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.
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.
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.
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.
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.
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.
The Associated Press: Pfizer Alzheimer’s disease drug fails in study
The Boomers are aging and Alzheimer’s incidence is expected to increase. This is disappointing news.
NEJM — Weighing Risks and Benefits of Liraglutide — The FDA’s Review of a New Antidiabetic Therapy
On January 25, 2010, the FDA approved liraglutide, a glucagon-like-peptide-1 (GLP-1) receptor agonist that can be taken once daily to improve glycemic control in adults with type 2 diabetes.
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.
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.
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