Adverse report

Any adverse report (verbal or written) received by a supplier from a customer. 

For example, Asuri and his co-workers (Asuri et al., 2007) reported that the proteases attached to the surface of SWCNTs can create self-cleaning surfaces that resist protein adsorption. This kind of SWCNT-enzyme composite exhibited 30 times higher overall catalytic activity than control composites where the proteases were conjugated to a non-nanoscale graphite support. Importantly, the enzymes preserved more than 90% of their initial activity over 30% days in the liquid buffer, with only negligible amounts of enzymes leaching out. The result demonstrates that the nanocomposites of SWCNTs and polymers can act as hosts for enzymes and can prevent protein contamination on the surface of medical devices. We consider that SWCNTs may have the function as biocatalyst to improve the enzyme activity attached to the surface of CNTs. Our previous work also indirectly hints that CNTs could improve the bioactivity of enzymes such as Taq enzyme Cui et al. (2004). However, there are also adverse reports. CNTs can... 

One study evaluated only the cognitive effects of single doses of 0.125-mg triazolam ( 324). Although the others assessed hypnotic efficacy, in all but one of these, study duration was 2 to 14 nights. In the remaining study, with a duration of 3 to 9 weeks, five of 22 elderly subjects (23%) were taken off triazolam between the third and fifth weeks because of serious adverse effects ( 323). The researchers reported, At week 3 significantly more triazolam patients were rated as more restless during the day (p < 0.05) and they also appeared more hostile, less relaxed, more irritable, and more anxious. After withdrawal of triazolam, these adverse reports... 

Interferons are uniquely species specific and are not active in rodents. In addition the class-specific product attributes, including the mechanisms of action of the respective subtypes, reduces cause for concern for carcinogenic risk. No malignancies have been reported under adverse reactions in clinical trials, and there are no warnings or precautions regarding carcinogenic risk in the product labels or adverse reports reported postmarketing. 

Bias may affect a drug company s overall analysis of the patterns of adverse reports from the clinical trials. In my forensic experience, the methodology of the analyses may deviate drastically from the scientific process. In addition, if the conclusions seem to threaten the future of the drug, the conclusions may be modified or kept secret (see chapter 14). In general, drug companies have learned to employ many of what Scott (2006) called tricks of the trade to make clinical trials produce exaggeratedly good results. 

Van Wyk reported an increase of 100% in sales of molybdenum disulphide as a solid lubricant between 1962 and 1972. However, this rapid expansion led to a number of adverse reports of its performance. BOAC reported accelerated corrosion of Boeing 707 undercarriage bogeys associated with its use, although other reports indicated that corrosion problems on the bogeys disappeared when conventional... 

Several publications have reported that composites of molybdenum disulphide with a high nickel content were not satisfactory , and nickel alloys are recognised to be susceptible to attack by sulphur or sulphur compounds at elevated temperatures. Al tman et al found that certain alloying elements, especially molybdenum, can stabilise the composite structures. However, the adverse reports of composites in nickel are not universal, and a few successful examples will be described later. 

The use of heparinized catheters for in vivo erythrocyte labelling with " Tc-pyrophosphate occasionally produces adverse reports, such as diminution of cardiac activity and increase of renal activity due to the formation of a technetium-heparin complex which localizes avidly in the kidneys. A few cases reported the possibility of reaction of radiopharmaceuticals with the components of a syringe or needle. 

The Yale doctors did conclude that peroxide enemas are safe if the concentration is carefully controlled. But that got lost in the adverse report. Govoni reported 30 cases using 10 cc of three percent H202 in one liter of water with no complications.3... 

A metabolic study in 10 healthy subjects found that the clearance of paracetamol 1.5 g was almost halved (from 6.23 to 3.42 mL/minute per kg) when it was taken 1 hour after a 1-g dose of probenecid. The amount of unchanged paracetamol in the urine stayed the same, but the glucuronide metabolite fell sharply. Another study in 11 subjects also found that probenecid 500 mg every 6 hours almost halved (from 329 to 178 mL/minute) the clearance of a 650-mg intravenous dose of paracetamol. The urinary excretion of the glucuronide metabolite was decreased by 68% and the excretion of the sulfate metabolite increased by 49%. These studies suggest that probenecid inhibits paracetamol glucuronida-tion, possibly by inhibiting glucuronyltransferase. See also paracetamol , (p.l33). The praetical consequences of this interaction are uncertain but there seem to be no adverse reports. 

Six healthy subjects were given a single 200-mg dose of mexiletine before and after faking fluconazole 200 mg daily for 7 days. Two of the subjects were given fluconazole 400 mg daily for a further 7 days. No significant changes in the pharmacokinetics of mexiletine were seen. The clinical outcome of concurrent use in patients was not studied, but there appear to be no adverse reports in the literature. No special precautions appear to be necessary if these drugs are used concurrently. 

The absence of adverse reports about these very widely used drugs suggests that concurrent use is normally uneventful. 

The interactions of ergot derivatives with erythromycin and troleandomycin are well documented, well establish, and clinically important, whereas information about clarithromycin appears to be eonfined to three possible cases and that relating to oleandomycin to one case. There are no adverse reports about midecamycin, but it is expected to interact similarly. The concurrent use of all of these macrolides and ergot derivatives should be avoided. Some of the cases cited were effectively treated with sodium nitroprusside or naftidrofuryl oxalate, with or without heparin. "" " Spiramycin, and josamycin would not be expected to interact because they do not inhibit CYP3A4. However, there is one unexplained and unconfirmed report of an interaction with josamycin. "... 

Apart from these few reports, the literature appears to be otherwise silent about an interaction between the MAOIs and xanthines. Whether this reflects their mildness and unimportance, or their rarity, is not clear. There would seem to be no need for any special precautions in patients taking MAOIs who are given xanthine bronchodilators or consuming caffeine-containing heverages or pharmaceuticals, but bear these adverse reports in mind in the event of any unexpected response. Nevertheless, some manufacturers of MAOIs recommend the avoidance of excessive amounts of tea and coffee, or caffeine in any form. " ... 

Leakage around calcium hydroxide sealers has been studied experimentally, and findings have generally been satisfactory [34-36]. However, there have been some adverse reports [37], and these variations have been attributed to crucial differences in experimental methods [38]. Leakage appears to be related to both the solubility of the material and the questionable adhesion to both the dentine walls and the gutta percha points. The calcium hydroxide sealer Apexit, for example, was found to have a high solubility when set compared with other types of endodontic sealer [39] and, in some studies, sealer particles have been found to occur with the tissues at a considerable distance from the sample [40,41],... 

Figure 1 Averaged distribution of adverse reports obtained on urine A samples emitted by all the IOC accredited laboratories in the recent years following the classes of prohibited substance. (Adapted from original 1995-2000 data released previously by IOC see, for example, www.olympic.org.)...

Kirby, R. L., Ackroyd-Stolarz, S. A., Wheelchair Safety—Adverse Reports to the United States Food and Drug Administration, American Journal of Physical Medicine Rehabilitation, Vol. 74, No. 4, 1995, pp. 308-312. 

Some halogenated flame retardants, such as the polychlorinated polycychc hydrocarbon DECHLORANE PLUS, have escaped adverse reports. Chloroparaf-fins have been found to be of toxicological concern at the low molecular weight end of the series (lARC 2B rating possible carcinogen) but above C13, the chloroparaf-fins are rated as noncarcinogenic (156,157). Likewise, the aquatic toxicity favors the long-chain chloroparaffins. 

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