Press coverage Around the World
Press Releases/News Update

DATE
CATEGORY
GENERAL HEADING & BRIEF DESCRIPTION
>>>> 2011 <<<<

Mar 2011

New Article

http://www.updateddailey.com Long Before Accutane Recall, Defective Acne Drug Caused Bowel Disease Injuries, and More. Roche Pharmaceuticals, also called Hoffman La-Roche, was aware before it even put acne drug Accutane on the market that the acne medication could cause harmful side effects. Read full article here

Mar 2011

New Article

Accutane Lawsuit News Accutane Side Effects Accutane is famous for its tradeoff: Clear skin in exchange for a lifelong battle with Accutane side effects.  Click here for Article

Mar 2011

New Article

Accutane Lawsuit News Possible Link Between Accutane and Celiac Disease. The list of Accutane side effects is fairly established since the drug has been in use since the early 1980s, but a new study indicates that a connection between Accutane and celiac disease could exist. Click here for Article

Mar 2011

New Article

Accutane Lawsuit News Accutane off-label Uses. Accutane off-label uses have drastically increased the number of individuals victimized by Accutane side effects.  Click here for Article

Mar 2011

New Article

lawyersandsettlements.com Accutane and Inflammatory Bowel Disease. Accutane acne medication has been linked to serious side effects including colitis and inflammatory bowel disease (IBD). The link between Accutane and inflammatory bowel disease has been shown in at least one preliminary study. Click here to Read Full Article

Feb 2011

New Article

virtualmedicalcentre.com The cause of coeliac disease. The study, published early online 9 February, points to two chemical signals – interleukin 15 and retinoic acid, a derivative of vitamin A – as triggers for the inflammatory response to gluten, a protein found in many grains that causes coeliac disease. Click here to read in full

Jan 2011

New Article

http://www.24-7pressrelease.com Accutane Victims Having Successful Days In Court With Their Lawsuits Men and women who took Accutane in their teens & 20s to clear up their acne and developed IBD are finally having their day in court - and with great success. In fact, over $75 million has been awarded to six Accutane injury victims in the past three years. Read Article in Full
Feb 2011
Le Messenger (France) Parents blame Roaccutane for suicide attempt. Click here to Read Full Article in French
>>>> 2010 <<<<
Jun 2010

The Independent (UK) 'Ireland's Erin Brockovich' and a 1m battle with the drugs industry His story has parallels with that of Erin Brockovich, whose David-and-Goliath battle against a US energy company became the subject of a Hollywood film. But unlike the American legal clerk, Liam Grant is taking on a giant pharmaceutical company. Click here to Read Full Article
May 2010

The Lancet Medical Journal Father wins battle to get anti-acne drug reports European Ombudsman Nikiforos Diamandouros who called on EMA to reconsider its refusal to give access to documents relating to isotretinoin, which is used to treat severe acne Click here to Read Full Article
May 2010

Irish Examiner Father wins battle to get anti-acne drug reports EU medical authorities have been sharply criticised by the European Ombudsman over their refusal to give access to an Irish citizen who sought information on adverse reactions to the controversial anti-acne drug, Roaccutane. Click here to Read Full Article
Feb 2010

Law.com In Retrial, N.J. Jury Awards $25 Million to Accutane User Lawyers suing Roche Laboratories Inc. had reason to be dismayed 14 months ago when a New Jersey state appeals court threw out a $2.5 million jury verdict they had won for a man who blamed the acne drug Accutane for his bowel disease. On Tuesday, the lawyers won 10 times more at the retrial.Click here to Read Full Article
Feb 2010

Bloomberg Roche Ordered to Pay $25 Million to Accutane User Roche Holding AG, the Swiss drugmaker, must pay $25.16 million in damages to a former user of its Accutane drug who blamed the acne medicine for his inflammatory bowel disease, a New Jersey jury ruled. Click here to Read Full Article
>>>> 2009 <<<<
Jun 2009

Bloomberg Roche Pulls Accutane Off Market After Jury Verdicts "The company faces as many as 5,000 personal-injury claims over Accutane, said Michael Hook, a Pensacola, Florida-based attorney" Click here to Read Full Article
Jun 2009
ZURICH (Reuters) Swiss drugmaker Roche Holding AG is no longer selling its acne drug Accutane as it has reached the end of its life cycle and is losing ground to generic alternatives, the company said on Friday. Read full Text
Jun 2009

Pittsburgh Post-Gazette Accutane medication blamed in girlfriend's killing. Trial begins in brutal slaying of Gateway High cheerleader. Click here to Read Full Article
Jun 2009

http://drdavidcorn
bleet.blogspot.com
Dr. David Cornbleet was murdered by a one time former patient, Hans Peterson. The rational for the murder focused on Accutane, a powerful acne medication prescribed by Dr. Cornbleet for Hans in April 2002. Read full Text
Jun 2009

Bloomberg Roche Loses $12.9 Million Three-Case Accutane Verdict Roche Holding AG must pay $12.9 million to plaintiffs who blamed the Accutane acne medicine for their inflammatory bowel disease, a New Jersey jury ruled, handing the company its fourth trial loss in the case. Click here to Read Article
May 2009

Reuters Acne drug linked to depression. Use of isotretinoin, the active ingredient in the acne drug Accutane, apparently more than doubles the risk of depression, according to results of a study. Read full Text
May 2009

Reuters US jury awards $2.5 mln in Roche Accutane trial. A New Jersey jury ... found that Swiss drugmaker Roche Holding AG failed to adequately warn a patient of the bowel disease risks associated with its potent acne medicine Accutane and awarded him $2.5 million in damages. Read full Text
>>>> 2008 <<<<
Jun 2008
The Times - Ireland Case against Roche firm can go ahead. Court Decision - Liam Grant appealed to the Supreme Court, where Mr Justice Hardiman upheld the decision of the High Court and ruled the proceedings could go ahead. Read full Text
May 2008
The Times - Ireland Court rejects pharma group's bid to stop case by MARY CAROLAN. THE SUPREME Court has upheld a decision by the High Court and rejected a bid by a pharmaceutical group to stop a father bringing a case against it alleging wrongful death following the death by suicide of his 20-year-old son. Click here to read article
Feb 2008
The Times - UK ‘Suicide rating’ could be given to every new drug licensed in UK by Alexi Mostrous and David Rose. Article outlines proposals for a big shake-up in the rules governing pharmaceutical development. Click here to read article
Jan 2008
Harvard Law School Babies, Blemishes and FDA: A History of Accutane Regulation in the United States by Julia Green, March, 2002. A comprehensive History of Accutane in the US Click here to read article
Jan 2008
Online Article

"The Sexual Effects of Accutane" by Kevin Pezzi, MD. Dr. Kevin Pezzi's website about Roche's cover-up of Accutane's sexual side effects. Click here for further info.

>>>> 2007 <<<<
November 2007 University of Bath

"Research suggests mechanism for acne drug’s link to depression", Monday 12 November 2007. New research has found that a drug used to treat severe forms of acne reduces the availability of the chemical serotonin, low levels of which have been linked to aggression and clinical depression. Click here for full Press Release or Click here to read Published Study

April 2007PharmalotAccutane: The Mass Tort Opens Next Week Mark your calendars. On April 16, the first Accutane trial gets under way in Madison County, Illinois, and two weeks later, another begins in Atlantic City, NJ, before state court Judge Carol Higbee, who is overseeing most of the 400 Accutane lawsuits that have been filed.
Click here for further info
April 2007FDA, US FDA WARNING:
Risks of buying Accutane (isotretinoin) over the Internet
Cick here to read the full warning
April 2007Point of Law, Info on US Litigation System Accutane mass tort litigation for inflammatory bowel disease. Cick here to read the full article
March 2007 BMJRoche denies claims it sacked employee for "whistle blowing"byMadeleine Brettingham. The pharmaceutical giant Roche this week accused a former senior manager of "jumping to conclusions" and "blowing the issues out of proportion." The senior manager claims she was sacked for uncovering their dealings with a network of private slimming clinics. Cick here to read the full article
March 2007The Bolton News

Acne drug linked to tragic suicide By Amanda Smith. 13th March 2007. Adam Long, aged 22, had taken a course of Roaccutane and later developed depression. Cick here to read the full article

Further Press Releases on Adam Long case:
Wigan TodayArticle
Manchester Evening News
The Bolton News
March 2007Daily Mail -UK

"Man treated with controversial acne drugs kills himself"by JAYA NARAIN, 13th March 2007. Adam Long, 22, an engineer committed suicide after taking a controversial anti-acne drug which has been linked to depression. Cick here to read the full article

>>>> 2006 <<<<
November 2006Switzerland National TV Station Television program broadcast in Switzerland, created by investigative journalist, Serena Tinari for the Swiss National TV station. Click here for English Translation or Click here to view original program
November 12 2006Baltimore Sun "New push for medical legislation expected" By Jonathan D. Rockoff, November 12, 2006, Administration watchdog, Rep. Henry A. Waxman of California, and Rep. Bart Stupak of Michigan, who has blamed his son's 2000 suicide on the drug Accutane to push for legislative changes to make pharmaceutical companies more accountable. Cick here to read the full article
October 11 2006The Oregonian, Portland,OR,USA"Hideous headaches provoke search by Vancouver family" By Andy Dworkin, 11th October 2006, Accutane linked to Intracranial hypertension. Cick here to read the full article
2006Neuropsychopharmacology (2006) - Nature Publishing Group"Chronic Administration of 13-Cis_retinoic Acid Increases Depression related Behaviour in Mice" By Sarah J Bailey, Dept of Pharmacy & Pharmacologym, University of Bath, UK Scientific Article setting out study on Roaccutane / Accutane which shows increased depression related behaviour in Mice. Click here to download the Scientific Article in .pdf format
19th September 2006The Times - UK "Scientists link acne drug to depression"By Nigel Hawkes, Health Editor, The Times, UK
EXPERIMENTS on animals have lent support to claims that a drug used widely in the treatment of acne can cause depression...Click here to read more
19th September 2006The Guardian - UK "Research shows link between acne treatment and depression" By Sarah Boseley
· Study provides first scientific evidence
· Condition itself may be at root of deaths, says firm
Click here to read Sarah Boseley's article, Health Editor for The Guardian
19th September 2006The Telegraph - UKScientists link acne drug to depression By Nic Fleming, Medical Correspondent
Prof David Nutt, the head of psychopharmacology at Bristol University, said the research could help doctors to understand the drug's mechanisms... Click here to read more
18th September 2006The Daily Mail - UK "Depression fears over acne drugs" By Fiona MacRaek
Biochemist Dr Sarah Bailey looked at how healthy mice were affected by a six-week course of Roaccutane, which has a similar structure to vitamin A. She found that when given levels of Roaccutane equivalent to those used to treat teenagers, the creatures developed symptoms of depression, stress or despair ....Click here to read full article
18th September 2006The Times - UK"Acne treatment found to cause depressive behaviour in mice" By Nigel Hawkes, Health Editor, The Times, UK
A mouse that is depressed spends longer in the immobile state than one that is healthy. So the [research] team gave adolescent mice Roaccutance in doses that are equivalent to those given to human adolescents, and found that the periods of immobility were significantly increased. ... Read the full article
22 August 2006The Times - UK"Top acne drug 'increases the risk of liver damage' " Study of 13,772 patients over 7 year period show higher levels of Triglyceride, Cholesterol and Liver Enzymes than patient Adverse Reaction Leaflet for Ro/Accutane advises...click here to see Report by Nigel Hawkes, Health Editor for The Times, UK
28 April 2006TV Report - Switzerland"Roche und der Fall Roaccutane - Drohen Milliarden-Klagen?"...click here to see Swiss Article
>>>> 2005 <<<<
01 October 2005TV Report - UK SKY NEWS - 'ACNE DRUG KILLED STUDENT' There is growing concern about a possible link between suicide and a drug taken for acne. The parents of 22-year-old medical student Jon Medland claim Roaccutane played a role in their son's death. They are convinced he had a psychotic reaction to the drug as he was happy with his life at the time. His father said his son was prescribed Roaccutane for acne on his back. Within a couple of weeks he began to feel depressed and stopped taking it. But two days later he hanged himself. The medical regulator closely monitors Roaccutance and the product has carried a warning since 1998...click here
27 September 2005Newspaper ArticleFamily of suicide victim learns his acne treatment lists suicide as side effect - Part One and Part Two - Tammy and David Hestand of rural Bloomfield are concerned that a prescription acne medication may have contributed to the suicide of their 17-year-old son, Caleb.
20-21 September 2005Newspaper Article

Call for ban on acne drug linked to suicide ...Coroner inquest into death of David Roberts - The Liverpool Community College student's parents believe their son was a victim of Roaccutane and want a full investigation into the drug.

Family blame acne drug for death
BBC News, UK - The family of a student who hanged himself have blamed a drug he was taking to treat acne. David Roberts, 21, had been taking Roaccutane ...

Call for ban on acne drug linked to suicide
Times Online, UK - By Adam Fresco.
THE mother of a talented student who committed suicide after taking an anti-acne drug that has been linked with scores ..

Family blame acne drug for man's suicide
Scotsman, United Kingdom - THE family of a student who hanged himself blamed a drug he was taking to treat mild acne. David Roberts, 21, had been taking Roaccutane ...

ACNE PILL SUICIDE LINK CLAIM
Mirror.co.uk, UK - By Brendon Williams. THE family of a student who hanged himself while on acne pills claim they made him depressed. David Roberts, 20 ...

Acne drug drove our boy to suicide
Liverpool, UK - By Mary Murtagh, Liverpool Echo. THE family of a "happy and cheerful" Liverpool student who hanged himself, today blamed a controversial ...

12 August 2005Label Warnings - USFDA Approves Accutane Registration Program - wholesalers who distribute isotretinoin, doctors who prescribe isotretinoin, pharmacies that dispense isotretinoin, patients that take isotretinoin must register and agree to carry out the iPLEDGE program.. The FDA also changed existing warnings on Accutane so doctors and patients could better identify depression, suicidal behavior and other psychiatric problems that could occur.Seehttp://www.fda.gov/cder/drug/InfoSheets/patient/IsotretinoinPT.htmand various news reports - HealthDayNews
July 2005News ArticleSunday Times article on Adverse Reactions of prescription drugs including Roaccutane - 'Death of the Magic Pill'
28 May 2005News ArticleJudge says father can sue drug firm over son's death..click here
May 2005Label Warnings -US FDA Issues Alert...FDA continues to assess reports of suicide or suicide attempts associated with the use of isotretinoin. All patients treated with isotretinoin should be observed closely for symptoms of depression or suicidal thoughts, such as sad mood, irritability, anger, loss of pleasure or interest in social or sports activities, sleeping too much or too little, changes in weight or appetite, school or work performance going down, or trouble concentrating....New data also presented....click here
May 2005New Study PublishedStudy entitled 'Functional Brain Imaging Alterations in Acne Patients Treated With Isotretinoin' is published in the American Journal of Psychiatry..click here or here for full study
**News Articles:
Study finds acne drug can affect brain.. The Star Ledger...
Study raises more questions about Accutane...CTV news
1st May 2005News Article'Raging injustice'fuels father's quest to take on acne-drug giant ..Sunday Independent (Irish)...click here
April 2005News Article**Excellent Article featured in Real Magazine entitled 'Wonder Drug or Deadly Weapon?'.. Click here
April 2005Adverse Reactions - UKMemorandum on Number of Suicides, Attempted Suicides, Suicidal Ideation and Cases of Depression reported for Roaccutane for the age group 13-17 for the period 1st Nov 2001 to 31st May 2004...click here
February 2005New Study PublishedArticles about Dr. Bremner's study and comments...
Give Me Accutane or Give Me Death: The Politics of Prescriptions ... click here for article and Acne drug helps, hurts...click here
27th January 2005Newspaper ArticleGrieving father spends $1 million nest egg to investigateClick here for article
>>>> 2004 <<<<
19th Dec. 2004Newspaper ArticleFight to prove acne drug caused suicides - Sunday Times. Click here for article
6th Dec. 2004Newspaper ArticleDrugmaker rebuffed call to monitor users - USA Today -"The maker of Accutane, a controversial acne medication, disregarded a company doctor's recommendation that users of the drug be monitored for signs of depression and that a warning to that effect be added to the drug's U.S. label, allegations in a federal court case show.."Click here for article
23th Nov. 2004Meeting of House of Commons Health Committee, UKPaul Flynn, MP, Member of the House of Commons Health Committee speaks of his concern regarding the drug Roaccutane at the 'Influence of the Pharmaceutical Industry' meeting. He became concerned when a constituent committed suicide using Roaccutane and he was shocked to discover that there was no organisation for the defence of people in this circumstance..See transcripts of meeting (see page 153)
23rd Nov. 2004Newspaper Article

U.S. says it will tighten distribution of Accutane By Rita Rubin, USA TODAY "Under the new Accutane plan, doctors who prescribe the drug, pharmacists who dispense it and patients who take it will have to register with a central clearinghouse. This applies to Accutane, which is the brand name for isotretinoin, as well as generic versions on the market. Any patient who could get pregnant must present a negative pregnancy test before getting a prescription filled."http://www.usatoday.com/news/health/2004-11-23-accutane_x.htm

18th/19th Nov. 2004FDA

FDA's Associate Director for Science in the FDA's Office of Drug Safety, David Graham, during a Senate hearing regarding Vioxx names five other drugs which he describes as posing serious safety concerns. He describes Roche's drug Accutane, approved to treat severe acne, as a "20-year regulatory failure".

*Dr. Graham's Testiomey - http://finance.senate.gov/sitepages/hearing111804.htm - click on Dr. David J. Graham.

*Dr. Graham's Memo - Congressional Hearing 2000 (Scroll down to 'Other Released Hearing Documents', Tab #48, 8,10 & 12) released at the Congressional Hearing in 2000 - stating that "There is no alternative to immeidate withdrawal of Accutane from the market. To delay only compounds the body count. All previous efforts by the FDA to achieve its goal of eliminating pregnancy exposure to Accutane have failed. Only the immediate withdrawal of Accutane from the market will work".

Press Reports - USA today

15th Nov. 2004Newspaper ArticleAfter last month's Helath Select Committee on the influence of the pharmaceutical industries, there is an interesting article by Margaret Cook in the New Stateman magazine in the UK..click here
14th Nov. 2004News Feature - Call for Worldwide Enquiry into RoaccutaneParents demand acne drug inquiry - BBC NEWS
28th Oct 2004Newspaper Articles - Suicide of 15-year old girl

Australia: The mother of a schoolgirl (Australia) who hanged herself has warned parents about a widely used acne drug after an inquest found it may have contributed to her daughter's suicide. The Coroner recommended that dermatologists who prescribe Roaccutane should monitor their patients specifically for depressive symptoms.
- ABC New South Wales - The New South Wales coroner has found a drug prescribed for severe acne may have contributed to the depression suffered by a Sydney teenager who committed suicide. Ms Pinch has made several recommendations, including that prescribing dermatologists monitor their patients specifically for depressive symptoms, and provide a written referral to a psychiatrist if adverse symptoms are discovered.
-http://www.preventsuicidenow.com/vivian-crane-suicide.html
-Sydney Morning Herald, 21st October 2004
-Sydney Morning Herald, 28th October 2004

25th October 2004New Study PublishedTranscript from CNN American Morning - Interview with Congressman Bart Stupak and Dr. Douglas Bremner on his new study -click here"psychiatrist Douglas Bremmer looked at the brains of 13 young adults taking Accutane for acne and another 15 on antibiotics. In the so-called Accutane brain, activity in this front part of the brain was down 21 percent. DR. DOUGLAS BREMMER, EMORY UNIVERSITY: This plays a critical role emotion because there is a decrease in function in that part of the brain and it makes sense that there'd be changes in mood."
20th October 2004Newspaper Articles - Suicide of 22-year old Medical StudentUK: A CORONER in the has said there is a "likely link" between the suicide of a "bubbly" student and a powerful acne drug, known to cause depression...
- The Guardian
- South Manchester Reporter
- Manchester Evening News
October 2004New Research

See recent articles on Congressman Rep. Stupak's continued efforts for renewed research into psychiatric effects of Accutane and shared results of a recent study which he states "These [brain] scans show the promise of more research, and Hoffman-LaRoche has always denied that Accutane affects the brain."
- Research News

September 2004Label Warning - UKThe Expert Working Group of the Committee on Safety of Medicines reviewed the issue of psychiatric adverse effects in association with isotretinoin and the views were encorporated into the European wide review assessment (see 17 October 2003). The warnings were were further strengthened in September 2004 to include more explicit descriptions of the symptoms and behaviours associated with psychiatric disorders - The Patient Information Leaflet (PIL) now reads.. "Rare cases of depression, worsening depression, anxiety, mood changes, psychotic symptoms and very rarely suicidal thoughts, suicide attempts and suicide have been observed. If you have any kind of mental problems, or, if you observe signs of depression while taking Roaccutane such as feeling very sad for no reason, crying spells, difficulty concentrating or you become withdrawn from your friends or family, please inform your doctor. Your doctor may refer you for appropiate treatment if necessary. Discontinuation of your Roaccutane therapy may not be sufficent to alleviate symptoms and you may require further psychiatric or psychological evaluation.There have been reports of patients on Roaccutane becoming violent or aggressive . The review is continuing. [Source: correspondence with MHRA, April 05]
June 2004Newspaper FeatureGlaxoSmithKline facing fraud charges in the US for allegedly concealing information that its leading antidepressant caused suicidal behaviour amoung children and teenagers during clinical trials.Read here..
February 2004FDARep. Stupak Statement to FDA Advisory Panel Hearing on Accutane SMART Voluntary Registry dated 2/27/04 (PDF - 8 pages) and Stupak Response to FDA Advisory Panel Recommendations Regarding Mandatory Accutane Registry dated 2/27/04
>>>> 2003 <<<<
December 2003BAD - advice for DermatologistsSee the Advice for British Dermatologists and GP's on prescribing Roaccutane/Accutane/Isotretinoin on the following website -http://www.bad.org.uk/healthcare/guidelines/acne.asp
November 2003ResearchAn extensive review of the association between isotretinoin administration and depression and suicide.Click here to read more (pdf format)
17 October 2003European Meeting - Label WarningsThe Product Information for Isotretinoin products was updated following the completion of the European wide review of product information - See EMEA Press Release, April 2003 -click here and click here (page 16) and discussions in UK Parliament [click here]
3 September 2003Internet Sale of Drugs - FDAFDA Issues Warning Letter to Internet Companies Selling Dangerous, Unapproved Drug Without Prescription - click here
8 May 2003Newspaper ArticleRoche psoriasis drug to include depression warning, Reuters -" Roche Holding AG (ROCZg.VX) said on Thursday its psoriasis drug, Soriatane (a retinoid), may cause depression, aggressive feelings and thoughts of self-harm, and has therefore added a new warning to the drug's label warning.
27 April 2003Newspaper Articles - Suicide of 14-year old SUICIDE WATCH - Did a powerful acne drug play a role in a Palo Alto 14-year-old's killing himself? by Mike Weiss San Francisco ChronicleClick here
February 2003ResearchLetter by members of the FDA, Division of Dermatological and Dental Drug Prodcuts and Office of Drug Safey, (O'Connell, Wilkin, Pitts) published by the Journal of American Academy of Dermatogy in February 2003. The letter is in response to the November 2001 issue of the Jnl Am Acad Der which included a supplement supported by an educational grant from Hoffman- La Roche. The authors, in the interest of public interest, comment on 3 articles in that supplement regarding the association of isotretinoin and psychiatric adverse events.Click here to read article
January 2003Newspaper Articles

Several reports on Accutane, and the link to depression, were featured in the Australian News/Newspapers

08-January 2003Newspaper Article - Call for Enquiry by DermatologistCALLS FOR INQUIRY INTO ACNE DRUG by James Meikle. Wednesday January 8, 2003 The Guardian, UK.
European medicine watchdogs are reviewing the safety record of the anti-acne drug Roaccutane which has been linked to suicide and depression. The move comes as a consultant, Anthony Chu, of Hammersmith hospital, west London, has called for a commission into the prescribing of Roaccutane...
Click here for article
>>>> 2002 <<<<
30 December 2002Newspaper Article - Call for Enquiry by DermatologistAcne drug misery - The country's leading skin specialist, Dr. Chu, called for a government inquiry into a controversial acne drug, Accutane/Roaccutane after patients told how it had ruined their lives. Manchester Evening News.Click here
11 December 2002Congress HearingThe House Energy and Commerce Committee's Oversight and Investigations Subcomittee will be holding a hearing on Accutane December 11, 2002 in Washington, DC. More information will be provided when available. In the meantime, you can contact Scott Schloegel from Congressman Bart Stupak office on Yooper@mail.house.gov for more information
November 2002Research - NIMH Meeting Workshop Meetings Findings - "Workshop participants reached consensus that available genetic, behavioral, and neurochemical data are consistent with the idea that retinoids do exert effects in the adult brain. " National Institute of Mental Health (NIH) recommend further research into effect of retinoids on the adult brain - Workshop, held in November 2002, was initiated in part as a response to recent reports of depressive-like behavior, aggression, or suicide in adolescents using Accutane...click here for more****
25 July 2002FDA Warning letter A warning letter was issued by the FDA to Roche for false or misleading statements and minimization of important risk information. A representative of Roche made false or misleading oral statements about Accutane (isotretinoin) Capsules at Roche's promotional exhibit booth at the American Pharmaceutical Association's (APhA) Annual Meeting and Exposition held in Philadelphia, Pennsylvania in March 2002. Roche's representative engaged in false or misleading promotional activities about a bolded warning and other risk information relating to psychiatric disorders in Accutane's approved product labeling (PI).
31 June 2002Newspaper Article2 Page Article in Sunday Times dated 31st June 2002. Click here for article
20 June 2002Label Warning - USFDA introduce additional wording of aggressive and/or violent behaviours in labelling and brochure. For a copy of the current Accutane Prescription Pak and complete package insert in the US, click the following: Accutane Prescription PakorPackage Insert(pdf files which require acrobat reader)
21 May 2002News FeatureAnother Roche drug, Laraim (anti-malaria drug) associated with depression and suicide. One study for UPI found a 150 times greater rate of depression and a 40 times greater rate of suicide attempts among Lariam users compared with doxycycline users. Click here
17 May 2002News FeatureRoaccutane/Accutane Press Statement on Medical Control Agency (UK) meeting held in London on 17th May 2002 Click here
17 May 2002News FeatureHealed by the 'bazooka drug' - The drug company denies a link to suicides - By Tom Geoghegan BBC News Online Click here for full article
17 May 2002News FeatureBBC Breakfast Show - 'UK Acne Drug Should be Banned..[unless Roche agree to carry out studies to investigate the link between Accutane and psychiatric adverse reactions]'.. Dr Tony Chu, a dermatologist at the Hammersmith Hospital in London said"I do think it's overused .. I do think too many patients are given it."Click here for full article
06 May 2002News FeatureDrug Agency to meet with relatives of acne patients by Steve Boggan- Click here for full article
05 May 2002News FeatureTwo studies probe suicide, Accutane linkBy Mark Benjamin and Dan Olmsted from the Washington Politics & Policy Desk- Click here for full article
May 2002News FeatureMental risks from Accutane draw attention by Victoria Stagg Elliott, AMNews staff. May 6, 2002. A case of rechallenge/dechallenge documented. '(Dermatologists) complain about a lack of scientifically validated screening tools for depression among Accutane users, particularly to determine who might be the most at-risk. -Click here for full article
29 April 2002News FeaturePatient sues over acne drug linked to suicides bySteve Boggan
A patient who was diagnosed as being a paranoid schizophrenic after taking Roaccutane, is to sue Leeds General Infirmary and the clinician who prescribed him the drug. The dermatological unit at Leeds has been at the forefront of research into Roaccutane. Trials there, which Roche helped to fund, were instrumental in the drug being given a licence in 1983. However, that licence states that it may be prescribed only for severe forms of acne. But, in the UK, inquiries by The Independent have established that Roaccutane is routinely prescribed for use beyond the purpose for which it was licensed in 1983. Then, it was approved for "cystic and conglobate acne and severe acne which has failed to respond to an adequate course of antibiotics".
Click here for full article
April 2002FDA - New ResearchMembers of the FDA publish study in the Journal of American Academy of Dermatology. It stated that an increasing proportion of accutane use for mild and moderate acne although the licence states that accutane should be used for severe recalcitrant nodular (cystic) acne that is unresponsive to conventional therapy including systemic antibiotics. The FDA have continued to limit the use of isotretinoin to its approved indication.Click here to read article (pdf file)
April. 2002News FeatureAccutane Acne Drug Maker Sued Over Florida Suicide - Click here for full article
Mother of Tampa suicide pilot sues acne drug maker - click here for full article
Teen Pilot's Family Sues Drug Maker -Click here for full article
Suit: Drug behind suicide flight -Click here for full article
Feb. 2002Label WarningAccutane Label Warnings Changed in the US(pdf file - 20 pages). Abrochure(pdf file, 20 pages)entitled 'Recognizing Psychiatric Disorders in Adolescents and Young Aldults: A Guide for Prescribers of Accutane (Isotretinoin)' Click here for full newspaper article
Jan. 2002News Report - Sucide of 15-year oldReports surfaced that Charles Bishop, the 15-year-old who flew a small plane into a Florida skyscraper, had a prescription for the acne medication Accutane and that this might have accounted for his suicide. Below are selection of articles published.

- London Independent 10th January 2002 - 'Could an acne drug have driven a boy to drive plane into tower?'Click here for full article
- Associated Press Release 7th January 2002
Click here for full article
- St. Petersburg Times 9th January 2002 'Pilot's Acne Drug tied to Suicides'
Click here for full article
Jan. 2002News Report

Acne drug a PR hurdle for Roche Treatment has been a constant headache by Ed Silverman / Star Ledger
Click here for full article

Jan. 2002News Report

Acne Drug under Fire- Ed Silverman criticises the finanical link between Dr Douglas Jacobs, author of article which found no scientific evidence to link Roaccutane to suicide.
Click here for full article

>>>> 2001 <<<<
October 2001FDAFDA limits Prescriptions for Acne Drug Accutane
Click here for full article
September 2001News Report

Deadly side effects? Suicide cast suspicion on acne drug by Tim Christie
Click here for full article (Acrobat Reader Document)

Ocober. 2001News Report

Suicides prompt new look at acne drug'
Article published in 'The Detroit News' dated October 7, 2001 by By Deb Price / Detroit News Washington Bureau

July 2001 News Report

Lawsuits: Acne drug dangerous. By Deb Price / Detroit News Washington Bureau
Click here for full article (Acrobat Reader Document)

April 2001News ReportAttorneys in several US states filed lawsuits in federal and state courts, claiming the acne drug was responsible for a number of suicides.
Attorneys website (www.accutanelitigation.com)
or Newspaper article
February. 2001TV Report

Marketplace, 'Accutane'. Producer: Christian Cote, Researcher: Colman Jones
Click here for full article (Acrobat Reader Document)

February 2001 News Report

Sunday Telegraph, 'Demand for Safety alert on acne drug linked to suicide'. Lorraine Fraser, Medical Correspondent.

January 2001News Report - New Label Warning

'Mass mailing warns of Accutane's psychiatric risks'. By Rita Rubin, USA TODAY
Click here for full article

January 2001News Report New Accutane Warnings: Patients Must Be Told of Possible Depression and Psychiatric Side Effects. By Robin Eisner ABC news.com
Click here for full article
January 2001News Report

Mail Tribune News, 'Family sues over son's suicide'. Chris Bristol
Click here for full article

January 2001FDAFDA Introduce New Medication Guide Read more... (only 2 other Meds. in US have attracted this guide)
>>>> 2000 <<<<
December 2000Congress HearingUS Congressional Hearing on psychiatric side effects including suicidal ideation held in Washington on the 6th December 2000 Read more...
5 October 2000Press StatementStatement of Rep. Bart Stupak regarding his son's, BJ, suicide and the link to Accutane treatment. Rep Stupak stated that "The warnings on BJ's Accutane package contained none of these [depression, suicide ideation, or suicide]. The only warnings contained on the package were for the side effects of : headaches, nausea, vomiting, blurred vision, changes in mood, severe stomach pain, diarrhea, rectal bleeding, persistent feeling of dryness of the eyes, and yellowing of the skin or eyes and/or dark urine. Nothing about depression, suicide ideation or suicide." [click here]
September 2000FDA HearingFDA hold public meeting in Washington on the 19th September 2000 to discuss psychiatric side effects Read more...
May 2000News Report - suicideBJ Stupak, son of Rep Bart Stupak died by suicide while taking Accutane
>>>> 1999 <<<<
12 December 1999Debate in Parliament of Ireland Dr. Upton calls for Acne Drug Inquiry - Dr Upton sets out information available on Roaccutane including adverse drug reaction (ADR) reports, studies and label warnings. Dr Upton calls on the Minister for Health and Children to obtain full list of ADR reports from Roche and to set up an independent, scientific inquiry to review the side effects of Roaccutane...click here
October 1999News article

Hot Press 'The Bitter Pill'. by Bairbre Flood
Click here for full article (Acrobat Reader Document)

1999News article

Roche Annual Report (1999) Released - $1.5 Billion to be paid in fines Read more...

 

>>>> 1998 <<<<
Nov. 1998 News article

Parent's heartache targets Accutane.The Star Ledger newspaper talks to FDA officials following the introduction of new suicide label warnings for Roaccutane in February 1998 in the USA.

11 Nov. 1998 TV ReportA 30-minute investigative program entitled “Cover Up” by PRIMETIME, RTE (Irish National Television Station), which featured several world experts who commented on the catalogue of serious side effects of this medication. Roche were shown to conceal serious side effects, including those known to it prior to the marketing of Roaccutane, which were not featured in the label warnings when the drug was introduced.
Aug. 1998 News article - Suicide attempt of 15-year old

Amanda's Low Point, The Advocate Online
Amanda Callais, a high-school sophomore from Denham, tells how she went through a personality change during treatment with Roaccutane, which lead her to attempt suicide in November 1997.
click here for full story

June 1998News report - Suicide of 20-year old

Man Found Hanged had been using acne drug - Father calls for Independent inquiry into side-effects. Click here..

June 1998 News report - Suicide attempt

My face cleared and my life went dark, The London Independent
Sheila Asprey feels sure that the drug - not the acne - was responsible for her suicide attempt. Sheila describes her mounting depression and irritability, which culminated in a suicide attempt 8 weeks in to her treatment with roaccutane.

June 1998 News report - Suicide of 19-year old

FDA: Prescription for danger?, The Star Ledger
This article tells of the tragic death of 19-year old Christopher Tremain, in June 1997. Christopher committed suicide just six weeks after starting to take Accutane for his acne. His parents noted changes in his mood within a month of taking the drug.

May 1998 News Report - Suicide of 18-year old

Pupils suicide may be linked to acne drug, The Times
David Tebby leapt 80ft to his death from a multi-story car park after taking Roaccutane to clear up his teenage spots. Within months of starting Roaccutane, he developed suicidal tendencies.Click here for full story

Mar. 1998News report

Accutane, depression lined in 16 more claims, Ottowa Citizen
Health Canada has received 16 reports of people becoming depressed, aggressive and even suicidal while taking an acne drug. Eight of the cases in Canada were reported in the last year alone.
click here for full story

Mar. 1998 News report

Anti-acne treatment linked to suicide, The Irish Times
The Irish Times examines the history and background of Roaccutane which prompted an FDA statement on safety information.

Mar 5 1998 FDAFDA warns Roche of false advertising Read more...
Feb 1st 1998
&
Feb 5th 1998
News report - suicide of 20-year old

To lose a child, The Sunday Times
The actor Richard Todd describes his struggle to come to terms with the suicide of his youngest son Seumas. Seumas shot himself in his family home in Grantham. The 20-year old student had been treated for depression after a bad case of acne for which he had been prescribed Roaccutane. His father believes Roaccutane may have been a factor in his sons' death.

>>>> 1997 <<<<
Aug 1997FDAFDA warns Roche of late ADR submission Read more..
March 1997Label WarningFrench Health Authorties increase label warning for Roaccutane to include 'suicide' as a possible adverse event.. See label warnings
>>>> 1996 <<<<
1996FDA FDA began a re-evaluation of the psychiatric illness reports in 1996, when a physician in the reviewing division noted two cases of suicide in a routine listing of recent adverse events associated with Accutane. Reports such as this do not necessarily mean that the event has any relationship to the drug. Accutane, however, had previously been associated with depression as already noted in the Accutane labeling. Because suicide is the most serious consequence of depression, the FDA reviewing division enlisted the help of specialists in the FDA epidemiology division to try to determine whether the cases could possibly be related to Accutane use. The division undertook a systematic analysis of the published literature, previously reported cases entered into databases, and incoming safety reports) STATEMENT BY JONCA BULL, M.D. DEPUTY OFFICE DIRECTOR OFFICE OF DRUG EVALUATION - Congressional Hearing 2000.

Top

Web Developer
Ro/Accutane Press reports from around the world History of Label Warnings for Ro/AccutanePlease post your messages on Adverse Reactions experienced while on Ro/Accutane