After recalling all batches of the drug "Mediator" available on the market, Department of Health has decided to withdraw all drugs containing "Dextropropoxyphene. A decision was taken because of the risk of cardiac toxicity that presents the active ingredient. A statement from the Ministry of Health, dated Wednesday, December 29, states that the department has called an emergency meeting of the Pharmacovigilance Advisory Commission, which ruled the benefit / risk adverse because of the risk of cardiac toxicity. The Ministry of Health has called on drug companies holding authorizations for the marketing of these drugs is recalling all batches available on the domestic market and the destruction of the recalled lots, and those held in inventories. Contacted by ALM, Raja Benkirane, Head of Pharmacovigilance Center Poison Control, who took part in the meeting at the Ministry of Health, said that "drugs being withdrawn are the Di-antalvic of Sanofi-Aventis Bi-Algan Sanofi-Synthemedic, Paradex of Coopermaroc, Bi-Sedal of PROMOPHARMA, Propofan of Frilab-Synthemedic, Xalgix of SOTHEMA Dextramol Pharma and 5 ".
According to an official of the Ministry of Health, the Di-antalvic in 2009 had been a warning. In the News Ministry of Health, it is emphasized that the withdrawal of seven drugs will be from 31 January 2011. So why wait a month before removing these drugs are at risk of cardiac toxicity of the national market?
"One month is the time required to notify all pharmacies in the Kingdom. It is also noteworthy that the danger is not imminent in this country unlike in Europe and the United States. If we found a potential danger, drugs were removed immediately. To date, there have been no cases of death following taking these drugs, "says Ms. Benkirane. A response indicating that the culture of the Moroccan government responsiveness is related to mortality: it responds only when a death on your conscience. Surprising but typically Moroccan. One month between the announcement and the actual withdrawal of these drugs is too long for products considered by the ministry at known risk of cardiac toxicity. In addition, Ms. Benkirane stresses that the Advisory Commission of Pharmacovigilance has opted out sequels to recent alerts in the United States. A U.S. study was published recently showed that drugs containing dextropropoxyphene could be responsible for adverse cardiac effects at dosages that are twice the recommended therapeutic doses in France. Regarding dextropropoxyphene, Ms. Benkirane said he "is an analgesic. It is a symptomatic treatment of painful conditions that existed since the late 60s. This active ingredient is a derivative of morphine which is widely eaten. " This drug acts against the pain of moderate to severe is marketed in combination with analgesics low power such as paracetamol. Because of the potential hazard of these drugs, the Ministry of Health therefore recommends that doctors not to prescribe these drugs to new patients and review of the analgesic treatment of patients currently treated with Dextropropoxyphene on the basis of the therapeutic alternatives available on the Moroccan market.
source aujoourdhui.ma
0 comments:
Post a Comment