ASU Health & Medical Essay

This is a very topical and I am interested in your assessment of the situation and what you think you might have done in response to the information.

The FDA recalled ranitidine (Zantac), a popular and widely used drug to decrease stomach acid. The link to the FDA announcement is attached here:

https://www.fda.gov/safety/medwatch-safety-alerts-...

to an external site.

There was also a voluntary recall of some widely used blood pressure medications:

https://www.fda.gov/drugs/drug-safety-and-availabi...

to an external site.

For this weeks assignment, do some research on the findings that led up to these recalls. Read some of the press coverage of the issue. Put yourself in the place of the person at FDA who had to make a decision about these drugs and describe the process you would go through in order to make that decision. Then write about your findings, how you would have handled the data as it came in, and what you think of the decisions that were made and what steps might have prevented these issues. Again, address all three of these issues.Please review the following website:

http://www.fda.gov/Safety/MedWatch

new england journal of medicine The established in 1812 September 20, 2018 vol. 379 no. 12 Cardiovascular Safety of Lorcaserin in Overweight or Obese Patients E.A. Bohula, S.D. Wiviott, D.K. McGuire, S.E. Inzucchi, J. Kuder, K.A. Im, C.L. Fanola, A. Qamar, C. Brown, A. Budaj, A. Garcia‑Castillo, M. Gupta, L.A. Leiter, N.J. Weissman, H.D. White, T. Patel, B. Francis, W. Miao, C. Perdomo, S. Dhadda, M.P. Bonaca, C.T. Ruff, A.C. Keech, S.R. Smith, M.S. Sabatine, and B.M. Scirica, for the CAMELLIA–TIMI 61 Steering Committee and Investigators*​​ a bs t r ac t BACKGROUND Lorcaserin, a selective serotonin 2C receptor agonist that modulates appetite, has proven efficacy for weight management in overweight or obese patients. The cardiovascular safety and efficacy of lorcaserin are undefined. METHODS We randomly assigned 12,000 overweight or obese patients with atherosclerotic cardiovascular disease or multiple cardiovascular risk factors to receive either lorcaserin (10 mg twice daily) or placebo. The primary safety outcome of major cardiovascular events (a composite of cardiovascular death, myocardial infarction, or stroke) was assessed at an interim analysis to exclude a noninferiority boundary of 1.4. If noninferiority was met, the primary cardiovascular efficacy outcome (a composite of major cardiovascular events, heart failure, hospitalization for unstable angina, or coronary revascularization [extended major cardiovascular events]) was assessed for superiority at the end of the trial. RESULTS At 1 year, weight loss of at least 5% had occurred in 1986 of 5135 patients (38.7%) in the lorcaserin group and in 883 of 5083 (17.4%) in the placebo group (odds ratio, 3.01; 95% confidence interval [CI], 2.74 to 3.30; P