Are off-label drugs for you?

August 25, 2009 4:00 PM

Ivanhoe Broadcast News

A prescription means the stamp of approval from your doctor, but it may not mean the government’s approval. You might need to be on the alert for off-label drugs.

It’s more common than you might think. More than 20 percent of prescription are written for conditions they’re not approved for, and in a recent study, a third of patients with metastatic breast cancer had received drugs off-label. Medicare recently expanded its coverage of drugs used off-label to treat cancer, and the FDA made it easier for drug companies to market drugs for off-label use. Your doctor gets to choose what drug you take, but should you take it into your own hands?

Drugs are often prescribed off-label for children and pregnant women because they’re routinely excluded from trials, one recent study found the most common medicine prescribed unsafely or ineffectively off-label were anti-depressants and anti-psychotics. To keep yourself safe, ask your doctor if the benefits outweight the risks and whether your insurance will cover it. Some doctors are prescribing a cocktail of off-label drugs called Prometa (pro-MET-uh) to treat alcohol and drug addictions. Critics say there’s no sound scientific support.

Some insurance companies deny coverage of off-label treatments. In some states, they are required to deny it for cancer treatment or other life-threatening conditions. If you or your doctor are trying to get coverage for an off-label treatment, experts say you should have your doctor provide the insurer with copies of peer-reviewed journal articles or other reliable sources that support the drug treatment for your condition.

Background:

Off-label prescribing happens when physicians prescribe drugs for conditions or diseases the drugs aren't FDA-approved to treat. Off-label use includes guideline-recommended cases like aspirin to prevent cardiovascular disease in diabetes patients as well as last-resort therapy for autoimmune disease and transplantation. Sometimes, off-label use is unavoidable, such as in the treatment of children. Three-quarters of marketed prescription drugs carry no labeling indications for children since they have only recently begun to be included in clinical trials. Pregnant women are also often prescribed drugs off-label because they are routinely excluded from studies (Source: PLoS Medicine).

Is it legal?

Although it's legal to prescribe drugs off-label, it's illegal for drug manufacturers to promote off-label use. Two physician researchers recently exposed some "covert" techniques drug companies were using to carry out this illegal practice in a PLoS Medicine study. Those techniques included seeking approval for new drugs for narrow indications even if the drug's makers believe there will be extensive off-label use. These indications act like decoys to avoid the costs and delay that long-term trials involve.

Drugs for rare conditions like rabies are eligible for speedier trials and enter the market faster. Another technique is having drug representatives promote off-label uses to doctors, which is an illegal practice. Drug companies also push for off-label use through nationally-known academic physicians who use "word-of-mouth" or "buzz" marketing.

Is it safe?

In a recent study published in the New England Journal of Medicine, a panel of experts looked into the use of 14 drugs they considered to be used unsafely off-label. They found the antipsychotic drug Seroquel topped the list. The drug led all others in a high rate of off-label use with limited evidence. Seroquel is also marketed at a cost of $207 per prescription. The groups of drugs most common on the list of those prescribed unsafely off-label were antidepressants and antipsychotics. Most often, the drugs were prescribed off-label to treat bipolar disorder. "A dialogue needs to occur more frequently between physicians and patients regarding the level of evidence that supports a particular use of a drug," lead study author Randall Stafford, M.D., Ph.D., an associate professor of medicine at the Stanford Prevention Research Center, was quoted as saying.

For more information, contact:

Daniel Kantor, MD, BScE

Neurologique

Ponte Vedra, FL

(904) 834-3007

info@neurologique.org

http://www.neurologique.org

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