admin February 24th, 2009
The FDA has issued a warning that zonisamide may be associated with metabolic acidosis in patients with with predisposing conditions or therapies. The young appear more at risk. Further info here.
The FDA recommends that healthcare professionals measure serum bicarbonate before starting treatment and periodically during treatment with zonisamide, even in the absence of symptoms. If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing zonisamide (using dose tapering), and modifying the patient’s antiepileptic treatment as appropriate. If the decision is made to continue patients with metabolic acidosis on zonisamide, then alkali treatment should be considered.
admin February 19th, 2009
The MHRA reports on an EMEA decision on Efalizumab (Raptiva):
The European Medicines Agency has completed a review of efalizumab (Raptiva) after concerns about its safety. The Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of efalizumab do not outweigh its risks, and that the marketing authorisation should be suspended across the EU.
Efalizumab is used to treat adults with moderate to severe chronic plaque psoriasis (a disease that causes red, scaly patches on the skin) who have not responded to, or who are unable to take, other treatments for psoriasis (including ciclosporin, methotrexate, and PUVA).
This medicine was reviewed after reports of serious side effects, including three confirmed cases of progressive multifocal leukoencephalopathy (PML, a rare but serious disorder of the central nervous system) in patients who had received efalizumab for more than 3 years; two of these patients died.
Although psoriasis is a disabling condition that can cause social and psychological problems for patients, it is very rarely life-threatening. The Committee concluded that the risk of PML is unacceptable for patients taking efalizumab. They recommended that the marketing authorisation should be suspended until there is adequate new evidence to identify a group of patients in which the benefits of efalizumab outweigh its risks.
EMEA press release [PDF].
EMEA Q&A on efalizumab [PDF].
admin February 4th, 2009
Drug Safety Update by the MHRA includes this month:
- Tibolone (Livial): increased risk of breast cancer recurrence
- Non-steroidal anti-inflammatory drugs: cardiovascular risk
- Toremifene (Fareston): risk of QT prolongation
- Methylphenidate: new guidance for use in treatment of ADHD
- Correction: Temsirolimus—severe hypersensitivity reactions during infusion