The U.S. Food and Drug Administration has issued a warning over the drug revlimid (lenalidomide) used to treat multiple myeloma and a blood disorder called myelodysplastic syndrome. Trials of revlimid found that there is an increase in the risk of developing other cancers among those who take the drug.
Despite this fact, the FDA has said that patients should continue to take the drug even though they admit they are still reviewing all the data from the trial and have no idea if the drug is safe.
Medical professionals are being reminded that if they choose to prescribe the drug, it may increase the risk of developing subsequent cancers, particularly acute myelogenous leukemia (AML) and B-cell lymphoma malignancies.
This isn’t the first time the drug has been in the spotlight for its adverse effects. Lenalidomide is an analogue of thalidomide, the drug responsible for causing birth defects in large numbers of babies after their mothers took it to ease morning sickness. It also led to the deaths of 100,000 babies in the womb worldwide, and many other babies who died in the first year of life. In Britain there were 5,000 deaths of infants up to one year and another 500 people who survived with deformities.
The drug was banned in 1961 after a gynecologist, William McBride, realized that the deaths and deformities were the result of thalidomide. In the 1990’s, he was struck off the medical register after it was alleged that he committed fraud during a study of another anti-morning sickness drug, Debendox, in 1980. He found that Debendox also caused deformities. In his book, "Killing the Messenger", Mr McBride wrote, "Without flattering myself, I am sure the decision [to strike me off] was received with pleasure by many of the international drug companies."
In 2008, the drug was re-introduced under a different name--lenalidomide, or revlimid--to be used for the treatment of multiple myeloma cancer, in spite of resistance from patient groups and thalidomide survivor charities. It had already been in use as a treatment for leprosy in Brazil and the country had seen a corresponding increase in the number of babies born deformed.
Now it appears to be causing cancer in people who are already seriously ill and the FDA has not recalled it, bringing the question, is it really the public’s interest they are protecting?
Sources:
FDA Drug Safety Communication: Ongoing safety review of Revlimid (lenalidomide) and possible increased risk of developing new malignancies, 8th April 2011 - http://www.fda.gov/Drugs/DrugSafety/ucm250575.htm
The Sunday Times, 23rd March 2008 - http://www.timesonline.co.uk/tol/comment/leading_article/article3602839.ece
The Times, 22nd April 2008 - http://www.timesonline.co.uk/tol/news/uk/health/article3671976.ece
The Independent, 22nd June 1994 - http://www.independent.co.uk/news/world/thalidomide-doctor-alleges-plot-to-gag-him-1424275.html
Joanna is a freelance health writer for The Mother magazine and Suite 101 with a column on infertility, http://infertility.suite101.com/. She is author of the book, 'Breast Milk: A Natural Immunisation,' and co-author of an educational resource on disabled parenting, in addition to running a charity for people damaged by vaccines or medical mistakes.