Pharma

High Dose Simvastatin = Muscle Injury Risk

/ SupremeCmdr / Leave a comment

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.

Generic NTG Lacks FDA Approval

/ SupremeCmdr / Leave a comment

After reading this article I remain in a state of disbelief.

F.D.A. Says Millions Got Unapproved Nitroglycerin – NYTimes.com

The problem of the unapproved tablets stems from a longstanding ambiguity about the rules for drugs whose use predates the establishment of the F.D.A. in 1938. Only one brand of nitroglycerin pills is federally approved: Nitrostat, made by Pfizer, on the market since 2000.

Don’t Take Plavix if You Are a Poor Metabolizer

/ SupremeCmdr / Leave a comment

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.

Venlafaxine and SCD Risk

/ SupremeCmdr / Leave a comment

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.

Watch That Paxil in Breast Cancer Applicants

/ SupremeCmdr / Leave a comment

Medical News: SSRI and Tamoxifen Increase Mortality Risk – in Hematology/Oncology, Breast Cancer from MedPage Today

Overlapping use of tamoxifen and the antidepressant paroxetine (Paxil) significantly increases the risk of breast cancer mortality, data from a large cohort of breast cancer patients showed.

The excess breast-cancer mortality risk ranged as high as 91%, depending on the duration of simultaneous use, researchers reported online in BMJ.

Oops.

Tysabri (Natalizumab) and PML – Update

/ SupremeCmdr / Leave a comment

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.