Name/CompanyApproval Dates and Comments

Basilea Pharmaceutica

The health authorities in Austria, Belgium,
and Luxembourg approved this new once-daily
oral treatment in March 2009 for the treatment
of adults with severe chronic hand eczema
unresponsive to potent topical corticosteroids.

Allos Therapeutics

The US FDA received a New Drug Application
in March 2009 for the treatment of patients
with relapsed or refractory peripheral T-cell

Benzyl Alcohol Lotion 5%
Sciele Pharma

The US FDA approved this new prescription
non-neurotoxic medication in April 2009 for
the treatment of head lice in patients 6 months
of age and older. This product kills head lice by
asphyxiation without potential neurotoxic side-.

Botulinum Toxin – Type A

The Danish Medicines Agency (DKMA) approved this once-daily oral treatment
in September 2008 for the treatment of adults with severe chronic hand eczema
that is unresponsive to potent topical corticosteroids. Marketing applications
for this product are also under review in Canada and Switzerland.

Drug News

The Genentech unit of Roche Holding AG reported in April 2009, that it is pulling
the psoriasis treatment Efalizumab (Raptiva®) off the US market because of links
to an often fatal brain infection. The drug was approved by the US FDA for
patients with chronic moderate-to-severe plaque psoriasis and this move comes
only about 6 months after the drug’s labeling was updated to carry warnings of
links to progressive multifocal leukoencephalopathy. The company said no new
prescriptions should be written, and the drug will no longer be available at all
after June 8, 2009. Genentech says patients should talk with their doctors before
stopping treatment with the drug, because abruptly halting it can lead to sudden
worsening of their psoriasis.

Health Canada and Allergan are informing healthcare professionals about
important safety information related to botulinum toxin – type A and the potential
risk of serious adverse effects of muscle weakness remote to the injection site. Key
safety updates within the new product monographs for this neurotoxin include:

  • Patients may experience muscle weakness remote to the injection site. Possible symptoms include muscle weakness, dysphagia, aspiration pneumonia, speech disorders, and respiratory depression. These reactions can be fatal.
  • Patients or caregivers should be advised to seek immediate medical care if swalling, speech or respiratory disorders arise.
  • Botulinum toxin – type A should only be given by physicians with appropriate qualifications and experience in the use of this product. The revised product monographs emphasize the need to follow the recommended dosage and frequency of administration.
  • Patients with a history of underlying neurological disorders, dysphagia and/or aspiration should be treated with extreme caution.

Any case of serious suspected distant toxin spread or other serious or unexpected
adverse reactions in patients receiving botulinum toxin – type A should be
reported to Allergan or Health Canada.