On October 18, 2017, the JAMA Surgery journal published an article titled "Breast Implant–Associated Anaplastic Large Cell Lymphoma A Systematic Review," in which they discuss the rate of occurrence of the condition. The article served as a review of 115 articles on the topic of breast implant–associated anaplastic large cell lymphoma (BIA-ALCL) … [Read more...]
FDA Warns of New Possible Side Effects for Nexium / Prilosec / Prevacid
The most recent report from the FDA Adverse Event Reporting System (FAERS) for April - June 2017 provides updates on adverse events experienced by those taking proton pump inhibitors (PPIs) such as Nexium, Prilosec, and Prevacid. The FDA provides the following list of PPIs: Nexium (esomeprazole magnesium) Nexium I.V. (esomeprazole … [Read more...]
J&J Tries to Expand Invokana Label to Include Cardiovascular Benefits
Johnson & Johnson's, the drug manufacturer of diabetes drugs Invokana, Invokamet, and Invokamet XR, recently submitted a supplemental new drug application (sNDA) to the FDA to request expansion of the labels for these drugs. If granted, the new label would include a cardiovascular indication concerning the reduction of risk of cardiovascular … [Read more...]
FDA Makes Adverse Drug Reactions Easier to Find with New Search Tool
On September 28, 2017, the FDA released a new search tool that allows patients, doctors, and others to see the adverse events reported for a particular drug or medical device by searching the product name, patient age, adverse event type and date, or timeframe in which an event occurred. This tool is referred to as the FDA Adverse Events … [Read more...]
New Anticoagulant BevyxXa Approved by the FDA
On June 23, 2017, a new anticoagulant drug called BevyxXa (betrixaban) was approved by the FDA for the prevention of venous thromboembolism and pulmonary embolism. This drug acts as a direct Factor Xa inhibitor, similar to the other anticoagulant drugs Eliquis, Savaysa, and Xarelto. Unlike the anticoagulant Pradaxa, which is a direct … [Read more...]
Can SGLT-2 Inhibitor Diabetes Drugs Increase Your Risk of Stroke?
While we have frequently discussed DKA, kidney damage, and amputations as possible side effects of diabetes drugs in the SGLT-2 inhibitors class -- such as Farxiga, Invokana, Jardiance -- strokes and thromboembolic events are also considered potential harmful effects of these drugs. Based on FAERS reports received during the second quarter of … [Read more...]
FDA Warns of Serious Pancreatitis Risk in Some Patients Taking Viberzi
In March of this year, the FDA released a Drug Safety Communication concerning the increased risk of serious pancreatitis in patients without a gallbladder who use the irritable bowel syndrome drug, Viberzi (eluxadoline). Viberzi is a relatively new drug manufactured by Allergan used to treat irritable bowel syndrome in adults when the main … [Read more...]
Risk of Lower Limb Amputations Doubled with Invokana and Invokamet Use
As of yesterday, May 16, 2017, the FDA issued a Drug Safety Communication regarding an increased risk of leg and foot amputations due to use of popular diabetes drugs Invokana, Invokamet, and Invokamet XR, which contain canagliflozin. These drugs belong to the sodium glucose cotransporter 2 (SGLT2) inhibitor class, and are the subjects of … [Read more...]
Breast Implants and Lymphoma: Who’s to Blame?
As previously discussed in my articles, "Breast Implants Linked to Rare Lymphoma Blood Cancer" and "Breast Implant Lymphoma: Causes Uncertain, but Costs Undeniable, the FDA recently updated their 2011 report of the association between breast implants and anaplastic large-cell lymphoma (ALCL), providing additional information on this rare form of … [Read more...]
Breast Implant Lymphoma: Causes Uncertain, but Costs Undeniable
As news of the possible link between breast implants and a rare form of lymphoma cancer has spread, more theories about how it develops have come to light. One such theory is outlined in the excerpt, below, from the article, "Increase in Australian cancer cases linked to breast implants": Dr. Gazi Hussain, Vice President of the Australian … [Read more...]