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serious side effects 70 articles

Serious mental health side effects risks with anti-smoking drugs Chantix, Zyban lower than thought

Serious side effects on mood, behavior or thinking with the anti-smoking drugs Chantix and Zyban are still a risk factor but the incidence appears to be lower than previously suspected, the Food and Drug Administration (FDA) announced in a Drug Safety Communication. The risk is greater in people being treated for mental illness such as depression, anxiety disorders, or schizophrenia, or who have been treated for mental illness in the past. However, most people who have suffered these symptoms were not hospitalized. In 2009, boxed warnings were placed on Chantix and Zyban after the agency received and assessed case reports of ... Read More

Teens whose mothers had gestational diabetes are at greater risk of type 2 diabetes

Obese teenagers whose mothers had gestational diabetes while pregnant with them are at greater risk of developing Type 2 diabetes, a new study shows. The study, conducted by researchers with the Hebrew University in Jerusalem, found that among obese children who had a normal initial glucose tolerance, those whose mothers had gestational diabetes were six times more likely to develop impaired glucose tolerance or type 2 diabetes by the time they reached age 15. This is concerning particularly because the number of women with gestational diabetes is increasing, which researchers warn could indicate more children will develop diabetes in the ... Read More

Lawsuits against Bayer alleging neurological side effects from Mirena IUD will not be centralized

Nine lawsuits against Bayer Healthcare Pharmaceuticals alleging the company’s Mirena IUD caused neurological conditions will not be consolidated into a multidistrict litigation because there are just too few to justify the motion. Plaintiffs had asked that the lawsuits be centralized in Tennessee; Bayer opposed centralization or to have them consolidated in New York. Bayer already faces multidistrict litigation with its Mirena intrauterine device over uterine perforation, a different injury. These nine lawsuits claim that the Mirena IUD contraceptive device releases a synthetic hormone that can cause neurological problems, including a type of brain damage known as pseudo tumor cerebra (PTC) ... Read More

Niacin with statin medications linked to serious side effects

Niacin offers no benefits to patients with heart disease and can cause serious side effects including diabetes, infections, and stomach ulcers, new research has found. Niacin is a type of B vitamin that has long been prescribed to increase HDL, or “good,” cholesterol and reduce cardiovascular risk. It is often prescribed in combination with cholesterol-lowering statin medications such as Lipitor or Crestor. Recent studies have questioned the safety and effectiveness of the drug, resulting in fewer prescriptions. The new research, published in the New England Journal of Medicine, raises serious safety concerns with the drug. The four-year study involved more ... Read More

FDA finds cardiovascular risk with blood pressure medication used by diabetics is inconclusive

There is no clear evidence that the blood pressure medication olmesartan increases the risk of cardiovascular events in diabetic patients, the Food and Drug Administration (FDA) said in a Drug Safety Communication. The FDA began a safety review of olmesartan in 2010 after results from the ROADMAP (Randomized Olmesartan and Diabetes Microalbuminuria Prevention) clinical trial raised cardiovascular risk concerns. The clinical trial was designed to see whether olmesartan could delay kidney damage in patients with type 2 diabetes. There was an unexpected finding of an increased risk of cardiovascular death in patients treated with olmesartan compared to patients given a ... Read More

AAFP endorses new cholesterol-lowering guidelines despite statin side effects

The American Academy of Family Physicians (AAFP) is endorsing the controversial new guidelines proposed by the American College of Cardiology (ACC) and the American Heart Association (AHA) for the treatment of high cholesterol and to reduce the risk of cardiovascular disease in adults. The new guidelines, introduced last fall, have raised concerns within the medical community that the new rules will unnecessarily expose millions of Americans to serious side effects from statin drugs. Under the new guidelines, about 10.4 million people would become eligible for statin therapy – most of whom have no history of heart disease. Previous recommendations for ... Read More

UK medical experts question safety of new statin therapy guidelines

Studies funded by the pharmaceutical industry influenced the UK’s National Health Service (NHS) to propose new guidelines that would dramatically increase the number of people taking cholesterol-lowering statin medication in the name of cardiovascular disease prevention, leading doctors warned the Health Secretary. These recommendations would increase the number of Europeans taking statins from 7 million to 12 million, unnecessarily exposing millions of people to “worrying” consequences, critics say. NHS has followed in the footsteps of the American College of Cardiology and the American Heart Association, which earlier this year introduced new guidelines for the treatment of cholesterol in the United States. ... Read More

European drug regulators approve new type 2 diabetes treatment

European drug regulators have approved Eli Lilly and Boehringer Ingelheim’s new Type 2 diabetes drug epagliflozin, which will be marketed under the brand name Jardiance. The once-daily tablet is designed to reduce blood sugar levels by blocking glucose reabsorption in the kidneys and remove excess glucose through the urine. Unlike other diabetes treatments, Jardiance does not rely on a patient’s insulin levels in order to be effective. Jardiance is in a class of Type 2 diabetes drugs known as sodium glucose co-transporter 2 (SGLT-2) inhibitors. Other drugs in this class include Canagliflozin, which was the first in the class to ... Read More

Newer type 2 diabetes drugs carry serious side effects, pancreatic cancer risks

The newest classes of type 2 diabetes drugs may help diabetics manage their disease, but it can come at a great price. Diabetes drugs known as GLP-1, DPP-4, and SLGT2 have been associated with serious side effects including acute pancreatitis, pancreatic cancer, thyroid cancer, urinary tract infections, gastrointestinal issues, and renal and gallbladder problems, according to AdverseEvents (AE), a company that analyzes post-market side effects data. According to DrugWatch.com, Glucagon-like peptide-1 receptor (GLP-1) agonists and dipeptidyl peptidase-4 (DPP-4) inhibitors both affect levels of the incretin hormone, which helps to control blood sugar. Sodium-glucose co-transporter 2 (SGLT2) inhibitors (glucuretics) block glucose reabsorption ... Read More

FDA questions value of aspirin therapy for heart attack prevention

The Food and Drug Administration (FDA) last week denied a request by German drug maker Bayer AG to change the label on packages of its aspirin to promote the benefits of regular aspirin therapy to ward off first heart attack or stroke in people who have never had cardiovascular problems. Now the agency is questioning whether the treatment carries any value to those with no heart issues and whether taking a daily aspirin may actually put these individuals at risk for potentially serious side effects. Aspirin therapy is often recommended for people with cardiovascular disease because it reduces the clotting ... Read More