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Safety-Based Drug Withdrawals definition: Removal of a drug from the market due to the identification of an intrinsic property of the drug that results in a serious risk to public health.
4 examples

Clinical Comparison of Two Contrast Agents for Oral Cholecystography: Radiologic Efficacy and Drug Safety of Iopanoic Acid and Iopronic Acid 1

Laurence Hedlund et al.

The Yale Journal of Biology and Medicine , 1979

Pooling, meta-analysis, and the evaluation of drug safety

Michel Lièvre et al.

Current Controlled Trials in Cardiovascular Medicine , 2002

Pregnancy Exposure Registries for Assessing Antimalarial Drug Safety in Pregnancy in Malaria-Endemic Countries

Stephanie Dellicour et al.

PLoS Medicine , 01 Sep 2008

Age factors potentiating drug toxicity in the reproductive axis.: Traditionally, drug toxicity in the reproductive system has been a concern only as it affects fertility and fecundity in young individuals. The purpose of this report is to address the potential problem of synergy between drug actions and abnormal secretion of reproductive hormones that together produce disease in older individuals. Thus, reproductive toxicity has different, but no less serious implications in aging individuals. During aging, the coordinated function of elements within the reproductive neuroendocrine axis degrades. This change promotes atypical secretion of hormones producing abnormal responses in target organs and thus creates a condition with pathogenic potential. Certain drugs may contribute to reproductive toxicity in aging individuals either by accelerating the process of dysregulation and/or by synergizing with hormones to stimulate pathologic changes in target tissues. The geriatric population of the world is increasing, and since it consumes a proportionately larger percentage of drugs than younger groups, this novel form of reproductive toxicity may represent a problem in drug safety that warrants serious ...

R F Walker

Environmental Health Perspectives , 01 Dec 1986

A phase 1–2, prospective, double blind, randomized study of the safety and efficacy of Sulfasalazine for the treatment of progressing malignant gliomas: study protocol of [ISRCTN45828668]: ... of progression or drug intolerance. Primary endpoints are drug safety in the setting of ...

Pierre A Robe et al.

BMC Cancer , 31 Jan 2006

Individual case safety reports in children in commonly used drug groups – signal detection: ... Due to few paediatric drug safety studies, knowledge on ...

Gertrud Brunlöf et al.

BMC Clinical Pharmacology , 17 Mar 2008

The L ipid lowering and O nset of R enal D isease (LORD) Trial: A randomized double blind placebo controlled trial assessing the effect of atorvastatin on the progression of kidney disease: ... inflammation and drug safety and tolerability. ...

Robert G Fassett et al.

BMC Nephrology , 18 Mar 2008

Balancing commercial and public interests: ... optimal disclosure of drug safety or inferiority ...

Curt D Furberg et al.

Current Controlled Trials in Cardiovascular Medicine , 2004

Evaluation and validation issues in the development of transgenic mouse carcinogenicity bioassays.: ... in chemical and drug safety assessments. Further, ...

R W Tennant

Environmental Health Perspectives , 01 Apr 1998

Diagnosis of drug-induced renal tubular toxicity using global gene expression profiles: ... changes associated with drug induced toxicities. It is expected that toxicogenomics can be an alternative or complementary approach in preclinical drug safety evaluation to identify ...

Ying Jiang et al.

Journal of Translational Medicine , 01 Oct 2007

11 further publications >>