Results 81 to 90 of about 6,029 (168)

Vigilância de eventos adversos pós-vacinação e segurança de programas de imunização Vigilancia de eventos adversos post vacunación y seguridad de programas de inmunización Surveillance of adverse effects following vaccination and safety of immunization programs

Revista de Saúde Pública, 2011
O objetivo da revisão foi analisar aspectos conceituais e operacionais de sistemas de vigilância de eventos adversos pós-vacina. Foram incluídos artigos disponíveis em formato eletrônico, publicados entre 1985 e 2009, selecionados nas bases Medline ...
Eliseu Alves Waldman, Karin Regina Luhm, Sandra Aparecida Moreira Gomes Monteiro, Fabiana Ramos Martin de Freitas   +3 more
doaj   +1 more source

Lessons from gefitinib-induced interstitial lung disease in Japan: Problems in approval, pharmacovigilance, and regulatory decision-making procedures

Pharmacy Practice, 2006
Objective: The objective of this study was to identify problems in the approval, pharmacovigilance, and post-approval regulatory decision-making procedures involving gefitinib and to propose countermeasures to prevent further drug-induced suffering in ...
Nishimura T,, Tada H, Nakagawa M, Teramukai S, Matsui S, Fukushima M   +5 more
doaj  

Retrospective analysis reveals significant association of hypoglycemia with tramadol and methadone in contrast to other opioids. [PDF]

, 2019
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, Atayee, Rabia S, Makunts, Tigran, U, Andrew   +3 more
core   +1 more source

DRUG THERAPY AND PREGNANCY: UNKNOWN RISKS LEAD TO HARD CHOICES [REDACTED VERSION] [PDF]

, 2012
This paper is a proposal to improve the quality of information available to pregnant patients in selecting treatment options. By providing drug companies with extended grants of exclusivity, the FDA has the ability to empower pregnant women to take ...
Goldstein, Lori M.
core  

Hepatotoxicity Associated with the Use of Anti-TNF-α Agents [PDF]

, 2015
Medications to inhibit the actions of tumour necrosis factor alpha have revolutionized the treatment of several pro-inflammatory autoimmune conditions.
Bonacini, Maurizio, Bonkovsky, Herbert L., Foureau, David, French, Joshua B., Ghabril, Marwan   +4 more
core   +2 more sources

Design of, and first data from, PATRO Children, a multicentre, noninterventional study of the long-term efficacy and safety of Omnitrope in children requiring growth hormone treatment

Therapeutic Advances in Endocrinology and Metabolism, 2013
Objective: To describe the rationale, design and first data from PATRO Children, a postmarketing surveillance of the long-term efficacy and safety of somatropin (Omnitrope ® ) for the treatment of children requiring growth hormone treatment.
Roland Pfäffle, Karl Otfried Schwab, Otilia Marginean, Mieczyslaw Walczak, Mieczyslaw Szalecki, Ellen Schuck, Markus Zabransky, Stefano Zucchini   +7 more
doaj   +1 more source

A Proactive Approach to Womens Concerns: Womens Longevity Groups and Funds [PDF]

, 2005
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
core  

Postmarket Surveillance of Medical Devices: A Comparison of Strategies in the US, EU, Japan, and China [PDF]

, 2013
Daniel Kramer and colleagues compare strategies for postmarket surveillance of medical devices and discuss ways to improve these systems.
Kesselheim, Aaron S., Kramer, Daniel B., Sato, Chiaki, Tan, Yongtian T.   +3 more
core   +2 more sources

Number of Patients Studied Prior to Approval of New Medicines: A Database Analysis [PDF]

, 2013
Background: At the time of approval of a new medicine, there are few long-term data on the medicine's benefit-risk balance. Clinical trials are designed to demonstrate efficacy, but have major limitations with regard to safety in terms of patient ...
Boer, A.C. (Anton) de, Bruin, M.L. (Marie) de, Duijnhoven, R.G. (Ruben), Hoes, A.W. (Arno), Raine, (Keiran), Straus, S.M.J.M. (Sabine)   +5 more
core   +1 more source

Vedolizumab: an α4β7 integrin antagonist for ulcerative colitis and Crohn’s disease [PDF]

, 2015
Ulcerative colitis (UC) and Crohn’s disease (CD) are chronic, relapsing inflammatory bowel diseases associated with significant morbidity. Conventional therapies for these diseases include corticosteroids, aminosalicylates, immunomodulators, and ...
Biogen Idec Inc, Erle D., Gingery D., Lichenstein G., Sandborn W., Sharon P., Takeda Pharmaceuticals America Inc   +6 more
core   +2 more sources