June 6, 2011 – Today, we learn from Health Canada the following very important safety information: Hoffmann-La Roche Limited, in consultation with Health Canada, would like to inform you of important new safety information regarding fatal infusion related reactions following …

Rituximab [Rituxan] – Fatal Infusion Related Reactions in Patients with Rheumatoid Arthritis Read more »

May 31, 2011 – The American Food and Drug Administration (FDA) has released today the following announcement aimed at physicians, family practices, and patients: ISSUE: FDA is aware of two newly published studies that evaluated the risk of venous thromboembolism …

The Pill: Possibly Increased Risk of Blood Clots with Birth Control Pills Containing Drospirenone Read more »

April 23, 2011 – In the history of flawed and/or market-withdrawn drugs, Lumiracoxib [Joicela], formely known as [Prexige], may only be a footnote, hardly comparable to the attention received by the high flying but ill-fated Rofecoxib [Vioxx], Troglitazone [Rezulin], and …

Could a biomarker rescue Lumiracoxib [Joicela], formerly known as [Prexige]? A genome-wide study identifies a strong assossiation of the HLA allele DQA1*0102 with Lumiracoxib [Joicela]-related serious liver injury Read more »

April 15, 2011 – From a press release as of today, we learn the following (text unchanged from  EMEA press release): The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that rare atypical fractures of …

EMEA: Rare atypical fractures of the femur is a class effect of medicines containing bisphosphonates Read more »

April 15, 2011 – The American Food and Drug Adeministration (FDA) informed today that it  continues to receive reports of a rare cancer of white blood cells (known as Hepatosplenic T-Cell Lymphoma or HSTCL) primarily in adolescents and young adults …

Tumor Necrosis Factor (TNF) blockers, Azathioprine and/or Mercaptopurine: Update on Reports of Hepatosplenic T-Cell Lymphoma (HSTCL) in Adolescents and Young Adults Read more »

January 14, 2011 – The American Food and Drug Administration (FDA) notified today healthcare professionals and patients about cases of rare, but severe liver injury, including two cases of acute liver failure leading to liver transplant in patients treated with …

Heart Medication Dronedarone [Multaq]: Risk of Severe Liver Injury Read more »

December 13, 2010 – We learn today that the European Medicines Agency (EMEA) has been informed of Pfizer’s decision to voluntarily withdraw Sitaxentan [Thelin] from the market worldwide further to new information on two cases of fatal liver injury. Pfizer …

Sitaxentan [Thelin] to be withdrawn from market worldwide due to cases of unpredictable serious liver injury Read more »

September 24, 2010 – Please find below a very significant announcement by the European Medicines Agency (EMEA) regarding the market suspensions of Avandia throughout the European Union. 09/23/2010 – The European Medicines Agency today recommended the suspension of the marketing …

European Medicines Agency Recommends Suspension of the Rosaglitazone Containing Drugs Avandia, Avandamet and Avaglim Read more »

September 23, 2010 – We present here a very significant announcement by the American Food and Drug Administration (FDA) in its original. Please note that the European Medicines Agency (EMEA) also today recommended the suspension of the marketing authorisations for …

FDA Significantly Restricts Access to the Diabetes Drug Rosiglitazone [Avandia] Read more »

2010-08-15 – From a recent health safety alert  we learn that  FDA notified healthcare professionals and patients that Lamotrigine [Lamictal], a medication commonly used for seizures in children two years and older, and bipolar disorder in adults, can cause aseptic …

Lamotrigine [Lamictal]: DrugLabel Change Because Risk of Aseptic Meningitis Read more »