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

Canada Updates Statin Labeling On Muscle Toxicity, Adds Predisposing Factors

This article was originally published in The Pink Sheet Daily

Executive Summary

Health Canada universalizes statin safety labeling; warning adds list of predisposing factors for rhabdomyolysis and myopathy. Lists are similar to U.S. labeling, but not identical.

You may also be interested in...



AstraZeneca’s Crestor Label Revised With Stronger Rhabdomyolysis Warnings

Labeling now emphasizes increased risk of rhabdomyolysis, especially at 40 mg dose, but FDA reaffirms that muscle toxicity is seen across the statin class and is not unique to rosuvastatin. Labeling also recommends caution in dosing in patients of Asian descent due to increased elevation in rosuvastatin exposure.

Statin Warning For Coenzyme Deficiency Sought In FDA Citizen Petition

Citizen petition supplement pushes for a warning, similar to that carried on statin drugs in Canada, about the risk of CoQ10 depletion. Petitioner seeks a statement that CoQ10 deficiency “is associated with impairment of myocardial function, with liver dysfunction, and with myopathies.”

Tarceva Pancreatic Cancer Indication Turned Down In The EU

Roche will consider requesting a re-examination of the negative decision by the Committee for Medicinal Products for Human Use.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS062546

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