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FDA approves injectable ibuprofen

16th June 2009

The US Food and Drug Administration (FDA) has approved Caldolor (Cumberland Pharmaceuticals), the first injectable formulation of ibuprofen, for the treatment of acute pain and fever. It will be available for hospital use only and is licensed for administration over 30min, in doses of 400-800mg every 6h for acute pain, and 400mg initially followed by 400mg every 4-6h or 100-200mg every 4h as necessary for fever.

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Disodium clodronate injection discontinued in UK

16th June 2009

Disodium clodronate injection 60mg/ml (Bonefos concentrate, Bayer 01635 563000) has been discontinued in the UK. There is no alternative injectable disodium clodronate product available and no residual stock. The company has confirmed that the tablets and capsules continue to remain available.

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MHRA recall oxybutynin 5mg tablets

15th June 2009

Oxybutynin 5mg tablets from Niche Generics and Actavis UK Ltd from the batches listed below are being recalled due to the possible inclusion of undispersed active ingredient which has the potential to result in patient overdose. It is not yet clear whether the undispersed active ingredient, found during the early stages of production, has reached the finished tablet, however all stock from the following batches is being recalled as a precautionary measure.
Niche Generics affected batches 09D02 and 09D04, first distributed 16/04/09.
Actavis UK affected batches 146401 and 146402, first distributed 05/05/09 and 22/05/09 respectively.
Both companies have requested that patients should be contacted and supplied with replacement stock from unaffected batches.
Medical information (for both companies) can be obtained from the Niche Medical Information Department (Dr Vineet Kacker, 07753 606357).
Further information can be accessed from the MHRA website link below.

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Antipsychotics: risk of venous thromboembolic events

9th June 2009

The UK Medicines and Healthcare products Regulatory Agency (MHRA) drug safety update has advised that there may be an increased risk of venous thromboembolic events associated with antipyschotics. There is insufficient data to determine any difference between conventional or atypical antipyschotics or between individual drugs. Healthcare professionals are advised to identify all possible risk factors for venous thromboembolism before and during antipyschotic use and take preventative measures.

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FDA website links have changed

9th June 2009

The US Food and Drug Administration (FDA) has changed it's website this week. Unfortunately many of the articles referenced on our site and in the Palliative Care Formulary (PCF3 and HPCFusa2) have been moved. We are in the process of updating links on the site and will ensure that all links are corrected in future publications.

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