Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Crestor Rhabodomyolysis Cases At 10 Mg Dose Prompt Renewed Call For Drug’s Removal

This article was originally published in The Pink Sheet Daily

Executive Summary

Public Citizen cites 11 additional cases of rhabdomyolysis in pressing for Crestor’s removal. AstraZeneca revises drug administration guidelines in “Dear Doctor” letter to U.K. physicians.

You may also be interested in...



Crestor Safety Data Under FDA Review; 11 Reports Of Rhabdomyolysis At 10 Mg Dose

The agency appears unlikely to make a significant change in the regulatory status of the statin in the near term; FDA notes that most of the reported cases of rhabdomyolysis and renal failure could be attributed to the underlying disease or concomitant medications. Public Citizen renews call for Crestor's withdrawal in Lancet article.

Crestor Safety Data Under FDA Review; 11 Reports Of Rhabdomyolysis At 10 Mg Dose

The agency appears unlikely to make a significant change in the regulatory status of the statin in the near term; FDA notes that most of the reported cases of rhabdomyolysis and renal failure could be attributed to the underlying disease or concomitant medications. Public Citizen renews call for Crestor's withdrawal in Lancet article.

Crestor European Label Changes Prompt FDA Public Health Advisory; Safety Review Ongoing

FDA is using European label update as an opportunity to remind physicians of three "key safety messages" contained in Crestor's U.S. label. FDA is not recommending changes to the U.S. label, pending an evaluation of postmarketing reports of rhabdomyolysis.

Topics

UsernamePublicRestriction

Register

LL1135972

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