Chronic administration of phenytoin and pleomorphic adenoma: A case report and review of literature.

Adverse drug effects that are uncommon or appear only on chronic administration of a drug may not be detected in clinical trials. This explains the need of strict post-marketing vigilance on drug use. Phenytoin administration has been shown in the literature to be associated with development of neoplasia (benign/malignant). In our knowledge current work represents the first case of pleomorphic-adenoma of sub-mandibular salivary gland developed following chronic phenytoin use. A 40 year old male having a history of head trauma twenty years back, had been on tablet phenytoin 100 mg thrice daily since then. One year back he noticed a small swelling in left sub-mandibular region and gradually increasing in size. FNAC and CECT revealed the diagnosis of pleomorphic-adenoma of sub-mandibular salivary gland. Other causes were ruled out. Surgical excision was performed successfully and continuing follow-up with no recurrence at the end of 6 months. Histo-pathogical examination of the tissue did not show any malignant changes.

Tracheo-Esophageal Fistula (TEF) in a Newborn Following Maternal Antenatal Exposure to Olanzapine.

There is a dearth of evidence on the safety of the use of antipsychotics during pregnancy. Olanzapine, a pregnancy category C drug, has no unequivocal evidence of harm to the fetus. Against this backdrop, we report the first case of a tracheo-esophageal fistula (TEF) in a newborn following maternal antenatal exposure to olanzapine. A 29-year-old woman with acute psychotic disorder had been treated with olanzapine for the last 7 years. Her first pregnancy, while taking olanzapine, resulted in a miscarriage at 4 months' gestation, following which she discontinued olanzapine. She reconceived after a few months and delivered a full-term normal child. However, due to the recurrence of psychiatric illness after her second pregnancy, she was prescribed olanzapine again, which was continued throughout her third pregnancy. The outcome of the third pregnancy was a full-term female baby with a TEF. The baby was managed surgically and discharged with satisfactory vital signs. Unfortunately, however, the baby did not survive beyond 11 months of age. Causality between antenatal maternal olanzapine exposure and TEF in the newborn was determined to be 'probable' (score +5) as per the Naranjo causality assessment scale. Greater knowledge of this potential teratogenicity caused by olanzapine is needed to reduce morbidity and mortality in newborns.

Comparison of online reporting systems and their compatibility check with respective adverse drug reaction reporting forms.

AIM: Different forms and online tools are available in different countries for spontaneous reporting, one of the most widely used methods of pharmacovigilance. Capturing sufficient information and adequate compatibility of online systems with respective reporting form is highly desirable for appropriate reporting of adverse drug reactions (ADRs). This study was aimed to compare three major online reporting systems (US, UK, and WHO) of the world and also to check their compatibility with the respective ADR reporting form. MATERIALS AND METHODS: A total of 89 data elements to provide relevant information were found out from above three online reporting systems. All three online systems were compared regarding magnitude of information captured by each of them and scoring was done by providing a score of "1" to each element. Compatibility of ADR reporting forms of India (Red form), US (Form 3500), and UK (Yellow card form) was assessed by comparing the information gathered by them with that can be entered into their respective online reporting systems, namely, "VigiFlow," "US online reporting," and "Yellow card online reporting." Each unmatching item was given a score of "-1". RESULTS: VigiFlow scored "74" points, whereas online reporting systems of the US and UK scored "56" and "49," respectively, regarding magnitude of the information gathered by them. Compatibility score was found to be "0," "-9," and "-26" in case of ADR reporting systems of US, UK, and India, respectively. CONCLUSION: Our study reveals that "VigiFlow" is capable of capturing the maximum amount of information but "Form 3500" and "Online reporting system of US" are maximally compatible to each other among ADR reporting systems of all three countries.

Blepharospasm: an uncommon adverse effect caused by long-term administration of olanzapine.

BACKGROUND: Blepharospasm is one of the components of drug-induced Meige's syndrome which is reported to be caused by typical antipsychotics. Reports of blepharospasm or Meige's syndrome caused by atypical antipsychotics are rare. CASE: A 30-year-old female patient presented to psychiatry out patient department (OPD) with chief complaints of inability to keep her eyes open for long and excessive blinking for 2 months, irritation of eyes, watery discharge from eyes and photophobia for last 1 month. The patient had been taking olanzapine 10 mg, sertraline 100 mg and divalproex sodium 500 mg per orally on once a day basis for the management of major depressive disorder with psychotic features for last 6 months. Routine blood analysis, thyroid function, EEG, MRI, lipid profile did not reveal any abnormality. Ocular examination was also within normal limits. Olanzapine was suspected as a culprit for the above symptoms of patient, so it was replaced with quetiapine 25 mg/day. Patient showed partial recovery of symptoms within 1 week and complete recovery within 2 months of stopping olanzapine. Causality of olanzapine-induced blepharospasm as per WHO-UMC scale was probable. CONCLUSIONS: Olanzapine (atypical antipsychotics) should also be kept in the list of suspected drugs causing blepharospasm in psychotic patients on treatment although further similar evidences from observational studies and/or reports are needed to establish the causal relationship.