Pfizer will ask FDA to remove black box suicide warning from its

by Matthew Perrone, The Associated Press Posted Sep 24, 2014 9:53 am MDT AddThis Sharing ButtonsShare to TwitterTwitterShare to FacebookFacebookShare to RedditRedditShare to 電子郵件Email Pfizer will ask FDA to remove “black box” suicide warning from its anti-smoking medication WASHINGTON – New government-approved labeling on Pfizer’s drug Chantix suggests that the anti-smoking medication may not carry the risks of suicidal behaviour that first earned it the Food and Drug Administration’s strongest warning more than five years ago.The FDA updated the drug’s label Monday to include data from a number of recent studies that found little to no evidence of psychiatric problems or suicidal tendencies in patients taking the twice-a-day tablet.The new labeling represents a victory for Pfizer Inc., which requested the update. Company executives say they will now ask the FDA to completely remove the drug’s so-called “black box” label — the strongest type — which warns prescribers of links to hostility, agitation, depression and suicidal behaviour.“Based on all this new information, a boxed warning is not supported,” said Pfizer senior vice-president, Steve Romano, in an interview with The Associated Press. “The bottom line is that the label needs to reflect the most current understanding of the product’s benefits and risks.”The FDA is convening a panel of its outside experts next month to review the latest data on Chantix’s safety — prompted by Pfizer’s request to update the label. The meeting comes more than a year after New York-based Pfizer paid $275 million to settle some 2,000 lawsuits alleging Chantix caused various psychiatric problems, injuries and suicides.The FDA originally added the boxed warning about suicide in 2009, after receiving dozens of reports of suicide and hundreds of reports of suicidal behaviour among patients taking the smoking-cessation drug.At that time, the FDA also required Pfizer to conduct additional studies to determine the extent of the drug’s psychiatric side effects.The new drug labeling includes results of five Pfizer studies enrolling nearly 2,000 patients which showed no increase in suicidal tendencies based on a medical questionnaire. The FDA also updated the label with results from four large independent studies of between 10,000 and 30,000 Chantix users. Those studies found no difference in self-injury, hospitalization and other serious adverse events between people taking Chantix and those using other quit-smoking aids, including nicotine patches and the medication bupropion.There were several limitations to these larger studies. First, they only recorded problems that resulted in hospitalization, meaning many issues likely went unreported. Additionally, the studies were conducted after news of Chantix’s side effects had been widely reported, which means doctors may have steered patients with a history of psychiatric issues toward the alternate therapies.The new FDA label isn’t all positive. It also contains new information about risks of seizure and interactions with alcohol among Chantix patients.Pfizer’s drug works by binding to the same spots in the brain that are activated by nicotine when people smoke. The drug, known chemically as varenicline, blocks nicotine from binding to those spots and prevents the release of “feel-good” brain chemicals that make smoking so addictive.The FDA first began investigating potential side effects with Chantix in 2007, the year after it hit the market.The drug’s labeling tells patients to stop taking Chantix immediately if they experience agitation, depressed mood, suicidal thinking and other behavioural changes. Doctors are advised to weigh the drug’s risks against its potential benefit of helping patients quit smoking.Chantix had global sales of $648 million last year. That was down about 26 per cent from the drug’s peak sales of $883 million in 2007.Pfizer shares rose 26 cents to $30.31. It shares had slipped almost 2 per cent through Tuesday’s close since the start of the year. read more

Child recruitment by armed groups in Central African Republic must end –

The United Nations Children’s Fund (UNICEF) today called on the Central African Republic (CAR) to immediately stop child recruitment by rebel groups and pro-government militias amidst reports of increasing use of this practice. “A number of rebel groups and various pro-government militias have become more active in recent weeks in the capital city of Bangui and across the country,” said the UNICEF Representative for CAR, Souleymane Diabate. “Reliable sources have informed us that children are newly being recruited among their ranks. These reports are of serious concern.” “Our team on the ground is working with partners to monitor, verify, and respond to grave violations of child rights, including recruitment into armed groups – those at greater risk are children who have lost their homes, are separated from their families or were formerly associated with armed groups,” Mr. Diabate added. According to UNICEF, even before the latest round of violence in CAR erupted in December last year, about 2,500 children – both girls and boys – were associated with multiple armed groups, including self-defence groups, in CAR. The UN agency estimates that this number will rise because of the recent conflict. Over the past weeks, widespread looting and violence occurred in the country as an alliance of rebel groups known as ‘Séléka’ attacked several towns in the northeast and threatened to march on Bangui. This week, the group reportedly halted their advance on the capital and agreed to start peace talks in Gabon. CAR has a history of political instability and recurring armed conflict. State authority is weak in many parts of the country, which are largely controlled by rebel groups and criminal armed groups, according to the UN Department of Political Affairs (DPA). Coupled with ethnic tensions in the north, frequent armed incursions by rebel elements from neighbouring countries and the presence of members of the armed Ugandan group known as the Lord’s Resistance Army (LRA), have added to insecurity and instability in CAR, which also has 170,000 people displaced internally. UNICEF said more than 300,000 children have already been affected by the violence in CAR and its consequences, including through recruitment, family separation, sexual violence, forced displacement and having limited access to education and health facilities. In particular, the agency is highly concerned about the involvement of youth under 18 years of age who may be forced to fight, carry supplies, perform other support roles and be abused as sex slaves by armed groups. “Recent commitments under international law by the Government and some rebel groups to keep children out of the fighting must be respected,” said Mr. Diabate. “All violations must stop. It is critical that everything is done to protect these children and keep their families safe.” UNICEF has worked in CAR since 2007 with both the Government and rebel factions to secure the release of more than 1,000 girls and boys from armed groups and self-defence groups and support their reintegration into families and communities. However, the volatile security situation has hampered the delivery of humanitarian assistance to affected communities and has led UNICEF to relocate 14 international staff and consultants last week. The agency has established an operational crisis centre for CAR in the city of Yaounde, Cameroon, where it said it will continue to work with partners to conduct emergency activities. In relation to the latest violence, Secretary-General Ban Ki-moon and the Security Council have condemned the attacks involving ‘Seleka’ and called for a halt hostilities. They have also called on both the Government and the rebels to resolve the current crisis through dialogue, and to abide by the 2008 Libreville Comprehensive Peace Agreement, which was signed by the Government and the three main rebel groups and which helped bring an end to conflicts inside CAR. The Secretary-General’s Special Representative and Head of the UN Integrated Peacebuilding Office in CAR (BINUCA), Margaret Vogt, has remained in close dialogue with the key parties and has offered support to political negotiations. read more

Wear parts giant ESCO finalises buyout of Hydra Mining Tools

first_imgLeading mining wear parts major ESCO has announced the completion of its strategic acquisition of Hydra Mining Tools International. Headquartered in the UK, Hydra is a preferred provider of underground mining cutting systems for the global coal mining market. In recent years, the company has been very successful in expanding its business in China, the world’s largest producer of coal.The acquisition of Hydra Mining Tools supports ESCO’s global expansion and, at the same time, provides a new range of products for underground mining markets. The statement said: “Hydra is an innovative designer, manufacturer and supplier of advanced technology underground mining cutting systems, specialising in shearer drums and cutting tools with carbide inserts, conveyor belts, and other related components. Hydra’s focus on underground consumable parts and related capital equipment is well aligned with ESCO’s position in consumables and equipment for surface mining.Hydra’s operations include sales and manufacturing in the UK and China, and a sales office in the US. “We are excited about ESCO’s acquisition of Hydra Mining Tools and the synergies and global opportunities that it will bring to ESCO,” said Cal Collins, ESCO’s President and Chief Operating Officer. “This acquisition opens the door for ESCO into the fast growing Chinese underground coal mining markets and positions ESCO for continued expansion into the established underground coal market in the US and Australia. We will leverage the ESCO brand and our expertise in mining wear parts and solutions to better service our customers.” With the formal closing of the deal, ESCO welcomes approximately 130 new employees to its workforce of approximately 5,200 globally.last_img read more