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FDA investigation 67 articles

Drug companies fight request for more information linking diabetes drugs to pancreatic cancer

A number of drug companies are fighting a request to produce documents involving reports linking pancreatic cancer to use of their type 2 diabetes treatments. Defendants Merck Sharp & Dohme Corp., Eli Lilly, Novo Nordisk, and Amylin Pharmaceuticals told a California federal court that gathering the requested information would be an “unreasonably burdensome fishing expedition.” Plaintiffs already have adverse events reports but are now seeking source files including underlying medical records of individual patients used to compile the reports. The motion is the most recent development in a multidistrict litigation against the drug companies that manufacture and distribute a newer ... Read More

New blood clot warnings added to testosterone replacement therapies

Testosterone treatments have been linked to dangerous blood clots in the legs, adding more safety concerns to the hormone supplement currently under review for increasing the risk for strokes, heart attack and death. The Food and Drug Administration (FDA) announced that it was ordering a new warning for deep vein thrombosis be added to the safety labels of testosterone treatments. Deep vein thrombosis is a blood clot that forms in a vein deep in the body. It mainly affects the large veins in the lower leg and thigh. It is a serious condition because blood clots in veins can break ... Read More

Death rate, incidents of pancreatic cancer continue to climb; diabetics in high risk group

Death rates from pancreatic cancer as well as incidents of the disease continue to rise in both men and women, according to a new study published in the journal Annals of Oncology. “The increased death rate is cause for concern because the prognosis for this tumor is bleak, with less than five percent of pancreatic cancer patients surviving for five years after diagnosis,” said Dr. Carlo La Vecchia, lead author of the study. Pancreatic cancer is typically diagnosed in an advanced stage, which makes it one of the more deadly forms of the disease. There are also no promising treatments ... Read More

Blood thinner Pradaxa linked to greater risk of major gastrointestinal bleeding events

The blood thinner Pradaxa (dabigatran) can help prevent strokes and death better than the long-used warfarin, however it puts users at greater risk for dangerous gastrointestinal bleeding events, according to a Food and Drug Administration (FDA) Drug Safety Communication. Both Pradaxa and warfarin are used to reduce the risk blood clots that can lead to strokes in patients with a common type of heart rhythm abnormality called non-valvular atrial fibrillation. Warfarin has been used for more than 50 years, but patients require regular monitoring due to the bleeding risks. Pradaxa was approved in 2010 and became the first anticoagulant alternative ... 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

Could ‘Low T’ treatments be dangerous to your health?

If you’re a man and you listen to the advertisements from some drug makers describing a condition known as “Low T” with symptoms such as low libido, zapped energy levels, weight gain and muscle loss, you might be tempted to take the drug maker’s advice and check with your doctor to see if you could be a candidate for testosterone replacement therapy. Who wouldn’t want to look better, feel better, and have that spring in your step again? However, the drugs may be too good to be true, according to a study recently published in the Journal of the American ... Read More

Repros enrolls men to test new topical testosterone treatment Androxal

Repros Therapeutics Inc. announced it has completed enrollment for one of two clinical trials pitting its topical testosterone gel alternative Androxal against other topical testosterone products currently on the market. Each trial will include 120 men, who will be divided into groups of 40 for three parallel study arms to test Androxal against an already marketed testosterone gel and a placebo. Studies will run for 17 weeks, which includes 16 weeks of dosing and one week of follow-up to gather information for the conclusion. Repros sought men who were at least 60 years of age who exhibited a normal sperm count ... Read More

Group with drug maker ties pushes for retraction of paper linking testosterone therapy to heart problems

The Androgen Study Group, a newly formed multidisciplinary group of clinicians and researchers focused on the science of testosterone deficiency in men and its treatment, is calling for the retraction of a paper published in the Journal of the American Medical Association (JAMA) that linked testosterone replacement therapy to an increased risk of heart attacks, strokes and death. In a letter to JAMA editor-in-chief, the group claims that the study the paper was based on was compromised and should be removed from the journal. The paper by Michael Ho, MD, PhD focused on a study that found a higher rate ... Read More

Alabama man files testosterone side effects lawsuit after suffering stroke

An Alabama man has filed a lawsuit against the makers of the testosterone replacement treatment Testim, claiming the drug caused him to have a stroke. Robert Hoehl, 64, had no history of cerebrovascular disease or neurological impairments when he began the hormone therapy in the fall of 2011. Less than a year later, he had a stroke. He immediately stopped taking Testim. Doctors noticed he had elevated hematocrit levels, a condition that can increase the risk of blood clots, heart disease and stroke. Hoehl’s blood levels were checked on a regular basis. Within months after quitting Testim, his hematocrit levels ... Read More

Philadelphia man claims Testim testosterone treatment gave him a heart attack

A 67-year-old Philadelphia man with no history of cardiovascular problems has filed a lawsuit against the makers of his testosterone replacement product claiming the drug caused him to suffer a heart attack. The lawsuit states that the injury was caused by the “exogenously administered testosterone-containing Testim,” a prescription drug made by Auxilium Pharmaceuticals and GlaxoSmithKline. Edwin Rios had been using Testim for a year when he had the heart attack. Testosterone replacement products are designed to boost the hormone’s levels in men who are experiencing symptoms of low testosterone such as weight gain, mood swings, and low libido. Testim was ... Read More