Billions of dollars are spent every year on drug research – the results of which get published in medical journals and are relied upon by doctors and patients across the nation. However, most people don’t know that a great deal of what gets published is actually written by the drug industry itself or by doctors, scientists and researchers who are paid by drug companies. That begs the question – can drug industry research really be unbiased? Case In Point: Avandia…
Drug Industry Research: Can It Really Be Unbiased?
The U.S. Food & Drug Administration announced that it has placed a black box warning on Incivek, a hepatitis-C drug generally used by liver disease patients. Manufactured by Vertex Pharmaceuticals, the drug has been linked to serious rash conditions including Toxic Epidermal Necrolysis (TEN), Stevens-Johnson Syndrome (SJS) and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) – all of which can lead to serious injury or death. Incivek Black Box Warning The FDA issued an Incivek black box warning on…
Thousands of women have been injured due to transvaginal mesh (TVM) devices used to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI) – conditions that typically occur after pregnancy and childbirth. So many TVM lawsuits have been filed that they have been consolidated into five vaginal mesh multidistrict litigations (MDLs) against manufacturers American Medical Systems (AMS), Ethicon, Boston Scientific, Coloplast and C.R. Bard. Three of those MDLs – AMS, Ethicon, and Boston Scientific – will begin Bellwether trials…
The U.S. Food & Drug Administration and Medtronic Neuromodulation, the Minnesota-based medical device giant, issued a Class I recall of the company’s SynchroMed II Implantable and SynchroMed EL Implantable Infusion pumps due to motor stalling and drug dispensing issues which could result in serious adverse health risks or death. Medtronic Drug Infusion Pump Recall & Follow Up In November, the FDA issued a Class I recall on the Medtronic SynchroMed II Implantable Drug Infusion Pump and the SynchroMed EL Implantable…
Johnson & Johnson’s Topamax, an epilepsy and migraine medication made by J&J subsidiary Ortho McNeil Pharmaceuticals, has been linked to a significantly increased risk of birth defects. According to the U.S. Food & Drug Administration (FDA), women who take Topamax – or its generic form topiragen – during pregnancy are 20 times more likely to have children with defects such as cleft lips and cleft palate (oral cleft) deformities. Topamax Injuries The FDA issued a warning letter in 2011 to…
Bayer’s Mirena, an IUD (intrauterine device) which can be implanted for up to five years as a form of birth control and a way to control menstrual bleeding, has been linked to a number of serious side effects. The U.S. Food & Drug Administration (FDA) warned Bayer about downplaying the risks of using Mirena – and the company now finds itself defending numerous lawsuits. How Bayer’s Mirena IUD Works Bayer’s Mirena IUD is a small, t-shaped device that releases low…
Millions of Americans undergo kidney dialysis, or hemodialysis, every day. While the procedure may be time consuming; it is generally thought to be safe. Until now. GranuFlo and NaturaLyte, two dialysate chemical solutions used in thousands of kidney dialysis centers, have been linked to metabolic alkalosis – a condition associated with low blood pressure, cardiac arrhythmia, heart attack, cardiac arrest and other cardiovascular problems. Nearly 1,000 incidents of cardiac arrests may be linked to these chemicals and the lawsuits filed…
Pradaxa, the anticoagulant drug manufactured by Boehringer Ingelheim and approved by the U.S. Food & Drug Administration (FDA) only two years ago, was supposed to be better than Coumadin to control blood clots that could lead to strokes in Americans with an irregular heartbeat known as atrial fibrillation. However, unlike Coumadin, Pradaxa has no known antidote to reverse its effects – which can lead to so-called bleed-out deaths. Thousands of injuries and deaths have been linked to Pradaxa, and more…
A team of medical researchers led by Kaiser Permanente Northern California report that women taking birth control pills containing drospirenone are at a sharply increased risk of blood clots and blockage of arteries. The study appears in the January 2013 issue of the journal Contraception. Newer oral contraceptives, including Yaz, Yasmin and the generic Ocella that are widely prescribed, contain drospirenone, a synthetic form of the female hormone progesterone. But many women have experienced serious side effects, including blood clots,…
A new Scottish study finds that diabetes patients taking the group of diabetes drugs that includes Actos are at increased risk of suffering hip fractures. The University of Dundee researchers said bone fractures are “a severe adverse effect” for users of the class of diabetes drugs containing the active ingredients pioglitazone or rosiglitazone. The study of diabetes drug side effects appears in the November issue of Diabetologia, the journal of the European Association for the Study of Diabetes. The study…