Testosterone Treatment and MI Risk

Filling a prescription for testosterone therapy was associated with a greater risk of having a nonfatal myocardial infarction (MI) in the next 3 months, a large observational study showed.

The risk after a prescription was filled was more than doubled in men 65 and older overall compared with that in the year before the prescription (rate ratio 2.19, 95% CI 1.27-3.77), according to Robert Hoover, MD, ScD, of the National Cancer Institute in Bethesda, Md., and colleagues.

The study was limited, however, by the observational design, the use of administrative data that lacked information on indications for treatment, and the inclusion of nonfatal MIs only.

via Study Feeds Concerns About MI Risk With Testosterone Tx.

Acetaminophen Prescription Combination Drug Products with more than 325 mg: FDA Statement – Recommendation to Discontinue Prescribing and Dispensing

ISSUE: FDA is recommending health care professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 milligrams (mg) of acetaminophen per tablet, capsule or other dosage unit. There are no available data to show that taking more than 325 mg of acetaminophen per dosage unit provides additional benefit that outweighs the added risks for liver injury. Further, limiting the amount of acetaminophen per dosage unit will reduce the risk of severe liver injury from inadvertent acetaminophen overdose, which can lead to liver failure, liver transplant, and death.

via Safety Alerts for Human Medical Products > Acetaminophen Prescription Combination Drug Products with more than 325 mg: FDA Statement – Recommendation to Discontinue Prescribing and Dispensing.

You like your liver?  You can keep your liver.

Farxiga (dapagliflozin) – Think Diabetes

The FDA has approved dapagliflozin (Farxiga) for treatment of type 2 diabetes in adults, along with diet and exercise, the agency said in a statement.

The approval comes with strings, however: drugmakers Bristol-Myers Squibb and AstraZeneca must conduct six post-market studies, which include a cardiovascular outcomes trial in patients with baseline cardiovascular disease risks, a bladder cancer risk trial, an animal study looking at drug-induced urinary flow and bladder tumor promotion, two trials on risks in pediatric patients, and an enhanced pharmacovigilance program to study liver abnormalities and pregnancy outcomes.

via FDA Approves New Diabetes Drug.

Lexiscan (regadenoson) and Adenoscan (adenosine): Drug Safety Communication – Rare but Serious Risk of Heart Attack and Death

BACKGROUND: Lexiscan and Adenoscan are FDA approved for use during cardiac nuclear stress tests in patients who cannot exercise adequately. Lexiscan and Adenoscan help identify coronary artery disease. They do this by dilating the arteries of the heart and increasing blood flow to help identify blocks or obstructions in the heart’s arteries. Lexiscan and Adenoscan cause blood to flow preferentially to the healthier, unblocked or unobstructed arteries, which can reduce blood flow in the obstructed artery. In some cases, this reduced blood flow can lead to a heart attack, which can be fatal. RECOMMENDATIONS: Screen all nuclear stress test candidates for their suitability to receive Lexiscan or Adenoscan. Avoid using these drugs in patients with signs or symptoms of unstable angina or cardiovascular instability, as these patients may be at greater risk for serious cardiovascular adverse reactions. Cardiac resuscitation equipment and trained staff should be available before administering Lexiscan or Adenoscan.

via Safety Alerts for Human Medical Products > Lexiscan regadenoson and Adenoscan adenosine: Drug Safety Communication – Rare but Serious Risk of Heart Attack and Death.

Testosterone Treatment Tied to Worse Cardiac Outcomes

After adjustment for the presence of coronary artery disease, testosterone therapy was associated with a greater risk of all-cause mortality, myocardial infarction, and ischemic stroke 3 years after angiography (25.7% versus 19.9%; HR 1.29, 95% CI 1.04-1.58), according to P. Michael Ho, MD, PhD, of the Department of Veterans Affairs (VA) Eastern Colorado Health Care System in Denver, and colleagues.

via Testosterone Tx Tied to Worse Cardiac Outcomes.

How come the television commercials don’t tell you this information when they try to make you think you have a disease called Low T?

Annual prescriptions for testosterone increased more than five-fold from 2000 to 2011. In 2011, the total number of prescriptions numbered 5.3 million and make up a market of 1.6 billion, the authors wrote.

Never mind.

Bisphosphonates Raise Afib Risk

Bisphosphonate use was associated with significantly increased risks of atrial fibrillation and serious atrial fibrillation, researchers found.

A systematic review of randomized controlled studies and observational studies showed use of bisphosphonates was associated with a 27% increased risk of atrial fibrillation (95% CI 1.16-1.39) in observational studies and, in randomized controlled trials alone, with a 40% increased odds of serious atrial fibrillation (95% CI 1.02-1.93), according to Abhishek Sharma, MD, of Maimonides Medical Center in Brooklyn, N.Y., and colleagues.

via Bisphosphonates Raise Afib Risk.