Drugs and Therapy Studies

Self-reported adverse reactions associated with topical ophthalmic medication use: a cross-sectional survey

Samuel Kyei — 2014-06-17

The aim of this study was to investigate self-reported adverse reactions associated with the use of topical ophthalmic medications. A cross-sectional survey, involving 500 ophthalmic patients recruited from three eye care facilities in the Central Region of Ghana was conducted. A structured questionnaire was administered to participants to collect data on demographics, name of drug, dosage form, and dosing frequency of ophthalmic medications used, as well as adverse reactions experienced. The pHs of frequently prescribed ophthalmic medications to the patients were measured. The prevalence of reported adverse drug reaction [predominantly burning sensation (55%), blurry vision (22%) and itching (13%)] was 44.8%. More Females reported adverse drug reactions than males (χ2=26.24, P<0.001). The aged reported more adverse reaction than others (P<0.01). Patients using cream ophthalmic medications reported more adverse drug reactions than those using other dosage forms (χ2=8.80, P=0.024). The pHs of the commonly prescribed ophthalmic medications measured ranged between 4.44-7.37 (desired: 6.6-7.8). There is a high prevalence of reported symptoms of adverse drug reactions among this clinical population attributable to the acid/base status of the drug agent.

Intracellular delivery of NF-κB small interfering RNA for modulating therapeutic activities of classical anti-cancer drugs in human cervical cancer cells

Anthony Stanislaus — 2013-12-10

Cervical cancer is the second most common cancer and fourth leading cause of cancer-related deaths among women. Advanced stage of the disease is treated with radiation therapy and chemotherapy with poor therapeutic outcome and adverse side effects. NFκB, a well-known transcription factor in the control of immunity and inflammation, has recently emerged as a key regulator of cell survival through induction of antiapoptotic genes. Many human cancers, including cervical carcinoma, constitutively express NF-κB and a blockade in expression of its subunit proteins through targeted knockdown of the gene transcripts with small interfering RNAs (siRNA) could be an attractive approach in order to sensitize the cancer cells towards the widely used anti-cancer drugs. However, the inefficiency of the naked siRNA to cross the plasma membrane and its sensitiveness to nuclease-mediated degradation are the major challenges limiting the siRNA technology in therapeutic intervention. pH-sensitive carbonate apatite has been established as an efficient nano-carrier for intracellular delivery of siRNA, due to its strong electrostatic interaction with the siRNA, the desirable size distribution of the resulting siRNA complex for effective endocytosis and the ability of the endocytosed siRNA to be released from the degradable particles and escape the endosomes, thus leading to the effective knockdown of the target gene of cyclin B1 or ABCB1. Here, we report that carbonate apatite-facilitated delivery of the siRNA targeting NF-κB1 and NF-κB2 gene transcripts in HeLa, a human cervical adenocar- cinoma cell line expressing NF-κB, led to a synergistic effect in enhancement of chemosensitivity to doxorubicin, but apparently not to cisplatin or paclitaxel.

From big data to bedside decision-making: the case for AdverseEvents

Giuseppe Biondi Zoccai — 2013-07-01

Evidence-based medicine has gained mainstream popularity, but it requires a delicate balance between clinical evidence, physician skills, patient preferences, and costs. Facing the individual patient, even a simple decision such as which antithrombotic agent should be prescribed becomes complex. There are several reasons for this conundrum, but one of the foremost is the limited external validity of pivotal randomized trials, with their extremely restrictive selection criteria. Post-marketing reporting of adverse events is a very useful and democratic means to appraise the risk-benefit profile, but to date such reports were not organized or available. The development of the Food and Drug Administration (FDA) venue for such task, the FDA Adverse Event Reporting System (FAERS) has substantially improved data collection. However, analysis of this extensive relational database remains complex for most but few companies or agencies. AdverseEvents is a novel online platform enabling updated and user-friendly inquiry of FAERS. Given its ease of use, flexibility and comprehensiveness, it is likely going to improve decision making for healthcare authorities and practitioners, as well as patients. This is clearly testified by the precise and informative comparative analysis that can be performed with AdverseEvents on novel antithrombotic agents.

Development of a drug safety ePlatform for physicians, pharmacists, and consumers based on post-marketing adverse events

Keith B. Hoffman — 2013-07-10

Rigorous clinical trials under the watchful eye of regulators remain the cornerstone of drug safety. However, the emergence of serious and life-threatening Adverse Events (AEs) across best-selling drug classes [sometimes many years after winning Food and Drug Administration (FDA) approval] underscores the limitations of current clinical trial processes and reinforces the need for careful post-approval pharmacovigilance. The FDA’s sizeable repository of patient case reports linking AEs to approved drugs is the Adverse Event Reporting System (FAERS). We believe that open and user-friendly access to the millions of case reports in FAERS would help advance the field of post-marketing pharmacovigilance. However, FAERS data are virtually inaccessible to most physicians, pharmacists, and consumers. Accordingly, we have recently launched a big data platform (www.AdverseEvents.com) that, unlike previous efforts, provides on-demand, user-friendly, and high-impact access to FAERS data. Bringing the power of big data to regular users, such as clinicians, pharmacists, and patients, is the logical next step in the transformation of health care to a model of shared decision making between consumers and the system.