n°91

October 2007

Issue Contents
Editorial

Free  Winners and losers

p.178
Testosterone mongering

Marketing Authorisations


Omalizumab (asthma) (new drug)

p.179-182
Too many unknowns for an anti-IgE

Methotrexate (psoriatic arthritis) (new indication)

p.182
Approved at last

Entecavir (chronic hepatitis B) (new drug)

p.183-185
A last resort

Rituximab (rheumatoid arthritis) (new indication)

p.186-188
For a few patients with close monitoring

Infliximab (psoriatic arthritis) (new indication)

p.188
Just another intravenous me-too drug

Free  Rituximab (lymphoma maintenance therapy) (new indication)

p.189
Inadequate follow-up

Testosterone patch (hypoactive sexual desire disorder) (new drug)

p.190-192
Don't use to stimulate women’s sexual desire

INN common stems: -mab

p.192

INN common stems: -glitazone

p.192

Adalimumab (ankylosing spondylitis) (new indication)

p.193
Just another TNF alpha antagonist

Evra° (labelling change)

p.193
Confirmed risks not emphasised in the SPC

Infliximab (ulcerative colitis) (new indication)

p.194
Caution is needed due to long-term risks

Copies and biosimilar products

p.195
Deliberate lack of precision

Deferiprone

p.196
Second-line treatment of iron overload in the absence of a better alternative

Deferasirox

p.196
For iron overload : only a third-line option

Adverse Effects


Cholinesterase inhibitors: tremor and exacerbations of Parkinson's disease

p.197-198

Risk of confusion between plastic ampoules and other unit-dose containers

p.199

Oseltamivir: neuropsychiatric disorders

p.200

Zolpidem: sleep walking and automatic behaviours

p.200

SSI° BCG vaccine: avoidable adverse effects

p.200-201

Metoclopramide: extrapyramidal symptoms in children

p.201

Rituximab: gastrointestinal perforation

p.201

Tianeptine abuse: yet again!

p.201

Aripiprazole: malignant syndrome

p.201

Reviews


Female sexual dissatisfaction

p.202-205
Hormone therapy inappropriate

Ginkgo and Alzheimer's disease

p.205-207
Little or no different from placebo

Long-term asthma therapy

p.208-211
Adapt steroid therapy to severity

Outlook


Free  India: Novartis' failed action

p.212-213

A strong U.S. and EU industry lobby weakened the REACH Regulation

p.214-216

“Risk management plans”: hardly reassuring!

p.216-217

Herbal medicinal products: towards European harmonisation

p.218

Civic responsibility and concrete action

p.220

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