USA. Pharmacia, in conjunction with the US FDA, has issued a ‘Dear Healthcare Professional’ letter advising prescribers of recent changes to the prescribing information for irinotecan (Camptosar). Irinotecan is indicated as a component for the first-line treatment of metastatic colorectal cancer in combination with 5-fluorouracil (5-FU) and leucovorin and for the treatment of metastatic colorectal cancer that has recurred or progressed following initial 5-FU based treatment.
The prescribing information has been revised to identify patients at higher risk of severe toxicity, to clarify dose modification guidelines and to augment information about the management of treatment-related toxicities. Principal changes reflect that Warnings and Precautions sections of the package insert now state that:
• patients with diarrhoea should be carefully monitored and treated with fluids and electrolytes if they become dehydrated, or with antibacterials if they develop ileus, fever or severe neutropenia
• subsequent courses of antineoplastic therapy should be delayed in patients who develop diarrhoea after the first cycle of treatment until pre-treatment bowel function has resumed for 24 hours. If grade 2, 3 or 4 late diarrhoea develops, subsequent doses of irinotecan should be reduced. The FDA has agreed with its Oncologic Drugs Advisory Committee that both the bolus and infusional regimens of irinotecan plus fluorouracil/ leucovorin remain approved for the first-line treatment of metastatic colorectal cancer and that, the starting dose and cycle schedules of both regimens remain unchanged.
‘Dear Healthcare Professional’ letter from Pharmacia, 10 May 2002. Available from URL: http://www.fda.gov/medwatch/SAF ETY/2002/camptosar.htm
ISOTRETINOIN - Reports of central nervous system disorders
Norway. Reports of central nervous system disorders associated with isotretinoin (Roaccutan) have been received by the Norwegian Medical Products Agency (MPA) and, changes to the product labelling are to be made accordingly. In Norway, isotretinoin is only available through a special license for compassionate use and requires the prescribing physician to take special responsibility for the patient. Included among the reports of psychiatric adverse events the agency has received are two reports of suicidal thoughts and suicide. Although the relationship between isotretinoin and suicide is unclear, the MPA has requested that the manufacturer of ‘Roaccutan’ informs dermatologists that a positive relationship cannot be excluded. In addition, the MPA states that the prescribing physician must evaluate the mental health of the patient before the agent is used and, monitor the patient for depressive symptoms throughout therapy. It has also requested that a warning regarding psychiatric adverse reactions be included in information given to the patient.
Reports in WHO-file: Depression 1389, depression aggravated 89, depression psychotic 35, suicide attempt 509
Buajordet I. Roaccutan (isotretinoin) and psychiatric reactions. Nytt om Legemidler 25: 4, Jan 2002.