Navigation Links
FDA To Reconsider Standards for Reviewing Low-Dose Oral Contraceptives

FDA in documents released Thursday announced it is reconsidering its standards for reviewing the failure rate of new oral contraceptives with lower doses// of estrogen and progestin, the Wall Street Journal reports.

According to the Journal, higher pregnancy rates in studies of new low-dose oral contraceptives have instigated the agency to reconsider what represents an "acceptable failure rate" for new drugs. The agency uses a measurement called the Pearl Index, which calculates a contraceptive's failure rate by measuring the amount of time women are exposed to a given product and the number of unplanned pregnancies that result.

According to FDA documents, the agency in the 1970s set a policy that it only approved oral contraceptives with failure rates less than 1.5 per 100 "woman-years," or the number of years a woman has used the drug. FDA has recently approved some pills with failure rates of more than two per 100 woman-years, the Journal reports.

FDA said that the number of pregnancies in clinical trials has increased in new oral contraceptives with lower dosages of estrogen and progestin. The increase in pregnancies is "consistent with less sustained ovulation suppression in new products as compared to the earlier higher dose regimens," but there might be other reasons, FDA said.

Scott Monroe, acting head of the agency's reproductive-drugs division, said the variations between the new contraceptives and the old pills might "not be statistically different." According to the Journal, FDA in an upcoming meeting will seek its advisers' input for new guidelines to review new oral contraceptives.

Source: Kaiser Family Foundation
'"/>




Page: 1

Related medicine news :

1. Reconsideration Of Heart Transplant Eligibility
2. Reconsider Health Benefits of Organic Baby Foods, advices new study
3. Britain Reconsidering New Visa Rules for Indian Doctors
4. Court Orders NHS To Reconsider Funding Lung Cancer Drug
5. Researchers Feel The Need For Standards Of Practice In Immunoglobulin Therapy
6. DMAA to Develop Disease Management Standards by December
7. Setting Standards: Benchmark Medical Tests to Gauge Accuracy of Medical Tests
8. Medical Colleges, Confident of Meeting Standards Before 90-days deadline
9. Cleanliness Standards Dropped In NHS Hospitals – Patient Report
10. International Food Standards Meet Set For Chiang Mai Bangkok
11. Government Warned Against Dilution of Medical Standards
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:10/13/2017)... ... October 13, 2017 , ... Lori R. Somekh, founder of the Law ... organization of elder law and special needs planning attorneys. “Membership in ElderCounsel helps our ... a forum to network with elder law attorneys nationwide,” said Somekh. , ...
(Date:10/13/2017)... ... October 13, 2017 , ... Global Healthcare Management’s 4th Annual Kids Fun ... NJ. This free event, sponsored by Global Healthcare Management’s CEO, Jon Letko, is ... is geared towards children of all ages; it is a non-competitive, non-timed event, which ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... “America On ... Christian identity. “America On The Brink” is the creation of published author, William ... several great-grandchildren. As a WWII veteran, he spent thirty years in the Navy. ...
(Date:10/12/2017)... ... October 12, 2017 , ... IsoComforter, Inc. ( https://isocomforter.com ), ... of an innovative new design of the shoulder pad. The shoulder pad provides ... while controlling your pain while using cold therapy. By utilizing ice and water that ...
(Date:10/12/2017)... Malvern, PA (PRWEB) , ... October 12, 2017 , ... ... is the recipient of a 2017 Folio Magazine Eddie Digital Award for ‘Best ... New York City on October 11, 2017. , The annual award competition recognizes editorial ...
Breaking Medicine News(10 mins):
(Date:10/5/2017)... 2017  In response to the nationwide opioid ... Surgeons (AAOMS) released prescribing recommendations that urge ibuprofen ... as a first-line therapy to manage a patient,s ... Recognizing the value and importance of ... Prescribing: Acute and Postoperative Pain Management" stresses that ...
(Date:10/2/2017)... -- Eli Lilly and Company (NYSE: LLY ) ... of 2017 on Tuesday, October 24, 2017. Lilly will ... the investment community and media to further detail the ... begin at 9 a.m. Eastern time. Investors, media and ... the conference call through a link that will be ...
(Date:9/28/2017)... 2017 Cohen Veterans Bioscience and Early Signal ... wearable and home sensors for real-time monitoring of patients ... a nonprofit organization focused on disruptive health solutions for ... analytical system to record and integrate behavioral, cognitive, physiological ... ...
Breaking Medicine Technology: