Although the pharmaceutical industry claims that prescription drugs are as safe as they can be, the medications prescribed pose a high risk to the patient's health. By law, drug manufacturers seek approval from the Food and Drug Administration (FDA) for specific uses of their products and conduct trials to test the safety and effectiveness of their drugs in patients with certain conditions. specific. The FDA requires pharmaceutical companies to conduct rigorous clinical trials to prove a drug's safety and effectiveness in treating a particular disease. However, once the FDA approves a drug for single use, doctors can prescribe it as they wish. The FDA is considering easing oversight of off-label prescribing, but regulations should instead be strengthened. Despite the practices of some medical personnel, the risk of serious medical complications requires that the FDA regulate and limit the off-label use of prescription drugs. Off-label use of any approved drug refers to use not included in the official label. Excluding uses for a specific disease or disorder from the official label proves that drug creators have not submitted the necessary evidence, required by law to allow admission, to the Food and Drug Administration. When this happens, the statement "safety and effectiveness in pediatric patients have not been established" is printed on the product label. Randall Stafford MD writes: “Although off-label prescribing, prescribing a drug in a manner other than that approved by the FDA, is legal and common, it is often done in the absence of adequate supporting data. Off-label uses have not been formally evaluated and evidence provided for one clinical situation may not apply to others” (Sta......middle of article......spx ?PIN=i0401300&term=off+label+ medicationshttp://www.sciencebasedmedicine.org/?p=283http://ic.galegroup.com.libproxy.gc.maricopa.edu/ic/ovic/ViewpointsDetailsPage/ViewpointsDetailsWindow?displayGroupName=Viewpoints&prodId =OVIC&action=e&windowstate=normal&catId=&documentId =GALE%7CEJ3010532206&mode=view&userGroupName=mcc_glendale&jsid=80bcb87d2d4ef94b055410d5f4dc7738http://web.ebscohost.com.libproxy.gc.maricopa.edu/ehost/detail?hid=13 &sid=20488a59-167c-4c1 f- a2a7-439627223fdf%40sessionmgr11&vid=5&bdata=JnNpdGU9ZWhvc3QtbGl2ZSZzY29wZT1zaXRl #db=f5h&AN=33942570http://ic.galegroup.com.libproxy.gc.maricopa.edu/ic/ovic/NewsDetailsPage/NewsDe tailsWindow?displayGroupName=News&prodId=OVIC&action=e&windowstate=normal&catId= &documentId=GALE|A145543528&mode=view&userGroupName=mcc_ glendale&jsid =9214fa9c3327cc8191ae2c0a5554a0afhttp://www.nejm.org/doi/full/10.1056/NEJMp0802107