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References: Therapie 1997 Nov-Dec;52(6):599-605 Reviewed: 12/1998

Trandolapril (antihypertensive) Post-marketing study 30,072 patients were investigated in a post marketing retrospective study. 6 % of patients reported an adverse effect: coughing was the more prominent reaction (3.1 %). A prior intolerance to an ACE inhibitor appeared to be a very strong predictor of coughing. Dizziness, headache, asthenia and nausea appeared less frequently, in less than 1.0 % of cases.

References: MCA Web Site (http://www.open.gov.uk/mca/whatsnew.htm): News December 1998 Reviewed: 12/1998

Tolcapone (anti-parkinson) Withdrawal from the market Tolcapone, a treatment for Parkinson's Disease, is to be withdrawn from the market because of reports of severe hepatotoxicity, including fatal fulminant hepatitis. This follows advice from the CPMP that the marketing authorisation should be suspended. Patients taking Tolcapone should not stop taking their medication abruptly but under medical supervision, because of the potential for serious adverse effects if the drug is suddenly stopped (worsening of the symptoms of Parkinson's Disease or, rarely, neuroleptic malignant syndrome). Tolcapone should be discontinued gradually and levodopa and/or other dopaminergic treatments be appropriately increased.

References: Tumori 1998; 84: 417-418 Reviewed: 12/1998

Tamoxifen (antihormone) Increase of libido A case was reported on the increase of libido after four years of tamoxifen treatment in a patient with metastatic breast cancer. There are few reports of sexual dysfunction with tamoxifen in the literature, and no special warnings in the italian Data Sheet Compendium.

References: WHO Pharmaceutical Newsletter N° 3-4, 1997 Bollettino di Informazione sui Farmaci, october 1997 Reviewed: 12/1997

Terfenadine (antihistamine) Product suspension Terfenadine, an histamine H1-antagonist for the treatment of asthma and allergies, was temporarily suspended in some european countries (Italy, France, Greece) because of the risk of rare but serious ventricular arrythmias, and of hepatic damage, when taken concomitantly with macrolide antibiotics, imidazole antifungal agents or class I / III antiarrhythmic drugs. In Italy it was suspended with decree appeared in the Official Gazette n° 149 of june 28, 1997. A metabolite of terfenadine, fexofenadine, was recently approved in the USA; this does not seem to induce ventricular arrhythmias.

References: Rev Prescr Nov 1997; 17: 748-749 Reviewed: 04/1998

Tetracyclines (antibiotic) Intracranial hypertension Tetracyclines and minocycline can cause benign intracranial hypertension. This is a rare reaction that carries the risk of papilloedema. The risk is higher if tetracyclines are associated to vitamin A (or its derivatives), which is another possible cause of intracranial hypertension. The french Health Authorities issued in 1997 a recommendation, not to combine isotretinoin and tetracyclines.

References: Drug Saf 1997; 16(2): 133-148 Reviewed: 04/1998

Theofilline (antiasthmatic) Sleep disturbances Theophylline (as well as other antiasthmatic drugs, such as b2-agonists, corticosteroids, antihistamines) is known to cause sleep disorder in adults with asthma 1. However, it does not disrupt sleep in asthmatic children; rather, it may have a protective effect with regard to apnoea and arterial oxigen saturation.

References: WHO Drug Information 1997; 11(3):142 Agence du Medicament, Infofax - Pharmacovigilance; july 4, 1997 Reviewed: 04/1998

Tilbroquinol (antidiarrhoeal) Contraindications The use of tilbroquinol alone, or in combination with tiliquinol, was restricted to the treatment of amoebiasis in adults only, after the occurrence of a few cases of asymptomatic increase of liver transaminases.

References: WHO Pharmaceutical Newsletter N° 3-4, 1997 Reviewed: 12/1997

Tolrestat (antidiabetic) Product withdrawal Tolrestat was withdrawn from the market worldwide after the appearance of severe liver toxicity (including one case of hepatic necrosis reported from Italy) and the failure of recent clinical trials. Tolrestat is a new aldose-reductase inhibitor that was to be used in the treatment of complications of serious diabetes such as neuropathy, retinopathy and nephropathy.

References: Tumori 1998; 84: 417-418 Reviewed: 07/1998	Toremifene (antiestrogen) New approval Toremifene is a new antiestrogen, with a mechanism of action similar to that of tamoxifen. Toremifene (tablet formulation) has been approved in Italy (Official Gazette, april 11, 1997) with the european centralized procedure for the first-line treatment of estrogen-receptor-positive metastatic breast cancer.
References: L'informatore Farmaceutico, 1997 Reviewed: 02/1998	Drug interactions Enzymatic inducers, such as fenobarbital, fenitoin, carbamazepin, alcool, can reduce the plasma levels of toremifene. The concurrent administration of antiestrogens and warfarin can increase the bleeding time. Macrolides antibiotics and some antifungals may inhibit the metabolism of toremifene and increase its plasma concentrations

References: FDA - MEDWATCH (may 1997) Reviewed: 10/1997

Triazolam (hypnotic) Drug interaction The co-administration of triazolam and nefazodone (neurological) causes a significant increase in the plasma level of triazolam so that a 75% reduction in the initial triazolam dosage is recommended. It is described in the italian Data Sheet Compendium that "the association of antipsychotics, hypnotics, anxiolytics, antidepressants, narcotics, antiepileptics, anesthetics and antihistamines can increase the CNS depressant effect of triazolam. P450 inhibitors (e.g. cimetidine, erythromycin) can increase the activity of benzodiazepines".

References: SCRIP No 2292 December, 1997 Reviewed: 02/1998

Troglitazone (antidiabetic) Liver toxicity Troglitazone, a new antidiabetic, has been voluntarily suspended in the UK after its market introduction, following the reporting of severe liver toxicity. However, it remains on the market in the US and Japan after making some changes in the Product Information Sheet. Troglitazone has not been launched in Italy. It has still to be assessed whether the drug really has an unfavourable benefit-to-risk ratio. An issue is whether such events could be ascribed to a class effect, so that other oral thiazolidinediones in development could be affected.

References: Parke Davis; July 28, 1998 FDA MedWatch; june 1998 Reviewed: 07/1998

Liver enzyme elevation Healthcare professionals were informed about the need of more stringent liver enzyme monitoring as reflected in the new product labeling for troglitazone. These new liver enzyme monitoring, aimed at discovering even modest ALT elevations, are intended to reduce the risk of rare but serious liver injury.

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