Safety monitoring marketed drugs

S. J., Yuen, N. (2007 Aug). Novel statistical tools for monitoring the safety of marketed drugs. Clinical Pharmacology and Therapeutics, 82(2), 157-166. 

Jones JK, Faich GA and Anello C. Post-Marketing Surveillance in the General Population - the U.S.A. In William H Inman, ed. Monitoring for Drug Safety, 2nd edn. Lancaster, U.K. MTP Press Limited, 1985 153-63. 

Coulter DM, Edwards IR, McQueen EG. Post marketing surveillance in the general population - New Zealand. In Inman WHW, editor. Monitoring for drug safety. 2nd ed. Lancaster (UK) MTP Press/Kluwer Academic Publishers Group 1986. p. 119-34. 

Postmarketing surveillance The FDA s ongoing safety monitoring of marketed drugs. 

Morse ML, LeRoy AA, Strom BL. COMPASS a population-based post-marketing drug surveillance system. In Inman WHW, ed. Monitoring for Drug Safety. Philadelphia JB Lippincott, 1986. 

Women often seek relief for premenstrual and perimenopausal symptoms from alternative or nontraditional treatments without consulting their health care providers. Herbal therapies, phytoestrogens, progesterone creams, megavitamins, folk remedies, and homeopathy are marketed to women without scientific evidence of efficacy or safety. Clinicians should ask women if they use alternative/ complementary therapies and become familiar with the products (e.g., mechanism of action, efficacy, dosing, side effects, monitoring, and drug-herb and herb-herb interactions). 

Another potential use for these drugs was to prevent the formation of adenomatous polyps in patients with a history of colorectal adenomas. Rofecoxib and celecoxib were both tested in this disease. It was the results of this test that prompted Merck to withdraw their drug from the market since this study clearly established the increased risk of cardiovascular events when rofecoxib is used. The results were sufficiently strong to have the safety monitoring board reevaluate the data for a similar trial with celecoxib. On the basis of these data the study with celecoxib was also terminated. Interestingly, another study in which celecoxib was used to prevent polyp formation resulted in no increase in cardiovascular events. The only difference between the two studies was that in the latter case celecoxib was given once a day whereas in the prior study celecoxib was administered at the same dose but twice a day. How this difference in treatment schedules affected the toxic outcomes is unknown at the present time. 

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