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The Drug Safety Update is an NHS Evidence accredited provider
20th January 2011
The MHRA and CHM have published the January edition of Drug Safety Update This edition advises healthcare professionals that:
- Cases of cardiac failure have been reported when pioglitazone▼ was used in combination with insulin
- Treatment with bevacizumab▼ or sunitinib▼ may be a risk factor for the development of osteonecrosis of the jaw
- Sitaxentan▼ has been withdrawn worldwide due to hepatotoxicity
- Studies have confirmed the cardiac risks of dextropropoxyphene (a constituent of co-proxamol)
- Moxifloxacin▼ should be used in pelvic inflammatory disease (and various other infections) only when other antibacterials are inappropriate or ineffective
- There is no evidence of an increased risk of febrile convulsions in children with seasonal flu vaccines.
There is also more information on the Implanon contraceptive implant.
Action
More details are available in Drug Safety Update (DSU), which also includes links to further useful sources of information. This publication is an essential read for everyone whose professional practice involves medicines.
Insulin combined with pioglitazone▼: risk of cardiac failure
Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for the development of cardiac failure. If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain, and oedema. Pioglitazone should be discontinued if any deterioration in cardiac status occurs.
A recent MeReC Rapid Review discusses the cardiovascular risks of pioglitazone and considers its place in the management of type 2 diabetes. More information on type 2 diabetes can be found on the type 2 diabetes section of NPC.
Bevacizumab▼ and sunitinib▼: risk of osteonecrosis of the jaw
Treatment with bevacizumab or sunitinib may be a risk factor for the development of osteonecrosis of the jaw. Patients receiving these drugs who have previously received, or are treated concurrently with bisphosphonates may be particularly at risk. Dental examination and appropriate preventive dentistry should be considered before treatment with bevacizumab or sunitinib. Invasive dental procedures should be avoided, if possible, in patients treated with bevacizumab or sunitinib who have previously received, or who are receiving, intravenous bisphosphonates.
Sitaxentan▼: worldwide withdrawal due to hepatotoxicity
New information regarding the risk of severe, unpredictable hepatic reactions associated with the use of sitaxentan means that it will be withdrawn from all markets because the benefit to patients no longer outweighs the risk. Advice for healthcare professionals and patients is given in the full article.
Dextropropoxyphene: new studies confirm cardiac risks
New clinical data from the USA show that dextropropoxyphene can have serious effects on the electrical activity of the heart, even at normal therapeutic doses. As a result, products that contain dextropropoxyphene, either alone or in combination with paracetamol (as co-proxamol), are being withdrawn from the US market, and the FDA is advising healthcare professionals to stop prescribing it. In addition, in June 2010, the European Commission advised that products containing dextropropoxyphene should no longer be available across Europe.
In the UK, all licenses for co-proxamol (dextropropoxyphene and paracetamol) were cancelled by the end of 2007. It is estimated that the withdrawal of co-proxamol from the UK has saved around 300–400 lives each year from self-poisoning, around a fifth of which were accidental. See Drug Safety Update, Nov 2007, for a reminder issued to prescribers about the withdrawal of co-proxamol.
Prescribers should reassess the balance of risks and benefits in each patient of continuing treatment with co-proxamol, taking into account the individual’s other medications and any comorbidities, in the light of the new US data. No new patients should start treatment with co-proxamol (see letter to Healthcare Professionals, Jan 31, 2005).
Moxifloxacin▼: use only when other antibacterials are inappropriate or ineffective
Because of evidence of serious adverse effects (including life-threatening liver reactions and QT interval prolongation), moxifloxacin should only be used when other antibacterials are inappropriate or ineffective. This restriction applies to treatment of mild to moderate pelvic inflammatory disease as well as treatment of acute bacterial sinusitis, acute exacerbations of chronic bronchitis, and community acquired pneumonia (except severe cases).
Seasonal flu vaccines: no evidence of increased risk of febrile convulsions in children
To date, there is no indication of an excess risk of febrile convulsions in children associated with seasonal influenza vaccines.
Implanon contraceptive implant: information for women and healthcare professionals
In light of recent media coverage regarding the contraceptive implant Implanon, advice to support safer use of this product is highlighted.
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