Tagged Articles

testosterone supplements 48 articles

Tri-Coast Pharmacy issues recall over sterility concerns

Tri-Coast Pharmacy Inc., based in Juno Beach, Fla., is recalling all sterile drug products prepared between May 17, 2016 and Nov. 17, 2016, that remain within the expiration date due to concerns by the Food and Drug Administration (FDA) over the lack of sterility assurance of the drugs named in the recall. Products affected include vitamins, blood pressure medications, heart drugs, human growth hormones, and testosterone supplements. A complete list can be found here. Administration of a drug product intended to be sterile that has microbial contamination has the potential to result in serious infections that may be life threatening. ... Read More

FDA rejects experimental testosterone-boosting drug

Apricus Biosciences’ experimental testosterone-boosting drug fispemifene was rejected by the Food and Drug Administration (FDA) as a treatment for hypogonadism, a condition in which men do not produce enough testosterone due to injury or disease. Regulators noted that fispemifene at 450 mg did boost testosterone levels in men, but it did not improve symptoms such as erectile dysfunction or low sex drive, diminishing its potential clinical benefit. Fispemifene works differently than testosterone treatments, but the goal is the same – restore testosterone levels in order to improve sex drive and other symptoms. Fispemifene is in a class of drugs known ... Read More

Abbott, AbbVie face varying lawsuits with AndroGel

Abbott Laboratories and AbbVie skirted racketeering claims alleging the companies made health plans pay unnecessarily for the arthritis drug Humira and the testosterone replacement AndroGel instead of less expensive generics. U.S. District Judge Robert Dow said plaintiffs New England Carpenters Health and Welfare Fund failed to show that the defendants teamed up with pharmacies and intermediaries to illegally increase sales of the drugs by offering savings cards or coupons to reduce copayments. The fund also accused Abbott and AbbVie of insurance fraud, alleging the companies instructed pharmacies to hid subsidies by processing them as secondary insurance rather than discounts. “While ... Read More

New Jersey man blames heart attack on Axiron testosterone treatment

New Jersey resident Patrick Miller was 54 when he started using Axiron, a testosterone replacement product used to treat men who have low levels of the hormone in their blood. A month later, on Oct. 3, 2012, he had a heart attack. Thirteen months later, the Journal of the American Medical Association (JAMA) published a study that found men who used testosterone treatments have a 30 percent increased risk of having a heart attack, stroke or dying. And, in January 2014, the journal PLOS One found a two-fold increased risk of heart attack among older men in the first 90 days ... Read More

Experts: testosterone treatments vastly overprescribed

Nearly 3 percent of American men aged 40 and older – about two million men – received prescriptions for testosterone replacement treatments in 2011 – three times more than a decade earlier, raising concerns that the drugs may be overprescribed. Testosterone therapy is intended for men who suffer from low testosterone levels, a condition known as hypogonadism, caused by damage or disease in their testes or other parts of the endocrine system. This can cause symptoms such as low sex drive, muscle loss, weight gain and fatigue. Testosterone levels typically drop as a man ages. But many middle-aged and older ... Read More

Panel recommends more studies on cardiovascular risks with testosterone drugs

Makers of testosterone replacement drugs should collect data on heart attacks and strokes in men who use their products, and the labels on the treatments should have stronger language to restrict intended uses to reduce over-prescribing, a Food and Drug Administration (FDA) advisory panel recommended. The FDA asked an outside panel of experts to address whether there is a risk of major cardiovascular events such as stroke, heart attack and death in men who used testosterone replacement therapies. The agency also asked the panel whether current evidence still supports the use of the drugs in certain patients. The FDA is ... Read More

New testosterone treatment in development carries fewer side effects

Testosterone levels in men typically drop as a man ages, but when it drops too low it signals a possible problem. In many cases the drop can be associated with obesity, diabetes and circulatory disease. Low testosterone levels can result in symptoms such as low libido, loss of muscle mass, increased body fat, and depression. Regardless the cause, many doctors prescribe testosterone replacement therapies, such as AndroGel, Axiron and Testim, to treat the condition. However, recent studies have shown that testosterone therapy can increase the risk of heart attack, stroke or death. The drugs can also be expensive, and after ... Read More

New testosterone replacement capsule fares well in clinical trials

Clinical trials for Clarus Therapeutic’s new testosterone replacement treatment Rextoro show the drug is comparable to other testosterone therapies and, if approved by the Food and Drug Administration (FDA), could provide patients with yet another treatment option to boost the amount of the male hormone in their systems. Rextoro is a softgel capsule that contains a testosterone prodrug, testosterone undecanoate, or TU. It is formulated to foster absorption via the intestinal lymphatic pathway. After oral TU is absorbed, natural enzymes in the body cause testosterone to be released from the prodrug. “This proprietary formulation enables us to increase the amount ... Read More

Drug company tests new drug to boost testosterone levels in men

A new treatment designed to boost testosterone levels in men, which is not a testosterone replacement therapy, is currently being tested in clinical trials. If data is favorable, the drug could be considered for regulatory approval by the end of the year. Repros Therapeutics’ Androxal is a single isomer of clomiphene citrate, which is widely prescribed under the brand name Clomid to induce ovulation in women. The drug has been used off-label as a treatment of secondary male hypogonadism, a condition of low testosterone. Repros is developing Androxal for men of reproductive age with low testosterone due to secondary hypogonadism. ... Read More

Testosterone therapy poses same safety risks to young men, teenagers

Young men and teenagers hoping to improve in sports are turning to testosterone boosting products, raising concerns about their long-term health. Testosterone replacement therapy is a prescription drug indicated for men whose blood levels show lower than normal levels of the male hormone, resulting in symptoms such as low sex drive, weight gain and fatigue. The treatment can also help build muscle mass, which makes it an attractive supplement to body builders and athletes. Many professional sports have cracked down on the use of performance enhancing drugs, which include testosterone therapy. However, some gyms sell testosterone supplements, says Chad Zimmerman, ... Read More