
Off-label use occurs frequently in cases of rare diseases or cancer. Advocates of the practice say it makes sense to utilize drugs that have shown promise in life-or-death situations, even if they haven’t yet crossed all the hurdles to FDA approval for this particular use — a process that can take eight years or more. But off-label prescribing is widespread; examples include using a drug designed to ease the effects of chemotherapy to treat morning sickness, and prescribing an epilepsy drug to treat obesity and psychiatric conditions. Studies and congressional testimony indicate that a substantial percentage of all drug prescriptions — some say more than half — are for off-label uses, even though the majority of those drugs lack solid scientific support for the way they’re being used.
While doctors can prescribe drugs for off-label uses, pharmaceutical companies are prohibited from marketing a drug to physicians for an unapproved use. The FDA considers promotion of off-label uses to be a form of “misbranding” or misrepresenting the drug. The companies have challenged the prohibition on First Amendment grounds, saying they have a right to discuss a drug’s qualities, dosage, and side effects with physicians contemplating off-label uses. The dispute has led to numerous court battles and even criminal prosecutions over allegedly misleading off-label promotion.
For the drugmakers, off-label use presents the prospect of additional sales, sometimes well in excess of the core market for the drug’s approved use. One of the most notorious cases of off-label marketing gone wrong concerns the antipsychotic medication Risperidone, marketed by Janssen Pharmaceuticals, a division of Johnson & Johnson, under the trade name Risperdal. In 1993 the FDA approved the sale of the drug in the United States for the treatment of schizophrenia in adults; later, it was also approved for short-term treatment of bipolar disorder. But Risperdal sales reps promoted the drug as a safe course of treatment for a wide array of problems, from anxiety, depression and attention deficit disorder to hostile outbursts associated with dementia. These supposed off-label benefits surfaced in promotional claims despite evidence in clinical trials that the drug could have particularly serious side effects for certain populations, including adolescents and the elderly.
As documented in the definitive account of the Risperdal debacle, Steven Brill’s epic 2015 series “America’s Most Admired Lawbreaker,” the expansion of the market to off-label uses proved costly to patients as well as Johnson & Johnson. Elderly patients on Risperdal experienced a high rate of strokes and cardiac events. There were reports of young males who took the drug developing breasts (gynecomastia). Facing a rising tide of litigation and investigations, in 2012 Johnson & Johnson agreed to pay $181 million to settle claims by 36 states over the off-label uses of Risperdal and another antipsychotic drug; a few months later, the company was fined $2.2 billion by the federal government for marketing Risperdal as a treatment for dementia. There have also been numerous civil suits and several multi-million-dollar jury verdicts against the company as a result of off-label prescribing of the drug.
Other companies have also faced ten-figure fines for similar offenses. Abbott Laboratories agreed to pay $1.5 billion to resolve civil and criminal liability for promoting the epilepsy drug Depakote for uses not approved by the FDA, including treatment of aggression in dementia patients and schizophrenia. GlaxoSmithKline was hit with $3 billion in fines for withholding data from the FDA and promoting off-label uses of Wellbutrin and Paxil; among other acts, the government alleged that GSK spent millions of dollars wooing prescribing doctors and was involved in preparing a misleading medical journal article that suggested Paxil was effective in treating depression in juveniles, when it hadn’t been approved for that use.
Despite such penalties, off-label usage remains a significant revenue generator for drug companies, accounting for as much as $40 billion in sales a year. Given the prevalence of the practice, how can patients protect themselves from misleading claims and dangerous side effects? Consumer Reports recommends asking pointed questions of your physician about whether the drug you’re being prescribed has been FDA-approved for that particular use and whether there is scientific evidence, such as peer-reviewed independent studies, of its safety and efficacy. You should have a clear understanding of the risks and possible side effects, and what other options (besides vibranium) might be available to you, before you start taking the prescription.
If you or a loved one have suffered injuries as the result of a defective medical device or experienced adverse consequences from taking a prescription drug, the product liability lawyers at FDAzar may be able to help. We have been helping injured people receive the compensation they deserve for more than thirty years. Call us today or contact us here for a free consultation.