Safety-related issues resulting in labelling amendments made to the local package inserts are listed below. Please note that there might be lag time in the availability of the package insert which reflect the latest change(s). Please refer to the company representative for details.
October 2003 to December 2003
- Buprenorphine (Subutex®; Reckitt Benckiser) Statements of coma & death associated with concomitant intravenous misuse of buprenorphine and benzodiazepines and misused of buprenorphine by self-injection of crushed tablets have been included. New ADRs reported included cases of bronchospasm, angioneurotic, oedema & anaphylactic shock.
- Carbamazepine (Tegretol®; Novartis) Women of childbearing age are advised to use alternative forms of birth control while taking Tegretol®. Lists of drugs that may raise or decrease Tegretol® levels have been included. New adverse events including very rare (<0.01%) occurrence of hepatic failure, pancreatitis and angioedema have been added.
- Ciclosporin (Sandimmun®; Novartis) Warnings of increased risks of developing malignancies and infections have been added. Statement that treatment using multiple immunosuppressants could lead to the development of lymphoproliferative disorders and solid tumours (with reports of fatalities) was included. New drugs that interact with ciclosporin and the various complications have been listed. New ADRs reported include motor polyneuropathy (rare), anorexia, nausea, vomiting, abdominal pain, diarrhoea (common), hyperlipidaemia (very common) and gynecomastia (rare).
- Doxazosin (Cardura®; Pfizer) Preclinical safety section has been added to include information on carcinogenesis, mutagenesis & impairment of fertility.
- Doxycycline (Vibramycin®; Pfizer) Reports of rare incidence of hepatotoxicity have been added in the section on “undesirable effects”. Statement regarding gastrointestinal events being caused by both oral and parental administration has been included.
- Fluticasone propionate (Flixonase®; GSK) New precautionary statements on interaction with ritonavir that could greatly increase fluticasone plasma levels resulting in markedly reduced serum cortisol concentrations. Post-marketing reports of this systemic corticosteroid effects including Cushing's syndrome and adrenal suppression have been included. Headache has been added as a new common ADR.
- Iodixanol (Visipaque®; Amersham) Warnings to prevent lactic acidosis in diabetic patients treated with metformin have been included in the amended PI. It is advised that the serum creatinine level of this group of patients be measured. Detailed instructions on when metformin should be stopped have been listed.
- Ipratropium bromide (Atrovent®; Boehringer Ingelheim) Gastrointestinal motility disorders (e.g. constipation, diarrhoea and vomiting) have been added to the list of most frequent non-respiratory side effects reported in clinical trials.
- Lactated Ringer's Injection USP (Baxter) Frequency of allergic reactions or anaphylactoid symptoms have been reported to be higher in women during pregnancy.
- Nelfinavir (Viracept®; Roche) Monitoring of liver function is recommended in patients with hepatic impairment who are taking combination antiviral therapy as worsening of liver function has been observed. Interactions between Viracept® and a range of products have been listed.
- Paroxetine (Seroxat®; GSK) Statements on the lack of efficacy in children with major depressive disorder have been included. A new section on adverse events arising from paediatric clinical trials has been added.
- Telmisartan (Micardis®; Boehringer Ingelheim) Advice on maximum dosage administration for patients with severe hypertension has been included. No safety data is available on the use of Micardis® in adolescents.
- Temozolomide (Temodal®; Schering-Plough) New ADRs have been added: lymphopenia (very common) and rare cases of opportunistic infections including Pneumocystis carinii pneumonia (PCP).
- Valsartan (Diovan®; Novartis) Post-marketing reports of very rare cases of impaired renal function, angioedema, rash, pruritus and hypersensitivity/allergic reaction (including serum sickness & vasculitis) have been included.
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July 2003 to September 2003
- Alendronate (Fosamax®; MSD) Prescribers are advised to monitor patient's serum calcium levels and symptoms of hypocalcaemia in those with mineral metabolism disorders. An acute phase response (myalgia, malaise and rarely, fever) has been reported with Fosamax®. Severe skin reactions including Stevens Johnson syndrome and toxic epidermal necrolysis have been reported rarely.
- Betamethasone as 17-valerate (Betnovate®; GSK) Warning that use of topical steroids may be hazardous in psoriasis has been added. Local skin burning and pruritus are listed as common ADRs.
- Bupropion (Zyban®; GSK) Instructions for use in renal and liver impaired patients have been included. New ADRs have been added based on post-marketing experience. These include palpitation, dystonia, hallucination, urinary frequency and/or retention, hepatitis and symptoms of serum sickness.
- Enoxaparin (Clexane®; Aventis Pharma) New precautionary statements on percutaneous coronary revascularisation procedures, bleeding and information on lab tests have been included. Details on the risk of patients (including pregnant women) with mechanical prosthetic valves are elaborated. Major haemorrhage cases including retroperitoneal and intracranial bleeding, some of which were fatal, have been included.
- Epoetin alfa (Eprex®; Johnson & Johnson) An increased incidence of thrombotic events in cancer patients has been reported.
- Haemaccel® Infusion Solution (Aventis Pharma) Very rare cases of air embolism have been reported. Instructions to expel air for infusion under pressure are included.
- Ketoprofen (Fastum Gel®; Pharmaforte) Under the contraindications section, hypersensitivity to other related products was elaborated. Patients are warned to avoid direct sunlight (including sunbeds) during treatment. Post-marketing experience of isolated but severe cases of erythema, burns, pruritus, dermatitis, urticaria and boil reactions have been reported.
- Pergolide mesylate (Celance®, Eli Lilly) Advice on gradual discontinuation of pergolide has been included. A complex symptom resembling the neuroleptic malignant syndrome (NMS) has been reported in association with rapid dose reduction, withdrawal of, or changes in antiparkinson therapy. Fibrotic and serosal inflammatory disorders have been reported after prolonged usage. Patients should be advised to exercise caution while driving or operating machinery during treatment with pergolide because of reported cases of somnolence and episodes of sudden sleep onset.
- Pneumococcoal 7-valent conjugate (Prevenar®; Wyeth) ADRs from post-marketing experience including blood, lymphatic & immune disorders have been added. Adverse events reported with overdose have been reported with recommended single dose of Prevenar®.
- Rofecoxib (Vioxx®; MSD) VIGOR study has been included in the PI to reflect the higher risk of cardiovascular thromboembolism in patients taking Vioxx® compared to naproxen. The side effects list has been updated with new post-marketing reports including bronchospasm, anaphylactic reactions, hypertensive crisis, hepatic failure, peptic ulcers, aplastic anaemia and toxic epidermal necrolysis.
- Sibutramine (Reductil®; Abbott Lab) Reports of bleeding disorders have been included. ADRs list has been updated with new post-marketing reports.
- Sildenafil (Viagra®; Pfizer) Clinical data showing simultaneous administration of sildenafil and doxazosin may lead to hypotension has been included. Additional clinical data on patients taking multiple antihypertensive agents was also elaborated.
- Vardenafil (Levitra®; Bayer) A new section on ‘Concomitant Medications' has been added. A maximum dose of 5 mg Levitra® is recommended for patients whom have been on stable long-term alpha blockers. Details of the clinical trials have been included. Use of Levitra® and protease inhibitors is contraindicated. Patients who are also taking other medications that may affect the QT interval are warned to avoid Levitra®.
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