Pharma

Testosterone Treatment and MI Risk

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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

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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

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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

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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

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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.

Notes from the Field: Acetyl Fentanyl Overdose Fatalities — Rhode Island, March–May 2013

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The GC/MS toxicology results for 10 of the 12 decedents showed, in addition to acetyl fentanyl, various mixtures of other drugs, including cocaine (58%), other opioids (33%), ethanol (25%), and benzodiazepines (17%).

via Notes from the Field: Acetyl Fentanyl Overdose Fatalities — Rhode Island, March–May 2013.

So what do you do when you see a script for Naloxone prescribed by an EM specialist?

 

Safety Alerts for Human Medical Products > Fluoroquinolone Antibacterial Drugs: Drug Safety Communication- Risk for possibly permanent nerve damage

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Safety Alerts for Human Medical Products > Fluoroquinolone Antibacterial Drugs: Drug Safety Communication- Risk for possibly permanent nerve damage.

ISSUE: FDA has required the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs be updated to better describe the serious side effect of peripheral neuropathy. This serious nerve damage potentially caused by fluoroquinolones may occur soon after these drugs are taken and may be permanent.

Acetaminophen: Drug Safety Communication – Association with Risk of Serious Skin Reactions

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FDA notified healthcare professionals and patients that acetaminophen has been associated with a risk of rare but serious skin reactions. Acetaminophen is a common active ingredient to treat pain and reduce fever; it is included in many prescription and over-the-counter (OTC) products. These skin reactions, known as Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), can be fatal.

via Safety Alerts for Human Medical Products > Acetaminophen: Drug Safety Communication – Association

Yikes!

 

with Risk of Serious Skin Reactions.