A drug shortage led to cancer relapses in children and young adults in 2010, a consequence of the problem of drugs in short supply in the USA, a hospital analysis showed for the first time on Wednesday.
The finding suggests that substitutes for drugs in short supply can pose unsuspected health risks for patients with cancer. In this case, the generic drug mechlorethamine is part of a three-month chemotherapy treatment for Hodgkin's lymphoma, a cancer of the lymph nodes and spleen that yearly afflicts as many as 9,000 people nationwide, mostly teenagers.
Mechlorethamine is one of hundreds of drugs that have been in short supply in the past three years, according to the Food and Drug Administration. In the New England Journal of Medicine report led by Monika Metzger of St. Jude Children's Research Hospital in Memphis, physicians show real harm from the shortage of the drug in 2010.
"The difference is just shocking. This had a real impact on patients," Metzger says. "We thought the alternative was just as safe, of course, so it was a real surprise when we reviewed the data."
The shortage ended in October, according to manufacturer Lundbeck of Deerfield, Ill., which recently sold the drug to another firm. Manufacturing facility problems triggered the shortage in 2010, forcing physicians in the study to switch to a different generic drug regimen.
"We did everything we could to minimize (the) disruption in supply," says Lundbeck spokesman Matt Flesch.
Study physicians compared cancer relapse rates among 181 patients treated with the original drug and 40 patients treated with a substitute. They found that 25(PERCENT) of patients on the new regimen suffered cancer relapses vs. 12(PERCENT) using the original drug. None of the patients died, but ones whose cancer returned faced more toxic doses of cancer drugs and bone marrow transplants.
"This is a ridiculous situation for the industry that leads the world in 21st-century meds but can't provide 1960s drugs," says cancer expert Bruce Chabner of Massachusetts General Hospital in Boston.
Stephanie Yao of the Food and Drug Administration said the agency remains "extremely concerned about the current and potential shortages." Last year, President Obama said prescription drug shortages "pose a serious and growing threat to public health." He issued an executive order that called for reporting on shortages and hastened reviews of steps needed to alleviate them.
