New ASA Advice

Medical News: Tighter Criteria Introduced for Aspirin Use in Diabetes – in Cardiovascular, Prevention from MedPage Today

A more conservative approach to aspirin for primary prevention in adults with diabetes is called for in a joint statement issued today by diabetes and cardiovascular associations.

Low-dose aspirin can be considered reasonable for diabetes patients with a cardiovascular disease risk above 10% over 10 years and no excess bleeding risk, according to the statement released by the American Heart Association, the American Diabetes Association, and American College of Cardiology.

Anticonvulsant Meds and Suicide Risk

JAMA — Abstract: Anticonvulsant Medications and the Risk of Suicide, Attempted Suicide, or Violent Death, April 14, 2010, Patorno et al. 303 (14): 1401

Results: The study identified 26 completed suicides, 801 attempted suicides, and 41 violent deaths in 297 620 new episodes of treatment with an anticonvulsant (overall median follow-up, 60 days). The incidence of the composite outcomes of completed suicides, attempted suicides, and violent deaths for anticonvulsants used in at least 100 treatment episodes ranged from 6.2 per 1000 person-years for primidone to 34.3 per 1000 person-years for oxcarbazepine. The risk of suicidal acts was increased for gabapentin (hazard ratio [HR], 1.42; 95% confidence interval [CI], 1.11-1.80), lamotrigine (HR, 1.84; 95% CI, 1.43-2.37), oxcarbazepine (HR, 2.07; 95% CI, 1.52-2.80), tiagabine (HR, 2.41; 95% CI, 1.65-3.52), and valproate (HR, 1.65; 95% CI, 1.25-2.19), compared with topiramate. The analyses including violent death produced similar results. Gabapentin users had increased risk in subgroups of younger and older patients, patients with mood disorders, and patients with epilepsy or seizure when compared with carbamazepine.

Conclusion: This exploratory analysis suggests that the use of gabapentin, lamotrigine, oxcarbazepine, and tiagabine, compared with the use of topiramate, may be associated with an increased risk of suicidal acts or violent deaths.

Combination Therapy for Crohn’s

Better Treatment Found for Crohn’s Disease – BusinessWeek

The international trial included 508 people with Crohn’s disease who had never been treated with immunosuppressive drugs. One-third were given infliximab alone, one-third received only azathioprine and one-third were treated with both. The trial was funded by Centocor Ortho Biotech, which markets infliximab, and Schering-Plough.

After 26 weeks, 56.8 percent of those getting combination therapy had complete remission of symptoms, compared to 44.4 percent of those getting only infliximab and 30 percent of those getting only azathioprine.

Neurotonin – Watch Off-label Usage

Pfizer Agrees to First Neurontin Lawsuit Settlement (Update1) – Bloomberg.com

Pfizer faces more than 1,000 lawsuits accusing it of illegally promoting Neurontin for unapproved uses and helping to cause some users’ suicides. The settlement comes a week after another Boston jury ordered Pfizer to pay more than $140 million in damages to an insurer over the drug. Pfizer has denied any wrongdoing in connection with its handling of Neurontin.

High Dose Simvastatin = Muscle Injury Risk

Zocor (simvastatin): increased risk of muscle injury with high doses

FDA notified healthcare professionals and patients that, based on review of data from a large clinical trial and other sources, there is an increased risk of muscle injury in patients taking the highest approved dose of the cholesterol-lowering medication, Zocor (simvastatin) 80 mg, compared to patients taking lower doses of simvastatin and possibly other drugs in the “statin” class. FDA is also reviewing data from other clinical trials, observational studies, adverse event reports, and data on prescription use of simvastatin to better understand the relationship between high-dose simvastatin use and muscle injury.

Don’t Take Plavix if You Are a Poor Metabolizer

A “poor metabolizer” does not effectively convert Plavix to its active form because of low CYP 2C19 activity.

How does someone figure out they are a “poor metabolizer”?

Read the FDA communication if you’re seriously interested in the answer to this question.

FDA Drug Safety Communication: Reduced effectiveness of Plavix (clopidogrel) in patients who are poor metabolizers of the drug

The U.S. Food and Drug Administration (FDA) has added a Boxed Warning to the label for Plavix, the anti-blood clotting medication. The Boxed Warning is about patients who do not effectively metabolize the drug (i.e. “poor metabolizers”) and therefore may not receive the full benefits of the drug.