MHRA Warns UK Doctors To Monitor Cancer Patients For ONJ Where There Is Concomitant Use Of These Drugs - Pfizer Sends "Dear Doctor" Letter in the UK but Not to Doctors in the U.S.
On November 30, 2010, the Medicines and Healthcare products Regulatory Agency (MHRA) issued two new safety warnings to doctors and other healthcare providers in the UK concerning the cancer drugs Avastin and Sutent.
The first item, "Avastin (bevacizumab) Cases of osteonecrosis of the jaw in patients with cancer treated with bevacizumab and concomitant or previous use of bisphosphonates", simply identified the nature of this emerging drug safety issue:
Cases of osteonecrosis of the jaw (ONJ) have been reported in cancer patients in association with Avastin treatment, the majority of whom had received prior or concomitant treatment with i.v. bisphosphonates.
Avastin treatment may be an additional risk factor for the development of osteonecrosis of the jaw....
Avastin is from the drug company Roche.
The second item, "Sutent (sunitinib) Cases of osteonecrosis of the jaw in patients with cancer treated with sunitinib and concomitant or previous use of bisphosphonates", included a so-called "Dear Doctor" letter from Pfizer with some more information about the extent of this problem, at least as it regards Sutent:
From 26 January 2006 (International Birth Date [IBD]) through 31 January 2010, the worldwide estimated exposure to Sutent is 101400 including post-marketing and clinical trials worldwide.
Overall, a total of 27 cases of ONJ have been reported as of 31 January 2010....
To date, Pfizer has only issued a Dear Doctor Letter in the UK even though Sutent is also sold in the U.S.
If you have suffered an injury related to Avastin or Sutent and have questions regarding your legal rights, please call me.
Claudine Homolash, Esquire
(215) 790-7379
Sheller, P.C.
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Perspective of a Legal Specialist in Whistleblower Law and Pharmaceutical Injury
Showing posts with label Pfizer. Show all posts
Showing posts with label Pfizer. Show all posts
Tuesday, December 7, 2010
Thursday, February 7, 2008
PERSONAL INJURY LAWSUITS INITIATE CHANGE IN CHANTIX WARNINGS
(Feb. 1, 2008) The FDA announced a public health advisory about abnormal behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior with Pfizer’s anti-smoking drug, Chantix. The FDA provided updated calculations reflecting the following:
- 491 cases of suicidal thinking or behavior, including 420 in the US. And of those, there were 39 suicides, including 34 in the US.
“We’ve become increasingly concerned as we see a number of cases that truly look like exposure to the drug and not other causes,” says Bob Rappaport, director of the FDA’s division of anesthesia, analgesia and rheumatology products, in a briefing this afternoon with reporters. As of now, he adds, “there’s no definitive evidence there’s a causal relationship” between Pfizer and the abnormal and suicidal behaviors. Although, the agency notes that “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.”
The FDA started reviewing cases last November after national attention grew as a result of the case of Carter Albrecht. Albrecht was a guitarist and keyboardist with the band Edie Brickell & the New Bohemians. He died September 3, 2007 after being shot in the head by a neighbor as he tried to kick in his door.
Earlier that day, Albrecht had been having drinks with his girlfriend Ryann Rathbone at a local Dallas bar. After he become intoxicated, Rathbone drove Albrecht to their home where they both took their dose of Chantix. After that, Albrecht became incoherent and violent, breaking a glass and hitting Rathbone. When Rathbone left the house, Albrecht followed and she locked him out. He pounded on the door then went next door and began pounding on the neighbor’s door. The neighbor warned Albrecht to stop and fired a warning shot through the door, which hit Albrecht. Family and friends say that this type of violent behavior was atypical of Albrecht and believe that the use of Chantix caused the events.
Albrecht’s case is not so uncommon when compared to other normally calm people who have taken Chantix. Suits like Albrecht's initiate change and assist in protecting individuals who may have otherwise ingested this dangerous drug.
- 491 cases of suicidal thinking or behavior, including 420 in the US. And of those, there were 39 suicides, including 34 in the US.
“We’ve become increasingly concerned as we see a number of cases that truly look like exposure to the drug and not other causes,” says Bob Rappaport, director of the FDA’s division of anesthesia, analgesia and rheumatology products, in a briefing this afternoon with reporters. As of now, he adds, “there’s no definitive evidence there’s a causal relationship” between Pfizer and the abnormal and suicidal behaviors. Although, the agency notes that “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.”
The FDA started reviewing cases last November after national attention grew as a result of the case of Carter Albrecht. Albrecht was a guitarist and keyboardist with the band Edie Brickell & the New Bohemians. He died September 3, 2007 after being shot in the head by a neighbor as he tried to kick in his door.
Earlier that day, Albrecht had been having drinks with his girlfriend Ryann Rathbone at a local Dallas bar. After he become intoxicated, Rathbone drove Albrecht to their home where they both took their dose of Chantix. After that, Albrecht became incoherent and violent, breaking a glass and hitting Rathbone. When Rathbone left the house, Albrecht followed and she locked him out. He pounded on the door then went next door and began pounding on the neighbor’s door. The neighbor warned Albrecht to stop and fired a warning shot through the door, which hit Albrecht. Family and friends say that this type of violent behavior was atypical of Albrecht and believe that the use of Chantix caused the events.
Albrecht’s case is not so uncommon when compared to other normally calm people who have taken Chantix. Suits like Albrecht's initiate change and assist in protecting individuals who may have otherwise ingested this dangerous drug.
Friday, December 7, 2007
Chantix Update: FDA Evaluating Reports of Suicidal Thoughts In Chantix Users
On November 20, 2007, the Food and Drug Administration ("FDA") reported that it is evaluating post-marketing adverse event reports about Pfizer Inc.'s smoking cessation drug Chantix upon receiving company submitted reports about Chantix users having suicidal thoughts.
The FDA asked Pfizer for the reports. The FDA said that while it analyzed data, it recommends that health care providers monitor Chantix patients for behavior and mood changes. The FDA said patients should report behavior and mood changes to their doctors.
Claudine Q. Homolash, Esq. represents consumers who have been injured as a result of dangerous drugs and other products.
Tuesday, December 4, 2007
Serious Side-Effects Linked to the Smoking Cessation Drug Chantix
The smoking cessation drug, Chantix, is manufactured and distributed by Pfizer, a pharmaceutical titan in terms of profits and influence. Chantix was marketed as a promising drug which was designed to work in conjunction with behavior modification therapy to help people work towards leaving their smoking habit behind for good.
Initially, minor side-effects were reported, such as nausea and dizziness, but as time progressed, the known side-effects became more serious. Reported side-effects include chronic feelings of extreme anxiety and depression, up to and including thoughts of suicide and acts of abuse.
Discovery remains ongoing in regards to Chantix, but if you're using it, seek medical attention immediately, especially if you're feeling any potential side-effects. If you have experienced side-effects regarding this drug, contact me directly so I can assist in investigating a potential claim on your behalf.
Claudine Q. Homolash is a personal injury attorney representing individuals injured by dangerous drugs and other products. Ms. Homolash represents injured individuals in litigations involving, but not limited to, the drugs Vioxx, Bextra, and Gadolinium. Ms. Homolash also represents plaintiffs in against Boston Scientific (formerly Guidant) and Medtronic.
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