A Proactive Approach to Womens Concerns: Womens Longevity Groups and Funds [PDF]
With the exception of ten countries in the world, according to the World Health Organization's 2005 report, women outlive men. In the United States, women outlive men by 5.3 years.
Myrna I. Lewis
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Hepatotoxicity Associated with the Use of Anti-TNF-α Agents [PDF]
Medications to inhibit the actions of tumour necrosis factor alpha have revolutionized the treatment of several pro-inflammatory autoimmune conditions.
Bonacini, Maurizio+4 more
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Squamous-cell carcinoma of the tongue following therapy of rheumatoid arthritis with abatacept [PDF]
A patient affected by rheumatoid arthritis developed a squamous-cell carcinoma probably due to abatacept, according to Naranjo algorithm. The case describes this adverse reaction for the first time and highlights the need for additional studies to ...
Deidda, Arianna+7 more
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Informatic Tools and Approaches in Postmarketing Pharmacovigilance Used by FDA [PDF]
The safety profile of newly approved drugs and therapeutic biologics is less well developed by pre-marketing clinical testing than is the efficacy profile. The full safety profile of an approved product is established during years of clinical use.
A. P. Fletcher+19 more
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A Critical Examination of the FDA’s Efforts to Preempt Failure-to-Warn Claims [PDF]
This article explores the legality and wisdom of the FDA’s effort to persuade courts to find most failure-to-warn claims preempted. The article first analyzes the FDA’s justifications for reversing its long-held views to the contrary and explains why ...
Kessler, David A., Vladeck, David C.
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\u3ci\u3ePLIVA v. Mensing\u3c/i\u3e and Its Implications [PDF]
The U.S. Supreme Court ruling in PLIVA Inc. v. Mensing will immunize generic drug manufacturers facing failure-to-warn claims from state-law liability, and may also have implications for preemption jurisprudence more generally, says attorney Brian ...
Feldman, Dena, Wolfman, Brian
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Proton-pump inhibitor use is associated with a broad spectrum of neurological adverse events including impaired hearing, vision, and memory. [PDF]
Proton-pump inhibitors, PPIs, are considered effective therapy for stomach acid suppression due to their irreversible inhibition of the hydrogen/potassium pump in the gastric parietal cells. They are widely prescribed and are considered safe for over-the-
Abagyan, Ruben+4 more
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Risk-Taking and Rulemaking: Addressing Risk Compensation Behavior Through FDA Regulation of Prescription Drugs [PDF]
Despite widespread acclaim for their potential to reduce public health harms, technological advances in health and safety frequently raise the ominous specter of risk compensation behavior-the possibility that individuals protected by these technologies ...
Underhill, Kristen
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Retrospective analysis reveals significant association of hypoglycemia with tramadol and methadone in contrast to other opioids. [PDF]
Tramadol is one of the most commonly used analgesics worldwide, classified as having a low abuse potential by U.S. Drug Enforcement Agency, and often recommended in pain management guidelines.
Abagyan, Ruben+3 more
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Incentivizing Postmarketing Pharmaceutical Product Safety Testing with Extension of Exclusivity Periods [PDF]
Kushner, Leslie
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