5/28/2015 Last year a Johnson & Johnson medical device, the laparoscopic power morcellator, was removed from the market. This year the FBI investigates the cancer-spreading hysterectomy device. The power morcellator was a favorite of surgeons for doing minimally-invasive hysterectomies and removing uterine fibroids. The device worked by grinding up tissue that could then be removed
5/26/2015 Perhaps no industry besides investment banks has been hit as hard by the federal court system than tobacco over the past several years. A pair of recent appeals rulings, however, indicates a substantial turn in the industry’s decades-long financial flogging. On Friday, the D.C. Court of Appeals delivered a mixed-ruling, in which some
5/25/2015 A recent ruling from the Court of Appeals for the Second Circuit tells Actavis it cannot withdraw Namenda IR. The drug, a popular drug for treating Alzheimer’s disease, needs to be taken twice daily. Actavis, in a bold move to make more money, decided to remove Namenda IR from the market, prior to a
5/21/2015 Quite surprising to me, I found that SGLT2 drugs have negative history with FDA. Not surprising, especially after finding the history, is the warning FDA released earlier this week. It appears that canagliflozin, sold as Invokana, may have created problems in the clinical trials that should have prevented its release. Just as other
5/19/2015 The Food and Drug Administration’s (FDA) May 15th warning of potential ketoacidosis among Type II diabetes patients who use a new class of oral treatments known as SGLT2 inhibitors should not be completely surprising. The first such medicine approved by the FDA in March, 2013 was Invokana (canagliflozin), manufactured by Janssen Pharmaceuticals in conjunction
5/19/2015 Yesterday we wrote about the warning issued by the FDA regarding SGLT2 type 2 diabetes medications. Today, I want to share the treatment regimen for SGLT2-related ketoacidosis. Always consult your physician before making changes in any medication protocol. If you find yourself experiencing any of the symptoms of ketoacidosis, get to the emergency room
5/18/2015 As my colleague wrote today, the FDA has issued a warning involving the class of type 2 diabetes drugs known as SGLT2 (sodium-glucose cotransporter-2). The drugs have been linked to approximately 20 known cases of ketoacidosis, a life-threatening condition. This post focuses on ketoacidosis associated with SGLT2 inhibitors, as well as how to test
5/18/15 The U.S. Food and Drug Administration (FDA) issued a warning on its website on Friday, May 15th regarding a popular oral type II diabetes class of medications known as SGLT2 inhibitors. The FDA warned that the increasingly popular class of drugs, which help blood sugar to be secreted in urine, has led to ketoacidosis,
Image courtesy of LifeWorld 5/8/2015 Welcome to the Trans-Pacific Partnership agreement, hailed as the best piece of secret policy making since Moses’ conversation on a mountaintop. This week, I’m focusing on how the TPP turns healthcare into wealthcare. You should be afraid, very afraid. It’s profits before people (again!) with Big Pharma coming out the
5/1/2015 Pending approval from U.S. district court in Minnesota, Medtronic Plc agrees to consent decree with the FDA regarding its SynchroMed implantable drug pump. The company will correct problems that cause the pumps to deliver either too little or too much medication. The pumps are used for treating cancer and chronic pain patients and those