Alerts

TGA has issued updated safety advice for consumers taking Pradaxa (dabigatran), highlighting risks such as bleeding and the importance of proper storage and patient monitoring.

Health professionals and consumers are advised that Roche Diagnostics Australia, after consultation with the TGA, has initiated a recall for product correction for its CoaguChek XS, CoaguChek XS Plus and CoaguChek XS Pro INR monitors.

Gardasil is a vaccine that protects males and females from a range of cancers (including cervical and anal cancers) and other diseases caused by human papillomavirus (HPV). It is administered as three injections over six months.

Yixiu L-Carnitine Slimming capsules pose a serious health risk and should not be taken. They contain undeclared sibutramine. This increases the risk of major cardiac events.

Beast Amphetalean powder poses a serious health risk and should not be taken. It contains prescription yohimbine, alpha‑yohimbine and DMAE, is unapproved, and includes a prohibited import.

TGA safety alert for Aurum Adrenaline 10 mL 1:10,000 pre‑filled syringes warns of label misalignment that may create the appearance of overfill, posing a risk of dosing errors and requiring cautious use.

BSN Hyper Shred capsules pose a serious health risk and should not be taken. They contain prescription-only oxedrine. Health risks may seriously increase if taken with interacting drugs.

Mojo Risen capsules pose a serious risk to your health and should not be taken. They contain undeclared tadalafil and have not been assessed for quality, safety or efficacy.

Ziyinzhuangyang tablets pose a serious risk to your health and should not be taken. They contain undeclared sildenafil and have not been assessed for quality, safety or efficacy.

Maxman III capsules pose a serious risk to your health and should not be taken. They contain undeclared sildenafil and have not been assessed for quality, safety or efficacy.

Health professionals and consumers are advised that Abbott Diabetes Care, after consultation with the TGA, has initiated a recall for product correction for its FreeStyle InsuLinx Blood Glucose Meter.

Health professionals and consumers are advised that Alcon Laboratories Australia, in consultation with the TGA, has issued a hazard alert regarding AcrySof Cachet Phakic Lenses.

Health professionals and consumers are advised that Hoya Surgical Optics, in consultation with the TGA, is recalling certain Hoya One-Piece Intraocular Lenses (IOLs) that are in the supply chain.

Health professionals and consumers are advised that Johnson & Johnson Medical Pty Ltd, after consultation with the TGA, is recalling its OneTouch Verio IQ Blood Glucose Meter.

Health professionals and consumers are advised that selected lots of AMS 800 Control Pumps may not function as intended by the manufacturer, American Medical Systems Inc (AMS).

Paiyouji Natural Slimming Capsules pose a serious risk to your health and should not be taken. They contain undeclared sildenafil and phenolphthalein, which is associated with serious safety concerns.

Health professionals and patients are advised that a review of post-market surveillance data has identified that the Adept 12/14 Modular Head has a higher-than-expected revision rate.

Health professionals and consumers are advised that sponsor, Sorin Group Australia, in consultation with the TGA, has issued a hazard alert for Isoline defibrillation leads.

Precautionary product notification for GlaxoSmithKline Australia (GSK) influenza vaccine, Fluarix

My Slimmer Me (MSM) soft gel capsules pose a serious risk to your health and should not be taken. They contain undeclared sibutramine. This increases the risk of major cardiac events.

Safety alert: TGA warns that GNY Australia MSV Strong, ESV Extra Strong, and RL Rapid Loss capsules contain undeclared sibutramine (a banned prescription drug linked to serious heart risks), making them unsafe, illegal, and potentially harmful; consumers should stop use immediately. [tga.gov.au]

About seasonal flu vaccine: 2013 seasonal influenza vaccines for use in children

Natural Miaotiaoyishen capsules pose a serious risk to your health and should not be taken. They contain undeclared sibutramine and phenolphthalein. Both substances have serious safety concerns.

Updated information regarding patient follow-up for the ABGII Modular Femoral Stem and Modular Neck hip replacement system.

Poly Implant Prothèse (PIP) update