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cardiovascular side effects 11 articles

Antares seeks FDA approval for QuickShot Testosterone auto-injector

Antares Pharma is the latest pharmaceutical company hoping to profit off the booming testosterone replacement therapy market. The company announced it has submitted an application to the Food and Drug Administration (FDA) for marketing approval for its QuickShot Testosterone therapy designed to boost levels of the hormone in men. QuickShot Testosterone is a drug-device combo that delivers testosterone enanthate through a subcutaneous auto-injector that can be self-administered. It’s also touted to be less painful than intramuscular injections. It uses high spring pressure to deliver the drug through a fine gauge needle. Antares says the delivery system essentially eliminates the risk of ... Read More

7 dietary supplements that can adversely affect heart health

About 20 percent of Americans who take dietary supplements do so to improve their heart health, according to a report by the Council for Responsible Nutrition. But consumers shouldn’t assume that all supplements are beneficial. In fact, some can interact with medications resulting in serious cardiovascular side effects. Here’s a rundown of nutritional supplements that could should be avoided especially by people with heart disease or at risk of developing the disease: Calcium – This widely used supplement is promoted for bone health, but a recent Johns Hopkins Medicine study found that calcium supplements may cause plaque buildup in the arteries ... Read More

FDA OKs new abuse warnings on testosterone replacement therapies, steroids

The Food and Drug Administration (FDA) has approved updated safety label on numerous testosterone replacement therapies to include a new subsection under Warnings and Precautions regarding the risk of abuse. The warning also advises physicians to check serum testosterone concentration in men if testosterone abuse is suspected, to counsel patients of possible serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids (AAS), and to consider the possibility of testosterone and AAS abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events. In October, the FDA announced it had ordered the safety label changes to ... Read More

UK celebrity doc advises men interested in testosterone replacement therapy to consult specialist

Dr. Mark Porter, one of the most experienced media medics in the U.K., was floored during a business trip to the United States. “It was difficult to turn the TV on without seeing an advert featuring a grizzled middle-aged male model enjoying life with his glamorous wife after applying testosterone,” he wrote in a doctor column in The Times. Testosterone replacement therapy is intended to boost levels of the male sex hormone in men with hypogonadism, a condition in which the body does not produce enough testosterone. Drug companies who make testosterone supplements are free to advertise directly to consumers ... Read More

Testosterone MDL swells with new cardiovascular side effects lawsuits

The number of lawsuits in multidistrict litigation (MDL) against makers of testosterone replacement therapies alleging the treatments caused cardiovascular side effects including death have significantly increased in recent months, according to a Reuters analysis of statistics from the U.S. Judicial Panel on Multidistrict Litigation. More than 4,000 lawsuits have been filed in federal court against various manufacturers of products including Androgel, Testim and Axiron. Testosterone treatments are approved to treat hypogonadism, a rare condition in which men do not produce enough testosterone due to injury or disease. The level of testosterone declines as men age – a natural process of aging. Testosterone ... Read More

Teva lowers dosage in tests of multiple sclerosis drug after rash of heart problems

Teva Pharmaceuticals’ experimental multiple sclerosis treatment has hit a snag on the road to Food and Drug Administration (FDA) approval. Independent advisors have recommended lowering the dosage of laquinimod in clinical trials after noting a rash of troublesome cardiovascular side effects. Seven patients receiving 1.2 mg of laquinimod experienced heart risks, and one patient in the high-dose group in a separate trial involving a rare type of primary-progressive MS had a similar problem. Teva said it will follow the advice of its data monitors and stop treating trial participants with the highest doses of the drug. Lower doses will be ... Read More

AndroGel makers unsuccessfully try to get out of lawsuit

The Belgian manufacturer of the top-selling testosterone treatment Androgel, and its American licensee, were not dropped from a class action lawsuit claiming the hormone treatment is ineffective and causes serious injuries. Both companies sought to be removed from the multi-state class action, which involves more than 2,000 plaintiffs. The lawsuit names several companies, including Besins Healthcare S.A., headquartered in Thailand, and its subsidiary Besins Healthcare Inc., a Delaware corporation with principal offices in Virginia. Plaintiffs conceded that six of the 14 counts did not apply to the companies. However, the remaining counts, which involved claims of design defect and neglect, ... Read More

Testosterone replacement therapy offers no proven benefits for aging men

There is no proof that testosterone replacement therapy is safe and effective for aging men, Food and Drug Administration (FDA) authorities said in a paper published in the Aug. 20 edition of the New England Journal of Medicine. Testosterone supplements have been heavily marketed to men as a treatment for so-called Low-T, or low testosterone levels. The ads ask men if they suffer from symptoms of this condition, which include low libido, weight loss and muscle loss. The marketing has been so successful that prescriptions for the hormone have jumped into the millions. Between 2009 and 2013, the number of U.S. ... Read More

FDA panel to review psychiatric side effects with antismoking drug Chantix

The Food and Drug Administration (FDA) will hold a public meeting in October to review psychiatric and behavioral side effects with Pfizer’s antismoking drug Chantix and how to better manage them. The FDA said it will convene a panel of psychiatric drug experts to conduct the review. The agency will also require Pfizer to conduct additional studies on the drug. Chantix, which contains the active ingredient varenicline tartrate, was approved by the FDA in 2006 to help cigarette smokers kick the habit. It works by blocking the effects of nicotine from smoking on the brain. At the time, it was ... Read More

New questionnaire designed to help identify Low T in men

A new assessment tool may help physicians screen men for low testosterone, according to a new study published in the Journal of Men’s Health. The male androgen deficiency syndrome (MADS) questionnaire, developed by researchers at Icahn School of Medicine in New York, is designed to be a more simplified screening tool to help doctors and patients identify patients at risk for hypogonadism, or low testosterone. The new questionnaire was used on 5,071 men from 44 centers in September 2010 and 2011. Nearly two-fifths of the men were identified as having a testosterone deficiency. These men were also more likely not ... Read More