Drug Information Bulletin

Drug Information Centre (DIC) Indian Pharmaceutical Association

Bengal Branch Tele fax: 033 24612776, E-mail: ipabengal.dic@gmail.com Web Site: http://www.ipabengal.org Contact: 09830136291

th

Year

Volume: 05

Number: 43

4th February 2012

Content World Cancer Day 2012: 4th February 2012 Dasatinib: pulmonary arterial hypertension Ondansetron: QT prolongation More than 50 medicines in development for COPD, third leading cause of death in U.S. SC pulls up central govt for delay in framing pharma policy to make essential drugs affordable to poor people The Morphine Manifesto: A call for affordable access to immediate release oral morphine

World Cancer Day 2012: 4th February 2012

Theme - "Together Throughout: World" Key facts of Cancer

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possible

Cancer is a leading cause of death worldwide, accounting for 7.6 million deaths (around 13% of all deaths) in 2008 (1). Lung, stomach, liver, colon and breast cancer cause the most cancer deaths each year.

The most frequent types of cancer differ between men and women. About 30% of cancer deaths are due to the five leading behavioral and dietary risks: high body mass index, low fruit and vegetable intake, lack of physical activity, tobacco use, alcohol use. Tobacco use is the most important risk factor for cancer causing 22% of global cancer deaths and 71% of global lung cancer deaths. Cancer causing viral infections such as HBV/HCV and HPV are responsible for up to 20% of cancer deaths in low- and middle-income countries. About 70% of all cancer deaths in 2008 occurred in low- and middleincome countries. Deaths from cancer worldwide are projected to continue rising, with an estimated 13.1 million deaths in 2030 (2).

2 Cancer is a generic term for a large group of diseases that can affect any part of the body. Other terms used are malignant tumours and neoplasms. One defining feature of cancer is the rapid creation of abnormal cells that grow beyond their usual boundaries, and which can then invade adjoining parts of the body and spread to other organs. This process is referred to as metastasis. Metastases are the major cause of death from cancer. For details: http://www.who.int/mediacentre/factsheet s/fs297/en/index.html Dasatinib: pulmonary arterial hypertension The manufacturer of dasatinib (Sprycel) has informed healthcare professionals of important new safety information regarding reports of serious pulmonary arterial hypertension (PAH) in patients treated with dasatinib. Dasatinib belongs to the class of proteintyrosine kinase inhibitors. It is marketed for adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. Dasatinib has also received marketing authorization for the treatment of adult patients with Ph+ chronic, accelerated, or blast phase CML and adult patients with Ph+ acute lymphoblastic leukemia (ALL) who are resistant or intolerant to previous therapies. A total of 60 serious pulmonary hypertension (PH) cases have been reported worldwide between June 2006 and June 2011, including 12 cases of PAH) confirmed by right heart catheterizatin, in association with dasatinib treatment. No Canadian cases of PH or PAH have been reported during this time period. Patients should be evaluated for signs and symptoms of underlying cardiopulmonary disease before initiating dasatinib therapy. Patients who develop symptoms suggestive of PAH such as dyspnea and fatigue after initiation of treatment with dasatinib should be evaluated for more common etiologies and treatment should be withheld during evaluation if symptoms are severe. Improvements in haemodynamic and clinical parameters have been observed in patients with PAH following cessation of dasatinib therapy and this should be permanently discontinued if the diagnosis of PAH is confirmed Reference: Communication from BristolMyers Squibb, 26 August 2011 at http://www.hc-sc.gc.ca. Ondansetron: QT prolongation The Food and Drug Administration (FDA) is informing the public of an ongoing safety review of the anti-nausea drug ondansetron (Zofran), ondansetron hydrochloride and their generics. Ondansetron may increase the risk of developing abnormal changes in the electrical activity of the heart, which can result in a potentially fatal abnormal heart rhythm. Ondansetron and ondansetron hydrochloride are 5-HT3 receptor antagonists used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy and surgery (1). The manufacturer of Zofran is being required to conduct a thorough QT study to assess the potential to prolong the QT interval. Results from this study are expected in the summer of 2012. Label changes may result after the additional information has been reviewed. Ondansetron labelling already contains information about the potential for QT prolongation. Additionally, published articles describe QT interval prolongation with ondansetron or droperidol (24). References:

3 1. National Center for Biotechnology Information. U.S. National Library of Medicine. PubMed Drug & Supplements Monograph Ondansetron. Available at: http://www.nlm.nih.gov/medlineplus/drugi nfo/meds/a601209.html. Accessed September 10, 2011. 2. Charbit et al. Droperidol and ondansetroninduced QT interval prolongation. Anesthesiology 2008; 109(2): 206-212. 3. Charbit et al. Prolongation of QTc interval after postoperative nausea and vomiting treatment by droperidol or ondansetron. Anesthesiology 2005; 102(6): 1094-1100. 4. Nathan et al. Implicationa of Anesthesia in Children with Long QT syndrome. Anesthesia and Analgesia 2011; 112(5): 1163-1168. 5. FDA Drug Safety Communication: Abnormal heart rhythms may be associated with use of Zofran (ondansetron). Safety Announcement,15 September 2011 at http://www.fda.gov/Drugs/DrugSafety More than 50 medicines in development for COPD, third leading cause of death in U.S. Washington, D.C. (February 2, 2012) Americas biopharmaceutical research companies are working on 54 medicines to treat chronic obstructive pulmonary disease (COPD), according to a report released today by the Pharmaceutical Research and Manufacturers of America (PhRMA). These exciting therapies are in late-stage development, meaning they are either in clinical trials or awaiting review by the Food and Drug Administration (FDA). Today, more than 13 million American adults suffer from COPD, one of the most common lung diseases in the U.S. COPD is a progressive lower respiratory disease that encompasses two main conditions chronic bronchitis and emphysema COPD is characterized by obstructed airflow to the lungs that interferes with normal breathing. People with COPD may be limited in their ability to work, exercise and perform routine activities. According to the National Institutes of Health (NIH), the number of patients with COPD is increasing. In addition to those who have been diagnosed with the disease, 12 million Americans likely have COPD without knowing it. "Early detection of COPD is imperative, as effective treatment can change the course and progression of this devastating disease," said PhRMA President and CEO John J. Castellani. "The promising new therapies highlighted in this report illustrate how emerging scientific approaches to treating respiratory diseases such as COPD offer great hope to improve and save the lives of future patients." Americas biopharmaceutical researchers are exploring various new ways to attack COPD. Examples of such approaches include: An adult stem cell therapy that targets a protein in the blood that is often elevated in COPD. A monoclonal antibody that acts on IL-1 receptors involved in the inflammatory component of COPD. A medicine that targets the underlying inflammation in COPD. More than 120,000 Americans die from COPD each year, making it the third leading cause of death in the U.S. In addition to the disability inflicted upon millions of patients, COPD costs the nation approximately $49.9 billion annually, including direct and indirect healthcare costs, according to the NIH. While smoking is the main risk factor for COPD, and nearly 90 percent of COPD deaths are caused by smoking, other causes include air pollution, second-hand smoke, occupational dusts and chemicals, hereditary and childhood respiratory infections. Americas biopharmaceutical research companies are devoted to the discovery

4 and development of medicines that allow patients to live longer, healthier and more productive lives. In fact, the biopharmaceutical sector invests roughly eight times the estimated R&D spending per employee in all manufacturing industries. This commitment to R&D helps to save and improve lives of patients around the world, promote American jobs and strengthen the U.S. economy. SC pulls up central govt for delay in framing pharma policy to make essential drugs affordable to poor people In what can virtually be termed as an indictment of their dilly-dallying tactics on the issue of framing a pharma policy, the Supreme Court has asked the Union ministry of health and Department of Pharmaceuticals (DoP) to immediately review and come up with their views to make the essential medicines affordable to the poor people of the country. Come up with your view on the policy by February 9, or else the Court will give its direction on the issue, the Supreme Court said. Literally pulling up the Union health ministry and the DoP for inordinate delay in framing the pharma policy and for its failure in bringing down the prices of medicines included in the National List of Essential Medicines (NLEM), the Supreme Court bench consisting of Justices G S Singhvi and S J Mukhopadhaya asked the government to come up with its views on the issue of reducing the prices of essential medicines. The NLEM has 348 drugs, of which the prices of only 37 medicines are controlled by National Pharmaceutical Pricing Authority (NPPA). The two-member SC bench also posed a question to the Organization of Pharmaceutical Producers of India (OPPI), an organization of multinational pharma companies in India, who was also made a party in the case. The SC bench asked its counsel U Lalit, why you cannot reduce the prices of essential medicines to make it affordable to the poor people of this country. The next hearing on the issue will be held on February 9. Hearing on a petition filed by All India Drug Action Network (AIDAN), an NGO working in the health sector, the court expressed its anger over the insensitivity of the concerned ministries on the issue. What have you done during the last several years to reduce the prices of essential medicines. It is a sensitive issue involving the health of crores of poor people of this country, the court said.
Source: pharmabiz.com

The Morphine Manifesto: A call for affordable access to immediate release oral morphine PRESS RELEASE 3 February 2012 KERALA, INDIA / WISCONSIN, USA Millions of people all over the world are in needless pain because simple inexpensive medication is denied to them. In conjunction with World Cancer Day 2012 (4 February 2012), Pallium India, the International Association for Hospice and Palliative Care, and the Pain & Policy Studies Group / WHO Collaborating Center at the University of Wisconsin have released a Morphine Manifesto.

Details: http://palliumindia.org/manifesto/press/