Home Health Study 329 Reanalysis: Paxil is not safe for adolescents

Study 329 Reanalysis: Paxil is not safe for adolescents

Ads

According to a recently conducted reanalysis, the 2001 study that paved the way for prescribing Paxil to hundreds of thousands of adolescents had serious flaws in it.

The research team conducting this reanalysis used data obtained from 77,000 pages of a document which was previous unavailable. The in-depth reanalysis of the data allowed the researchers to conclude that paroxetine, a drug marketed under the brand name of Paxil by pharmaceutical firm GlaxoSmithKline, is not more effective than placebos and is significantly more harmful than what the previous study indicated.

The previous study, which was referred to as “Study 329” started to face similar criticisms within a year of getting published. However, the reappraisal published in The BMJ, a widely read medical journal, is probably the most thorough one yet.

The two consecutive years 2003 and 2004 saw the Food & Drug Administration issue warnings regarding a rise in the rate of suicidal thinking among some adolescents and children who consumed drugs belonging to an antidepressant class called selective serotonin reuptake inhibitors; two drugs of this class were Zoloft and Paxil.

Ads

Paxil, however, can still be prescribed to teens, but, in 2004, the FDA issued an order asking manufacturers to add an additional “black box” warning on Paxil’s labels informing users about increased suicidal thinking in some young people using the medication.

Then, in 2007, the agency ordered an expansion of the warning. This time it asked the manufacturer to include individuals under 25. Five years after that i.e. in 2012, the manufacturing company of Paxil GlaxoSmithKline pleaded guilty. The company had to pay a fine of $3 billion for unlawfully marketing some drugs including Paxil.

The research team that published the new study in The BMJ this Wednesday was led by Professor Jon Jureidini of the University of Adelaide, Australia. The researchers under Prof. Jureidini analyzed the raw data and discovered that Study 329 was filled with transcription errors. Also, it also contained a range of other problems which violated GlaxoSmithKline’s own policies for statistical analyses,

The researchers said that they have failed to determine the reason behind a number of mistakes detected by them. However, they admitted that the mistakes were exceedingly egregious, which made them believe that they cannot be unintentional.

Ads
SOURCEBMJ
Previous articleChildren spending more time outside stay away from Myopia (Nearsightedness)
Next articleYoga shows 20 percent improvement in Arthritis patients
An entrepreneur by birth, blogger by choice, and geek by heart. He founded Sprouts Media, a blogs/websites network company, currently owns over 10 popular web properties, to cater his passion of journalism and entrepreneurship. He is also known as an avid reader, technology enthusiast, explorer, and a broken lover. His passion for knowledge keeps him running all the time. A pure vegetarian, who believes in reincarnation & law of karma and follows the philosophy of “Live and let others Live” because all living beings have equal right on the resources of this planet. He loves to write about Technology and Social Issues on his blogs. He can be reached at nitin [at] sprouts.media.