Potential for adverse effects

System considers surface water and groundwater pathways of exposure in evaluating the potential for adverse effects. Air and soil pathways will be added as will numerous built-in error checking routines. 

Medications that have been used as treatment for anxiety and depression in the postwithdrawal state include antidepressants, benzodia2epines and other anxiolytics, antipsychotics, and lithium. In general, the indications for use of these medications in alcoholic patients are similar to those for use in nonalcoholic patients with psychiatric illness. However, following careful differential diagnosis, the choice of medications should take into account the increased potential for adverse effects when the medications are prescribed to alcoholic patients. For example, adverse effects can result from pharmacodynamic interactions with medical disorders commonly present in alcoholic patients, as well as from pharmacokinetic interactions with medications prescribed to treat these disorders (Sullivan and O Connor 2004). 

Weight of evidence demonstrates potential for adverse effects in humans EU Category 1 or 2 or CHS Category 1A or 1 B Evidence of adverse effects in humans ... 

Potential for adverse effects or need for lifelong replacement... 

While there are many non-contraceptive benefits associated with the use of combined oral contraceptives, their use is not without risk or potential for adverse effects. 

Select therapy based on comorbidities and potential for adverse effects. In patients with no other disease states, NSAIDs are the preferred drug class. 

Empirical therapy should be based on patient- and antimicrobial-specific factors such as the anatomic location of the infection, the likely pathogens associated with the presentation, the potential for adverse effects, and the antimicrobial spectrum of activity. 

Most initial antimicrobial therapy is empirical because cultures usually have not had sufficient time to identify a pathogen. Empirical therapy should be based on patient- and antimicrobial-specific factors such as the anatomic location of the infection, the likely pathogens associated with the presentation, the potential for adverse effects in a given patient, and the antimicrobial spectrum of activity. Prompt initiation of appropriate therapy is paramount in hospitalized patients who are critically ill. Patients who receive initial antimicrobial therapy that provides coverage against the causative pathogen survive at twice the rate of patients who do not receive adequate therapy initially.8... 

One of the mandates of the Agency forToxic Substances and Disease Registry (ATSDR) (under the Comprehensive Environmental Response, Compensation, and Liability Act, Section 104(i)(3), or Superfund) is to address the potential for adverse effects on public health resulting from lead exposure. Lead has been identified as a contaminant in at least 1,026 of the National Priorities List (NPL) sites and is currently ranked first on the Priority List of Hazardous Substances (ATSDR 1996a). Consequently,... 

Eversole 1980). It is probable that bioavailable concentrations from the water in each test did not exceed 1.0 pg/L. However, delayed mortality frequently occurs for extended periods after exposure, and the potential for adverse effects at the population level remains high (NAS 1978). Latent biocidal properties of mirex were documented for hsh (Van Valin et al. 1968 Koenig 1977) and crustaceans (Ludke et al. 1971 Hyde 1972 Cripe and Livingston 1977). Crustaceans were the most sensitive group examined. For example, the crayfish (Procambarus blandingi) immersed in nominal concentrations of 0.1 to 5.0 pg mirex/L for periods of 6 to 144 h died 5 to 10 days after initial exposure (Ludke et al. 1971). Immature crayfish were more sensitive than adults, and mortality patterns were similar when mirex was administered in the water or in baits (Ludke et al. 1971). 

A metaanalysis indicated that EGb 761 (an extract of ginkgo biloba) may have some therapeutic effect at doses of 120 to 240 mg of the standard leaf extract twice daily. Because of limited efficacy data, the potential for adverse effects (e.g., nausea, vomiting, diarrhea, headache, dizziness, weakness, and hemorrhage), and the poor standardization of herbal products, it is recommended that ginkgo biloba be used only with caution. 

Ligand binding or enzyme data suggesting a potential for adverse effects. 

Antispermatogenic effects of 1,2-dibromoethane have been observed in humans occupationally exposed to 1,2-dibromoethane (Ratcliffe et al. 1987 Takahashi et al. 1981 Ter Haar 1980). These effects include changes in sperm velocity and count. Whether or not these effects are associated with reduced fertility in humans cannot be totally addressed, since the epidemiologic study (Wong et al. 1979) was not capable of detecting such a sensitive effect. Although this study had several limitations, it indicates a potential for adverse effects of 1,2-dibromoethane on fertility. 

Plants have been used as biologic indicators of oxidant pollutants for many years. Attempts have been made to use plants as monitors, but too many unknown variables are involved. Plants may be capable of monitoring the total biologic potential for adverse effects, but no research has been developed along these lines. 

Lactation Although it is not known whether indinavir is excreted in breast milk, there exists the potential for adverse effects from indinavir in nursing infants. Instruct mothers to discontinue nursing if they are receiving indinavir. 

The US National Toxicology Program (NTP) and the National Institute of Environmental Health Sciences (NIEHS) have established the NTP Center for the Evaluation of Risks to Human Reproduction in 1998. The Center provides scientifically based, uniform assessments of the potential for adverse effects on reproduction and development caused by agents to which humans may be exposed. 

The most important determinant of appropriate dosing is clinician s judgment of the patients response to therapy the clinician must monitor the patients response in terms of clinical control and adjust the dose accordingly. Once control of asthma is achieved, the dose medication should be carefully titrated to the minimum dose required to marntam control, thus reducing the potential for adverse effects. 

Designation of low, medium, and high doses is provided from manufactures recommendations where possible. Clear demonstration of dose response relationships is seldom provided or available. The principal is therefore to establish the minimum controlling dose in each patient as higher doses may not be more effective and are likely to be associated with greater potential for adverse effects. 

III.c.2.2. Intravenous versus oral therapy. Intravenous therapy (IVT) generates maximum, fast, and long lasting efficacy with minimum adverse effects while the efficacy of oral therapy is less, slow and short lasting with more potential for adverse effects. 

Teratology testing is only listed as a requirement at 100 tonnes or more (Annexes IX and X), although where there are serious concerns about the potential for adverse effects on development a teratology study may be proposed for substances at 10 tonnes or more. 

Geriatric Considerations - Summary Dicyclomine is a weak anticholinergic but has the potential to cause adverse effects in the older adult, including urinary retention, hypotension, and confusion. The potential for adverse effects limits the usefulness of this drug for older adults. 

In addition, the development of optimal research designs with appropriate blinding is necessary to adequately assess acute and maintenance efficacy, as well as the potential for adverse effects (192). Studies of TMS as a treatment for depression have also addressed issues such as coil location and configuration, stimulus frequency, and intensity. Varying parameters and number of treatments, however, make it difficult to compare these studies. Table 8-13 summarizes the most commonly considered parameters (193). 

Thus, any potential strategy must carefully consider the risk-benefit ratio on an individualized basis, because a given patient may be particularly vulnerable to certain adverse events. This section considers the potential for adverse effects associated with mood stabilizers. The goal is to help clinicians develop strategies that minimize these risks (77). 

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