FDA re-examining risk profile of FDA-approved testosterone products
SILVER SPRING, Md. — The Food and Drug Administration is investigating the risk of stroke, heart attack and death in men taking FDA-approved testosterone products, the agency announced Friday.
"We have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy," the agency stated. "We are providing this alert while we continue to evaluate the information from these studies and other available data, and will communicate our final conclusions and recommendations when the evaluation is complete."
At this time, FDA has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack or death. Patients should not stop taking prescribed testosterone products without first discussing any questions or concerns with their healthcare professionals. Healthcare professionals should consider whether the benefits of FDA-approved testosterone treatment is likely to exceed the potential risks of treatment.
Testosterone is a hormone essential to the development of male growth and masculine characteristics. Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition. Examples of these conditions include failure of the testicles to produce testosterone because of reasons such as genetic problems or chemotherapy. Other examples include problems with brain structures, called the hypothalamus and pituitary, that control the production of testosterone by the testicles.
None of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition. FDA-approved testosterone formulations include the topical gel, transdermal patch, buccal system (applied to upper gum or inner cheek) and injection.
The first publication that prompted FDA to reassess the cardiovascular safety of testosterone therapy was an observational study of older men in the U.S. Veteran Affairs health system published in the Journal of the American Medical Association in November 2013. The men included in this study had low serum testosterone and were undergoing imaging of the blood vessels of the heart, called coronary angiography, to assess for coronary artery disease. Some of the men received testosterone treatment while others did not. On average, the men who entered the study were about 60 years old, and many had underlying cardiovascular disease. This study suggested a 30% increased risk of stroke, heart attack and death in the group that had been prescribed testosterone therapy.
A second observational study reported an increased risk of heart attack in older men, as well as in younger men with pre-existing heart disease, who filled a prescription for testosterone therapy. The study reported a two-fold increase in the risk of heart attack among men aged 65 years and older in the first 90 days following the first prescription. Among younger men less than 65 years old with a pre-existing history of heart disease, the study reported a two- to three-fold increased risk of heart attack in the first 90 days following a first prescription. Younger men without a history of heart disease who filled a prescription for testosterone, however, did not have an increased risk of heart attack.
"We urge healthcare professionals and patients to report side effects involving prescription testosterone products to the FDA MedWatch program, using the information in the ‘Contact FDA’ box at the bottom of the page," the agency stated.
NEHI and Prescriptions for a Healthy America convene on HIT policy best practices discussion
WASHINGTON — HIT policy needs to focus on specific goals for improving patient medication adherence in order to realize the goals of improving patient health and achieving cost savings in the U.S. healthcare system, according to an expert panel convened today by the Network for Excellence in Health Innovation and Prescriptions for a Healthy America.
In particular, the panel said the two highest priorities for HIT should be providing electronic access to accurate mediation lists and complete drug formulary information for prescribing physicians.
Just as important, according to the panel, users and patients should redouble efforts to win a realignment of payment priorities that will support utilization of numerous HIT capabilities that already exist but are lying dormant.
"There is room in HIT policy for specific priorities that will sharpen the focus on patient medication adherence,” stated NEHI executive director Valerie Fleishman. "But our panel also made clear that much can be done to exploit existing HIT capabilities and existing sources of data that are not being utilized for lack of payment support.”
The discussion took place Friday at “Connected Health, Better Adherence”, a roundtable at the Pew Conference Center in Washington hosted by NEHI, a national health policy institute, in partnership with Prescriptions for a Healthy America. The roundtable explored the potential of HIT to improve patient care, outcomes, safety and to lower costs through improved medication management and adherence. Speakers debated which innovations should be prioritized in technology adoption to meet the needs of all stakeholders.
BMS completes sale of global diabetes business to AstraZeneca
NEW YORK — Bristol-Myers Squibb Co. on Monday announced that it has completed the previously announced sale of its global diabetes business to AstraZeneca.
Bristol-Myers Squibb received from AstraZeneca a payment of approximately $2.7 billion in connection with the closing, and will receive by mid-February, a $600 million milestone payment from the recent U.S. approval of Farxiga (dapagliflozin). Under terms of the agreement, Bristol-Myers Squibb also will receive from AstraZeneca potential regulatory and sales-based milestone payments of up to $800 million, and royalty payments based on net sales through 2025.
In addition, AstraZeneca will make payments of up to $225 million if and when certain assets are subsequently transferred.
The transaction includes the rights to Bristol-Myers Squibb’s global diabetes business that was part of its collaboration with AstraZeneca, the former Amylin manufacturing facility in West Chester, Ohio, and also covers the future purchase by AstraZeneca of Bristol-Myers Squibb’s Mount Vernon, Indiana, manufacturing facility, no earlier than 18 months following the closing date.