June 2 2016 by Ray Sahelian, M.D.
Bayer pharmaceutical company is a global enterprise in the fields of health care, nutrition and high-tech materials.
Bayer HealthCare has received approval from the US Food and Drug Administration (FDA) for Gadavist (gadobutrol) injection for use with magnetic resonance imaging (MRI) in pediatric patients less than two years of age, including term neonates. The injection is designed to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system (CNS).
Attorneys general in Illinois, Oregon and California said that Bayer AG agreed to a $3.3 million settlement over misleading claims that the drug maker's vitamins reduced men's risk of prostate cancer. Under the terms of the settlement, Bayer cannot make claims that its One A Day Men's multivitamins can prevent or cure prostate cancer or any other disease without scientific evidence, Illinois Attorney General Lisa Madigan said in a statement.
Bayer Health Care
Aprotinin - Traysol - A drug used to limit blood loss while patients undergo coronary-artery bypass surgery also carries a higher five-year risk of death than cheaper generic alternatives. Based on five years of data on thousands of heart bypass patients from around the world, the death rate among patients given Bayer AG's drug aprotinin was nearly 21 percent, two-thirds higher than the mortality rate among surgery patients not given anti-bleeding drugs. In coronary-artery surgery, a clogged artery that normally feeds the heart is bypassed with a section of vein or artery transplanted from the patient's leg or from elsewhere. Many heart patients are given a blood thinner upon arriving at the hospital, while aprotinin administered during surgery would cause blood to clot. Dr. Dennis Mangano of the Ischemia Research and Education Foundation, based in San Bruno, California discovered that a majority of the deaths in the study were caused by heart attacks, heart failure, strokes or kidney failure. Clots started by the drug likely build up over time and block arteries, starving organs of oxygen. But Bayer AG, which makes aprotinin under the brand name Traysol, responded in a statement that the analysis by Dr. Dennis Mangano was faulty in part because the drug is usually given to the sickest patients more likely to die if they bleed excessively. Dr. Dennis Mangano said he had extensive data on the patients and controlled for how sick they were at the start of the study. An editorial accompanying the study showed how important, and how rare, it is to fully monitor drugs after they gain regulatory approval. The drug has been administered to 4 million patients worldwide since 1985, including 600,000 in 2005, at a cost of up to $1,500 a patient. The study found the death rate following aprotinin use was 1 percent higher each year following surgery compared to two generic anti-bleeding alternatives. The alternatives, which belong to a different class of drugs, cost between $11 and $44 per patient.
Trasylol - A higher rate of allergic reactions and deaths were reported with
Bayer AG's heart-surgery drug Trasylol in 2005. Studies show Trasylol increases
the risks of heart attacks, stroke and kidney problems in patients undergoing
heart bypass surgery. Yet, Bayer AG's drug Trasylol provides acceptable safety
and effectiveness for preventing blood loss in certain patients undergoing heart
bypass surgery, a U.S. advisory panel said in Semptember 2006. The Food and Drug
Administration advisers voted in favor of Trasylol after reviewing data on heart
attacks, strokes, kidney damage and allergic reactions in people treated with
2006 - The heart surgery drug Trasylol by Bayer AG can increase the risk of kidney damage. The Food and Drug Administration also said Trasylol will come with a stronger warning about possibly fatal allergic reactions, or anaphylaxis. Patients should not receive Trasylol if they have already been given the drug within the past year. Use of Trasylol should also be limited to certain patients at an increased risk of blood loss and transfusions during coronary bypass graft surgery. Doctors should consider the "balance of benefits and risks" before giving Trasylol to patients who already have kidney problems or those at risk of them.
Cipro - There is now a generic versions of
Bayer corporation Pharmaceutical Division's
Cipro I.V., a drug to treat
certain bacterial infections.
Rivaroxaban - An experimental thrombosis pill from Bayer AG, seen by analysts as the German group's most important pipeline asset, has produced promising results in two clinical trials. Rivaroxaban, which was tested for up to three months as a treatment for deep vein thrombosis (DVT), reduced clot size with little recurrence of venous thromboembolism (VTE). Investigator Harry Bueller of Amsterdam's Academic Medical Center said the results highlighted the potential of rivaroxaban for both acute and long-term care, since the drug does not require constant patient monitoring like warfarin. Whether rivaroxaban from Bayer provides benefits much better than aspirin is not clear at this time. The biggest commercial opportunity for the product is in preventing stroke in patients with atrial fibrillation, or irregular heartbeats.
Bayer and weight loss pill
In January 2007, Bayer AG and several smaller companies agreed to pay the U.S. government almost $26 million to settle allegations of false weight-loss pill advertising claims. The settlements involve Bayer's One-A-Day WeightSmart multi-vitamin, as well as the diet pills CortiSlim, TrimSpa and Xenadrine EFX, which are made and sold by other companies. In the case of Bayer, the company will pay a $3.2 million civil penalty to settle FTC allegations that ads for One-A-Day WeightSmart multivitamins violated an earlier agency order requiring all health claims for One-A-Day brand vitamins to be supported by scientific evidence. One-A-Day WeightSmart contains epigallocatechin gallate, a green tea extract, which Bayer ads claimed could help increase the body's metabolism to control weight. In a statement, Bayer said its WeightSmart product provides "safe and effective nutritional support to those who are watching their weight." The company said it "strongly disagrees" with the FTC's description of the product as weight-loss pills.
The Center for Science in the Public Interest, a U.S. advocacy group filed a lawsuit against German drugmaker Bayer AG saying the company made false claims that the selenium in Men's One-A-Day multivitamins might reduce the risk of prostate cancer. The group filed the suit in the Superior Court of California in San Francisco. A spokesman for Bayer said the company had not yet been notified of the filing. He said the company had based its advertising for the vitamin supplement on the U.S. Food and Drug Administration's claim that selenium could help reduce the risk of certain types of cancer. The FDA earlier in 2009 changed its stance on selenium and Bayer has been working on altering its packaging and advertising to remove any connection between selenium and a reduced risk of certain types of cancer.