DATE | CATEGORY | GENERAL HEADING & BRIEF DESCRIPTION |
>>>> 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. |
| 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 2007 | Pharmalot | Accutane: 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 2007 | FDA, US | FDA WARNING: Risks of buying Accutane (isotretinoin) over the Internet Cick here to read the full warning |
| April 2007 | Point of Law, Info on US Litigation System | Accutane mass tort litigation for inflammatory bowel disease. Cick here to read the full article |
| March 2007 | BMJ | Roche 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 2007 | The 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 2007 | Daily 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 |
| November 2006 | Switzerland 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 2006 | Baltimore 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 2006 | The 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 |
| 2006 | Neuropsychopharmacology (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 2006 | The 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 2006 | The 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 2006 | The Telegraph - UK | Scientists 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 2006 | The 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 2006 | The 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 2006 | The 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 2006 | TV Report - Switzerland | "Roche und der Fall Roaccutane - Drohen Milliarden-Klagen?"...click here to see Swiss Article |
| 01 October 2005 | TV 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 2005 | Newspaper Article | Family 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 2005 | Newspaper 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 |
| 12 August 2005 | Label Warnings - US | FDA 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 2005 | News Article | Sunday Times article on Adverse Reactions of prescription drugs including Roaccutane - 'Death of the Magic Pill' |
| 28 May 2005 | News Article | Judge says father can sue drug firm over son's death..click here |
| May 2005 | Label 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 2005 | New Study Published | Study 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 2005 | News Article | 'Raging injustice'fuels father's quest to take on acne-drug giant ..Sunday Independent (Irish)...click here |
| April 2005 | News Article | **Excellent Article featured in Real Magazine entitled 'Wonder Drug or Deadly Weapon?'.. Click here |
| April 2005 | Adverse Reactions - UK | Memorandum 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 2005 | New Study Published | Articles 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 2005 | Newspaper Article | Grieving father spends $1 million nest egg to investigateClick here for article |
| 19th Dec. 2004 | Newspaper Article | Fight to prove acne drug caused suicides - Sunday Times. Click here for article |
| 6th Dec. 2004 | Newspaper Article | Drugmaker 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. 2004 | Meeting of House of Commons Health Committee, UK | Paul 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. 2004 | Newspaper 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. 2004 | FDA | 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". |
| 15th Nov. 2004 | Newspaper Article | After 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. 2004 | News Feature - Call for Worldwide Enquiry into Roaccutane | Parents demand acne drug inquiry - BBC NEWS |
| 28th Oct 2004 | Newspaper 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. |
| 25th October 2004 | New Study Published | Transcript 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 2004 | Newspaper Articles - Suicide of 22-year old Medical Student | UK:
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 2004 | New 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." |
| September 2004 | Label Warning - UK | The 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 2004 | Newspaper Feature | GlaxoSmithKline 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 2004 | FDA | Rep. 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 |
| December 2003 | BAD - advice for Dermatologists | See 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 2003 | Research | An extensive review of the association between isotretinoin administration and depression and suicide.Click here to read more (pdf format) |
| 17 October 2003 | European Meeting - Label Warnings | The 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 2003 | Internet Sale of Drugs - FDA | FDA Issues Warning Letter to Internet Companies Selling Dangerous, Unapproved Drug Without Prescription - click here |
| 8 May 2003 | Newspaper Article | Roche 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 2003 | Newspaper 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 2003 | Research | Letter 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 2003 | Newspaper Articles | Several reports on Accutane, and the link to depression, were featured in the Australian News/Newspapers
|
| 08-January 2003 | Newspaper Article - Call for Enquiry by Dermatologist | CALLS 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 |
| 30 December 2002 | Newspaper Article - Call for Enquiry by Dermatologist | Acne 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 2002 | Congress Hearing | The 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 2002 | Research - 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 2002 | FDA 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 2002 | Newspaper Article | 2 Page Article in Sunday Times dated 31st June 2002. Click here for article |
| 20 June 2002 | Label Warning - US | FDA 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 2002 | News Feature | Another 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 2002 | News Feature | Roaccutane/Accutane Press Statement on Medical Control Agency (UK) meeting held in London on 17th May 2002 Click here |
| 17 May 2002 | News Feature | Healed 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 2002 | News Feature | BBC 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 2002 | News Feature | Drug Agency to meet with relatives of acne patients by Steve Boggan- Click here for full article |
| 05 May 2002 | News Feature | Two studies probe suicide, Accutane linkBy Mark Benjamin and Dan Olmsted from the Washington Politics & Policy Desk- Click here for full article |
| May 2002 | News Feature | Mental 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 2002 | News Feature | Patient
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 2002 | FDA - New Research | Members 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. 2002 | News Feature | Accutane
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. 2002 | Label Warning | Accutane 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. 2002 | News Report - Sucide of 15-year old | Reports 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. 2002 | News Report | Acne drug a PR hurdle for Roche Treatment
has been a constant headache by Ed Silverman / Star Ledger |
| Jan. 2002 | News 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. |
| October 2001 | FDA | FDA limits Prescriptions for Acne
Drug Accutane Click here for full article |
| September 2001 | News Report | Deadly side effects? Suicide
cast suspicion on acne drug by Tim Christie |
| Ocober. 2001 | News Report | Suicides prompt new look at acne drug' |
| July 2001 | News Report | Lawsuits: Acne drug dangerous.
By Deb Price / Detroit News Washington Bureau |
| April 2001 | News Report | Attorneys 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. 2001 | TV Report | Marketplace, 'Accutane'. Producer:
Christian Cote, Researcher: Colman Jones |
| February 2001 | News Report | Sunday Telegraph, 'Demand for Safety alert on acne drug
linked to suicide'. Lorraine Fraser, Medical Correspondent.
|
| January 2001 | News Report - New Label Warning | 'Mass mailing warns of Accutane's psychiatric risks'.
By Rita Rubin, USA TODAY |
| January 2001 | News 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 2001 | News Report | Mail Tribune News, 'Family sues
over son's suicide'. Chris Bristol |
| January 2001 | FDA | FDA Introduce New Medication Guide Read more... (only 2 other Meds. in US have attracted this guide) |
| December 2000 | Congress Hearing | US Congressional Hearing on psychiatric side effects including suicidal ideation held in Washington on the 6th December 2000 Read more... |
| 5 October 2000 | Press Statement | Statement 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 2000 | FDA Hearing | FDA hold public meeting in Washington on the 19th September 2000 to discuss psychiatric side effects Read more... |
| May 2000 | News Report - suicide | BJ Stupak, son of Rep Bart Stupak died by suicide while taking Accutane |
| 12 December 1999 | Debate 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 1999 | News article | Hot Press 'The Bitter Pill'. by Bairbre Flood |
| 1999 | News article | Roche Annual Report (1999) Released - $1.5 Billion to be paid in fines Read more...
|
| 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 Report | A 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 |
| June 1998 | News 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
|
| June 1998 | News report - Suicide of 19-year old | FDA: Prescription for danger?, The Star Ledger |
| May 1998 | News Report - Suicide of 18-year old | Pupils suicide may be linked to acne drug, The Times |
| Mar. 1998 | News report | Accutane, depression lined in 16 more claims, Ottowa
Citizen |
| Mar. 1998 | News report | Anti-acne treatment linked to suicide, The Irish Times
|
| Mar 5 1998 | FDA | FDA 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 |
| Aug 1997 | FDA | FDA warns Roche of late ADR submission Read more.. |
| March 1997 | Label Warning | French Health Authorties increase label warning for Roaccutane to include 'suicide' as a possible adverse event.. See label warnings |
| 1996 | FDA | 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. |
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