Despite Concerns About Testosterone Therapy, FDA Approves New Drug
Although the US Food and Drug Administration stated last month that it would investigate complaints about testosterone therapy and its dangers to older male patients, the organization has approved a new testosterone therapy from Endo International called Aveed.
The testosterone therapy was approved strictly to treat male hypogonadism, which can cause complications with testosterone levels. The drug is not approved for use for “low T” that occurs as men age.
Reportedly, the FDA rejected Aveed three times before finally approving the drug in early March. Last May, the FDA rejected the drug because one of the ingredients, castor oil, could cause blood clots, and the company did not submit a thorough plan to manage the potential side effects of the ingredient.
Testosterone therapy has been criticized for causing heart attacks and strokes in patients over the age of 50.
Now that Aveed has been approved, Endo stated that it will launch the injectable testosterone therapy this month.
“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. “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.”
“Physicians have prescribed FDA-approved testosterone replacement therapies for many years to help treat men diagnosed with testosterone deficiency, or hypogonadism. Aveed is an important new option that may be suitable for some men given its dosing schedule and administration,” said Martin Miner, co-director of the Men’s Health Center at Miriam Hospital and a clinical associate professor of Family Medicine and Urology at Brown University’s Warren Alpert School of Medicine, Providence. “As with any prescription therapy, hypogonadal men should talk to their doctor about the potential risks and benefits of testosterone replacement therapy so they can make an informed treatment decision.”
“It is quite clear that testosterone treatment increases the risks of cardiovascular diseases, including heart attacks,” said Dr Sidney Wolfe, of Public Citizen’s health group.
“At the current rate of prescribing, almost 13,000 prescriptions a day are filled for testosterone products in this country,” Wolfe said. “Each day of delay of the black box warning ensures much more exposure, too often for men who cannot benefit from the drug but will only be exposed to its risks.”
The FDA originally approved testosterone therapy for treatment of low testosterone due to genetic factors, especially for patients with hypogonadism, a condition that affects the testes, pituitary gland, hypothalamus. However, testosterone therapy has been marketed to older men whose “low T” is related to age, not to a medical condition. Patients prescribed testosterone therapy by their doctor may not have a medical need for the drug, and can therefore put themselves at risk of serious side effects.
The Strom Law Firm Can Help with Dangerous Drug Cases, Including Testosterone Therapy and Supplements
The Strom Law Firm, L.L.C. is a leader in the consumer protection battle against dangerous prescription drugs and medical devices, from Actos to testosterone therapy. We represent individuals who have been killed or injured by dangerous or defective pharmaceuticals. If you or a family member have been injured or killed after using a dangerous drugs or medical products such as testosterone therapy or supplements, contact our dangerous drug lawyers as soon as possible so that we can begin taking steps to preserve evidence and your claim immediately. We offer free consultations to discuss the facts of your case. 803.252.4800