Tagged Articles

FDA review 136 articles

Most health-related mobile apps do not require FDA oversight

More than 30,000 health-related mobile apps are on the market – from thermometers to stethoscopes – designed to empower consumers to take a more active role in managing their health. But how can these devices be regulated to ensure safety and efficacy, while not stifling innovation? This question has come up in the House and Senate, both of which have introduced bills in the past year calling for Food and Drug Administration (FDA) oversight for apps that pose a potential risk to consumers, while limiting regulatory authority for low-risk applications. Literally thousands of mobile health apps are available in Apple ... Read More

Man says his stroke was caused by AndroGel testosterone treatment

Ed Downes’ stroke seemed to come out of nowhere. Ed, who was in his upper 40s at the time, was taking medication for hypertension and attention deficit disorder (ADD), but was otherwise healthy. When he began to lose interest in sex and his energy level plummeted, he, like hundreds of thousands of other men, followed the advice of a drug company’s television commercial and had a “conversation with his doctor” to see if he was suffering from low testosterone, or, as the advertisement called it, “Low T.” Ed was prescribed AndroGel, a testosterone replacement gel, which he took for two years. ... Read More

Physicians question safety of testosterone replacement therapy

Increasing numbers of physicians are questioning whether testosterone replacement therapy to boost libido, muscle mass and mood may do more harm than good. Recent studies have linked testosterone therapy to an increased risk of heart attack, stroke and death. News of the study results rang loudly throughout America, where nearly 3 percent of men older than 40 are using prescription testosterone supplements as a “fountain of youth.” And they didn’t come blindly to their doctors in search of a cure. Many were swayed by heavy marketing campaigns waged by drug companies concocting a disorder they called “Low T,” and urging men ... Read More

FDA wants to overhaul process for reviewing nonprescription medicines and products

The Food and Drug Administration (FDA) wants to overhaul its process for regulating over-the-counter medicines, saying the decades-old system is flawed and grossly outdated. A two-day meeting among drug regulators is planned next month to discuss a modern-day alternative. The current monograph was established in 1972 as a way to set dosing, labeling and other standards for nonprescription drug ingredients, from aspirin to anti-bacterial soaps. But the process is slow and laborious, requiring scientific reviews, public hearings and comments before a final monograph is published, resulting in a review backlog of many common pain relievers. It also stalls the addition ... Read More

Cholesterol drug Vascepa hits FDA roadblock while seeking wider indication

The Food and Drug Administration (FDA) has rejected Amarin Corp’s preset testing process that is critical to the company’s plan in seeking a wider usage for its cholesterol-lowering drug Vascepa. Vascepa is a prescription-strength fish-oil pill designed to lower triglyceride levels in patients with high cholesterol. The drug was approved in 2012 for a very small and specific use in patients with unusually high triglycerides. Amarin was hoping to expand usage of the drug to include patients at high risk of coronary heart disease who are also taking statin medications. The first line of defense for treating high cholesterol beyond a ... Read More

FDA panel split on whether to loosen restrictions on diabetes drug Avandia

An expert advisory panel for the Food and Drug Administration (FDA) was split on its decision whether to relax the tightened restrictions on the type 2 diabetes drug Avandia. Half of the 26 members voted to allow doctors more freedom to prescribe the drug despite research that suggests the drug puts users at greater risk of dying from heart attacks. The FDA is not required to follow the recommendations of its advisory panel, but it often does. In this case, where the panel was so divided on removing the restrictions, the agency will have broad discretion on how to proceed. ... Read More

Attorneys investigating cancer cases in patients taking type 2 diabetes drugs

An experimental type 2 diabetes drug vying for Food and Drug Administration (FDA) approval is being tested as an add-on therapy for type 1 diabetes. In January 2012, the FDA declined to approve dapagliflozin, also known by the brand name Forxiga, based on concerns over breast and bladder cancer. The drug’s makers, Bristol-Myers Squibb and AstraZeneca, said they will resubmit the application for approval before the end of the summer. Meanwhile, they are testing the drug for other indications, including a treatment for type 1 diabetes. Currently, type 1 diabetes is typically treated with insulin. Drug makers say dapagliflozin is ... Read More

FDA rejects experimental sleeping pill for people with insomnia

A first drug in a new class of insomnia treatments was rejected by the Food and Drug Administration (FDA) because the agency said safety data didn’t support approval of the treatment at the dosing proposed. The drug, called suvorexant, made by Merck & Co., was under review by the FDA in both 30- and 40-milligram doses. The FDA advised Merck that suvorexant was effective at doses as low as 10 milligrams up to 40 milligrams, with 10 milligrams seen as the starting point. As a result, the FDA advised that Merck seek approval for the lowest dosage before it grants ... Read More

FDA panel votes to loosen restrictions on Avandia despite heart attack risk

An advisory panel to the Food and Drug Administration (FDA) voted to recommend that the severe restrictions the agency placed on the type 2 diabetes drug Avandia be loosened. The vote was far from unanimous, with five members voting to keep the tight restrictions on Avandia and one member (the consumer representative) calling for the withdrawal of the drug. Avandia, also known as rosiglitazone, was a top-selling diabetes medication until, in 2010, the FDA placed severe restrictions on the medication based on studies that showed the people who took the medication were at greater risk of dying from a heart ... Read More

Fatal heart attack risk with type 2 diabetes drug Avandia under second FDA review

Three years ago the Food and Drug Administration (FDA) took a bold step by placing severe restrictions on the type 2 diabetes drug Avandia based on studies that showed the medication put users at greater risk of dying from heart attacks. This week, advisers to the FDA agreed to a two-day re-review of data dealing with safety concerns with Avandia. The first day’s meeting rallied discussions about whether an early clinical trial turned up enough convincing evidence that Avandia raises a patient’s risk of heart attack or death. For the review, researchers have been asked to provide a “re-adjudication” of ... Read More