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ADVERSE REACTION NEWSLETTER 1996:4 NATIONALLY CIRCULATED INFORMATION Back Australia Austria Denmark Japan Malaysia New Zealand Philippines United Kingdom USA NATIONALLY CIRCULATED INFORMATION
Australia
ADRAC Bulletin Vol 15,No 4.November 1996 Minocycline and the liver, the CNS,the skin Minocycline (Minomycin) use appears to be increasing and much of it is for the treatment of acne. There are 425 reports describing adverse effects in three particular areas: the liver, the CSN,and the skin. There have been 27 reports involving hepatic dysfunction variously described as hepatitis (9 cases), jaundice (6 cases), fatty liver (1 case) and abnormal hepatic function (11 cases). Minocycline was the only drug suspected in 24 of the reports. Minocycline also has been associated with a variety of CNS effects, particularly dizziness. Of the 425 reports to ADRAC, dizziness or the related symptoms of vertigo, labyrinthine disorder or ataxia are described in 146 cases. Minocycline is the drug most commonly reported to ADRAC in this context. Another unusual adverse reaction in association with minocycline is skin discolouration, for which minocycline has been reported to ADRAC as a cause more than any other drug. ADRAC recently reviewed a report of a child born with microcephaly and dystonia whose mother had inadvertently ingested large quantities of vitamin A during the first 4 or 5 weeks of pregnancy. The child subsequently died. Excess amounts of vitamin A are suspected causes of birth defects and its therapeutically used congeners are established causes of birth defects. It is important for prescribers to realise that the recommended adult daily allowance of vitamin A from all sources is 2500 IU. file://J:\Publications\Newsletter\Archive\1996\96_4.htm Slightly less than 1% of all reports to ADRAC describe angioedema as a suspected adverse reaction and the drugs most commonly involved are ACE inhibitors, antibiotics and NSAIDs with ACE inhibitors particularly prominent. Angioedema appears to be a class effect of ACE inhibitors and ADRAC has received reports in association with all members of the class marketed in Australia. These reports describe a total of 270 patients. In the majority of cases (84%), the ACE inhibitor was the only drug suspected of causing the reaction. ADRAC reminds prescribers that ACE inhibitors are an important cause of angioedema. There can be an extended period of latency before onset, recurrent episodes can occur, and visceral involvement is possible. Recognition should lead to cessation of therapy with all members of the class. Although hypertension was not shown to be associated with moclobemide (Aurorix) in premarketing studies, ADRAC has had 12 reports of this association. In at least 5 cases, the reaction occured in patients with a past history of hypertension, and in the others, hypertension appeared to be a new development. ADRAC is keen to define further this potentially important "signal" and seeks more reports. Such reports should preferably contain blood pressure readings before and during therapy with moclobemide. There have been some reports after papaverine injection in the treatment of impotence. The injection in corpus cavernosum penis, with for example high doses after the first use, in some cases leads to painful priapism for some hours and in one case it was up to 4 days duration. Information from Sundhedsstyrelsen, Adverse Reaction Section. Overview of ADR reporting in 1995 In 1995 the Bivirkningsnaevnet received 1242 reports of suspected adverse drug reactions. This is a marked drop compared to previous years. Generally far too few ADRs are being reported, this is especially true for spontaneous reporting. A questionnaire revealed that it is the practical problems with reporting, like that not having the time needed for reporting or not having the reporting forms at hand, that has lowered the report frequency. The Bivirkningsnaevnet tries to increase understanding of the importance of ADR reporting, especially of unexpected reactions occurring with newer drugs. The Bivirkningsnaevnet is continuously publishing reporting forms and lists of drugs registered during the previous year. Hospitals have a special responsibility for reporting of ADRs , but over the past three years have only contributed about 40% of the total amount of reports. Therefore the Bivirkningsnaevnet sent out a letter to all hospitals stressing the importance of reporting as part of the routine work for physicians, just as other standard functions like writing of case summaries etc. The results of 1995 show a need for better organisation and that ADR reporting gets higher priority. file://J:\Publications\Newsletter\Archive\1996\96_4.htm During 1996 the Bivirkningsnaevnet has published 6 notifications and 4 publications. Penicillin (PO) - anaphylactic shock Anaphylactic shock (AS) is a serious ADR usually associated with parenteral drug administration. The Bivirkningsnaevnet, between 1967 and 1980, received 13 reports of AS following PO administration of penicillin, of these 11 were following phenoxymethyl-penicillin treatment and two following pivampicillin (1). Since then another 27 such reports have been received, 17 following phenoxymethyl-penicillin and 10 following various broad spectrum penicillins. The 17 cases with phenoxymethyl-penicillin concerned 11 men and 6 women. The age ranged from 16 to 55 years with a median of 50 years. In 15 cases the onset of AS occurred after the first tablet (in the other two cases information about onset was not given). In six cases with known previous penicillin exposure AS started 5-60 min after drug intake, with a median of 30 min. All patients were treated with epinephrine and all but one were hospitalised. All patients survived. The broad spectrum penicillin cases concerned two men and eight women. The age range was 36-81 years, median 53 years. The patients were treated with pivampicillin (6), bacampicillin (2), amoxicillin (1) and mecillinam (1). In nine cases (one unknown) AS occurred after the first tablet. In six cases it was stated that the patient had taken the drug before, in three cases 1-3 weeks earlier. AS developed 5-90 min after intake, median 15 min. All patients except two were hospitalised and seven were treated with epinephrine. All patients survived. The total use of penicillin in Denmark is 40 million DDDs per year. Thus, AS following PO administration of penicillin is a rare ADR, most often seen in middle age patients 15-30 min after the first tablet intake. Reference: (1) UgeskrLaeger 1980; 142:1169. Information on Adverse Reactions to Drug in Japan, No 136, March 1996 Histamine H2 receptor antagonist Induced blood disorders Histamine H2 receptor antagonists are prescribed for the treatment of gastric ulcers and duodenal ulcers. The approved drugs of this class in Japan are cimetidine, ranitidine, famotidine, roxatidine acetate HCl and nizatidine. The Pharmaceutical Affairs Bureau has already cautioned health professionals about blood disorders associated with the use of histamine H2 receptor blockers. Patients receiving H2 blockers must be carefully followed throughout the course of therapy. Oxytocic-induced serious adverse reactions such as uterine rupture and threatened fetal distress Oxytocin (OXY) and the prostaglandin preparations dinoprost (PGF2a) and dinoprostone (PGE2) are oxytocics used for induction of labor and stimulation of labor. Excessively strong uterine contraction and threatened fetal distress have been reported as adverse reactions to administration of these oxytocic agents and are mentioned in the current "Precautions". Adverse reactions to nonionic contrast media Nonionic contrast media are widely used, based on their generally accepted merits of a relatively file://J:\Publications\Newsletter\Archive\1996\96_4.htm low incidence of adverse reactions and less discomfort during angiography compared with ionic contrast media. Adverse reactions to nonionic contrast media, although less frequent, may be serious, and are often delayed in onset. Because of this, they should be confined to inpatients who can be carefully observed after use, and should be avoided in outpatients because of the potential risk of serious reactions which may occur after returning home. Malaysia
Berita Ubat-Ubatan, Newsletter of the Drug Control Authority Malaysia, Vol 10, No 2, June 1996 Glibenclamide - Cholestatic hepatitis A 43-year old woman with non-insulin dependent diabetes mellitus received 10 mg glibenclamide twice daily for the past five years. The patient was admitted with a four-day history of generalised pruritus and yellow discolouration of the eyes. While hospitalised, she continued taking glibenclamide. Her pruritus remained refractory to treatment with antihistamines, steroids and cholestyramine. When her diabetes control deteriorated after 12 weeks of her initial presentation, she was switched to insulin. After a 20-week stay in the hospital, she was discharged with a diagnosis of primary biliary cirrhoisis (PBC). The patient was expected to deteriorate with the known complications of PBC. However, she showed remarkable improvement. Her symptoms, and jaundice resolved completely about 1 ½ years after the initial presentation. The spontaneous recovery of the patient following withdrawal of glibenclamide and the regeneration of bile ducts seen on repeat liver biopsy strongly suggests that the damage was due to glibenclamide. The traditional remedies are often presented to the consumer as effective therapeutic agents with no adverse effects. These medicines can be toxic and harmful. In the past 5 years MADRAC has received 17 reports of adverse reactions in association with the use of traditional remedies.
Preparations Adverse Comments
Effects
Chinese herbal Wieght Sample tested found to
Medicine(UI) Increased contain steroids. Possible
adulteration with steroids.
" Hepatitis Likely drug-induced as patient never took
other drugs and the liver function returned to normal
after drug withdrawal.
Chinese herbal Acute renal Sample tested found to contain
Medicine(UI) failure salicylates. Possible adulteration with salicylates.
file://J:\Publications\Newsletter\Archive\1996\96_4.htm " Hypokalemia, Preparation contains multiple
Weakness of ingredients, the identification of
limbs he causative ingredient(s) is not possible.
" Vertigo, Rashes "
Chinese herbal Urticaria Preparation contains multiple
Medicine(UI ingredients, the identification of the causative
ingredient(s) is not possible.
" Hepatic failure Patient's serum found to contain toxic level of
salicylates. Preparation likely to be adulterated
with salicylates as patients did not take other drugs.
" Appetite No other drugs taken by patient. Sample
increased tested did not contain steroids. Likely to be
induced by preparation because patients had no
more problem following drug withdrawal.
Ginseng Cardiac Preparation tested found to contain
powder failure a high level of potassium.
(Death)
Ginseng Worsening of A female patient had taken this
capsule diabetic preparation to relieve back pain.
control Her diabetes had previously been satisfactorily
controlled with oral hypoglycaemic agents.
Ginseng-Oral hypoglycaemic agents interaction?
Preparations Adverse Comments
Effects
Gingko Petechiae Patient had no past history of
Biloba bleeding tendencies: Likely to be
Extract drug-induced because no other drugs were
taken and patient recovered following drug
withdrawal
Chinese Nausea Likely to be induced by the tea, no
Herbal Vomiting other medications taken.
Tea Vertigo
Propolis Blood in stool The event may have arisen from
Extract factors related to underlying disease.
Herbal oil Application Likely to be induced by the
site inflam- preparation. Local reaction.
mation
Malay Herbal Ketosis Preparation contains multiple
Medicine (UI) ingredients, the identification of the
causative ingredient(s) is not possible.
" Exfoliative "
dermatitis
MADRAC encourages the reporting of all suspected adverse reactions to traditional remedies.
file://J:\Publications\Newsletter\Archive\1996\96_4.htm Isoniazid : fever and polyarthritis A 33-year old man with pulmonary tuberculosis was started on daily dose of isoniazid 300 mg, pyrazinamide 1.5 mg, rifampicin 600 mg and pyridoxine 10 mg. After 2 days on these drugs, he developed fever and polyarthritis. He was unable to walk because of the pain, but after he stopped the medications on his own, he felt better. Two weeks later the anti-TB drugs were restarted and he developed the same symptoms within two days. All the drugs were withdrawn and the symptoms resolved. Subsequently, on rechallenge with isoniazid, the patient experienced similar symptoms. A 64-year old man with non-insulin dependent diabetes mellitus received glibenclamide 10 mg twice a day and metformin 500 mg twice a day. He was hospitalized for acute mycocardial infarction. Streptokinase, heparin, soluble aspirin, isosorbide dinitrate and furosemide were started. Within a week, the patient developed acute renal failure. BP was 160/90 mm hg. His baseline BP was 100/70 mm hg. Renal profile showed a rise in blood urea and electrolytes. Serum creatinine was 927 mmol/L (normal 133 mmol/L). All the drugs except furosemide were continued. Within 4 weeks of stopping furosemide, the renal profile returned to normal with serum creatinine of 107 mmol/L. New Zealand
Acute liver injury occurs with the use of amoxicillin-clavulanic acid (Augmentin) at a rate of around 1.7 cases per 10,000 prescriptions in those aged 10-79 years. As with some other antibiotics, the risk of this adverse reaction increases in elderly people and in those who receive prolonged treatment. Hepatic reactions with amoxicillin alone appear to be extremely rare. These risks should be considered when choosing between Augmentin and amoxicillin. Mefloquine and neuropsychiatric reactions Patients should be informed of the small risk of neuropsychiatric reactions with mefloquine (Lariam) which should be balanced against the much higher risk of Plasmodium falciparum malaria with its attendant morbidity amd mortality. Doxycycline is an alternative but has to be taken daily. Doxycycline may be associated with gastrointestinal side effects such as anorexia, vomiting, diarrhoea and oesophagitis, and photosensitivity reactions. Doxycycline is contraindicated in pregnancy and children to the age of 12 years. Prophylactic use of mefloquine in the first trimester of pregnancy is not recommended. Mefloquine can, however, be given to children. Interaction between warfarin and oral miconazole gel Miconazole oral gel (Daktarin) should not be considered a topical preparation as patients do not expectorate the gel after application. Up to 50% of a swallowed dose may be absorbed. Prescribers need to be aware of the potential for interaction with warfarin resulting in considerable enhancement of anticoagulant effect. Adverse reactions of current concern A list of adverse reactions of current concern was first initiated in December 1994. A- To raise the level of awareness of these adverse reactions. file://J:\Publications\Newsletter\Archive\1996\96_4.htm B- To evoke reports so that more information may be gathered and appropriate action taken. Medicine Adverse Prescriber
Reaction Update reference
Clozapine myocarditis No.7.Dec 1994
Flucloxacillin cholestatic No.7,Dec 1994
hepatitis
Herbal all adverse No.13,Dec 1996
medicines reactions
Non-sedating cardiac effects No.7.Dec 1994
anti-histamines
Intramuscular injection site No.13,Dec 1996
NSAIDs reactions
Medicine Adverse Prescriber
Reaction Update reference
Intramuscular renal damage No.13,Dec 1996
NSAIDs
Oral venous No.11,Feb 1996
contraceptives thromboembolism
Roxithromycin cardiac No.11,Feb 1996
arrhythmias
Terbinafine haematological No.8,May 1995
reactions
Tiaprofenic cystitis No.7,Dec 1994
acid
The Centre for Adverse Reactions Monitoring (CARM) is receiving increasing numbers of reports of adverse reactions to herbal products. Recently reports of liver damage, including one death, prompted the Ministry to recall "K4", a herbal product promoted for prostate problems. Herbal medicines are not subjected to the rigorous testing given conventional medicines, yet they are often perceived to be without adverse effects by the consumer. It is important that adverse reactions to herbal products are reported to CARM in order for products associated with serious events to be identified early and appropriate action taken. K4 was advertised for the treatment of prostate problems and only sold by mail order in New Zealand. K4 contains 25-30 herbs. The Ministry of Health has been unable, to date, to ascertain which ingredient(s) of K4 may be responsible for the reported liver damage. 1- Patients stop taking K4 and attend a general practitioner for an assessment of liver function; and 2- Medical partitioners report any adverse effects from herbal medicines, especially K4, to the Centre for Adverse Reactions Monitoring. Top ten adverse reactions to fluoxetine in the IMMP These Intensive Medicine Monitoring Programme findings are presented as part of a series on file://J:\Publications\Newsletter\Archive\1996\96_4.htm the "Top Ten" adverse reactions and follow those of moclobemide publised earlier. Fluoxetine was intensively monitored for 5 years from 1988. In that time prescription and adverse events data were compiled for 6599 patients. Approximately two thirds of the patients were women and about 40% of all patients were in the 30-49 age range. As with moclobemide, there was a significantly higher rate of adverse reactions, but not of incidents, in women. The most frequent adverse reactions to fluoxetine: All Nz PEM regions
6599 patients 1840 patients
Reactions No. Rate/1000 No. Rate/1000
Anxiety/agitati. 28 4,2 22 12
Nausea/vomiting 27 4,1 18 9,8
Sleep disturbance 20 3,0 18 9,8
Diarrhoea 18 2,7 12 6,5
Extrapyr.effects 18 2,7 8 4,4
Lethargy/malaise 17 2,6 14 7,6
Depression worse/ 14 2,1 12 6,5
suicidal/suicide
Headache/migraine 12 1,8 10 5,4
Urticaria/angioede. 12 1,8 9 1,9
Seizures 9 1,4 5 2,7
Sexual disturbance 8 1,2 8 4,3
Intensive Medicine Monitoring Programme The medicines currently being monitored are: Medicine Propriety Indications/Action
name
Copper IUCD Multiload Cu375 IUCD
Eformoterol* Foradil Potent long-acting
B2-agonist
Omeprazole cap Losec Proton pump inhibitor
Salmeterol Serevent Potent long-acting
B2-agonist
Sumatriptan Imigran migrain relief/selective
5HT1-like recep.agonist
*Ciba-Geigy New Zealand Ltd recently notified the Ministry of health that they have changed the generic name of formoterol to eformoterol, the later being the widely recognised generic name in the UK. The intensive monitoring of omeprazole capsules will cease on 31 December 1996. Philippines
SIGNALS in Adverse Drug Reactions Monitoring, Vol 1, No 10, October 1996 Pethidine/midazolam combination and women in labor Sometimes anesthetists administer both pethidine (meperidine) and midazolam during the final stage of labor in a pregnant woman. Although adverse effects are not clinically noted in the mother, severe respiratory depression may be seen in neonates. Placental transfer of these drugs to the neonate is very likely. Fetal depression was not apparent when delivery occured within an hour of pethidine administration, but was present in 6 of 24 infants delivered 1 to 3 hours after injection, and in all of 5 infants delivered 3 to 6 hours after injection.
file://J:\Publications\Newsletter\Archive\1996\96_4.htm SIGNALS in Adverse Drug Reactions Monitoring, Vol 1, No 11, November 1996 Second national ADR training course The second national training course is envisioned sometime May 1977 in Manila. The ADR monitoring programme (ADRMP) office plans to invite hospital ADR-co-ordinators who have been active in promoting and monitoring ADR with their hospital therapeutics committees. Also invited are community medical practitioners who can assist in implementing a sustainable nationwide notification scheme for adverse drug reactions. 1-How to translate signals into policies. 2-The psychology of prescribing drugs of new interest. The ADRMP office reports a case of a 48 year old man with a history of duodenitis. Following an episode of abdominal pain, the patient took mefenamic acid thinking that the pain would be relieved. His symptoms, consisting of epigastric pain with cold sweats worsened for the next 24 hours. Since mefenamic acid is now an OTC drug, pharmaceutical companies should make it clear in their precautions that the drug is not indicated for visceral pain and may even aggravate gastric or duodenal ulcers. United Kingdom
Current Problems in Pharmacovigilance, Vol 22, October 1996. Risk of venous thromboembolism with hormone replacement therapy Oral contraceptives are well-recognised to increase the risk of venous thromboembolism but, until now, it has been unclear whether hormone replacement therapy (HRT) has a similar effect. HRT relieves symptoms of the menopause and when taken for several years prevents fractures by reducing thinning of the bones (osteoporosis). It has also been suggested that it may reduce heart disease. Blood clots in the veins are more common in women who take HRT, whatever the type. However, the chance of getting a blood clot is low regardless of whether or not you take HRT. There is no need for women without predisposing factors for venous thromboembolism to stop taking HRT. Extension of the Yellow Card scheme to unlicenced herbal remedies From October 1996 the Yellow Card scheme has been extended to include reporting of suspected adverse reactions to unlicensed herbal remedies. In 9 cases toxicity from heavy metals was confirmed following exposure to traditional remedies from the Indian Sub-Continent. 21 cases of liver toxicity, including 2 deaths, were associated with the use of traditional Chinese remedies, although no causative agent was identified. Please report adverse reactions to all herbal remedies. file://J:\Publications\Newsletter\Archive\1996\96_4.htm Tramadol - (Zydol, Tramake and Zamadol) Tramadol has been available in the UK since June 1994 for the treatment of moderate and severe pain. Although the precise mode of action is unclear, the analgesic properties of tramadol appear to result partly from an action on opioid receptors, and partly through inhibition of noradrenaline-uptake and enhanced serotonin release. It is estimated that approximately 200,000 patients have received tramadol in the UK. There are 872 reports for tramadol describing 1,721 suspected adverse reactions (ADRs). The main issues of concern are withdrawal reactions and the potential to cause dependence, and convulsions. FDA Medical Bulletin, Vol 26, No 3, October 1996 Pimozide (Orap) contraindicated with clarithromycin (Biaxin) and other macrolide antibiotics The labeling for pimozide (Orap), approved for the treatment of Tourette´s disorder, has been updated to contraindicate use of pimozide in patients receiving macrolide antibiotics such as clarithromycin, erythromycin, azithromycin, and dirithromycin. Two sudden deaths have been reported when clarithromycin was added to ongoing pimozide therapy. Clin Pharmacol Ther. 1996; 59: 189. Abstract. Fosamax tablets (alendronate sodium) A number of cases of oesophagitis and oesophageal ulceration have been reported in patients taking Fosamax. In a large majority of the reports, it appears that patients did not comply with the recommended dosing instructions (for example, patients were taking Fosamax with little or no water, taking it at bedtime and/or lying down within minutes after taking it, and so on). Several patients continued taking Fosamax after experiencing symptoms (difficulty or pain on swallowing, chest pain, or heartburn) suggestive of oesophageal irritation. In a few cases, patients were found to have previously undiagnosed oesophageal disorders such as stricture or achalasia. The company has revised the product circular (and patient package insert) to advise strict compliance with the dosing instructions. (March 15, 1996 (letter) - Merck & Company, Inc.) Reports of serious renal impairment with cidofovir Gilead Sciences has issued a warning letter to health care professionals because it has become aware of several reports of severe renal impairment associated with the use of cidofovir injection (VISTIDE). Cidofovir is indicated for the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS. REGULATORY DECISIONS
FDA Medical Bulletin, Vol 26, No 3,October 1996 file://J:\Publications\Newsletter\Archive\1996\96_4.htm The FDA have issued letters to the manufactures of antimicrobial agents: ciprofloxacin, enoxacin, lomefloxacin, norfloxacin, and ofloxacin, requesting that they revise their package inserts to include the following information: The WARNINGS section will have a new paragraph that should read: "Ruptures of the shoulder, hand, and Achilles tendons that required surgical repair or resulted in prolonged disability have been reported with (the specific drug name). "Patients should be advised to discontinue treatment and inform their physician if they experience pain, inflammation, or rupture of a tendon, and to rest and refrain from exercise". Zoloft (sertraline hydrochloride) Because cases of serious, sometimes fatal, reactions have been reported in patients receiving Zoloft in combination with a monoamine oxidase inhibitor (MAOI), the Zoloft package insert has been revised to contraindicate its use in combination with an MAOI. As has always been recommended, a washout period of at least 14 days should be observed beween discontinuing an MAOI and starting Zoloft. Similarly, at least 14 days should pass between stopping Zoloft and starting an MAOI. (August 1,1995 (letter)-Pfizer, Inc.) WITHDRAWALS
Argentina
Hepatic necrosis related to Tolrestat and its withdrawal from market In October, 1996 the Manufacture´s Medical Director informed the National Pharmacovigilance System of Argentina that the manufacturer decided to suspend the marketing of tolrestat worldwide. This was due to two deaths related to tolrestat and hepatic necrosis (one in Canada and one in Italy), and the poor efficacy shown in clinical trials. Withdrawal of Trancopal and other chlormezanone products The Daiichi Pharmaceutical Co, Ltd., the licence holders of trancopal and all six other licence holders of chlormezanone have announced that they will recall chlormezanone products, reflecting withdrawal of trancopal and other chlormezanone products from European market by French pharmaceutical manufacturer, Sanofi. LITERATURE REFERENCES
U.Pedersen-Bjergaard, M. Andersen & P.B. Hansen. Journal of Internal Medicine 1996: 239: 509-515
Thrombocytopenia induced by noncytotoxic drugs in Denmark 1968-91 The spectrum of drugs reported as causing drug-induced thrombocytopenia is broadening and changing progressively, reflecting changes in drug consumption. The most frequently reported drugs at present are valproic acid and measles-mumps-rubella vaccine. file://J:\Publications\Newsletter\Archive\1996\96_4.htm Netherlands
R.H.B. Meybroom, F.W.J. Gribnau, G.H.P. de Koning and A.C.G. Egberts. Clin.Drug Invest. 1996 Oct. 12(4): 207-219. Characteristics of topics in pharmaco-vigilance in the Netherlands A retrospective analysis was made of the nature and composition of 107 consecutive topics presented in publications by or in collaboration with the national pharmacovigilance centre in The Netherlands, containing data obtained through `spontaneous reporting`. These topics were published in various national and international professional journals or special bulletins or as `dear doctor letters`. The topics constituted wide variety of events and disorders. There was, however, a predominance of definitive and often serious diseases, notably specific hypersensitivity reactions, toxic manifestations or syndromes, and drug interactions. Most topics presented predominantly qualitative information. 62% of topics concerned type B, 33% type A and 3% type C adverse drug effects. The topics often referred to small numbers of case reports: 10 or less in 70% of the 107 topics. 46% of the topics concerned new information. There was some predominance of established over new drugs. Five pharmacotherapeutic groups accounted for 74% of topics. Of the 72 approved drugs or drug groups, 12 have been removed from the market. These findings increase our understanding of the functioning of pharmacovigilance and may enable further improvement of the methods and strategies involved. New Zealand
P.I. Pillans, D.M. Coulter and P. Black. Eur.J. Clin. Pharmocol ( 1996) 51: 123-126. Angiooedema and urticaria with angiotensin converting enzyme inhibitors Although reactions are more common shortly after initiation of ACEI therapy, late onset reactions may be less well recognised. Clinicians should be reminded, and ACEI data sheets should emphasise, that onset may be delayed for weeks or months, that patients may have multiple episodes with long symptom free intervals, and that angiooedema may occur with or without urticaria. M. Sakaguchi, Journal of Allergy and Clinical Immunology In very rare cases, children can have an extreme, potentially life-threatening allergic reaction to the measles-mumps-rubella (MMR) shot. A new study in Japan suggests that a sensitivity to gelatin, used as a stabilizing agent in the vaccine, might be the cause. The report included 26 children between the ages of 1 to 4 who had allergic reactions. 24 of the 26 children had IgE antibodies against gelatin in their blood, while there were no signs of such antibodies in other children who had no reaction to the vaccine. "The extremely large amount of gelatin, 1 to 10 mg/shot, present in the vaccines may have caused the systemic allergic reactions on vaccination in vaccine recipients who had IgE antibody to gelatin". The gelatin used in the vaccine was derived from either pig or cow tissue. MMR Vaccine reactions due to gelatin The U.S. Centers for Disease Control (CDC) and Prevention, National Immunization Program, file://J:\Publications\Newsletter\Archive\1996\96_4.htm Vaccine Safety and Development Activity and the U.S. Food and Drug Administration (FDA), Center for Biologics, Evaluation and Research, Epidemiology Branch, have designed a study to determine if the gelatin stabilizers used in the U.S. MMR vaccine are associated with systemic allergic reactions.This study is expected to be completed in this year. the Uppsala Monitoring Centre * contact webmaster * Tel: +46-18 65 60 60 * Fax: +46-18 65 60 88 * Privacy Policy file://J:\Publications\Newsletter\Archive\1996\96_4.htm

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