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Testosterone drugs should warn of cardiac risk, consumer group says

By Toni Clarke (Reuters) - Drugs used to treat low testosterone should carry strong warnings about the risk of heart attacks and other cardiovascular problems, the consumer advocacy group Public Citizen said on Tuesday. The group has petitioned the U.S. Food and Drug Administration to add a black box warning, the most serious possible, to the product labels of the drugs.

Lilly weekly diabetes drug succeeds vs market leader Victoza -study

By Bill Berkrot (Reuters) - An experimental once-weekly medicine for type 2 diabetes developed by Eli Lilly and Co proved as effective in lowering blood sugar as Victoza from Danish drugmaker Novo Nordisk in an eagerly anticipated late stage study. The Lilly drug, dulaglutide, achieved the primary goal of the 599-patient study by demonstrating so-called non-inferiority to the highest approved dose of Victoza after 26 weeks, according to initial results released by the company on Tuesday.

Public Citizen says FDA should add heart warning to popular testosterone drugs for men

WASHINGTON - A consumer advocacy group is calling on the Food and Drug Administration to add a bold warning label to popular testosterone drugs for men in light of growing evidence that the hormone treatments can increase the risk of heart attack. The group Public Citizen says the agency should immediately add a "black box" warning — the most serious type — to all testosterone medications and require manufacturers to warn physicians about a higher risk of heart attack, stroke and death with the treatments.

Police identify Calgary parents charged in murder of teenage son with diabetes

CALGARY - Police on Wednesday identified a man and woman charged in the death of their 15-year-old son. Rodica Radita, 51, and Emil Marian Radita, 62, of Calgary have been charged with first-degree murder. Police earlier said their son, Alexandru Radita, died of a bacterial infection stemming from neglect and starvation due to Type 1 diabetes. They allege his parents did not provide him with proper medical treatment and, when his health declined, confined him to his room.

US regulators probing cardio risks in testosterone products

US federal regulators said Friday they were investigating products containing testosterone after recent studies suggested a higher risk of strokes and heart attacks in men being treated with the hormone. The Food and Drug Administration stressed, however, that it has "not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack or death." "FDA is providing this alert while it continues to evaluate the information from these studies and other available data," it said in a safety alert, referring to two related studies.

FDA reviews safety of testosterone gels, patches and shots after studies suggest heart risk

WASHINGTON - The Food and Drug Administration says it is reviewing the safety of popular testosterone drugs for men in light of recent studies suggesting they can increase the risk of heart attack, stroke and death. A study published earlier this week suggested testosterone therapy could double the risk of those problems in men older than 65. Another study published in November found that the hormone increased the risk by 30 per cent. The FDA says it is evaluating information from those studies and others but hasn't yet reached any conclusion.

Israel's Oramed a step closer in race for first insulin pill

By Steven Scheer JERUSALEM (Reuters) - Israel's Oramed, which is racing Novo Nordisk of Denmark to develop the world's first insulin pill, moved a step closer to its goal on Thursday by announcing successful results from a small mid-stage test. The oral drug delivery specialist said its insulin capsule had met all primary and secondary endpoints in a Phase IIa clinical trial and it now plans to launch a larger mid-stage study in the third quarter.

EU regulator backs Bayer, GSK drugs, knocks back Novartis, Teva

By Kate Kelland LONDON (Reuters) - Europe's drugs regulator gave its backing on Friday for marketing approval to be granted for Bayer's pulmonary hypertension drug Adempas and for GlaxoSmithKline's diabetes medicine Eperzan. The European Medicine Agency (EMA) also backed a new drug from Dainippon Sumitomo Pharma called Latuda, for the treatment of schizophrenia, and Bemfola, a new biosimilar medicine for the treatment of infertility.

Google's contact lens glucose monitor prototype could end finger pricks for diabetics

MOUNTAIN VIEW, Calif. - Google unveiled Thursday a contact lens that monitors glucose levels in tears, a potential reprieve for millions of diabetics who have to jab their fingers to draw their own blood as many as 10 times a day. The prototype, which Google says will take at least five years to reach consumers, is one of several medical devices being designed by companies to make glucose monitoring for diabetic patients more convenient and less invasive than the traditional finger pricks.

FDA approves previously rejected diabetes pill from Bristol-Myers and AstraZeneca

WASHINGTON - The Food and Drug Administration on Wednesday approved a new diabetes drug from Bristol-Myers Squibb and AstraZeneca that uses a novel approach to reduce blood sugar. Farxiga is a once-a-day tablet designed to help diabetes patients eliminate excess sugar via their urine. That differs from older drugs that decrease the amount of sugar absorbed from food and stored in the liver. The drug is the second product approved in the U.S. from the new class of medicines known as SGLT2 drugs. In March the FDA approved Johnson
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