Giovanni Polimeni

• Degree in Pharmacy
• Italian Medicines Agency

A 76-year-old woman presented with an indurated and painful, ecchymotic plaque on her right buttock 48 h after an intramuscular injection of ketorolac tromethamine for coxarthrosis (Figure 1). She stated that injection had been extremely painful, with initial blanching at the injection site. At presentation, blood results, including creatinine kina...

Multiple sclerosis (MS) is an inflammatory disease of the central nervous system (CNS), characterized by inflammation, demyelination and axonal loss underlying progressive clinical disability. The chronic inflammatory tissue damage involving myelin and axons is driven by autoreactive T cells and represents a key mechanism in the immunopathogenesis...

Neurodegenerative diseases are chronic and progressive disorders characterized by selective destruction of neurons in motor, sensory, and cognitive systems. Despite their different origins, the majority of central and peripheral nervous system degenerative diseases (including Parkinson’s disease (PD), Alzheimer’s disease (AD), Huntington’s disease...

Adverse drug reactions (ADRs) are a common and important cause of morbidity and mortality that represent a major health problem worldwide, with high social costs for communities. Several studies have shown that ADR-related hospital admissions comprise up to 10 % of the total number of hospitalizations. Owing to the well-known limitations of pre-mar...

Sweet's syndrome, or acute febrile neutrophilic dermatosis, is an uncommon severe cutaneous condition, not previously associated with allopurinol therapy. We describe the case of an 87-year-old woman with hyperuricemia who developed classic Sweet's syndrome manifestations 8 days after being treated with allopurinol. Patient's symptoms included feve...

Biosimilar insulins are likely to enter the market of diabetes therapies as patents for major branded insulin products start to expire in the next few years (on June 2014, the European Medicines Agency authorized the first biosimilar of insulin glargine, Abasria, 100 Units/ml, for the treatment of diabetes mellitus). This would allow providing comp...

Background Sweet’s syndrome (acute febrile neutrophilic dermatosis) is an uncommon, severe cutaneous condition. It may be induced by several drugs but it has not been previously associated with allopurinol treatment.

We report a memorable case of severe septal panniculitis in an MS patient following the subcutaneous administration of interferon beta-1b, manifesting as a painful, indurated, erythematous lesion of the thigh, which appeared at the injection site.

On June 2008, the European Medicines Agency (EMA) introduced changes to the Summary of Product Characteristics (SPC) for cabergoline and pergolide, to reduce the risk of cardiac valvulopathy in users of these drugs. To assess the effectiveness of EMA recommendations in Italian clinical practice, we retrospectively reviewed medical charts of patient...

Multiple sclerosis is a chronic disease, likely to condition patients' daily living and quality of life: given the unpredictability of frequency and severity of the attacks, patients experience a high level of uncertainty. While there have been many analyses whose purpose was to monitor multiple sclerosis (MS) patients' quality of life, the role of...

Neurogenic erectile dysfunction (ED) can be broadly defined as an inability to sustain or maintain a penile erection owing to a neurological impairment, either centrally or peripherally or both. Although significant advances in the pharmacological treatment of ED have occurred in recent years, especially after the introduction of oral selective pho...

Neurodegenerative diseases are chronic and progressive disorders characterized by selective destruction of neurons in motor, sensory and cognitive systems. Despite their different origin, free radicals accumulation and consequent tissue damage are importantly concerned for the majority of them. In recent years, research on melatonin revealed a pote...

Sleep related problems affect approximately 25-40% of children and adolescents. The acquisition of sleep patterns characterised by later bedtimes, insomnia and excessive daytime sleepiness is related to poorer school performance, daytime drowsiness, physical tiredness and a higher rate of psychiatric illnesses. Many studies have investigated the co...

To describe the case of a woman with poststroke choreoathetosis whose symptoms improved after treatment with tetrabenazine. A 48-year-old left-handed woman developed progressive involuntary dystonic choreoathetoid movements of her arm following a cerebrovascular event. Involuntary abnormal movements (IAMs) were treated with haloperidol, but they wo...

Ejaculation is a complex and still poorly understood neurological mechanism, at both spinal and cerebral levels as it is closely associated with orgasm. Physiologically, ejaculation is defined as the expulsion of seminal fluid from the urethral meatus and consists of two phases, namely emission and expulsion. Ejaculation is mediated by a spinal con...

Erection is a neurovascular event characterized by the tumescence of the cavernous bodies that relies upon integration of neural and humoral mechanisms requiring the participation of autonomic and somatic nerves and the integration of numerous spinal and supraspinal sites. Erectile dysfunction (ED) is a highly prevalent problem increasing with age,...

Nicolau syndrome (NS), or embolia cutis medicamentosa, is a well-known but rare adverse effect of a still largely unidentified pathogenesis, observed primarily after the intramuscular administration of various drugs. NS is characterized by immediate excruciating pain, early pallor and erythema and oedema at the injection site, followed by cutaneous...

Telephone interviews have been used extensively as a tool to explore and assess sleep disorders and psychopathological conditions. The aim of this study was to set up and validate a telephone interview aimed at assessing the correlation between mood and sleep variables in adolescents. The study included 16-18 years subjects. A total of approximatel...

The overall objective of the EU-ADR project is the design, development, and validation of a computerised system that exploits data from electronic health records and biomedical databases for the early detection of adverse drug reactions. Eight different databases, containing health records of more than 30 million European citizens, are involved in...

PurposeData mining on electronic health records (EHRs) has emerged as a promising complementary method for post-marketing drug safety surveillance. The EU-ADR project, funded by the European Commission, is developing techniques that allow mining of EHRs for adverse drug events across different countries in Europe. Since mining on all possible event...

A healthy 33-year-old woman consumed a slimming product containing a mixture of herbal remedies without seeking medical advice. Two months later, the patient had hemorrhagic cystitis and discontinued the herbal product. Symptoms spontaneously remitted in a few days. Four months later, she took the same herbal remedy and the hemorrhagic cystitis rea...

The current case describes epistaxis in a patient treated with a daily regimen of topiramate 100mg for migraine. The patient had not a past medical history of nosebleeds and laboratory parameters were within normal ranges. She was then advised to withdraw topiramate, and the epistaxis resolved within 12 hours after its discontinuation. Since then,...

Multiple bioengineered agents has been recently developed to attack other parts of the immune/inflammatory system, achieving therapeutic implications for dermatologic diseases. On the other side, each new therapy has the potential for adverse cutaneous reactions. We present herein the first two cases of Gibert's pityriasis rosea occurring during et...

Background: The Internet may play a crucial role in the prompt provision of updated drug safety information. Nevertheless, limited knowledge of the English language among healthcare professionals or suboptimal search skills constitute barriers to widespread and appropriate use of the Internet for this purpose in Italy. In order to provide accurate...

Despite the considerable number of newer antibacterials made available over the past decades, amoxicillin, alone or in combination with clavulanic acid, still accounts among the most widely used antibacterial agents. Although they are often considered 'twin drugs', they are different both in terms of antibacterial activities and of safety profile....

The Internet may play a crucial role in the prompt provision of updated drug safety information. Nevertheless, limited knowledge of the English language among healthcare professionals or suboptimal search skills constitute barriers to widespread and appropriate use of the Internet for this purpose in Italy. In order to provide accurate information...

Despite the wide number of studies investigating on drug-induced allergy, limited data focused on allergies associated with orally administered drugs are available. The aim of the study is to evaluate allergic drug reactions associated with oral drug use, using an Italian spontaneous reporting database of adverse drug reactions (ADRs). Spontaneous...

Gynecomastia is characterized by benign progressive enlargement of the male breast. A pharmacologic origin is identified in 10-20% of cases. Several case reports have associated this condition to the use of statins. However, to our knowledge, no case of rosuvastatin-induced gynecomastia has been reported in the literature. We describe a 57-year-old...

Treatment of hypercholesterolemia has been shown to reduce mortality in patients with coronary artery disease. Patients with severe lipid abnormalities may require high-dose statin therapy, at times used in combination with additional agents. The occurrence of rhabdomyolysis is one of the rare side-effects of the cholesterol-lowering agents. During...

To report the case of a patient who developed marked anxiety associated with episodes of panic attacks after starting rabeprazole therapy. An otherwise healthy 55-year-old woman was prescribed rabeprazole 20 mg/day administered in the morning for persistent symptoms of dyspepsia. Ten days later, she presented with a 7 day history of marked anxiety...

Diagnostic contrast media (CM) are a widely used class of drugs with poor information regarding their safety. Nevertheless, epidemiological studies showed that CM cause adverse reactions commonly considered unpreventable and unavoidable. Because spontaneous reporting is a valuable methodology for better defining the safety profile of drugs after th...

To analyse an Italian database of spontaneous reporting of suspected adverse drug reactions in order to compare the safety profile of amoxicillin and amoxicillin/clavulanic acid. Data were retrieved from the spontaneous reports collected by six Italian regions (the GIF database) from January 1988 to June 2005. Drug utilization data were also availa...

Memory loss and cognitive impairment have been reported in the literature in association with several 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins), but we found no published case reports associated with rosuvastatin. To our knowledge, this is the first reported case of rosuvastatin-related short-term memory loss. A 53-year-o...

Objectives: To (i) evaluate the suspected adverse drug reactions (ADRs) related to NSAIDs and antibacterials that were reported to Sicilian local health officers by healthcare professionals; and (ii) to detect new or serious potential signals of alarm related to these two widely used drug categories. Methods: We selected all the spontaneous report...

To (i) evaluate the suspected adverse drug reactions (ADRs) related to NSAIDs and antibacterials that were reported to Sicilian local health officers by healthcare professionals; and (ii) to detect new or serious potential signals of alarm related to these two widely used drug categories. We selected all the spontaneous reports of ADRs sent between...

The authors report a case of urinary incontinence (UI) that occurred in a woman after administration of venlafaxine. UI resolved after discontinuation of the drug and did not reappear after switching to sertraline therapy. A 56-year-old white woman with a diagnosis of reactive depression developed severe UI after a 30 days' treatment with venlafaxi...

Limited information is available on drug-induced neuropsychiatric disorders in general practice. The spontaneous reports of both neurological and psychiatric adverse drug reactions (ADRs) collected during a 2-year period in PharmaSearch database, an Italian database recording reports of ADRs from general practitioners (GPs), were examined. Between...