Spontaneous case reports

Mononeuropathy multiplex (MM) is an infrequent complication that can occur in early HIV infection, because of dysimmune or vasculitic mechanisms (Gherardi et al. 1989 Chamonard et al. 1993 Bradley and Verma 1996 Schifitto et al. 1997 Mahadevan et al. 2001). Seroconversion-related MM has been described in a case report (Sngimoto et al. 2006). Most of these patients have a good prognosis as symptoms resolve spontaneously and treatment may not be necessary. In others, treatment has focused on intravenous immunoglobulin, judicious short-term use of steroids, and a combination of zidovudine and plasmapheresis (Chamouard et al. 1993 Cohen et al. 1993 Bradley and Verma 1996 Schifitto et al. 1997). 

Despite the anecdotal nature and sometimes poor documentation, publication of case reports in journals remains one of the most useful primary sources of information on ADRs. ADR reports in the literature can be identified in several different ways. Prepublication manuscripts describing a spontaneous case report or an event from a clinical trial are sometimes provided by authors to the manufacturer of the drug and the regulatory authority in that country. Pharmaceutical companies are required to be aware of the literature as to the safety of their approved therapeutic products, and are assumed (by law) to be cognizant of such. 

Several case reports of spontaneous bilateral subdural hematomas associated with chronic ginkgo use have been reported ( 241, 242). Although these reports may simply reflect the underlying vascular problems for which ginkgo is most often taken, they may also be due to the effect of ginkgo on platelet function. There has also been one case of tonic-clonic seizures and loss of consciousness following a ginkgo overdose in an infant ( 243). 

By contrast, a number of studies have not found verapamil monotherapy to be effective for acute mania (Table 10-14). Several case reports in the literature have not supported verapamil s potential antimanic properties. For example. Barton and Gitlin ( 262) found that none of eight acutely manic or hypomanic patients treated openly improved on verapamil. By contrast, there are several case reports of hypomania (some monoamine oxidase inhibitor—induced) improving with verapamil. Dubovsky (255) notes that, in his experience with spontaneous mania, he has been unimpressed with verapamil in patients who had previously been unresponsive to lithium. 

Published case reports on alprazolam show a slightly different profile (266, 267, 268 and 269). Four patients had taken the drug for 4.5 months or less one had also taken chlorpromazine and trazodone and a fifth patient had taken alprazolam (3 mg/day for 26 weeks) and phenelzine (45 mg/day for 13 weeks), abruptly stopping both. According to the FDA s Spontaneous Adverse Event Reporting System, more seizures have been reported with alprazolam than with all other BZDs combined (270). The next highest incidence was reported for lorazepam. The FDA report stated the following ... 

Rose KD, Croissant PD, Parliament CF, Levin MB. Spontaneous spinal epidural hematoma with associated platelet dysfunction from excessive garlic ingestion a case report. Neurosurgery 1990 26 880-882. 

Information in the PI is typically based on the studies submitted by a drug s manufacturer. The FDA has also utilized spontaneous adverse event case reports as a tool in the evaluation of drug-grapefruit juice interaction labeling. Other sources of data that contribute to labeled information include studies or case reports from the medical literature. 

Spontaneous case reports have been an important addition to literature reports and manufacturer-submitted clinical studies to help the FDA continuously evaluate product labeling for drug-grapefruit interaction. 

Ley [426] has reported a case of spontaneous elimination of benzenesulfinic acid in the reactions of the anion of 2-benzenesulfonyl-tetrahydropyran with electrophiles. A convenient synthesis of spiroketals... 

Rupture of the plantar fascia induced by glucocorticoids has usually been reported in athletes. However, a case of spontaneous degenerative rupture has been reported in a 72-year-old man who had received four glucocorticoid injections over 1 year for plantar fasciitis (SEDA-21, 418) (277). 

Porcu G, Courbiere B, Sakr R, Carcopino X, Gamerre M. Spontaneous rupture of a first-trimester gravid uterus in a woman exposed to diethylstilbestrol in utero a case report. J Reprod Med 2003 48 744-6. 

Bent S, Goldberg H, Padula A, Avins AL. Spontaneous bleeding associated with ginkgo biloba-. a case report and systematic review of the literature a case report and systematic review of the literature. J Gen Intern Med. 2005 20 657-661. 

Factors that indicate a causal association between triazolam and adverse behavioral reactions include corroborating case reports and sleep laboratory studies in the literature, reports of reactions in otherwise normal persons, acute onset and temporal relationship to reactions with initial dose, spontaneous recoveries and return to normalcy with drug discontinuation, and occurrences of positive rechallenge. Also, the high benzodiazepine receptor affinity with triazolam has been postulated as a possible biological mechanism. 

Two cases of spontaneous pneumothorax in intranasal cocaine users have been reported from Italy (112). 

Steinhauer JR, Caulfield JB. Spontaneous coronary artery dissection associated with cocaine use a case report and 112. brief review. Cardiovasc Pathol 2001 10(3) 141-5. 

Hunter JG, Loy HC, Markovitz L, Kim US. Spontaneous pneumomediastinum following inhalation of alkaloidal cocaine and emesis case report and review. Mt Sinai J Med 1986 53(6) 491-3. 

A brainstem cavernoma demonstrating a dramatic spontaneous decrease in size during follow-up case report and review of the literature. Surgical Neurology 63 170-173... 

Primary reports describing adverse reactions and drug-induced diseases include spontaneous reports and other unpublished data available from the manufacturer or the FDA. All reports of adverse reactions reported to the FDA can be retrieved (without identifiers) under the legal authority of the Freedom of Information Act. Anecdotal and descriptive reports of ADRs (including case reports and case series) are occasionally reported in the literature but are often incomplete and inconclusive. Guidelines for evaluating adverse drug reaction reports have been described (56). 

Jayaraj, K., di Bisc Ue, A.M., Gibson, S. Spontaneous bacterial peritonitis caused by infection with Listeria monocytogenes a case report and review of the hterature. Amer. X Gastroenterol. 1998 93 1556-1558... 

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