pharmaceutical

Don’t Take Plavix if You Are a Poor Metabolizer

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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.

Byetta – Watch That Kidney Function

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Show #96, March 2010

From April 2005 to October 2008, FDA received 78 reports of altered kidney function in patients treated with Byetta. Some of the patients had pre-existing kidney disease and other risk factors for developing kidney problems. Acute renal failure occurred in 62 patients and renal insufficiency in 16 patients.

Venlafaxine and SCD Risk

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Use of venlafaxine compared with other antidepressants and the risk of sudden cardiac death or near death: a nested case-control study — Martinez et al. 340: c249 — BMJ

Conclusions In this large, population based study, the use of venlafaxine was not associated with an excess risk of sudden cardiac death or near death compared with fluoxetine, dosulepin, or citalopram, in patients with depression or anxiety.

ASA May Reduce CVD and All-Cause Mortality in T2DM

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Aspirin Is Associated With Reduced Cardiovascular and All-Cause Mortality in Type 2 Diabetes in a Primary Prevention Setting — Diabetes Care

RESULTS There were 160 deaths (24.6%) during follow-up, with 70 (43.8%) due to CVD. In Kaplan-Meier survival analysis, there was no difference in either CVD or all-cause mortality in aspirin users versus nonusers (P = 0.52 and 0.94, respectively, by log-rank test). After adjustment for significant variables in the most parsimonious Cox models, regular aspirin use at baseline independently predicted reduced CVD and all-cause mortality (hazard ratio [HR] 0.30 [95% CI 0.09–0.95] and 0.53 [0.28–0.98[, respectively; P ≤ 0.044). In subgroup analyses, aspirin use was independently associated with reduced all-cause mortality in those aged ≥65 years and men.

CONCLUSIONS Regular low-dose aspirin may reduce all-cause and CVD mortality in a primary prevention setting in type 2 diabetes. All-cause mortality reductions are greatest in men and in those aged ≥65 years. The present observational data support recommendations that aspirin should be used in primary CVD prevention in all but the lowest risk patients.

Tysabri (Natalizumab) and PML – Update

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Medical News: FDA Adds PML Risk to MS Drug Label – in Product Alert, Prescriptions from MedPage Today

A warning of a risk of progressive multifocal leukoencephalopathy has been added to the label for the multiple sclerosis drug natalizumab (Tysabri), the FDA announced. The labeling change was prompted by continuing reports of PML in MS patients. The current number of confirmed cases stands at 31 — 10 in the U.S. — up from 13 as recently as last September.

Meridia (sibutramine hydrochloride) – Update

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Oops.

Meridia (sibutramine hydrochloride): Follow-Up to an Early Communication about an Ongoing Safety Review

Sibutramine is not to be used in patients with a history of cardiovascular disease, including:

* History of coronary artery disease (e.g., heart attack, angina)
* History of stroke or transient ischemic attack (TIA)
* History of heart arrhythmias
* History of congestive heart failure
* History of peripheral arterial disease
* Uncontrolled hypertension (e.g., > 145/90 mmHg)