Management of drug-induced interstitial lung disease Amitava Ganguli BSc, MRCP and Munir Pirmohamed PhD, FRCP

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1 Management of drug-induced interstitial lung disease Amitava Ganguli BSc, MRCP and Munir Pirmohamed PhD, FRCP VM Our series on serious ADRs focusses on rare but potentially fatal drug reactions and how to recognise and avoid them. This article describes the drugs most commonly associated with interstitial lung disease and discusses subsequent management. Figure 1. CT scan showing pulmonary fibrosis (green areas) Interstitial lung disease () occurs as a result of an insult to the lung parenchyma, and many classes of drugs have the potential to induce. Injury to alveoli, the alveolar epithelium and the surrounding vasculature results in an inflammatory response. 1 If the disease becomes chronic, inflammation spreads to adjacent portions of the interstitium and vasculature, resulting in interstitial fibrosis. Consequently, the alveolar epithelium thickens and loses its natural elasticity, thereby reducing its capacity to stretch. The net effect is a decrease in gas exchange across the epithelium and a restrictive pulmonary defect impairing gas exchange. Table 1 provides a stepwise approach to the diagnosis of. Incidence of drug-induced Drug-induced lung diseases often have no pathognomonic signs or symptoms and are underdiagnosed. Worldwide incidence of is not clearly known but per cent of cases are drug induced. 2 Table 2 provides a list of drugs causing ; some examples are discussed in greater detail below. Pathophysiology of druginduced The mechanism of drug-induced lung injury is not fully understood. However, cytotoxic damage from a drug or a hypersensitivity reaction to the drug and/or its metabolites is thought to be the main pathophysiological event. Direct toxicity usually occurs over time before manifesting clinically. Alveolar and bronchial epithelial cells may be injured by inhalation of a drug or through the vascular system. 3,4 In response to injury to the lung parenchyma, there is an immediate requirement to initiate tissue repair and restore barrier function. Acute injury may progress to chronic inflammation and eventually lead to fibrotic change that ultimately interferes with gas exchange. Hypersensitivity reactions do not show a simple dose-response relationship and require prior sensitisation to the drug (although this may be covert rather than overt). 5 The immune damage to the lung may be due to drug-specific antibodies or, more likely, drug-specific T cells. However, the Prescriber 5 May

2 Noninvasive evaluation history clinical examination blood tests lung function tests chest X-ray HRCT* Invasive evaluation bronchoalveolar lavage lung biopsy *HRCT: high-resolution computer tomography Table 1. Diagnostic features of interstitial lung disease this initiates an immune response, and what the individual predis- posing factors are. mechanism is poorly understood in terms of what constitutes the antigen, the mechanism by which occupation, pets, drugs; progressive dyspnoea fine end inspiratory crackles in lung; finger clubbing often normal; autoimmune screen, rheumatoid factor and ESR should be performed restrictive pattern and decreased transfer factor reticulonodular shadowing more accurate than conventional X-ray may reveal increased cell numbers for indeterminate cases and disease staging Clinical features of druginduced Drug-induced can be difficult to diagnose. It is important to rule out other causes before making this diagnosis and hence a careful history, examination and relevant investigations are essential. Patients should be asked about occupational history (farmers), environments they have been exposed to (asbestos) and pets (pigeons, parrots and budgerigars). With drug-induced the temporal relationship between commencing drug therapy and respiratory symptoms is important in differentiating acute from chronic disease. Acute pneumonitis secondary to drug therapy can present with acute breathlessness occurring over several hours. Fever, rash, wheeze and 42 Prescriber 5 May

3 peripheral eosinophilia are features of these reactions. The chronic form of the disease manifests as decreased exercise tolerance mainly as a result of progressive dyspnoea. Dry cough, weight loss and clubbing may also be present. It is also important to be aware that drug-induced lung injury may be enhanced by other factors such as age, impaired renal function, smoking and radiation therapy. Drugs causing Cytotoxic agents Bleomycin is the drug most commonly studied as a cause of. Some studies have shown that up to 25 per cent of patients develop some degree of lung injury, 6 although in the larger studies rates of 8-10 per cent have been observed. 6 Lung injury is due to cytotoxic damage and rarely due to a hypersensitivity reaction. Symptoms first appear 4-10 weeks following chemotherapy and the damage is predominantly at the lung base. Mitomycin, a similar drug, has been reported to induce pulmonary fibrosis in 2-12 per cent of patients. 7 Cyclophosphamide causes early-onset with a low incidence, estimated at less than 1 per cent. 8 Busulfan may cause months after initiation of treatment in 4 per cent of cases. 8 Immunosuppressants and antiinflammatory agents Methotrexate Methotrexate is a folate antagonist used to treat both malignancies and non-neoplastic disorders. It may cause both cytotoxic injury and hypersensitivity reactions. Methotrexate pulmonary toxicity occurs in 1-5 per cent of patients with rheumatoid arthritis and in as many as per cent of patients treated for primary biliary cirrhosis. 9 Gold and penicillamine Goldinduced interstitial pneumonitis is seen in less than 1 per cent of patients and occurs, on average, after three months of therapy and at a cumulative dose of approximately 700mg. 8 Penicillamine use in patients with rheumatoid arthritis is associated with chronic alveolitis/fibrosis, hypersensitivity pneumonitis, alveolar haemorrhage and bronchiolitis obliterans Prescriber 5 May

4 Anti-inflammatory gold penicillamine methotrexate Immunosuppressants bleomycin busulfan chlorambucil cyclophosphamide ciclosporin vinca alkaloids Cardiovascular amiodarone flecainide hydralazine procainamide Antimicrobial amphotericin ethambutol isoniazid minocycline nitrofurantoin tetracycline Antidepressants, antipsychotics fluoxetine phenothiazines trazodone tricyclics Miscellaneous appetite suppressants (dexfenfluramine, fenfluramine) bromocriptine methysergide propylthiouracil radiation Table 2. Drugs causing interstitial lung disease 2,8,15 Azathioprine Azathioprine is rarely associated with the development of chronic pneumonitis and fibrosis, and in fact the drug is used in the treatment of idiopathic pulmonary fibrosis. NSAIDs NSAIDs may cause acute pulmonary hypersensitivity reactions resulting in bilateral interstitial infiltration. 11 Onset of such a reaction can occur within the first week and up to thee years after first exposure. Antiarrhythmic agents Amiodarone Pulmonary toxicity has an incidence of approximately 5 per cent and, amongst these cases, fatality rates range from per cent. 12 The drug is concentrated in lung tissue and has a relatively long half-life. Clinically there are two patterns of pulmonary toxicity. The most common form is a subacute presentation characterised by cough, dyspnoea and weight loss. Chest X- rays demonstrate diffuse interstitial opacities. A less common form is that of an acute presentation that simulates an infectious process. Chest X-rays show patchy alveolar opacities that tend to be peripheral in distribution. CT scans may show pleural-based areas of focal consolidation or atelectasis. These opacities have increased CT density that is due to the fact that amiodarone accumulates in the lung and has a high iodine content. Procainamide (Pronestyl) Between 50 and 90 per cent of patients taking procainamide for longer than two months develop serum antinuclear antibodies (ANAs); per cent of these ANA-positive patients develop symptomatic drug-induced SLE, per cent of these have pulmonary manifestations that, in up to 40 per cent, are accompanied by bibasilar pulmonary infiltrates. 10 Antibiotics Nitrofurantoin may cause severe acute toxicity in 1 out of 5000 new administrations. 13 Mixed interstitial and alveolar infiltrates on chest X-ray are seen in 16 per cent of these patients and are associated with a mortality of 0.5 per cent. Chronic pulmonary toxicity occurs in 1 of 750 patients on long-term therapy for asymptomatic bacteriuria. Approximately 70 per cent of patients fail to improve or show significant residual pulmonary abnormalities, and mortality has been reported at 8-10 per cent. 10 Anticonvulsants Carbamazepine is a commonly used antiepileptic that can cause an acute hypersensitivity syndrome, but the incidence of this is not well known. Antidepressants Tricyclics (amitriptyline, imipramine and dosulepin) It is well documented that pulmonary injury occurs with acute overdose of tricyclic antidepressants. There is also some evidence of an association between cryptogenic fibrosing alveolitis and tricyclic use, particularly imipramine and dothiepin. 14 Antipsychotics and miscellaneous drugs Phenothiazines and atypical neuroleptics There are reports of eosinophilic pneumonitis and non- 44 Prescriber 5 May

5 cardiogenic pulmonary oedema with these classes of drugs. 15 Miscellaneous drugs Bromocriptine, a dopamine agonist used in the treatment of pituitary tumours, has been reported to cause pulmonary fibrosis and pleural disease. 15 Leukotriene antagonists zafirlukast (Accolate) have been associated with hypereosinophilic-type. 15 Management of druginduced The diagnosis of this condition is usually made from the history. The next steps are to confirm the diagnosis. In an acute hypersensitivity response, blood tests may show a peripheral eosinophilia. Pulmonary function tests are a useful and simple investigation: they are likely to demonstrate a restrictive picture and decreased gas transfer coefficient (DLCO). A chest X-ray should be done and this may show a spectrum of changes from pulmonary infiltrates to lung fibrosis. Further investigations such as bronchoscopy and high-resolution computer tomography may need to be performed under the guidance of respiratory physicians. The primary goal of treatment is to suppress the inflammatory response and prevent the deposition of fibrotic tissue. Treatment consists mainly of discontinuing the offending drug immediately, and supportive management of the pulmonary symptoms, eg inhaler therapy and oxygen if required until the drug-induced lung disease improves. Challenge tests (reintroducing the suspected medication to see if symptoms recur) are rarely performed. Steroid therapy (such as prednisolone) is sometimes used to quickly reverse the lung inflammation caused by the offending drug. Prognosis of acute druginduced is usually excellent. Symptoms will resolve within hours, with full recovery generally being achieved. Chronic syndromes may take longer to resolve but often leave significant scarring that may need long-term supportive therapy. References 1. King TE. Interstitial lung disease. In: Braunwald E, Isselbacher KJ, Fauci AS, et al, eds. Harrison s principles of internal medicine. New York: McGraw-Hill, Ch 9: Coultas DB, Zumwalt RE, Black WC, et al. The epidemiology of interstitial lung diseases. Am J Respir Crit Care Med 1994;150: Tiddens H, Silverman M, Bush A. Prescriber 5 May

6 The role of inflammation in airway disease: remodeling. Am J Respir Crit Care Med 2000;162:S7-S Shimabukuro DW, Sawa T, Gropper MA. Injury and repair in lung and airways. Crit Care Med 2003;31:S Kline JN, Hunninghake GW. Hypersensitivity pneumonitis and pulmonary infiltrates with eosinophilia. In: Braunwald E, Isselbacher KJ, Fauci AS, et al, eds. Harrison s principles of internal medicine. New York: McGraw-Hill, Jules-Elysee K, White DA. Bleomycin induced pulmonary toxicity. Clin Chest Med 1990;11: Buzdar A, Legma S, Luna M, et al. Pulmonary toxicity of mitomycin. Cancer 1980;45: Cooper JAD, White DA, Matthay R. Drug-induced pulmonary disease. Part 1: cytotoxic drug. Part 2: non cytotoxic drugs. Am Rev Respir Dis 1986;133:321-40, Sharma A, Provenzale D, McKusick A, et al. Interstitial pneumonitis after low-dose methotrexate therapy in primary biliary cirrhosis. Gastroenterology 1994;107: Zitnik RJ, Matthay RA. Drug-induced lung disease. In: Schwarz MJ, King TE, eds. Interstitial lung disease. 3rd edn. Hamilton, BC Decker Inc, 1998; Zitnik RJ, Cooper JAD. Pulmonary disease due to antirheumatic agents. Clin Chest Med 1990;11: Martin WJ, Rosenow EC. Amiodarone pulmonary toxicity: recognition and pathogenesis. Chest 1988;93: , Jick S, Jick H, Walker A, et al. Hospitalisations for pulmonary reactions following nitrofurantoin use. Chest 1989;96: Hubbard R, Venn A, et al. Exposure to commonly prescribed drugs and the aetiology of cryptogenic fibrosing alveolitis. Am J Respir Crit Care Med 1998;157: Ozkan M, et al. Drug induced lung disease. Cleveland Journal Medicine 2001;68: Dr Ganguli is a specialist registrar and honorary lecturer in clinical pharmacology and therapeutics, and Munir Pirmohamed is professor of clinical pharmacology and honorary consultant physician at Royal Liverpool University Hospital Pharmacy Stamp Age Title, Forename, Surname & Address D.o.B Please don t stamp over age box Number of daysʼ treatment N.B. Ensure dose is stated Endorsements S 46 Prescriber 5 May

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