General safety profile

Ross, D. Telithromydn (Ketek) General Safety Profile, www.fda.gov/ohrms/ dockets/ac/01/slides/3746s 05 Ross/ sld041.htm, last accessed on 17th March 2003. 

The general safety profile from CEREP including 155 in vitro assays specifically designed to identify potential side effects of drug candidates (not in a specific pathology). 

General precautions for each medication that has been used for smoking cessation are listed in the sections describing each medication. All FDA-approved first-line medications for smoking cessation have a relatively good safety profile. Consensus opinions on the safety of the various medications for persons with cardiovascular disease, other medical conditions, and pregnancy are beyond the scope of this chapter but can be found elsewhere (Society for Research on Nicotine and Tobacco 2003). 

Layton D, Riley J, Wilton LV, et al. Safety profile of rofecoxib as used in general practice in England results of a prescription-event monitoring study. Br J Clin Pharmacol 20(B 55 166-74. 

In chnical trials, zolpidem shortened sleep latency, improved the quahty of sleep, and accelerated the restoration of normal sleep patterns (Lee, 2004). In insomniac patients it increased the amount of slow wave, restorative sleep as seen in normal sleepers. Zolpidem has high oral bioavailability (70%), a short duration of action (tj /2 = 2 h), and is relatively highly bound to plasma proteins (92%). The recommended dose is generally 10 mg/day as needed. Zolpidem is extensively metabolized, mainly by CYP3A4 but also by CYP1A2 and CYP2C9, and its major metabolites do not appear to have pharmacological activity. It has minimal daytime residual effects, and a low risk for tolerance and abuse. The safety profile showed a low incidence of adverse events, close to that observed with placebo. The medicine is available in over 80 countries. 

The efficacy of TCAs, principally impramine, has also been tested as treatment of separation anxiety and school phobia. Four placebo-controlled studies involving 140 children have been conducted (153, 158, 159 and 160). Whereas early studies were positive, subsequent reports were not. Gittelman-Klein and Klein ( 161) demonstrated a significant benefit over placebo from 6 weeks of treatment with imipramine (mean dose = 159 mg per day) in 45 children with school phobia. A subsequent study using lower amounts of clomipramine (40 to 75 mg per day) was negative but the doses used make interpretation difficult. Also, because of its tolerability and safety profile, clomipramine is generally not used as an anxiolytic agent in children or adolescents. 

Clinical trials, also known as clinical studies, test potential treatments in human volunteers to see whether they should be approved for wider use in the general population. A treatment could be a drug, medical device, or biologic, such as a vaccine, blood product, or gene therapy. Potential treatments, however, must be studied in laboratory animals first to determine potential toxicity before they can be tried in people. Treatments having acceptable safety profiles and showing the most promise are then moved into clinical trials. 

In general, ciclesonide in daily doses of up to 640 micrograms can be considered to be safe with respect to adrenal function. Its long-term safety profile is similarly advantageous, and administration in daily doses up to 1280 micrograms over 52 weeks was not associated with systemic or local adverse effects in patients with persistent asthma (50). 

In general, the better safety profile of the newer generation nonbenzodiazepines, for example, zaleplon compared to benzodiazepines, makes them better first-line choices for long-term treatment of chronic insomnia [39]. 

The major activity or obstacle of concern in developing and registering a plant growth regulator, or any pesticide, involves the total toxicity and safety profile. Of primary concern is the impact of federal agency regulations attention is generally focused on the EPA (14, 15, 16, 17, 18). 

---