Drug companies illegally promote off-label use of potent medications

posted on:
March 14, 2010


Cephalon peddled potent and potentially harmful painkillers as if they were “actual lollipops,” according to the U.S. Attorney’s office. The statement was released following an investigation into the drug company’s marketing activities. Cephalon was also slapped with a $425 million penalty.

The investigation was a result of a study into how the drug company’s painkiller Actiq was used. The drug is approved by the Food and Drug Administration (FDA) for the treatment of breakthrough pain in cancer patients who are on around-the-clock morphine-based drugs. Actiq is given as a lozenge on a stick that resembles a lollipop.

However, the study found that the drug was prescribed for off-label use as much as 90 percent of the time. This unapproved use included prescribing Actiq for the treatment of backaches, migraines and even injuries. Another study also showed that Cephalon’s other painkiller, Fentora, a painkiller considered even more powerful that Actiq, was also prescribed predominantly for off-label use.

Use of Actiq and Fentora in patients who have not already built up a tolerance to opioids like morphine proved fatal for some. Severe side effects with Actiq, including respiratory complications, were reported 91 times to the FDA. More than 100 fatalities have been associated with off-label use of the drug.

An investigation by the FDA and the Attorney General’s office found that Cephalon had actually paid nearly 1,000 doctors and other health care professionals to speak about the off-label benefits of the drug. Unfortunately, Cephalon isn’t the only drug company paying professionals to convince doctors to prescribe drugs for uses for which they are not approved. Last year, Eli Lilly was found guilty of illegally marketing Zyprexa, a medication approved to treat schizophrenia and bipolar, as a medication to treat sleep disorders in elderly patients. That investigation led to a $1.4 billion fine for Eli Lilly.

Source: Milwaukee-Wisconsin Journal Sentinel 

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