admin June 29th, 2007
Health Canada and Hoffmann-La Roche Limited have issued a letter to health care professionals warning of the risk of tracheo-esophageal fistula associated with bevacizumab:
- Serious adverse events, including fatal events, of tracheo-esophageal (TE) fistula have been reported in association with use of AVASTIN clinical trials of small cell lung cancer (SCLC), non small cell lung cancer (NSCLC) and esophageal cancer.
- AVASTIN should be permanently discontinued in patients with tracheo-esophageal (TE) fistula or any gastrointestinal fistula. There is limited information on the continued use of AVASTIN in patients with other fistulas.
- In cases of internal fistula not arising in the GI tract, discontinuation of AVASTIN should be considered.
admin June 26th, 2007
Restrictions have been placed on the use of piroxicam. First prescriptions should not be for longer than 2 weeks and it can only be used in patients with osteoarthritis, rheumatoid arthritis, or, ankylosing spondylitis as second line treatment.
The European Medicines Agency (EMEA) has recommended restrictions on the use of piroxicam containing medicinal products because of the risk of gastrointestinal side effects and serious skin reactions. The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that piroxicam should no longer be used for treatment of short-term painful and inflammatory conditions.
Piroxicam can still be prescribed for the symptomatic relief of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. However it should not be the first choice of non-steroidal anti-inflammatory drug (NSAID) treatment in these conditions.
More at EMEA in PDF format.
Also see:
EMEA Question and Answer sheet.
MHRA statement.
admin June 20th, 2007
Over the past month the New England Journal of Medicine has published a meta-analysis and an interim results paper of the RECORD study concerned with the cardiovascular safety of rosiglitazone. There is coverage of both the meta-analysis and the trial data at prescriber.org.uk
Currently the MHRA and EMEA are not taking any action based on these results. Avandia is a centrally licensed drug, and therefore the European Medicines Agency has issued a statement about the cardiac safety of rosiglitazone. Patients are advised not to stop their treatment with rosiglitazone, but should discuss any concerns about their medication at their next routine appointment with the doctor. The statement is available at the MHRA website.
admin June 9th, 2007
The Lancet [registration required] reports on a case of sumatriptan-induced sulfhaemoglobinaemia:
In October, 2005, a 42-year-old man presented to our hospital, having developed a compartment syndrome in both lower legs. He was a smoker; his medical history included migraine. His regular medications were sumatriptan, which he had been taking at a dose of 200 mg per day, for several months, diclofenac, and zopiclone.
[...]
several attempts to insert an indwelling radial-arterial catheter yielded dark, greenish-black blood. Eventually, the catheter was advanced, and pressure transduction confirmed arterial placement. The displayed SpO2 was 96% on supplemental oxygen (inspired oxygen fraction [FIO2], 0.5). A sample of the greenish-black blood was sent to the laboratory for co-oximetry. The oxygen saturation (SaO2) was 94%, and the oxygen partial pressure (PaO2) 135 mm Hg. The methaemoglobin concentration was within the normal range, at 1·17 g/L (0·9%), as was the carboxyhaemoglobin concentation—but the analyzer displayed an alert to the presence of sulfhaemoglobin. Quantitative analysis (Beckman DU65 Spectrophotometer, Beckman Coulter, Mississauga, Canada) revealed a sulfhaemoglobin concentration of 2 g/L. The patient recovered uneventfully, and stopped taking sumatriptan after discharge. When seen 5 weeks after his last dose, he was found to have no sulfhaemoglobin in his blood.
M Flexman A, Del Vicario G, Schwarz SKW. Dark green blood in the operating theatre. The Lancet 2007; 369: 1972
The BBC also reports on the story.
admin June 5th, 2007
Cases of endophthalmitis, eye inflammation, increased intraocular pressure, and visual disturbances after unapproved route of intraocular administration of Adcortyl/Kenalog injections (triamcinolone acetonide).
Occurrence of tracheoesophaegeal fistula during study of chemotherapy plus radiotherapy plus Avastin in patients with limited-stage small-cell lung cancer (unapproved indication) with Avastin (bevacizumab).
Genotropin (somatropin): Small electronic calculators for auxology measurement and dosing of growth hormone may overestimate body surface area.
MHRA statement on cardiac safety of rosiglitazone (brand name Avandia).