FDA OPENS IT'S EYES: REMICADE AND CHILDREN
Saturday, June 7, 2008
Last week, Andrew Pollack of the New York Times wrote that the FDA would investigate whether Remicade and three other drugs could increase the risk of cancer in children.This is long overdue. As mentioned in March, here is Canada's stance on the pediatric use of Remicade:
> REMICADE® is not authorized in Canada for use in children.
> A rare form of cancer (hepatosplenic T-cell lymphoma), a lymphoma that affects the liver and spleen, has been reported in children and young adults taking REMICADE® for Crohn's disease.
(note: Hepatosplenic T-cell lymphoma is an extremely rare cancer, with only 150 cases reported worldwide since the disease was first recognized in the early 1990's. The cancer is aggressive and most patients die within 2 years of diagnosis.)
> A total of six (6) cases have been reported, with five cases resulting in death. Patients had been receiving REMICADE® for up to 4 years.
source: Health Canada Safety Information
> A rare form of cancer (hepatosplenic T-cell lymphoma), a lymphoma that affects the liver and spleen, has been reported in children and young adults taking REMICADE® for Crohn's disease.
(note: Hepatosplenic T-cell lymphoma is an extremely rare cancer, with only 150 cases reported worldwide since the disease was first recognized in the early 1990's. The cancer is aggressive and most patients die within 2 years of diagnosis.)
> A total of six (6) cases have been reported, with five cases resulting in death. Patients had been receiving REMICADE® for up to 4 years.
However, if you are investing in Remicade, your money is most-likely safe. As pointed out in USA Today, the current FDA is either doing nothing--or spending all of it's time having closed door meetings with the industry it regulates. [Note: Putting it in historical perspective, the FDA has been on this seesaw for over 100 years--becoming too lax, doing it's legal duty, becoming too lax, etc. About now, the pendulum will perhaps, begin swinging back toward protecting the public.]
