Surrogate markers, emboldened and boxed warnings, and an expanding culture of misinformation. Evidence-based clinical science should guide FDA decision making about product labeling

Contraception

Volumn 73, Issue 5, 2006, Pages 440-442

  Shulman, Lee P ^a   Bateman, Louise H ^b   Creinin, Mitchell D ^c   Cullins, Vanessa E ^d   Doyle, Lee Lee ^e   Godfrey, Emily ^f   Murphy, Patricia ^g   Rodriguez, Pablo ^h   Spear, Scott J ⁱ   Stewart, Felicia H ^j   Thomas, Michael A ^k   Westhoff, Carolyn L ^l   Worthington, Sandra ^b  

^a NORTHWESTERN UNIVERSITY   (United States)

^b University of Pittsburgh ^*

^c UNIVERSITY OF PITTSBURGH   (United States)

^d University of Arkansas for Medical Science ^*  (United States)

^e UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES   (United States)

^f UNIVERSITY OF ILLINOIS AT CHICAGO   (United States)

^g UNIVERSITY OF UTAH   (United States)

^h Planned Parenthood of Rhode Island   (United States)

ⁱ UNIVERSITY OF WISCONSIN MADISON   (United States)

^j UNIVERSITY OF CALIFORNIA   (United States)

^k UNIVERSITY OF CINCINNATI   (United States)

^l NewYork Presbyterian Hospital   (United States)

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Author keywords

[No Author keywords available]

Indexed keywords

ANGIOTENSIN 2 RECEPTOR ANTAGONIST; CALCIUM; CONTRACEPTIVE AGENT; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; DROSPIRENONE; DROSPIRENONE PLUS ETHINYLESTRADIOL; ESTROGEN; ETHINYLESTRADIOL; ETHINYLESTRADIOL PLUS LEVONORGESTREL; MEDROXYPROGESTERONE ACETATE; ORAL CONTRACEPTIVE AGENT; ORTHOEVRA; POTASSIUM; SPIRONOLACTONE; UNCLASSIFIED DRUG;

ACCURACY; ARTICLE; BONE DENSITY; CALCIUM BONE LEVEL; CARDIOVASCULAR DISEASE; CLINICAL PRACTICE; CONTRACEPTION; DISEASE COURSE; DISEASE MARKER; DRUG EFFICACY; DRUG EXPOSURE; DRUG PACKAGING; DRUG POTENCY; DRUG SAFETY; EVIDENCE BASED MEDICINE; FOOD AND DRUG ADMINISTRATION; FRACTURE; GROUPS BY AGE; HEALTH HAZARD; HUMAN; HYPERKALEMIA; LABORATORY; MEDICAL DECISION MAKING; MEDICAL INFORMATION; OVARY FOLLICLE; POTASSIUM BLOOD LEVEL; PREDICTION; SIDE EFFECT; THROMBOEMBOLISM; UNSPECIFIED SIDE EFFECT; VAGINA RING;

EID: 33646057979     PISSN: 00107824     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.contraception.2006.01.007     Document Type: Note

References (6)

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2. Kaunitz A.M. Depo-Provera's black box: time to reconsider?. Contraception 72 3 (2005) 165-167
3. Preston R.A., White W.B., Pitt B., Bakris G., Norris P.M., and Hanes V. Effects of drospirenone/17-beta estradiol on blood pressure and potassium balance in hypertensive postmenopausal women. Am J Hypertens 18 (2005) 797-804
4. Heinemann L.A., and Dinger J. Safety of a new oral contraceptive containing drospirenone. Drug Saf 27 (2004) 1001-1018
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6. Chaker A.M. Doctors back off birth-control patch after FDA warning on excessive hormones, some stop prescribing popular method weighing choices. Wall St J (2005)