Case-control studies adverse drug reactions

Soldatos et al. (1986) reported on serious adverse drug reactions in all five psychiatric inpatients during a clinical trial of 0.5 mg triazolam and placebo. The patients and nurses were blind in the study, but not the physician with medical responsibility for the patients. The study consisted of 1 week of placebo baseline, 2 weeks of triazolam administration, and 1 week of withdrawal on placebo. All five patients developed severe reactions to triazolam. Case 1 developed anxiety and hallucinations on the last two days of triazolam administration and the first withdrawal day. Case 2 had a sudden increase in anxiety and became irritable, uncooperative, and depressed. She became withdrawn and cried, and showed considerable impairment of memory and orientation. On withdrawal of triazolam, she became more incoherent, expressing paranoid ideas of persecution that persisted about a week. She required Haldol to control her delusions. Case 3 developed severe insomnia during withdrawal and reported considerable anxiety and irritability along with an uncontrollable fear of death, which persisted to the next day when she additionally manifested a marked degree of memory impairment. Case 4, by... 

The primary evaluation (in our system at the end of the hospital stay) for such cases must be checked again by a secondary or even a further evaluation in connection with the specific characteristics of the problem studied. This final or secondary evaluation has to be independent from the causality level originally attributed (Inman 1982). Assessing the causality of adverse drug reactions, even with standardized approaches, should remain an activity under control of physicians (Venulet 1982). 

Gau SS, Chao PF, Lin YJ, Chang CJ, Gau CS. The association between carbamazepine and valproate and adverse cutaneous drug reactions in patients with bipolar disorder a nested matched case-control study. J Clin Psychopharmacol 2008 28(5) 509-17. 

Drug contamination Adverse reactions to heparin contaminated with oversulfated chondroitin sulfate have been evaluated in a US case-control study of patients in dialysis facilities who had signs and symptoms of allergic reactions after 1 November 2007 [122 ]. There were 152 adverse reactions associated with heparin in 113 patients from 13 states from 19 November 2007 to 31 January 2008. The use of heparin manufactured by Baxter Healthcare was the factor most strongly associated with reactions, which occurred in 100% of 21 facilities in which cases were reported versus 4.3% of 23 control facilities. Vials of heparin manufactured by Baxter from facilities that reported reactions contained a contaminant identified as oversulfated chondroitin sulfate. Adverse reactions to the contaminated heparin were often characterized by hypotension, nausea, and shortness of breath within 30 minutes of administration. Of 130 reactions for which information on the heparin lot was available, 128 occurred in a facility that had contaminated heparin on the premises. Of 54 reactions for which the lot number of the heparin was known, 52 occurred after the administration of contaminated heparin. 

BXSB/Mp, NZBxNZW/Fl, NZM, AKR). Experience with any of these strains is scarce and is restricted mainly to salts of heavy metals such as mercury. Mercury has been clearly shown to have immunostimulatory effects in NZBxNZW/Fl mice (Pollard et al., 1999). In a study examining the immunotoxic effects of diphenyl-hydantoin (Bloksma et al., 1994), MRL mice were exposed to the drug in the drinking-water for a period of six months in this case, however, no indications of adverse immune reactions were found. Future studies should include more autoimmunogenic pharmaceuticals and negative controls in order to determine the extent to which systemic lupus erythematosus-prone models are useful to study or predict chemical-induced autoimmunity. 

Placebo-controHed studies In a doubleblind, randomized, placebo-controlled study in 105 unconscious adults with suspected drug overdose, 73 of whom had taken benzodiazepines, flumazenil caused adverse effects in nine cases agitation (n = 3), a depressive mood (n = 3), nausea and vomiting (n = 1), shivering (n = 1), and one severe adverse reaction—a sudden fall in blood pressure in a 28-year-old woman in deep coma after combined poisoning with benzodiazepines and maprotiline [95 "]. 

In addition to the three more recent withdrawals of Merital, Serzone, and Cylert, I have also reviewed the entire list of serious adverse reactions to psychiatric drugs detected during the postmarketing period in the GAO (1990) study. It seems probable that every one of them was discovered and confirmed through a combination of the SRS, individual case reports, and general clinical experience. As far as I can ascertain, not one of these adverse reactions was primarily, if at all, identified by means of a controlled clinical trial. As a result of postmarket discoveries, alprazolam (Xanax) had rage added to the label as a paradoxical reaction, and amoxapine (Asendin) had NMS added. 

Skin testing with vancomycin and teicoplanin has not been well studied and the procedure remains to be validated with both positive and negative predictive values unknown. Skin test results, and particularly details of drug concentrations used and methodologies employed, are hard to find in the vancomycin-teicoplanin literature on adverse reactions. In a case study of vancomycin anaphylaxis followed by successful desensitization, intradermal skin tests with the drug were positive at a concentration of 0.1 pg/ml. Control subjects showed positive responses at concentrations of 10 pg/ml or greater. A loss of skin test reactivity to vancomycin has been demonstrated in one case study after successful desensitization to the drug. 

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