Comment On: FDA-2012-P-0298-0001 Joseph Dedvukaj Firm P.C. (On Behalf of Arena Pharmaceuticals, Inc. et al) - Citizen Petition
Document: FDA-2012-P-0298-0005 Donald P Galamaga MPA CCP DGCP - Comment Submitter Information Address:
RI, Submitter's Representative: Donald P. Galamaga MPA CCP DGCP, Principal Organization: Organizations and Healthcare General Comment
Lorqess, from my review of the information presented by Arena Pharmaceuticals, represents a safe and urgently needed medication to address the obesity crisis in the general populkation of the united States. The net weight loss results reported are effective across the age spectum and compare most favorably with those of Qnexa from VVUA Pharmaceuticals, with no negative comparable side effect profile. The prospect of Lorqess, thus, becoming a medication of first choice for physicians is , indeed very high, as is the prospect of patients adhering to approved medication regimens for long lasting effect. I therefore strongly recommend approval of Arena's Lorqess by the adviosory committee and the FDA at the forthing coming panel review session and FDA PDUFA date, if not sooner, without qualification
I've been trying to tell folks that Qn- is too risky. Elevated heart rate is not a good side effect for an obese patient who already has a high heart rate. Push it too high, and you get tachycardia, clotting, stroke, SCA (Sudden cardiac arrest) and high blood pressure. Now add in the risk of oral contraceptives.
When physicians see the risks involved with Qn- they are going to hesistate to prescribe it.