Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Depo-Provera Black Box Warning Challenged In Physician Petition

This article was originally published in The Pink Sheet Daily

Executive Summary

Two obstetrician/gynecologists argue there is no published clinical evidence that extended use of the injectable contraceptive is harmful; they cite a Pfizer-funded study that found Depo-Provera users already had a higher risk of bone fracture than nonusers and the risk did not increase with use of the drug.

You may also be interested in...



Depo-Provera "Black Box" Urges Limited Long-Term Use

Pfizer's injectable contraceptive should be used longer than two years "only if other birth control methods are inadequate," the "black box" states. Warning regarding bone loss is based on two five-year Phase IV studies in adolescents and adults.

Companies Reveal Hurdles In Providing Drugs Via Expanded Access Programs

GSK, Stealth BioTherapeutics and Blueprint Medicines discuss the difficulties getting participation of physicians, the excessive cost of expanded access, and whether physicians should report research data.

Current Pathways For Rare Disease Drugs Are Not Optimal, US FDA’s Califf Says

Anticipating a ‘tsunami of therapies’ for rare diseases, commissioner says the agency will have to think of creative approaches and employ regulatory flexibility for them. FDA considers copying the oncology center’s Project Facilitate for expanded access to other diseases.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS075709

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel