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LOWRY: Off-label drug use just too dangerous

If your doctor writes you a prescription, it is not unreasonable to expect that drug to be safe and appropriate for your medical condition.

However, off-label prescriptions are on the rise in the United States, contributing to a number of deaths and injuries because these medications are not approved by the U.S. Food and Drug Administration (FDA).

“Off-label” means a drug is being used in a manner not specified in the FDA’s approved packaging label or insert. Every prescription drug marketed in the U.S. has detailed instructions regarding the approved uses and doses based on the results of clinical studies the drug maker submitted to the FDA.

Once the FDA approves a drug, licensed physicians can prescribe it for any purpose they consider medically appropriate. The off-label use of FDA-approved drugs is legal in the United States and many other countries, but it is illegal for pharmaceutical companies to market, advertise or promote their medications for off-label uses.

The off-label market for sales is often much bigger and more profitable for manufacturers. Therefore, manufacturers have large incentives to push their products for off-label use.

According to Web MD, more than one in five outpatient prescriptions written in the U.S. are for off-label therapies that are not FDA-approved. Lack of information about off-label drug use and outcomes can put patients at a higher risk for medication errors, side effects and potentially dangerous drug reactions.

One of the biggest problems related to widespread off-label use is the lack of information about how to best use the drug other than for what it was approved. This has resulted in a number of cases where off-label drug use has contributed to birth defects, injuries and even death.

Two recent studies suggest off-label testosterone therapy medications such as Androgel, Testim, Testoderm and other products prescribed to treat low testosterone or “low T” can cause an increased risk of heart problems in men. The FDA is investigating the risk of stroke, heart attack and death in men taking testosterone gel and other prescription testosterone replacement products.

Testosterone therapy has been marketed off-label to treat low energy, decreased sex drive, depression and other symptoms that can occur in men who supposedly have low testosterone levels.

A recent study of men in the U.S. Veterans Affairs healthcare system found that patients taking testosterone therapy were 30 percent more likely to suffer a stroke, heart attack or even death. A second study found that men who were younger than 65 and had a history of heart disease were up to three times at risk of having a heart attack within 90 days of filling their first testosterone prescription.

In addition, men 65 and older were twice as likely to have a heart attack within 90 days of filling their first prescription, even if they did not have a history of heart disease.

At the same time, off-label use of Zofran to treat morning sickness in pregnant women is also coming under scrutiny. Zofran has been sold in the U.S. since 1991 and has never been FDA-approved for use as a treatment for morning sickness during the first trimester of pregnancy.

Zofran’s manufacturer did not conduct clinical trials to investigate the drug’s possible side effects in pregnant women. However, three independent studies recently found a significantly increased incidence of major birth defects in babies born to women who were prescribed Zofran during the first trimester, including congenital heart defects, cleft palates and kidney malformations.

Off-label drug use is not a new phenomenon. It has been going on for decades and, in recent years, has been linked to deaths resulting from the fenfluramine/phentermine diet pill combination, better known as “fen-phen,” and to the increased incidence of bladder cancer in patients taking Actos.

The drug label is one of the most reliable and useful sources of information available to health professionals and patients. However, the label only includes information that has been approved by the FDA. It does not cover off-label uses that can put patients at risk.

Be sure to ask your doctor about the safety of any off-label prescriptions. If you or your loved ones have been injured due to off-label medication, contact an attorney who can help fight for your rights and secure potential compensation for your damages.

 

Stephen G. Lowry is a partner with the law firm of Harris Penn Lowry LLP. He and his law firm handle numerous prescription drug and product safety claims. He can be reached at steve@hpllegal.com or 912-651-9967.

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