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.

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.

Metformin and Cognitive Impairment

In a retrospective study, diabetic patients who were taking metformin had worse cognitive performance than those not taking the drug (odds ratio 2.23, 95% CI 1.05-4.75), Eileen Moore, PhD, of the University of Melbourne in Australia, and colleagues reported online in Diabetes Care.

Additionally, patients with diabetes who had vitamin B12 levels less than 250 pmol/L also had worse cognitive performance (OR 2.29, 95% CI 1.12-4.66), and the association between metformin and cognitive impairment was weakened after adjusting for vitamin B12 levels, they stated.

via In Some Patients Metformin Impairs Thinking.