n°98

December 2008

Issue Contents
Editorial

Free  Premature marketing authorisation: danger

p.222
Patients at increased risk of adverse effects

Marketing Authorisations

Temsirolimus (metastatic kidney cancer) (New Drug)

p.223-225
More assessment needed

Trimetazidine (Transparency)

p.225
Information withheld from patients

Imatinib (chronic myeloid leukaemia) (A Second Look)

p.226-228
Clear advantages

Lamivudine/zidovudine (HIV-infected children) (Paediatric Indication)

p.228
Possibly helpful

Fluticasone/salmeterol (asthma and COPD) (Labelling Change)

p.229
Regulators pander to Big Pharma

Lenalidomide (myeloma) (New Drug)

p.230-232
Many questions remain unanswered

Abatacept (rheumatoid arthritis) (New Drug)

p.232
Comparison with rituximab is needed

Posaconazole (mycosis and oropharyngeal candidiasis) (New Indications)

p.233
No therapeutic advantage

Adjuvanted hepatitis B vaccine (renal failure) (New Drug)

p.234-236
Fewer boosters needed

Bevacizumab (metastatic breast cancer) (New Indication)

p.236
Not acceptable

Dantrolene (cerebral palsy in children) (New Indication)

p.237
Uncertain clinical benefit

Bosentan (scleroderma and finger ulcers) (New Indication)

p.238
No tangible efficacy

Abacavir: pretreatment screening (Warning)

p.239
Encouraging method but uncertainties remain

Adalimumab (moderate to severe plaque psoriasis) (New Indication)

p.240
Just another TNF alpha antagonist

Common stems - INN: -rolimus

p.240

Common stems - INN: -cept

p.240

Adverse Effects

Patient reporting improves pharmacovigilance

p.241-242
Patients will ultimately benefit from the increased knowledge

Isotretinoin: psychiatric disorders

p.242
Disturbing reports of suicides

Free  Progestagen-only treatment before menopause: increased risk of breast cancer

p.243
Widespread use in spite of the lack of robust evidence

Dangerous paediatric prescriptions

p.244
In France, a large number of children are exposed to risks

Abacavir, didanosine: myocardial infarction

p.244
Not a first-line option

Pregabalin: hypersensitivity

p.244
Further adverse effects

Echocardiography: fatal reactions to contrast agents

p.245
Determine the necessity before performing an investigative procedure

Actiq°: keep out of reach of children

p.245
Medicines versus lollipops

Mycophenolate: encephalopathy

p.245
JC virus infection

Reviews

Dental amalgam

p.246-250
Few proven harmful effects

Dental amalgam: numerous alternatives, but more evaluation needed

p.249

Preventing mosquito-borne infections Part one - Insect repellents and insecticides

p.250-253

Repellents and insecticides: assessment and regulation

p.251

Preventing mosquito-borne infections Part two - Malaria prevention and public health

p.252-253

Prescrire’s advice: Preventing mosquito-borne infections with repellents and insecticides

p.253

Type 2 diabetes and HbA1c targets

p.254
Results of Accord and Advance trials do not challenge the existing target of 7%

Outlook

Free  Editorial: Patients in France are going without healthcare for financial reasons

p.255

Clinical trials registries: towards improved access to therapeutic data

p.256-259

Free  Evaluation of treatment benefits: clinical endpoints relevant to patients

p.260

Free  OTC drug sales authorised in France

p.261

ISDB : a global network championing independent information

p.264

Forum

Free  Forum - No, using the INN system does not necessarily mean prescribing a generic

p.262

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