Doctors Group Sues FDA to Withdraw Approval of Heart Drug

Friday, February 07, 2014
(AP graphic)

Physicians for Integrity in Medical Research has sued the Food and Drug Administration (FDA) over the heart medication roflumilast, claiming it should be pulled off the market.


Intended to treat chronic obstructive pulmonary disease (COPD), the Forest Laboratories product does more harm than good, according to the plaintiff.


The group says roflumilast (trade name Daliresp), which the FDA approved in 2011, “does not work as stated,” and is similar to a discredited COPD drug, theophylline.


“The clinical effects of roflumilast appear identical to those of theophylline except that roflumilast appears to have more frequent and more severe side effects than theophylline,” the complaint states.


Because “theophylline has already been discredited in the treatment of COPD, roflumilast has no place in treatment of COPD,” the doctors group says.


Side effects of roflumilast include an increase in suicide, cancer and acute pancreatitis, the doctors say.


The group approached the FDA directly and asked it to withdraw its approval of the drug. But the agency rejected the request, stating that the approval decision was sound.


“FDA approved roflumilast because the sponsor demonstrated that it is safe and effective for its stated indication and met other requirements for approval,” the FDA said in a letter to the physicians group.

-Noel Brinkerhoff


To Learn More:

Doctors Group Sues FDA, Saying Drug Does More Harm Than Good (by Elizabeth Warmerdam, Courthouse News Service)

Forest Laboratories (Influence Explorer)


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