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Indian Journal of Pharmacology, Vol. 40, No. 7, Supp. 1, February, 2008, pp. 1-2 Editorial Pharmacovigilance: Safety matters… Biswas Pipasha Principal Consultant and Director, Symogen Ltd Code Number: ph08012 I remember the day Dr. Shivpraksh called me and asked me to be the Guest Editor for the Pharmacovigilance Supplement that he wanted to publish, soon after my article on Proactive Pharmacovigilance: The Way Forward in India was published in the Indian Journal of Pharmacology (IJP). I was a bit skeptical, whether this would actually work, an entire Pharmacovigilance Supplement! but nevertheless wanted professionals in India to get a feel of the advances in pharmacovigilance and to gain knowledge on the subject. So the challenge of inviting eminent pharmacovigilance people to write for IJP set in and I contacted them and explained to them if they could write articles for IJP?: And no one refused! The deadline was given and the articles received in time. Of course I was happy. As I sit to write this editorial for the IJP as a Guest Editor for the Pharmacovigilance Supplement, I feel very happy and proud for taking the decision to publish this supplement which could not have come at a much better time, when the importance of pharmacovigilance should be taken seriously in India. Pharmacovigilance is not new to India, and has in fact been going on from 1998 when India decided to join the Uppsala Centre for Adverse Event Monitoring, and already 10 years have passed! Yes, something has been achieved during this period, but much more still needs to be done in this field in India to be at par with the West. The importance of pharmacovigilance is increasing day by day, and with recent high-profile drug withdrawals the regulatory agencies, media, consumers and others have raised the bar and have become more aware about the benefit and risks of medicines. The year 2007 was yet another eventful year; many drugs were put in the spotlight of the regulatory agencies. The year started with the recombinant human erythropoietins (r-HuEPOs) story, which is indicated for the treatment of anemia in patients with chronic kidney disease (CKD). Some r-HuEPOs are also authorized for the treatment of patients with nonmyeloid cancer who develop anemia after chemotherapy. Apart from the major five r-HuEPOs that are marketed worldwide, Biosimilar analogs of epoetin alfa have also been granted Marketing Authorizations. The safety of r-HuEPOs has been reviewed due to recently published data from clinical trials, which have shown a consistent, unexplained statistically significant excess mortality in patients with anemia associated with cancer that have been treated with r-HuEPOs. Furthermore, results of studies suggested that treatment of anemia with r-HuEPOs in patients with CKD to achieve relatively high target hemoglobin concentrations may be associated with increased risk of mortality and cardiovascular morbidity. No sooner had this safety issue been discussed at the FDA Advisory Committee Meeting and companies marketing these drugs asked to update their labels, the safety of Rosiglitazone was in question and the regulatory authorities asked GSK the MAH for Rosiglitazone to update labels and add new contraindications and warnings for the treatment of type 2 diabetes. As a result of various meetings and Advisory Committee decisions, Rosiglitazone is now contraindicated in patients with acute coronary syndrome, and is not recommended for use in patients with ischemic heart disease or peripheral arterial disease. Both these group of drugs belonging entirely to two different class and well established, indicated for the treatment in diverse population groups, with substantial sales through out the world, had safety issues that caused a lot of anguish within the pharmaceutical sector. There have been many other drugs that were withdrawn from the market as a result of safety issues during 2007. One of them was Lumiracoxib, a selective inhibitor of COX-2, indicated for the symptomatic treatment of osteoarthritis of the knee and hip. Worldwide, there have been about 8.5 million prescriptions of lumiracoxib since July 2005. After a review of the worldwide data for spontaneously reported cases of serious hepatotoxicity associated with the used of lumiracoxib 100 mg daily, major regulatory agencies decided that the risks far more outweighed the benefits and that it should be withdrawn from the market. The other drug that was withdrawn in 2007 was Co-proxamol in the United Kingdom. Suspensions for Marketing Authorizations were issued for Aprotinin (Trasylol), following preliminary results of "BART" study which found a higher overall death rate associated with use of aprotinin in cardiac surgery than with comparators (tranexamic acid and aminocaproic acid). Observational studies also showed similar risks for aprotinin and increased risks of cardiac, cerebrovascular, and renal adverse effects. Similarly, European Medicines Agency (EMEA) has recommended suspending the Marketing Authorization of Carisoprodol, a drug indicated for the treatment for short-term symptomatic relief of muscle spasm that there was a risk of abuse, addiction, intoxication, and psychomotor impairment, and that there are effective alternatives with a more favorable safety profile and hence should be withdrawn. Other high-profile drugs like Rituximab, a monoclonoal antibody, used for the treatment of patients with serious malignancies like non-Hodgkins lymphoma and moderate to severe rheumatoid arthritis are being investigated by the major regulatory agencies due to serious adverse events reported in association with rituximab treatment known as progressive myeloleukoencephalopathy (PML). PML is a rare fatal demyelinating disease that is caused by a viral infection of the brain following reactivation of the JC or BK polyomavirus (also known as papovavirus) present in about 80% of adults. Diseases and conditions (e.g., leukemia, AIDS, lymphoma, and organ transplantation) and medications (e.g., nataluzimab, fludarabine, and tacrolimus) are other risk/confounding factors that affect cell-mediated immunity have been associated with PML development that make it increasingly difficult for proper assessment. It nearly takes a billion dollars to develop a drug. With so many drugs every year facing scrutiny, the three major regulatory agencies including the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMEA), and Medicines and Healthcare products Regulatory Agency (MHRA) have started the publication of Drug Safety News Letters to keep our medical community posted - including physicians, dentists, nurses, and pharmacists - about selected postmarketing drug safety reviews, important emerging drug safety issues, and recently approved pharmaceutical products. Pharmacovigilance is not easy, and its errors and problems are repeated. Of course, by proactively detecting signals and with better risk management plans, some of the questions may be answered. However, without proper educational training in this field and good work experience it is difficult to understand the intricacies that are involved and what to look for. I am happy that in India, pharmacovigilance courses have started, but future students who wish to join these courses should take a thorough look at the faculty and the course content before making a conscious decision to join. I get a number of queries from prospective candidates wishing to pursue pharmacovigilance in India, on whether they should join a BPO or a pharmaceutical company in the area of pharmacovigilance. To that I do not have any answer, as both the sectors in India are growing in this field and there are miles and miles to go before any one can master everything of pharmacovigilance. But again, I am optimistic that India can do good pharmacovigilance and the time will not be far away if we all can put in a bit of effort and dedication to achieve it! Copyright 2008 - Indian Journal of Pharmacology |
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