Ziagen, Videx under safety review by FDA and EMEA.Both FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. and the European Medicines Agency The European Medicines Agency (EMEA) is a European agency for the evaluation of medicinal products. Until 2004, the European Medicines Agency was known as The European Agency for the Evaluation of Medicinal Products. Roughly parallel to the U.S. (EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. ) are looking closely at the potential risks of GlaxoSmithKline's Ziagen (abacavir) and Bristol Myers-Squibb's Videx (didanosine didanosine /di·dan·o·sine/ (-dan´o-sen) 2, an analogue of dideoxyadenosine; an antiretroviral agent used for the treatment of advanced HIV-1 infection and acquired immunodeficiency syndrome, administered orally. ), both anti-HIV drugs. "FDA continues to evaluate the overall risks and benefits of abacavir and didanosine. This evaluation may result in the need to revise labeling for the products. Until this evaluation is complete, health-care providers should evaluate the potential risks and benefits of each HIV-1 antiretroviral drug their patients are taking, including abacavir and didanosine," the agency said in a statement. According to an April 2 "Washington Post" article, many people with HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. take a combination of antiretroviral drugs, which include a protease inhibitor and a nucleoside reverse transcriptase inhibitor Noun 1. nucleoside reverse transcriptase inhibitor - an antiviral drug used against HIV; is incorporated into the DNA of the virus and stops the building process; results in incomplete DNA that cannot create a new virus; often used in combination with other drugs such as abacavir or didanosine. Concerns have been raised about the cardiovascular effects of long-term use of these drugs. "We have investigated a number of drugs used to treat HIV patients for whether they are associated with an altered risk of having a heart attack," said researcher Jens Lundgren, M.D., from the University of Copenhagen The University of Copenhagen (Danish: Københavns Universitet) is the oldest and largest university and research institution in Denmark. in Denmark, lead investigator on the D:A:D study. His team concluded that Ziagen and Videx did show increased risk. The actual risk of having a heart attack when using these drugs varies with whether a patient already has underlying risk for heart attack, Lundgren added. For example, a patient who is at risk for having a heart attack will increase his or her risk by 38% by using either abacavir or didanosine, he said. "However, if you have a very small underlying risk of heart attack, the risk will only be slightly increased," Lundgren said. For the study, published April 2 in the online edition of "The Lancet," Lundgren's team collected data on 33,347 HIV patients who participated in D:A:D and looked specifically for a connection between HIV medications and heart attack. For patients taking abacavir, there was a two-fold increased risk for heart attack. For those taking didanosine, the increased risk was about 50%. Patients who stopped using these drugs decreased their risk for heart attack within six months, Lundgren's group found. EMEA's Committee for Medicinal Products for Human Use “CHMP” redirects here. For French language Canadian radio station, see CHMP-FM. CPMP, Committee for Proprietary Medicinal Products, now CHMP Committee for Medicinal Products for Human Use (CHMP CHMP Committee for Medicinal Products for Human Use CHMP Cultural Heritage Management Plan CHMP Centrale Humanitaire Médico-Pharmaceutique CHMP Certified Hazardous Materials Practitioner (Institute of Hazardous Materials Managers) ) concluded at its March meeting that the available data do not allow for a definitive conclusion on the association between the use of abacavir and an increased risk of myocardial infarction. The agency does not plan to require changes to the prescribing information for abacavir-containing medicines, but concluded that further information is needed to determine the risk of myocardial infarction with abacavir-containing medicines. The CHMP is requesting information from ongoing epidemiological studies to determine this risk, the press release noted. The D:A:D study is a prospective observational study that now includes more than 33,000 patients in Europe, Australia and the U.S. It was initiated in 1999 with the aim of assessing associations between the use of anti-HIV medicines and the risk of cardiovascular disease. In a pooled analysis of 54 clinical trials sponsored by GSK, no increased risk of myocardial infarction with the use of abacavir was observed. These studies included a total of almost 10,000 patients taking abacavir. |
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