Pharmacology

FDA Warns of Possible Link Between Chantix Therapy and Mood Disturbances

December 14, 2007
FDA Warns of Possible Link Between Chantix Therapy and Mood Disturbances

Commentary by Robert Leonard PharmD, Pharmacy Resident New York Harbor Healthcare System

On November 20, 2007 the FDA announced mounting evidence linking varenicline (Chantix®) therapy for smoking cessation with suicidal ideation and erratic and aggressive behavior. The announcement comes in response to post-marketing case reports submitted to the FDA by the makers of Chantix®, Pfizer Inc. Early review of the cases reveal new onset of depressed mood, suicidal thoughts, and changes in emotions or behaviors within days to weeks of starting Chantix® therapy. A direct…

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FDA Approves Raltegravir- A First in New Class of HIV Medications

November 14, 2007
FDA Approves Raltegravir- A First in New Class of HIV Medications

Commentary by Helen Kourlas PharmD, Pharmacology Section Editor

On October 16th the FDA announced the approval of raltegravir (Isentress®) for the treatment of Human Immunodeficiency Virus (HIV)-1 infection in combination with other antiretroviral agents. The use of raltegravir is recommended for patients who have HIV-1 strains resistant to multiple antiretroviral medications. Raltegravir belongs to a new pharmacologic class of antiretrovirals called HIV integrase strand transfer inhibitors. Integrase is one of the three enzymes necessary for the HIV-1 virus to replicate, and integrase inhibitors can stop the…

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FDA Approves Label Revision for Erectile Dysfunction Drugs

October 24, 2007
FDA Approves Label Revision for Erectile Dysfunction Drugs

Commentary by Kathy Lee, Pharm.D. Pharmacy Practice Resident

On October 18 2007, the FDA announced the approval of labeling changes to erectile dysfunction (ED) drugs in the class known as phosphodiesterase type 5 (PDE-5) inhibitors. This includes drugs Cialis®, Levitra®, Viagra®, as well as Revatio®, a PDE-5 inhibitor indicated for pulmonary arterial hypertension (PAH). The label revisions draw attention to the potential risk of sudden hearing loss, sometimes associated with vestibular symptoms such as tinnitus, vertigo, and dizziness. Based on 29 postmarketing reports of this incidence,…

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Clinical Pharmacy Corner: How Do Sulfonylureas Work?

October 17, 2007
Clinical Pharmacy Corner: How Do Sulfonylureas Work?

Commentary by Helen Kourlas, PharmD and John Papadopoulas, PharmD, Pharmacology Section Editors

The sulfonylureas are members of a class of substituted arylsulfonylureas that have been used clinically since the 1950s. These agents are usually divided into two categories or generations. First generation agents include acetohexamide, chlorpropamide, tolazamide, and tolbutamide (the first widely utilized agent). The more potent second-generation agents include glimepiride, glipizide, and glyburide.

Sulfonylureas acutely lower plasma glucose by stimulating the release of insulin. The primary mechanism is through binding to sulfonylurea receptors (SUR-1)…

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Breaking News: FDA Issues New Warnings for Haldol

September 21, 2007
Breaking News: FDA Issues New Warnings for Haldol

Commentary by Helen Kourlas, PharmD

On September 17th 2007, the FDA issued an advisory warning healthcare professionals to avoid the use of higher than recommended doses of haloperidol, marketed as Haldol, Haldol Decanoate and Haldol Lactate. In addition to this warning, the FDA also emphasized that the injectable form of haloperidol is only approved to be administered as an intramuscular injection. Common off – label intravenous administration of haloperidol has led to numerous case reports of QT prolongation, Torsades de Piontes (TdP) and sudden death.…

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Clinical Pharmacology Corner: Beta-Adrenergic Receptors Antagonists

August 14, 2007
Clinical Pharmacology Corner:  Beta-Adrenergic Receptors Antagonists

Commentary by Helen Kourlas, PharmD

Beta-adrenergic receptor antagonists, commonly known as beta-blockers (B-blockers) have been used for decades to treat hypertension, ischemic heart disease and some arrhythmias – and more recently to treat congestive heart failure. (1,2) Typically, B receptors are located in the heart (B1) and in peripheral vessels (B2) and the binding of catecholamines (epinephrine, norepinephrine and dopamine) to B1 receptors produce positive chronotropic and inotropic effects, while the binding of the B2 receptors produce a vasodilatory response in the peripheral…

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Clinical Pharmacy Corner: Sulfonamide Allergy and Cross-Reactivity

July 26, 2007
Clinical Pharmacy Corner: Sulfonamide Allergy and Cross-Reactivity

Commentary By Susan Morey PharmD, Pharmacy Practice Resident

Approximately 3% of patients who use sulfonamide antibiotics develop an allergic reaction, with the most common being the development of a maculopapular rash. (1, 2, 3) Sulfonamides are chemical compounds which contain a SO2NH2 moiety and can be divided into 3 groups based on their structure. (1, 2)  The first group, the sulfonylarylamines includes the sulfonamide antibiotics. The second group, the nonsulfonylarylamines, includes carbonic anhydrase inhibitors (CAI), cyclooxygenase 2 (COX-2) inhibitors, loop diuretics, thiazides, and…

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Can You Give A Cephalosporin to a Patient Who is Allergic to Penicillin?

June 21, 2007
Can You Give A Cephalosporin to a Patient Who is Allergic to Penicillin?

-Commentary by Susan Morey, PharmD. Pharmacy Practice Resident

A true allergy to penicillin is known to occur in less than 10% of patients exposed to penicillin. 1, 2 The cross-reactivity to cephalosporins has been reported to be approximately 8% to 18% in patients with a documented penicillin allergy. True allergic, type I reactions are IgE mediated, with a spectrum of presentation ranging from urticaria to severe anaphylactic shock.1, 2

The beta-lactam ring has been implicated as the structure responsible for cross-reactivity…

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Clinical Commentary: The Travesty of Grinding Axes with Science: Rosiglitazone and Cardiac Risk

June 12, 2007
Clinical Commentary: The Travesty of Grinding Axes with Science: Rosiglitazone and Cardiac Risk

Welcome to our first blog commentary. One of the purposes of the blog is to generate discussion about issues in health care. This “Clinical Commentary” section is an invitation to our housestaff and faculty to submit their own thoughts and viewpoints on current issues. The views expressed in this section are soley those of the authors and do not necessarily represent the views of Clinical Correlations.

Commentary by Gregory Mints MD and Nirav Shah MD, MPH

The meta-analysis of Rosiglitazone’s effect on cardiovascular events…

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Not So Rosi…

May 24, 2007
Not So Rosi…

Commentary by Seagram Villagomez MD, Chief Resident

Since its approval in 1999, nearly 1 million Americans have used the thiazolidinedione (TZD) rosiglitazone (Avandia – GlaxoSmithKline) for the treatment of Type 2 Diabetes.  However, in a drug class which seems plagued by concerns, the safety profile associated with rosiglitazone has been brought to question. Previously, troglitazone (Rezulin) was pulled off the market secondary to hepatoxicity, while muraglitazar was not approved by the FDA given adverse cardiovascular events during early clinical trials.  In a…

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Clinical Pharmacy Corner-The Thiazides

May 17, 2007
Clinical Pharmacy Corner-The Thiazides

 We’d like to introduce you to Clinical Correlations’ newest feature-Clinical Pharmacy Corner. This will be a bimonthly pharmacy themed post which will tackle both basic and complicated pharmacy issues. We will review the mechanisms of actions of various classes of medications, a worthwhile refresher for those of us who may have forgotten what we learned in pharmacology 101 in medical school. We will also answer our reader’s pharmacy questions based on actual cases. As always please send your clinical questions and feedback to…

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ShortCuts-The War on the Pharmaceutical Industry Edition

May 14, 2007
ShortCuts-The War on the Pharmaceutical Industry Edition

Welcome to our first theme issue of ShortCuts. This week, we decided to focus on the tribulations of the pharmaceutical industry, which recently seems to be plagued by new FDA advisories and NY Times exposés.

The first bad news for pharmaceutical companies occurred on May 2nd when the FDA expanded its black box warning on antidepressant medications, stating that the drugs may have the potential to increase suicidal symptoms in young adults between the ages of 18 and 24. The warning, previously targeting…

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