Adverse drug reactions

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ADVERSE DRUG REACTIONS

reported in the Press, February 19 to May 2002.

AN-1792 (Elan): for Alzeimers. Trials end after 15 patients develop brain inflammation. Various media. 4 March 02.

Alpha-1- antitrypsin (PPL): for lung disease. Delay of 2 years as caused wheezing (BBC Sci/Tech) 25 March 02.

Vevesca (Oxford Glyco-Sciences): Gaucher's Disease. 11% patients developed nervous system disease. Financial Times 21 March 02

Gliadel (Guilford Pharmaceuticals): for brain cancer. FDA rejected request to expand use. When compared to placebo, did not significantly reduce patients risk of death during clinical trial. The Baltimore Sun, March 21 02,

Vioxx, (Merck and Co): painkiller, linked to meningitis. This has been added to list of side effects. sfgate.com FDA report, March 25 02

Sibutramine/Reductil (Abbott Laboratories): for weight loss. Deaths. Being monitored. Reuters Health, March 15 02

Bexxar (Corixa Corp): non-Hodgkins lymphoma. FDA 3rd rejection. wsrn.com, 13 March 02

Zithromax (Pfizer): antibiotic. Failed to show it helps reduce hardening of arteries in heart attack patients. Reuters, 19 March 02

Picovir (Viropharma Inc): anti viral cold treatment. Rejected by Government Advisory Panel. Risks outweigh benefits. The Boston Globe, 20 March 02

Intron A, Interferon alfa 2b etc. Schering Sales Corp. A boxed warning added re numerous disorders. FDA, 14 March 02

Zyprexa (Lilly): schizophrenia drug. Adverse effects on diabetics. Reuters, 3 May 02

Glivec (Novartis): leukaemia. Very limited licence as not adequate evidence of effectiveness. Times, 15 May 02

Roaccutane (Roche): acne. Possible suicides. Call for inquiry. Ananova News, 17 May 02

Exubera (Pfizer): diabetes. Removed at late clinical trial but may be marketed this year. Hurt breathing ability. Cnet, 16 May 02

Colostrinin (Regen Therapeutics): Alzeimers. Has yet to show conclusive benefits during clinical trials. FT, 22 March 02

Marimastat (British Biotech): cancer. 1986-3 May 01 when it seemed to disappear. No better than existing medicines. Various media sources

RecAAt (PPL Therapeutics/Bayer): emphysema. Phase 3 trial suspended when 3 patients dropped out. FT 19 March 2002

Pralnacasan (Vertex Pharmaceuticals /Aventis): arthritis. Did not show significant efficacy in clinical trials. Reuters, 24 April 02

Lotronex (GSK). IBS. Pulled from market due to sometimes lethal bowel ischaemia. May be cleared again but with stringent restrictions. CBS News, 23 April 02

Claritin (Schering- Plough Corp): allergy. May cause birth defects in humans. CNN Money, 26 April 02

Avandia (Glaxo): diabetes. Added warnings of heart and liver disease. Taipei Times 28 April 02

Actos (Lilly): diabetes. Added warnings of liver disease. Taipei Times, 28 April 02

Avastin (Genentech): cancer. Abstracts may contain negative safety data. Cnet, 11 April 02

Arava (Aventis Pharma): rheumatoid arthritis. Linked to liver disease and death. FDA to consider. Nando Times 28 March 02, and FDA urged to ban. MSNBC News, 28 March 02

Erbitux (Imclone/Bristol-Myers Squibb Co): cancer. Rejected by FDA. East Bay Business Times, 8 February 02

Lovonex (Aventis): Not recommended for thromboprophylaxis in patients with prosthetic heart valves. FDA, 4 April 02

Oxytrol (Watson Phamaceuticals Inc): skin patch for urinary incontinence. More clinical data needed. Bloomberg.com, 28 March 02

Selegiline (Somerset Pharmaceuticals Inc): depression. FDA has not approved. Need additional efficacy data. PR News 27 March 02

Clozaril (Novartis): schizophrenia. Strengthened warning re myocarditis. Pschominded.co.uk, 1 April 02

CTV-01 (Cambridge-based Medicines Co): bacterial vaginosis. Failed in study. Boston Business Journal, 27 March 02

Geodon (Pfizer): schizophrenia. FDA strengthened warnings. FDA April 2002 and MCA 26 March 2002

Reductil (Abbott Laboratories Inc): obesity. Withdrawn after human deaths. Financial Express, 10 April 02

Oxycontin (Purdue Phara): painkiller. Implicated in causing or contributing to deaths. ABC News, 16 April 02

Factive (GlaxoSmithKline): antibiotic. Abandoned. The Independent, 16 April 02

Olanzapine (Lilly): antipsychotic. Side effects in diabetic patients. Reuters Health, 19 April 02

Irofulven (MGI): pancreatic cancer. Stopped late stage clinical trials. The Street 17 April 02

· And while not a drug side effect, the following is of interest:

Lipitor (Pfizer): cholesterol drug. World's best selling drug. Investigations re pricing and marketing practices. Digitalmass, 17 May 02

Also:

…'the complexity and reach of modern medicines had come to represent new levels of harm to patients'…….more people in Great Britain die from adverse reactions to medical drugs each year, than are killed on the roads. BMJ 15 April 02 (Italics added)

Human Trials.

You must ensure that patients or volunteers understand that they are being asked to participate in research and that the results are not predictable'. General Medical Council  The Role and responsibilities of Doctors', 2002 (Italics added)

'The company (Bristol-Myers Squibb) is struggling with a shortage of promising drugs in the pipeline, a surplus of lawsuits, several failed products and generic competition'. 'Drug firms becoming desperate as industry changes' Nando Times,

8 April 02

Compiled 19 May 02 by JR

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