FDA approves new heart attack-inducing testosterone drug
(NaturalNews) The Food and Drug Administration has just given approval for another testosterone drug, even though such medications have been linked to heart attacks in older men.
Endo Pharmaceuticals, the Irish company making the drug, announced March 6 that it had received approval from the U.S. agency for its long-acting testosterone injection Aveed; the drug joins a "crowded field of hormone-boosting drugs aimed at aging American men," The Associated Press (AP) reported.
Endo said in an announcement that the FDA had approved the drug for men who experience low levels of testosterone, a condition that can be associated with weight gain, low libido and fatigue. According to reports, the company's Aveed is to be injected once every 10 weeks, versus weekly or biweekly dosing for currently available drugs.
"Today's FDA approval of Aveed is a significant milestone for Endo. Aveed expands our branded portfolio of men's health products and highlights our passion and commitment to providing high quality therapies that improve patient care," said Rajiv De Silva, president and chief executive officer of Endo, in the announcement. "With Aveed, Endo can now offer men living with hypogonadism different treatment options to raise testosterone levels. We are focused on getting Aveed to market to ensure that appropriate patients have access to it."
Double the rate
The Dublin-based pharma said it would likely begin marketing Aveed in late March. Already, the company sells Fortesta, a prescription form of testosterone gel.
Despite the FDA's approval, testosterone drugs have been under increasing scrutiny.
Ironically, the agency said in January that it was reviewing the safety of testosterone drugs following the release of a federal study of 45,000 patients which found that testosterone therapy could actually double the risk of heart attack in men aged 65 and older.
In February, a noted consumer advocacy group -- Public Citizen -- called on FDA regulators to add to testosterone drugs a new, bold warning citing the increased cardiovascular risks. As reported by AP:
The approval was criticized by Public Citizen's Health Research Group founder Dr. Sidney Wolfe, who sent a letter to the FDA Thursday asking it to reverse its decision. He noted that an FDA panel of outside advisers issued a split opinion on Aveed's safety last year, voting 9-9 on the question of whether the drug was safe for treatment of low testosterone. He adds that the meeting, held last April, did not include a discussion about heart risks.
Boost testosterone naturally
"It is likely, if not certain, that the vote against safety would have been even greater had there been a presentation and discussion of the cardiovascular risks known at that time," Wolfe said.
The FDA said in a statement to the network that the agency's review of testosterone products was ongoing, but that so far there did not appear to be any evidence that Aveed's risks of causing cardiovascular problems are any greater than those products which are currently on the market.
"The FDA's current view is that the benefits of testosterone therapy, including Aveed, outweigh the known risks when used as directed in patients for whom the drug is indicated," spokeswoman Andrea Fischer said.
U.S. prescriptions for testosterone therapies have increased more than five-fold in recent years, with sales exceeding $1.6 billion, AP reported.
Indeed, as Natural News has reported, men -- as they age -- certainly do lose testosterone, but they can stem that loss and even reverse it naturally:
-- Broccoli and cauliflower contain natural ingredients that help the body eliminate estrogen;
-- ACETYL-L-CARNITINE increases testosterone production;
-- Zinc deficiencies seem to contribute to lower testosterone levels;
-- In fact, zinc magnesium aspartate (ZMA) is believed to provide some benefits in boosting anabolic and catabolic hormone profiles..