Reporting adverse reactions

Adverse reactions reported with didanosine include headache, peripheral neuropathy, rhinitis, cough, diarrhea, nausea, vomiting, anorexia, hepatotoxicily, and pancreatitis. 

The answer is d. (Hardman, pp 1398-MOO.) Methimazole is classified as a thioamide and is used in the treatment of hyperthyroidism It prevents the organification of F by blocking the oxidation of F to active I and also inhibits coupling of iodotyrosines. Excessive treatment with this drug may induce hypothyroidism. Some other adverse reactions reported for... 

Irey, N.S., Drug adverse reaction reports related to immunotoxicity, in Inadvertent Modification of the Immune Response The Effects of Foods, Drugs, and Environmental Contaminants, Asher, I.M., Ed., US Food and Drug Administration, Washington, D.C., 1978, p. 140. 

From 1980 through June 2000, the FDA received a total of 34,011 reports describing adverse reactions attributed to food additives, food products, infant formula, medical foods, dietary supplements, and other substances in food. Adverse reaction reports were submitted by consumers, food companies, consumer advocacy groups, and by individuals commenting on various FDA initiatives and proposals. The food additives receiving the most complaints are shown in Table 7.1. The fat substitute olestra accounted for more than half of all complaints received by ARMS. The following six sections pertain to food additives that have generated controversy because of safety concerns. For each additive, pertinent data from the ARMS database are presented. 

Table 7.1 ARMS data. Food additives receiving adverse reaction reports, 1980-June 2000. (Data include adverse reactions reported to FDA before ARMS was officially established in 1985)...

Article 83.6 also states that Articles 24(1) and 25 (which set out adverse reaction reporting requirements for centrally authorised products) will apply to products supplied for compassionate use. 

Table 15.7 Adverse reaction reports in WHO database from EU countries. Distribution of reports per therapeutic drug group as percentage of total number of reports...

All such reports should be reported immediately and in no case later than 15 calendar days from receipt. The clock for expedited reporting starts as soon as one or more of the following has received the minimum information reqmred for the submisssion of an adverse reaction report ... 

Griffin JP, Weber JCP Voluntary systems of adverse reaction reporting. Part I. Adv Drug React Ac Pois Rev 1985 4 213-30. 

Voluntary adverse reactions reporting system the yellow card scheme ... 

This spontaneous adverse reaction reporting system was the brainchild of Professor Leslie Witts and was, and still is, based upon the submission of ADR reports by doctors and dentists by means of reply-paid yellow cards, and hence it is popularly known as the Yellow Card Scheme. ... 

Table 16.4 Annual number of total and fatal Adverse Reaction Reports to the CSD and CSM...

The most frequent adverse reactions reported were back pain, pain, nausea. 

The most common adverse reactions reported in patients were dry mouth and constipation. 

Adverse reactions reported in at least 3% of patients include the following Abdominal pain, diarrhea, dyspepsia, nausea, flatulence. 

Enuretic children - Consider adverse reactions reported with adult use. Most common are nervousness, sleep disorders, tiredness, and mild Gl disturbances. These usually disappear with continued therapy or dosage reduction. 

Adverse reactions with other methylphenidate hydrochloride products -Nervousness and insomnia are the most common adverse reactions reported with other methylphenidate products. In children, loss of appetite, abdominal pain, weight loss during prolonged therapy, insomnia, and tachycardia may occur more frequently however, any of the other adverse reactions listed also may occur. 

Estazolam Other adverse reactions reported only for estazolam include the following somnolence (42%) asthenia (11%) hypokinesia (8%) hangover (3%) cold symptoms, lower extremity/back/abdominal pain (1% to 3%). 

Miscellaneous Optic neuritis, superinfections caused by resistant organisms. Monohydrate/macrocrystals In clinical trials of monohydrate/macrocrystals, the most frequent adverse reactions that were reported as possibly or probably drug-related were nausea (8%), headache (6%), and flatulence (1.5%). Additional clinical adverse reactions reported as possibly or probably drug-related occurred in less than 1% of patients studied and are listed below ... 

The spectrum of adverse reactions reported in 120 immunocompromised pediatric clinical trial participants with serious CMV infections receiving IV ganciclovir were similar to those reported in adults. Granulocytopenia (17%) and thrombocytopenia (10%) were most commonly reported. 

Monitoring safety of marketed medicines including collecting and analysing adverse reaction reports... 

The major adverse reactions reported are hypersensitivity rashes and diarrhea. The rash is usually itchy, morbilliform, and general. Gastrointestinal intolerance with abdominal pain, nausea, and vomiting occurs infrequently. Hepatotoxicity and bone marrow suppression have been noted. 

The most frequent adverse reactions reported are sedation, followed by dizziness, weakness and unsteadiness. Less frequent adverse reactions include disorientation, depression, nausea, change in appetite, headache, sleep disturbance, agitation, dermatological symptoms including very serious reactions, eye-function disturbance, together with various gastrointestinal symptoms and autonomic manifestations. The incidence of sedation and unsteadiness increases with age. 

Adverse reactions reported are bron-chospasm, throat irritation and rarely headache, dizziness, rashes and nasal congestion. 

Chen MC, Huang S-M, Mozersky R, Beitz J, Honig P. Drug interactions involving St. John s Wort-data from FDA s adverse reaction reporting system. Presented at the American Association of Pharmaceutical Scientists Annual Meeting, Denver CO, October 2001. 

Category X Studies in animals or humans or adverse reaction reports, or bodi, have demonstrated fetal abnormalities. The risk of use in pregnant women clearly outweighs any possible benefit. 

Adverse reaction reports and device defect reports, if imposed in the PMA approval order, 21 CFR 814.82(a)(9) but only to the extent that such reports do not duplicate MDR reporting requirements... 

Other components in the Echinacea products may contribute to many of the adverse reactions reported, not only Australian, but also the United States, United Kingdom, Canada and New Zealand. Additional studies are needed to further support the IgE-mediated hypersensitivity reported in Echinacea-containing products. Studies could include growing and processing of Echinacea under environmentally controlled conditions, with the intent to minimize foreign contaminants, and administration of extracts to patients under supervision. Although this would not represent real-world conditions, it may further support or refute the IgE-mediated hypersensitivity observed in subjects taking commercial Echinacea products. Additional work is also needed to identify the component responsible for the IgE-mediated hypersensitivity. 

Of the three methods, the first, or checklist technique, has the greatest tendency to make patients introspective regarding their symptoms. Not surprisingly, this approach elicits the largest number of adverse reaction reports. Regardless of the method used, however, it is imperative that the questions be applied in the same way at each patient assessment, preferably by the same person, for the duration of the study. It is also recommended that patients be carefully questioned prior to administration of the study drug. It is remarkable how many so-called adverse reactions are, in fact, symptoms of other conditions present before the study treatment starts. 

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