Tagged Articles

long-term 37 articles

Long-term safety, efficacy data needed for ADHD drug use in children

Children who are prescribed medication to treat symptoms of attention-deficit hyperactivity disorder, or ADHD, take the drugs for several years. However, there have been no studies to show how effective or safe the medication is for the long-term, or how to detect rare side effects, according to a report in the journal PLOS ONE. According to the Centers for Disease Control and Prevention (CDC), 11 percent of children in the United States between the ages of 4 and 17 – or about 6.4 million – are diagnosed with ADHD. The Food and Drug Administration (FDA) has approved 20 drugs to ... Read More

Study links insulin therapy to bladder cancer deaths in diabetics

Type 2 diabetics on insulin therapy are more likely to die from bladder cancer than those using other treatments, a new study suggests. Researchers with the Department of Internal Medicine at the National Taiwan University College of Medicine in Taipei, followed more than 86,000 patients with type 2 diabetes aged 25 or older from 1995 through 2006 for bladder cancer deaths. They concluded that patients who used insulin to keep their blood sugar levels in check were nearly twice as likely to die from bladder cancer compared to those who did not use insulin. Patients who used insulin and who ... Read More

New rules are needed to protect athletes if football is to survive

Increasing reports of serious, long-term health problems from repeated blows to the head are causing more parents to keep their children out of high-impact sports like football, and leaving many to wonder if the sport is headed for extinction if new rules are not adopted to protect athletes. In the past few years, dementia-like symptoms in professional football players have made scientists wonder if brains damaged during hard hits to the head on the playing field may have contributed to their degenerative brain diseases later in life. As of 2012, 33 former National Football League (NFL) players have been diagnosed ... Read More

FDA orders tighter restrictions on powerful narcotic opioid painkillers

The Food and Drug Administration (FDA) is urging doctors to only prescribe the strongest narcotic painkillers to patients who require long-term, round-the-clock treatment that cannot be managed with other treatments. The agency is also requiring the manufacturers of long-acting opioids to change their safety labels to reflect the new prescribing guidelines. The action is designed to curb the growing epidemic of prescription drug abuse and overdoses, which contributed to 16,651 overdose deaths in 2010, according to the Centers for Disease Control and Prevention (CDC). The center estimates that more than 12 million people abuse the drugs every day. Opioids are ... Read More

Nearly 25,000 adverse events associated with diabetes drug Actos

More than 24,000 adverse events have been reported to the Food and Drug Administration (FDA) regarding the type 2 diabetes drug Actos since the medication was introduced nearly 14 years ago. The most commonly reported side effect in which Actos is the primary culprit is bladder cancer. Other, less commonly reported side effects reported with Actos include weight gain, fluid retention, congestive heart failure, heart failure, and abnormal liver function. Actos is a medication used to control blood glucose levels in adults with type 2 diabetes. It is manufactured by Japanese drug company Takeda Pharmaceuticals. In 2011, the FDA issued ... Read More

FDA panel sees greater risk than benefit with osteoporosis drug

A Food and Drug Administration (FDA) advisory panel is recommending that marketing of calcitonin salmon for osteoporosis in post-menopausal women should no longer be permitted, and that drug companies with the products in development prove they are effective in reducing fractures. Calcitonin salmon is a synthetic version of the hormone calcitonin that is found in salmon. It is available in injections and nasal sprays under brand names such as Miacalcin and Fortical, as well as in generic versions. A review of calcitonin salmon was conducted following an FDA staff review of the drug in which significant questions were raised about ... Read More

Johnson and Johnson internal analysis shows recalled hip implant could have 40 percent failure risk

Not long after health care giant Johnson & Johnson and its subsidiary DePuy Orthopaedics issued a worldwide recall of the ASR hip replacement system and ASR hip resurfacing system due to a higher rate of premature failures than competitive devices, the company launched an internal analysis of its recalled metal-on-metal devices. What the company discovered is that the devices were far more defective than first thought. The analysis showed that the hip implants could be expected to fail within five years in an estimated 40 percent of patients who received the all-metal hip. It was data from the National Joint ... Read More

European regulators skeptical about new prescription diet pills

European drug regulators are leery about approving the new weight loss drug Belviq because of safety concerns, including heart valve problems and psychiatric side effects in patients, and tumors observed during studies on lab rats. Belviq is currently under review by an advisory panel for the European Medicines Agency (EMA), which is expected to make a recommendation for the EMA by March whether to approve the drug. Arena Pharmaceuticals, the drug’s maker, has been working with the agency to answer questions and clear up any matters that stand in the way of approval. But its chances may be slim. The ... Read More

Pancreatitis precaution added to label of type 2 diabetes drug Byetta

Another type 2 diabetes treatment may be slapped with new warnings by the Food and Drug Administration (FDA). The agency has asked Amylin Pharmaceuticals Inc. to include information about pancreatitis among the “precautions” on the label of its drug Byetta (exenatide) based on a large study. Pancreatitis is an inflammation of the pancreas that requires immediate medical attention and hospitalization during an attack. Symptoms include upper abdominal pain that radiates into the back, swollen and tender abdomen, nausea and vomiting, fever, and increased heart rate. In some cases, the pain with pancreatitis may be debilitating. According to the study, 30 ... Read More

Johnson and Johnson seeks FDA approval for new type 2 diabetes treatment

Johnson & Johnson’s Janssen Research & Development is hoping to win approval for its new type 2 diabetes treatment, a fixed-dose therapy combining canagliflozin and immediate release metformin. Canagliflozin is a selective sodium glucose co-transporter 2 (SGLT2) inhibitor that works by blocking the reabsorption of glucose by the kidney, increasing glucose excretion, and lowering blood glucose levels. Metformin, an older medication, is a biguanide that lowers blood glucose levels by decreasing the amount of glucose made by the liver. In its New Drug Application (NDA) to the Food and Drug Administration (FDA), Janssen provided data from the comprehensive global Phase ... Read More