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Influenza vaccination may rarely trigger severe AIHA, shortly after vaccine administration. A mechanism of molecular mimicry is probably involved in the development of these reactions, although the possible role of adjuvants can not be excluded. Patients should be instructed to report signs and symptoms of autoimmune disorders occurring in the first weeks after administration of influenza vaccine.

General consensus exists about the need to avoid drug intake as much as possible during pregnancy due to the lack of thorough evidence about the safety of pharmacologic treatments during gestation for both mothers and fetuses. In this respect, the overall safety profile of selective serotonin reuptake inhibitors (SSRIs) in pregnancy remains unclear. This article reviews current evidence about the safety of each SSRI during pregnancy in order to describe their specific teratogenic potential, with a particular focus on major and cardiovascular malformations, and to verify whether such toxicity can be considered as a class effect. The literature review included controlled studies and meta-analyses (retrieved using PsychINFO, EMBASE, and Medline from January 1966 to May 2010) from which the risk of major and/or cardiovascular malformations associated with a specific SSRI (ie, fluoxetine, paroxetine, sertraline, citalopram, escitalopram, and fluvoxamine) could be estimated. Although there is evidence to support the association between birth defects and first-trimester exposure to paroxetine, findings from the studies reviewed suggest a teratogenic potential of the whole SSRI class, consistent with preclinical evidence. These teratogenic effects are mainly in the heart region, and they are often described as septal defects. It may be suggested that the higher frequency of teratogenic effects reported for paroxetine might depend on specific pharmacologic features of this drug compared with other SSRIs, although it is difficult to test this hypothesis. It is noteworthy that current evidence on SSRI teratogenicity stems from studies affected by several methodological weaknesses (ie, lack of investigations using control groups of untreated depressed mothers, confounding by indication, and recall bias). Accordingly, we are not yet able to rule out the possibility that positive associations, as determined in some studies, result from analyses of poor quality.

Taste and/or smell abnormalities are common, sometimes unexpected and often persistent complaints of patients during pharmacological treatments. Physicians should be aware of the impact of these ADRs on patients' quality of life.

A relatively small number of possible statin-associated psychiatric ADRs have been found in our database. No significant risks for a higher overall reporting of psychiatric ADRs associated with statins were identified in comparison with all other drugs combined. However, statin-associated insomnia resulted in a significant ROR that requires further investigation.

Background The rate of gastrointestinal (GI) complications with non-steroidal antiinflammatory drugs (NSAIDs) or low-dose aspirin (LD-ASA) varies according to risk factors. For at risk patients, the Italian regulatory resolution enforce prophylaxis with proton pump inhibitors (PPIs) or misoprostol. Objective This study evaluated the consistency with such resolution in patients receiving NSAIDs or LD-ASA and assessed whether patients continued to receive GI protection with PPIs for an adequate time following NSAID discontinuation. Setting An observational retrospective study was conducted using data from Health District of Pisa. Methods The analysis was performed on patients receiving prescription of NSAIDs or LD-ASA, with or without concomitant PPIs or misoprostol, accordingly with the presence of risk factors (2008-2010). Prescription data were retrieved from the database of reimbursement claims for dispensed drugs, while history of past GI diseases was obtained from primary or secondary discharge diagnosis. Main outcome measure The consistency rates of PPI and misoprostol prescriptions with Italian regulatory rules in patients receiving chronic NSAIDs or LD-ASA. Results 6869 patients, receiving NSAIDs or LD-ASA during the observation period, were eligible for the analysis. For NSAIDs or LD-ASA, gastroprotection rates in patients without risk factors were: 8 and 6 % in 2008; 10 and 8 % in 2009; 9 and 6 % in 2010; while the proportions of patients with one or more risk factors not receiving gastroprotection were: 12 and 17 % in 2008; 25 and 22 % in 2009; 15 and 17 % in 2010. In patients discontinuing chronic NSAIDs, 62 % were maintained on protection with PPIs, but only 28 % continued the PPI treatment for an adequate time (60 ± 7 days). Conclusions The present analysis, although restricted to prescription patterns in a single health district, suggests scarce levels of consistency with Italian regulatory resolution on the prophylaxis of GI adverse events associated with chronic NSAIDs or LDASA.

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