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Are Your Medications Safe? The Risks of "Off-Labeling"

[Column 333, April 18, 2005] Archived Columns

By Todd A. Smith*

Have you ever received a free sample of a drug from your doctor? Or picked up a prescription, read the instructions, and were puzzled because it is for a disease you don't have?

This practice is called "off-label use," and doctors do it routinely. Off-label use means a certain drug has been approved by the Food and Drug Administration (FDA) for treatment of a specific condition or disease, but not necessarily for treatment of your specific condition or disease.

Many Americans are unaware that once an FDA-approved drug goes on the market, the FDA cannot regulate what a doctor does with the medication. Doctors may use a drug for any situation they deem medically appropriate, including:

• A disease other than the one for which it has been approved;
• A alternative dose, duration or frequency than instructed on the label;
• Medication for a child when the drug has only been approved for adults.

Consequently, many drugs are prescribed by doctors for uses that the drug manufacturer did not intend, and that have not been tested for safety.

Most doctors will not prescribe a drug for off-label use without broad experience and knowledge of the drug's side effects. However, when their personal reference is limited, physicians often base these decisions on research papers, academic studies, and, unfortunately, articles and information about off-label uses of the drug provided by manufacturer. That can be a dangerous mistake.

The FDA does not allow drug manufacturers to advertise or promote a product for a use that it has not been approved. But pharmaceutical manufacturers and their sales representatives can, and do, provide physicians with articles and information about clinical trials of off-label uses of their products, along with free samples.

Re-submitting a drug for FDA testing and approval for a new use can be a lengthy process. And for many manufacturers, it is more cost-efficient to simply provide doctors with information about off-label uses for the drug without actually going through the regulatory process.

Medications such as antibiotics, pain medicine, and allergy pills are examples of drugs that are frequently applied for off-label use with few harmful results. Indeed, off-label use has proven especially beneficial in treating AIDS, cancer, and rare diseases.

But the potential for abuse is great. The drug Cytotec, for example, is an ulcer medication. But it is prescribed by some doctors in the US for the off-label use of helping induce labor in pregnant women - despite the drug manufacturer's warning of the possibility of serious brain damage to babies if used by pregnant women.

That's exactly what happened to Ian Malone in Washington State. When his mother Christine Malone went into the hospital for delivery, her physician prescribed Cytotec to induce labor. As a result of the drug and related complications, Ian was born with severe brain damage and died before his fifth birthday.

Most people who take a prescription drug off-label never even know it and don't have any complications. But the fact that these drugs have not gone through the normal approval process for these new uses puts patients at a greater danger. Even FDA-approved drugs such as Vioxx, as we have tragically learned, can be dangerous when used as intended.

You can help protect yourself and your family, by always asking your doctor these questions about any new prescription medication:

• How will this help me?
• What are the risks and side effects?
• How long will it be before I see results?
• What happens if I take too much?
• What should I do if I miss a dose?
• Are there any foods, medications or supplements that I should not take with this drug?

For more health and safety information and tips, please visit AAJ's "Keep Our Families Safe" Web site at http://www.justice.org/private/kofs/index.aspx.

*Todd A. Smith, president of the American Association for Justice, is a partner in the Chicago, IL, law firm of Power Rogers & Smith.