Off-Label Use of Prescription Drugs

2017 Words5 Pages

Although the pharmaceutical industry says that prescription medicines are as safe as they can possibly be, prescribed drugs have a high increase of risking a patient’s health. According to the law, drug makers seek Food and Drug Administration (FDA) approval for specific uses of their products and conduct trials to test their drugs safety and effectiveness in patients with specific conditions. The FDA demands that drug companies conduct rigorous clinical trials to prove a drugs safety and effectiveness in treating a particular disease. However, once the FDA approves a drug for one use, doctors can prescribe it for whatever they want. The FDA is considering loosening the monitoring of off-label prescriptions, but if anything, regulations should be tightened. Despite the practices of some medical personnel, the risk of serious medical complications demands that the FDA regulate and restrict off-label use of prescription drugs. The off-label use of any approved drug relates to the use not included in the official label. The exclusion of uses for a specific disease or disorder from the official label proves that drug creators have not submitted the needed evidence, required by law to allow admittance, to the Food and Drug Administration. When this occurs, the statement, “safety and efficacy in pediatric patients have not been established” is printed in the product label. Randall Stafford M.D. writes, “Although off-label prescribing, the prescription of a medication in a manner different from 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 paper ... ...spx?PIN=i0401300&term=off+label+drugs http://www.sciencebasedmedicine.org/?p=283 http://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=80bcb87d2d4ef94b055410d5f4dc7738 http://web.ebscohost.com.libproxy.gc.maricopa.edu/ehost/detail?hid=13&sid=20488a59-167c-4c1f-a2a7-439627223fdf%40sessionmgr11&vid=5&bdata=JnNpdGU9ZWhvc3QtbGl2ZSZzY29wZT1zaXRl#db=f5h&AN=33942570 http://ic.galegroup.com.libproxy.gc.maricopa.edu/ic/ovic/NewsDetailsPage/NewsDetailsWindow?displayGroupName=News&prodId=OVIC&action=e&windowstate=normal&catId=&documentId=GALE|A145543528&mode=view&userGroupName=mcc_glendale&jsid=9214fa9c3327cc8191ae2c0a5554a0af http://www.nejm.org/doi/full/10.1056/NEJMp0802107

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