Home Politics Religion Media Biz Society Tech Travel Books Intl. Autos Automobiles
                        Aviation   Pharma   About Us   Feedback   Links

Anti-depressant Seroxat defended by GSK against new findings



25 August, 2005: In an attempt to defend its tarnished anti-depressant Seroxat, GlaxoSmithKline has vehemently denied the findings of a scientific paper written by researchers at Norway's University of Oslo and published in the BMC Medicine journal. 

Seroxat contains paroxetine, a selective serotonin reuptake inhibitor (SSRI). 

The new paper, which reviewed some 16 randomised and, for the large part, previously unpublished studies of the drug, concluded that `the data strongly suggest that the use of SSRIs is connected with an increased intensity of suicide attempts per year' and that `the recommendation of restrictions on the use of paroxetine for children and adolescents conveyed by regulatory agencies should be extended to include usage by adults'. 

The data show that in 1,466 people, there were seven suicide attempts among the 916 people randomized to receive Seroxat, but just one among 550 placebo recipients. 

Charges linking Seroxat to suicides have already been levelled at GSK, though largely in relation to its use in children and adolescents and/or during the process of treatment withdrawal. The Norwegian revelations portray the data in such a way as to account for the risk to adults as well as to take the exposure time of the patients `properly into account' by comparing intensities (rather than numbers) of suicide attempts per year in drug and placebo groups. 

However, GSK branded the Norwegian findings `misleading' and serving `only to cause confusion and unnecessary concern for patients using an SSRI such as paroxetine for treatment of depression'. 

The sub-analysis is misleading as it focuses on incorrectly selected data, collected 15 years ago, which formed part of the successful regulatory submission in 1989 for use of paroxetine to treat depression in adults. The sub analysis also fails to acknowledge the current body of data, which is significantly more extensive and which has been recently reviewed by EU authorities,the company said in a press statement.

In 2005, the Committee for Medicinal Products for Human Use (CHMP) having re-examined all existing safety and efficacy data for paroxetine, reaffirmed the positive benefit-risk for paroxetine’s use in the treatment of depression and anxiety disorders in adults. 

Paroxetine along with other SSRIs, has substantially helped the treatment of depression and other psychiatric diseases. As is stated in the prescribing information for paroxetine, depression is associated with an increased risk of suicidal thoughts, self harm and suicide and it is general clinical experience with all antidepressant therapies that the risk of suicide may increase in the early stages of recovery. Patients and physicians should be alert about the need to monitor for the emergence of suicidal ideation/behaviour when treating depression, the release added.


Pharma News Headlines

Cancer News

Cardiac News


Pharma industry news

Diseases - Alzheimer's, Parkisonson's and Obesity

Contraception and Abortion News


Anti fungal terbinafine launched in Europe: Actavis

HIV entry blocking drug data encouraging: Progenics

Allegra generic to be launched in US

Long-acting pain drug data positive: Pain Therapeutics

New kidney cancer drug seeks EU nod

Inhaled insulin may get US FDA clearance

A vaccine against fungus is on way

Enzyme stops progression of HIV in survivors, confirms study

Aclasta found faster-acting in Paget's disease treatment

Beta blocker can start therapy in heart failure: Merck

Halobetasol generic launched in US

Anemia drug darbepoetin's late-stage studies begin: Amgen

Cholesterol generic gets marketing nod in US: Par

Aricept for severe Alzheimer’s disease too: Eisai

Bone regeneration trials begin in US:Mesoblast

New dye to detect early Alzheimer's

Breast forming gene discovered

Thyroid drug to be supplied by IVAX in US

Rituxan, cancer drug can treat rheumatoid arthritis

Yasminelle, low-dose oral contraceptive approved in the Netherlands

Fluarix, anti-flu shot by Glaxo approved

Increlex, drug to treat `abnormally short’ kids approved in US

Anti-HIV drugs prices cut: Gilead

US FDA approves Takeda’s drug combo for type 2 diabetes

Novartis’ drug for breast cancer recurrence to be given priority review in US

US puts off decision on contraceptive pill again

Shire’s ADHD drug Adderall back on list in Canada

WHO calls for emergency action to halt TB in Africa

Some of the Vioxx suits may be settled: Merck

Nasdaq delists Able on bankruptcy filing

Hospira ships ceftriaxone generics to US

Renovis stops sciatica drug studies

Merck sets up generic arm Genpharm in US

Morning after pills still not within easy reach in US

New cancer combo therapy results positive:OXiGENE

Aceon approved for heart disease treatment in US

Cell Therapeutics to seek approval for lung cancer therapy in US and Europe

Anti-depressant Seroxat defended by GSK against new findings

Vioxx verdict: Merck’s defeat to trigger thousands of lawsuits from US, UK

Aspirin stops colon cancer, but may trigger bleeding

New blood test method approved in US

Skin disease drug turns into anti-tumor therapy for cancer

Step-by-Step instructions for dealing with Asthma Attacks

Potential Alzheimer's Disease drugs under investigation

New Molecule may help obese lose weight

Paxil (Paroxetine) may heighten suicide risks, finds study

"Breast cancer chances higher due to fried chips"

Safety alert on Gambro Dasco’s Prisma renal system

Merck responsible for Vioxx death: Jury

Heart disease deaths more among New Yorkers

Pfizer to offer drugs risk/benefit summary to consumers 

Merck lied to public on Vioxx: lawyer tells jurors

Novartis acquires rights of kidney dialysis drug from SeBo

J&J's Concerta approved treatment of ADHD in teenagers in Canada

US FDA stalls Roche’ Accutane use in pregnancy

Novo Nordisk, Eli Lilly remove insulin products from Australia

British drug supply chain safety questioned after another fake Lipitor find

Wyeth starts support programme for Effexor patients

P&G’s Actonel with Calcium approved for osteoporosis

Pozen gets patent on pain management product

Genmab studies new drug for rheumatoid arthritis

Painkillers may increase blood pressure: study

Nektar buys out Aerogen for $32 m

Predix records positive data on anxiety drug

Insmed files against Increlex approval

Hepatitis A vaccine for kids approved in US

Psoriasis drug data positive: Cytochroma

Novo Nordisk’s 24-hour acting insulin Levemir gets US FDA okay

US FDA approves Teva's generic for osteoporosis 


Home Politics Religion Media Biz Society Tech Travel Books Intl. Autos Automobiles
                        Aviation   Pharma   About Us   Feedback   Links

Latest updates    Contact Us - Feedback    About Us