October 06, 2010 (Press-News.org) After the Food and Drug Administration (FDA) delayed taking action regarding the diabetes drug Avandia, many are calling on the federal agency to remove the drug from the market.
Safety of Diabetic Drug Up for Second Review
Avandia was first approved for treatment of Type-2 diabetes in 1999. Concerns about the drug's safety and link to heart attacks were raised at least six years ago, but the FDA failed to warn the public of these risks.
In 2007, a study conducted by the Cleveland Clinic and published in the New England Journal of Medicine found that the drug increased the risk of heart attacks by 43% and the risk of cardiovascular death by 64%.
Based on the recommendations of an expert panel, the FDA decided not to remove Avandia from the market at that time, but instead issued a black box warning about the drug's increased risk of heart attacks, which are the number one killer of diabetic patients.
Now, new safety concerns surface again regarding Avandia. These concerns include allegations that the drug's manufacturer, GlaxoSmithKline, withheld data that showed problems with the drug, and failed to adequately warn users of the potentially life-threatening side effects. Evidence also proves that the FDA's internal staff warned of the increased risk of cardiovascular problems associated with Avandia's use, but were ignored.
GlaxoSmithKline continues to maintain that Avandia is safe for use and should not be removed from the market.
Lack of Autonomy, Infrastructure Causes Delay in FDA Action
The criticisms of the FDA's inability to quickly identify safety risks and take action to remove dangerous drugs from the market began long before the current controversy over Avandia. In fact, the agency was similarly criticized for failing to timely remove the prescription painkiller Vioxxfrom the market, which eventually was pulled in 2004 for its link to heart attacks.
Critics have pointed out that the FDA's current procedure is a major factor preventing the agency from acting efficiently if a problem in a newly released drug has been detected.
Currently, the FDA's Office of Surveillance and Epidemiology is responsible for keeping track of the potentially harmful side effects of drugs once they are released on the market. If this office detects a problem, the next step in the procedure is to report the issue to the Center for Drug Evaluation and Research, which happens to also be the department in charge of initially testing new drugs prior to receiving FDA approval.
It stands to reason that a conflict of interest may exist when the department in charge of the initial evaluation is the same department in charge of determining whether a drug it approved for release is dangerous enough to require a black box warning and/or removal.
Some argue that providing the Office of Surveillance and Epidemiology with a measure of autonomy in its decision-making process is vital. And if the department determines there is a potentially life-threatening risk with a newly approved medication, this information should be forwarded directly to the FDA Commissioner to ensure swift action is taken rather than funnel the information through the various levels of agency bureaucracy.
For its part, the current FDA Commissioner Margaret Hamburg promised in March 2010 to evaluate how the agency's procedures impact its ability to make decisions. However, the FDA has not made any recent moves to change its current operational structure.
Dangerous Drugs and the Manufacturer's Responsibility
Drug manufacturers have a duty to ensure that their products are safe for public use. If the drug has known side effects or other potential dangers, then the manufacturer must adequately warn the public about these risks.
Manufacturers of prescription drugs are required to provide not just adequate warning of the potential dangers that may occur from using their product, but timely warning. In other words, if a side effect does not become known until after the medication has been available for a few years, the manufacturer still must warn the public about the danger even though it did not exist at the time the drug initially was approved.
Drug manufacturers also have a duty to warn of potential side effects even in cases when the risk potentially may only affect a small number of those using the medication.
Regardless of the timeframe, size or nature of the potential harm or group affected, prescription drug manufacturers have a continuing duty to warn the public, even once the drug receives FDA approval.
Your Legal Rights
When a drug manufacturer fails to provide adequate warnings to consumers about risks associated with its product's use, the company may be liable for harm that results. In these cases, an injured party can file a products liability claim against the manufacturer, distributor, seller or other party in the "chain of distribution" responsible for the defective product, and seek monetary compensation for current and future medical expenses and lost wages. In cases when a person dies from using a defective drug, the person's family may bring a wrongful death action against the manufacturer.
If you have been harmed from using Avandia or another dangerous prescription drug, contact an experienced prescription drug claims attorney to learn more about your legal options.
Article provided by Robert Peirce & Associates, P.C.
Visit us at www.peircelaw.com
Avandia Controversy Renews Calls for FDA Reform
The FDA is slow to issue drug warnings and recalls, prompting critics to ask the why and how of FDA reform.
2010-10-06
ELSE PRESS RELEASES FROM THIS DATE:
Hays Reports Graduates Turning to UK Call Centres to Get a Foot on the Career Ladder
2010-10-06
Hays, in conjunction with the Top 50 Call Centres for Customer Service initiative, has reported that UK call centres are attracting more graduate employees.
Hays Contact Centres revealed that over two in five (43%) call centre managers have experienced a rise in graduate applications over the last twelve months and 35% of call centre workers are now educated to an undergraduate university level, compared to 25% in 2009.
The level of interest from graduates is not surprising, given that there are currently around 70 graduates for every job vacancy compared to just ...
5pm.co.uk Announces that Nominations for the 2011 Scottish Restaurant Awards are Now Open
2010-10-06
5pm.co.uk, the restaurant reservation and reviews website, and free business newspaper Business7 have announced that nominations for The Scottish Restaurant Awards 2011, which take place on Monday 28th February 2011 at the Glasgow Science Centre, are now open.
Dining out is a multi-million pound industry in Scotland and a big part of daily life, with the restaurant trade a vital component both as an employer and as a service provider to millions of customers every year. The Scottish Restaurant Awards celebrate and reward Scotland's very best eating establishments, whether ...
Northern Rocks Innovative Mortgage Website Scoops Prestigious Award
2010-10-06
Northern Rock's new interactive mortgage website has been commended by a leading magazine for its 'best use of digital by sector'.
The new Northern Rock mortgage site was launched in April this year and managed to fight off stiff competition to win the prestigious accolade at the Communicate Magazine's Digital Impact Awards.
The award presentation was held at the Tabernacle in Notting Hill in order to celebrate excellence in digital stakeholder communications.
Northern Rock, along with digital agency TH_NK, who helped design the website, succeeded in beating off ...
Guoman's The Royal Horseguards Named London Hotel of the Year
2010-10-06
Guoman's five-star The Royal Horseguards has scooped the prestigious accolade of London Hotel of the Year, receiving the sought-after award at the renowned AA Hospitality Awards 2010 - 2011.
AA Hotel Services group area manager Giovanna Grossi said: "We selected The Royal Horseguards Hotel as AA Hotel of the Year for London because this historic hotel has risen from the ashes, successfully managing the transformation from a commercial four star hotel to an impressive five star property. A stylish refurbishment programme, heavy investment in staff training and development, ...
Promethean Brings World's Fastest Car to Maidenhead
2010-10-06
Promethean, the interactive learning technology provider, organised a rare opportunity for pupils from Maidenhead and Reading to see a life size replica of the Bloodhound Supersonic Car. They were also able to meet and question Richard Noble OBE about the Bloodhound project, and its attempts to set a new World Land Speed Record and exceed the 1,000mph milestone for the first time.
The event was organised by Promethean to mark the official opening of its new offices in Maidenhead. The company is the Bloodhound project's official interactive education technology partner ...
Chamonixinfo.com Launches Live Hotel Booking Service
2010-10-06
ChamonixInfo.com is an expert on all things Chamonix and the portal has decided to make the most of this knowledge to expand the services offered on its website by launching an online hotel booking service with live availability.
Chamonix is one of the most popular alpine resorts in France, with a high demand for accommodation year round. Online booking has become a lifestyle choice, unlike traditional ways of organising holidays, which is why more and more travellers are choosing to arrange and book their own independent holiday to resorts such as Chamonix for added ...
British Airways Increases Flights to the Caribbean and Florida for 2011 Schedule
2010-10-06
British Airways is to increase the number of flights to the Caribbean starting from March 27, 2011 due to the success of its long-haul leisure routes departing from London Gatwick.
The airline continues to show its commitment to the Caribbean with a total of 15 destinations to choose from, making it even easier and more convenient than ever before for customers to book their dream Caribbean holidays.
Flights to Barbados will increase from 10 to 12 services a week, Antigua will increase from five to six services a week and the St Lucia - Port of Spain service will ...
Seeger Salvas Warns DePuy Hip Replacement Recall Victims that Recorded Phone Calls Could be Used Against Them
2010-10-06
After recalling 93,000 hip implants and admitting a shocking 13 percent failure rate, Johnson & Johnson's DePuy Orthopaedics is now blaming victims of the defective hip implants, arguing that they were careless and caused their own injuries. At the same time, an insurance adjuster hired by DePuy may be recording phone calls with patients injured by the defective hip, and DePuy may attempt to use these recordings against the victims. Seeger Salvas LLP, a law firm that represents victims of DePuy's hip replacement recall, warns patients to be aware that DePuy may record their ...
The 7th Heaven Band to Play at '85 Chicago Bears Reunion 'Allstate GLORY DAYS'
2010-10-06
Chicago's own 7th heaven band will be featured on stage at the official 1985 Chicago Bears Reunion, Allstate GLORY DAYS 'Legends of the '85 Chicago Bears.'
The band will play in the event's opening and closing, and throughout the show while accompanying Coach Mike Ditka, Dan Hampton, Jim McMahon, Gary Fencik, Willie Gault and the '85 Chicago Bears team on stage. These Legends of the Chicago Bears are reuniting after 25 years to reminisce together and share never-before-heard personal stories from the '85 season and Super Bowl XX.
"To play at the Bears Reunion show ...
Zap-Zinfandel Advocates and Producers Celebrate 20 Years of Zinspiration; The World's Largest Zinfandel Wine Festival Takes Place January 27-29, 2011
2010-10-06
The 20th Anniversary ZAP Festival consists of four events in three days, showcasing approximately 250 wineries, pouring their barrel samples and new releases, together with educational seminars, culinary demonstrations and decadent food pairings. The ZAP Festival is the most comprehensive showing of Zinfandel wines in the world.
Main Festival Events:
- Thursday January 27, 2011: "Good Eats and Zinfandel Pairing", Fort Mason Center, San Francisco: 6:00 to 9:00pm. Foodies rejoice! Enjoy delectable pairings from 50 restaurants and 50 wineries. Cost: $140 public/$100 members
- ...
LAST 30 PRESS RELEASES:
A toolkit for unraveling the links between intimate partner violence, trauma and substance misuse
Can everyday physical activity improve cognitive health in middle age?
Updated guidance reaffirms CPR with breaths essential for cardiac arrest following drowning
Study reveals medical boards rarely discipline physician misinformation
New treatment helps children with rare spinal condition regain ability to walk
'Grow Your Own' teacher prep pipeline at the University of Louisiana at Lafayette funded by US Department of Education
Lab-grown human immune system uncovers weakened response in cancer patients
More than 5 million Americans would be eligible for psychedelic therapy, study finds
Children’s Hospital of Philadelphia researchers find community health workers play critical role in coordinating asthma care across home, school and community
Comprehensive Genomic Profiling leads to better patient outcomes, new joint study says
Animated movie characters with strabismus are more likely to be villains, study finds
How retailers change ordering strategy when a supplier starts its own direct channel
Young coral use metabolic tricks to resist bleaching
Protecting tax whistleblowers pays off
Bioluminescent proteins made from scratch enable non-invasive, multi-functional biological imaging
New study links air pollution with higher rates of head and neck cancer
LSU researchers excavate earliest ancient Maya salt works
Building a diverse wildland fire workforce to meet future challenges
MBARI researchers discover remarkable new swimming sea slug in the deep sea
Decentralized social media ‘increases citizen empowerment’, says Oxford study
Validating an electronic frailty index in a national health system
Combination approach shows promise for treating rare, aggressive cancers
Raise the roof: How to reduce badminton birdie drift
Ouch! Commonalties found in pain vocalizations and interjections across cultures
Income-related disparities in mortality among young adults with type 2 diabetes
Medical board discipline of physicians for spreading medical misinformation
First-ever randomized clinical trial uses telehealth for suicide prevention
DNA packaging directly affects how fast DNA is copied in cells
Scientists develop advanced catalyst for self-driven seawater splitting with enhanced chloride resistance
City of Hope researchers discover why taking a mushroom supplement slows or prevents prostate cancer from getting worse
[Press-News.org] Avandia Controversy Renews Calls for FDA ReformThe FDA is slow to issue drug warnings and recalls, prompting critics to ask the why and how of FDA reform.