The levothyroxine spectrum: Bioequivalence and cost considerations
August 1st 2005Levothyroxine, a critical medication for millions of Americans, has had a long and turbulent history. In the face of tougher FDA regulations and especially its reclassification as a "new drug" in 1997, manufacturers have struggled to carve out their niche in an expansive market. The principal concern of physicians, patients, endocrinologists, manufacturers, and FDA is levothyroxine's relative bioequivalence. Even after FDA classified several products as bioequivalent, a single brand name product still holds most of the market share, despite the fact that it is more costly. Current issues surrounding levothyroxine include: controversy about research, the number and types of recalls, the lack of a single reference-listed drug for comparison, and conflicting claims about the bioequivalence of various formulations. (Formulary. 2005;40:258–271.)
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Crawford seeks to restore confidence in FDA approval process
August 1st 2005After months of delay, the Senate confirmed Lester M. Crawford, DVM, PhD, in July as the official head of FDA. Despite efforts by some Senators to hold up the vote pending resolution of some FDA policies, most legislators agreed with Republican and Democratic leaders that the agency would be better off with a permanent chief than without.
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Tigecycline: A novel glycylcycline antiobiotic
August 1st 2005Highly resistant strains of both gram-positive and gram-negative bacteria are becoming commonplace in both the inpatient and outpatient setting. Recently developed antimicrobials have targeted resistant gram-positive pathogens, but the problem of resistant gram-negative pathogens remains. Tigecycline (Tygacil, Wyeth) is an injectable antimicrobial and the first in a new class of agents (the glycylcyclines) that possesses activity against key gram-positive and gram-negative bacterial pathogens. Tigecycline overcomes common tetracycline resistance mechanisms and has shown in vitro and in vivo activity against multidrug-resistant organisms. Tigecycline treatment produced clinical and microbiologic outcomes similar to standard comparator agents in patients with complicated skin and skin structure infections and complicated intra-abdominal infections and was approved for these indications in June 2005. The most common adverse events associated with tigecycline's administration during clinical trials were..
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FDA approved moxifloxacin (Avelox, Schering-Plough) tablets and injection for the once-daily treatment of adults with complicated skin and skin structure infections (cSSSIs) caused by methicillin-susceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, or Enterobacter cloacae.
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Bank on the fact that CDHC is here to stay
August 1st 2005As healthcare costs continue to spiral, the search for solutions is reaching a frantic pace. My experiences over the years have led me to believe that while Consumer- Directed Healthcare (CDHC) has entered the mainstream lexicon, it is far from understood.
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As a third grader, Jean Fraser thought she would become a doctor. Her science class dissected a chicken, and she became so fixated by the experience that she described the process in detail to her father during the family dinner each night. Unbeknown to her until recently, her descriptions back then had made her father sick to his stomach.
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NSAID utilization patterns following market withdrawal of rofecoxib
July 1st 2005Cyclooxygenase-2 (COX-2)-selective nonsteroidal anti-inflammatory drugs (NSAIDs) have been widely prescribed for patients with arthritis and other conditions because of their lower risk for gastrointestinal adverse events compared with nonselective NSAIDs 1,2
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Dapoxetine: A novel, fast-acting serotonin reuptake inhibitor
July 1st 2005Dapoxetine (Alza/Ortho-McNeil) is a novel oral medication undergoing FDA review for premature ejaculation, one of the most common disorders of sexual dysfunction in men. Dapoxetine is a fast-acting inhibitor of the serotonin reuptake transporter. It has a short half-life and is structurally related to the antidepressant fluoxetine, allowing for on-demand dosing.
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Cost analysis of combination vs single dosage lipid-lowering
July 1st 2005A study was conducted to determine the cost and patient adher- ence rates of lipid-lowering therapy with an extended-release niacin and lovastatin (ERNL) combination agent versus a separate extended-release niacin and statin (ERN-S) combination or statin monotherapy.
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Trends in utilization of alternative analgesics after rofecoxib withdrawal
July 1st 2005The objective of this study was to track the utilization of anti-inflammatory drugs among patients with active rofecoxib prescriptions at the time of market withdrawal through retrospective analysis of pharmacy records and to assess the need for COX-2 inhibitor therapy due to gastrointestinal risk factors.
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