Giulia Milano received a Bachelor's degree from Genoa University School of Medicine. She is currently pursuing her specialization in Medical Toxicology at the Department of Internal Medicine, Clinical Pharmacology and Toxicology Unit at the University of Genoa. She has published several papers and is speaker in different conferences.
Diosmin is a natural bioflavonoid isolated from various plants or derived from the flavonoid hesperidin. It is used to relieve symptoms of venous insufficiency and hemorrhoidal syndrome. Short-term administration of diosmin is usually considered safe, with only minor side effects occasionally observed. During a period of about 4 years, a general practitioner noticed 17 cases of mild diosmin-induced side effects, two of which showed particular interest. The first case is about a 55-year-old Caucasian woman with chronic leg venous insufficiency. Five days after starting diosmin treatment, the patient complained of diffuse leg pain, and, for this reason, she stopped diosmin therapy and her myalgias disappeared. She made a rechallenge and her myalgias reappeared. So the physician prescribed her some blood tests: Serum creatine phosphokinase (CPK) dosage was the only out-of-range biochemical value. The second case concerns a 79-year-old Caucasian man, who was diagnosed with acute hemorrhoidal syndrome. After 21 days of continuous diosmin treatment, increased levels of serum lactic dehydrogenase (LDH) were observed. After 1 month, blood tests showed a normalization of LDH values. In this case, rechallenge was not performed. In both cases a comprehensive analysis of all possible causes for enzyme elevation was made. We ascribe these reported ADRs to a concurrence of events: An individual predisposition and the presence of severe comorbidities that may have enhanced noradrenaline tone on microcirculation, leading to an excessive peripheral vasoconstriction and subsequent ischemic damage.
Michelle Perry has completed her MPhil at the age of 25 from the University of Portsmouth in collaboration with the Drug Safety Research Unit, Southampton. She also has a BSc (Hons) in Applied Pharmacology from Queen Margaret University, Edinburgh and is currently a Pharmacovigilance Associate at Aspen Pharmacare Trading Limited, based in Dublin, Ireland.
Pharmacovigilance (PV) works towards ensuring the safe use of all medicinal products on the market today in line with an acceptable benefit risk balance for each product. Marketing authorisation is passed when there is sufficient evidence that a medicinal product is; of good quality, effective and safe for the intended purpose. The benefit risk balance must be continuously assessed throughout the products lifespan, taking into account all available information. Recent legislative changes introduced risk minimisation plans, ensuring that PV has a proactive approach to identifying, communicating and managing any potential safety risks. PV has developed considerably over the past 50 years and continues to do so as the range of medicinal products on the market increases. Thalidomide resulted in international efforts to address drug safety in early 1960s. As technology advances, various opportunities arise further to re-evaluate current medicinal products, both on and off the market, improving overall knowledge of mechanisms of action and therefore safety. Even those off the market have the potential to benefit many people if used with caution and awareness of identified and potential adverse effects. Thalidomide is re-emerging for treatment in dermatology, multiple myeloma and other cancers including oral and prostate, highlighting the importance of a continuous attempt to gain a complete understanding and improve drug safety monitoring. Non-steroidal anti-inflammatories have highlighted the challenges and need for on-going monitoring over recent years, with PV monitoring in the UK leading to a change in diclofenac to a prescription only medicine in January 2015.