March 18, 2023 – Valtrex (Valacyclovir) is an antiviral medication used to treat outbreaks of herpes simplex or herpes zoster (shingles). It is also used to prevent cytomegalovirus following a kidney transplant in high risk cases. It is a prodrug, …

Canada: DRESS Syndrome associated with Valtrex (Valacyclovir) Read more »

August 13, 2022 – Breast cancer: Is BIA-ALCL increasing in women in the US? Over the last couple of years, the recognition of an seemingly increased rate of incidence of Anaplastic Large-Cell Lymphoma (ALCL) in woman who received breast implants …

Breast cancer: Is BIA-ALCL increasing in women in the US? Read more »

May 08, 2022 – Umbralisib (Ukoniq) is a medication for the treatment of marginal zone lymphoma (MZL) and follicular lymphoma (FL). Umbralisib (Ukoniq) inhibits multiple kinases. In biochemical and cell-based assays, Umbralisib inhibited PI3Kδ and casein kinase CK1ε. PI3Kδ is expressed in …

Umbralisib (Ukoniq): Drug recall because increased risk of patient death 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Sitaxentan [Thelin] to be withdrawn from market worldwide due to cases of unpredictable serious liver injury Read more »

October 08, 2010 – Today, we learn that Abbott Laboratories and FDA notified healthcare professionals and patients about the voluntary market withdrawal of Sibutramine [Meridia], an obesity drug, from the U.S. market because of clinical trial data indicating an increased …

Sibutramine [Meridia]: Market Withdrawal Due to Risk of Serious Cardiovascular events 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 20, 2010 – We learn today from a press release by the American Food and Drug Administration (FDA)  the following (text adapted): Aromatase inhibitors in products marketed as dietary supplements are being  recalled, including the products Arom-X, Arom-X UTT, …

Recall of Products Marketed as Dietary Supplements Containing Aromatase Inhibitors Read more »

June 21, 2010 –  FDA notified healthcare professionals that results from a recent clinical trial raised new concerns about the product’s safety, and the drug failed to demonstrate clinical benefit to patients enrolled in trials. Background: Gemtuzumab Ozogamicin [Mylotarg], indicated …

Gemtuzumab Ozogamicin [Mylotarg]: Market Withdrawal Read more »