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KNOW THE DRUGS YOU TAKE: TIPS FOR CONSUMERS Patients have a right to know if they are being prescribed a drug for an off-label use. You can determine if you are being prescribed a drug for an off-label use by checking the drug’s FDA-approved professional product label. The professional product label is the tightly folded piece of paper written in a tiny font than accompanies each container of a drug sold to the pharmacy. Although professional product labels are not routinely... |
KNOW THE DRUGS YOU TAKE: TIPS FOR CONSUMERS Patients have a right to know if they are being prescribed a drug for an off-label use. You can determine if you are being prescribed a drug for an off-label use by checking the drug’s FDA-approved professional product label. The professional product label is the tightly folded piece of paper written in a tiny font than accompanies each container of a drug sold to the pharmacy. Although professional product labels are not routinely distributed to prescription drug consumers, there are a number of ways of obtaining a professional product label for a particular drug. The “Indications and Usage” section of the professional product label contains the drug’s FDA-approved uses. One of the easiest ways of getting a professional product label is to ask the pharmacist. There is nothing that prevents a pharmacist from giving patients professional product labels. Another low-tech solution for accessing professional product labels is the book the Physicians’ Desk Reference (PDR). The PDR is available in most public libraries and is just a book of professional product labels. In addition, the FDA operates a Web resource called Drugs@FDA that contains the professional labels for many drugs. The Internet address for this site is http://www.accessdata.fda.gov/scripts/cder/drugsatfda. Also, the National Library of Medicine and the FDA are currently in the process of building a Web site called DailyMed that will eventually provide the public and healthcare professionals free access to the most up-to-date professional labels for all drugs marketed in the United States. At this time, the number of labels available is limited but growing. DailyMed can be found at http://dailymed.nlm.nih.gov/dailymed/about.cfm. |
There are numerous recent examples of the harm that has been caused by off-label prescribing.
Atypical Antipsychotic Drugs
The FDA issued a public health advisory in April 2005 to alert the public and health professionals that the family of drugs known as the atypical antipsychotics are associated with an increased risk of death when used off-label to treat dementia in elderly patients (see Worst Pills, Best Pills News, February 2006). Since September 2005, all the atypical antipsychotics now carry a black-box warning in their professional product labels that warns of increased risk. A black-box warning is the strongest type of alert that the FDA can request of a drug manufacturer.
The atypical antipsychotic drugs include aripiprazole (ABILIFY), clozapine (CLOZARIL), olanzapine (ZYPREXA), olanzapine with fluoxetine (SYMBYAX), quetiapine (SEROQUEL), risperidone (RISPERDAL), and ziprasidone (GEODON).
Tiagabine (GABITRIL)
The FDA issued a public health advisory on Feb.18, 2005 to announce that a bolded warning had been added to the professional product labeling of tiagabine (GABITRIL). The new label will warn of seizures in patients prescribed the drug off-label for psychiatric illnesses such as bipolar disorder (see Worst Pills, Best Pills News, April 2005).
Amiodarone (CORDARONE)
A 2003 investigative report from Knight Ridder found that in 2002, nearly 2.3 million amiodarone (CORDARONE) prescriptions (82 percent of all prescriptions for the drug) were dispensed for uses that had not been approved by the FDA.
The heart rhythm drug amiodarone has several potentially fatal toxicities, the most important of which is lung toxicity that has resulted in clinically evident disease at rates as high as 10 to 17 percent of the time in some series of patients. This type of lung toxicity has been fatal about 10 percent of the time.
Liver toxicity also is common with amiodarone and has been fatal in some cases.
As is true with other drugs used to treat heart rhythm disturbances, amiodarone can make the heart rhythm disturbance worse. This has occurred in two to five percent of patients using the drug.
Amiodarone is only FDA-approved for adults with life-threatening heartbeat problems called ventricular arrhythmias, for which other treatments did not work or were not tolerated (see Worst Pills, Best Pills News, April 2005).
Topiramate (TOPAMAX)
Internet advertisements are heavily promoting the use of topiramate (TOPAMAX) as a weight-loss agent, even though the prescription drug is approved by the FDA only for the treatment of seizures. It has not been shown to be safe and effective for weight loss.
In December, the FDA required that topiramate’s manufacturer, the Ortho-McNeil Division of Johnson and Johnson, send a strong warning letter to doctors stating that topiramate has caused a very common and sometimes life-threatening abnormality in acid-base balance known as metabolic acidosis, in which the body becomes too acidic. Some of the adverse effects manifested in metabolic acidosis include hyperventilation, fatigue, cardiac arrhythmias, stupor and kidney stones (see Worst Pills, Best Pills News, February 2004).
Serotonin Re-Uptake Inhibitor (SSRI) Antidepressants
The use of SSRI antidepressants has been shown to increase the risk of suicidal tendencies in children and adolescents when used to treat major depressive disorder. The use of these drugs in this age group is off-label and not FDA-approved. All of the antidepressants sold in the United States now carry a black-box warning about the increased risk of suicidal tendencies in children and adolescents (see Worst Pills, Best Pills News, August 2003 and October 2003).
The SSRIs used off-label include escitalopram (LEXAPRO), citalopram (CELEXA), fluoxetine (PROZAC, SARAFEM), fluvoxamine (LUVOX), paroxetine (PAXIL), and sertraline (ZOLOFT).
Long-Term Hormone Replacement Therapy (HRT)
The long-term use of HRT has been in vogue for years to prevent a range of chronic conditions. These included the off-label uses of preventing heart disease, Alzheimer’s disease and, of course, to supply women with estrogen lost during menopause. A large government-sponsored study, called the Women’s Health Initiative, found that the harms of HRT outweighed the supposed benefits. This study found an increased risk of invasive (as opposed to localized) breast cancer in women receiving HRT. This fact, combined with an increase in cardiovascular problems that began in the first year of HRT treatment and persisted, outweighed the benefits of HRT, among which were a reduced incidence of colon cancer and hip fractures (see Worst Pills, Best Pills News, September 2002).
Drugs used off-label for long-term HRT include conjugated estrogens (PREMARIN) and conjugated estrogens with progestin (PREMPRO), among others.
Gabapentin (NEURONTIN)
Gabapentin (NEURONTIN) was approved by the FDA for treating seizures, a market with a relatively small potential. The manufacturer of the drug, Parke-Davis (now Pfizer), conducted an economic analysis and determined that it would be more cost-effective to promote gabapentin for off-label uses using ghostwritten medical journal articles rather than going through the FDA’s drug approval process.
This “publication strategy” transformed the drug into a blockbuster, with sales approaching $1.5 billion in 2001. Gabapentin was promoted illegally for uses such as bipolar disorder, attention deficit disorder and migraines (see Worst Pills, Best Pills News, May 2002).
The Archives of Internal Medicine study discussed in this issue pointed out that 83 percent of gabapentin prescriptions are for uses that have not been shown to be safe and effective according to FDA standards.
Gabapentin is still one of the most frequently prescribed drugs in the United States. In 2005, more than 1.5 million prescriptions were dispensed for the drug, with sales topping $250 million. If 83 percent of prescriptions for gabapentin are for off-label uses, then more than $211 million was wasted on the drug in 2005. Belatedly, the number of prescriptions and the sales of gabapentin have decreased more than 85 percent since 2004.
There have not been a large number of reports of adverse drug reactions associated with the off-label use of gabapentin. However, patients can be harmed in ways other than needless adverse drug reactions. Patients can be harmed economically when they are paying for a drug that is not safe and effective when effective drugs are available, often at a lower cost.
What You Can Do
If you are taking any of the drugs listed above for any of the inappropriate uses we describe, contact your physician to be switched to another drug. If you are unsure whether you are taking the drug for an off-label use, check the professional product label and discuss your concerns with your physician.
