What's new in June 2008

New for June

• 30 Jun 2008| MDA/2008/045 - Gambro and Hospal blood sets (lot numbers 0806 - 0817)

  This Medical Device Alert has been issued after Gambro identified the potential for a total or partial occlusion of the arterial (red) and/or venous (blue) dialyser connectors of these blood tubing sets.
  

• 28 Jun 2008| Antiepileptics

  A European review of antiepileptic medicines has concluded that any medicine in this class may be associated with a small risk of suicidal thoughts and behaviour. This review assessed clinical trial data, spontaneous reports of adverse drug reactions received after marketing, and literature reports of suicidal thoughts and behaviour associated with the following antiepileptic medicines: carbamazepine; divalproex sodium; felbamate; gabapentin; lamotrigine; levetiracetam; oxcarbazepine; pregabalin; tiagabine; topiramate; vigabatrin; and zonisamide.

• 27 Jun 2008| Good Manufacturing Practice (GMP) & Good Distribution Practice (GDP) Symposium - 11-12 November 2008

  The MHRA is pleased to announce 2 days of events aimed at Qualified Persons, Responsible Persons and all individuals involved in GMP and GDP Inspections.
  
  

• 27 Jun 2008| Complaints about advertising of medicines

  The outcomes of the investigations into four complaints about the advertising of medicines have been published.

• 27 Jun 2008| Advertising complaint - H-F Antidote Gel (calcium gluconate gel), E-mailed advertisement - May 2008

  We have received a complaint about an advertisement for H-F Antidote Gel which was e-mailed to potential customers on 7 May 2008 by First Aid Warehouse, trading name of Crest Medical Limited. The complaint was not upheld.

• 27 Jun 2008| Advertising complaint - Clinorette & Bedol, healthcare professional advertising - May 2008

  We received a complaint about the advertising material including a leavepiece and Dear Doctor letter for Clinorette and Bedol produced by Resource Medical UK Limited. We upheld the complaint.

• 27 Jun 2008| Advertising complaint - CalCold & CalCough, healthcare professional advertisement - May 2008

  A healthcare professional complained about an advertisement for CalCold and CalCough produced by McNeil Products Limited for healthcare professionals, which was published in Chemist & Druggist of 10 May 2008. We upheld the complaint.

• 27 Jun 2008| Advertising complaint - Metformin Hydrochloride, healthcare professional advertisement - March 2008

  We have become aware of advertisements for Metformin which were published in the Pharmaceutical Journal on 22 March 2008 and Geriatric Medicine of April 2008. The case was upheld.

• 26 Jun 2008| MDA/2008/044 - Action³ manual wheelchair with fixed back and height adjustable push handles manufactured by Invacare

  This Medical Device Alert has been issued as Fixed backrests on Action³ wheelchairs fitted with height adjustable push handles have fractured in use, placing the occupant and carer at risk of injury.

• 24 Jun 2008| MDA/2008/043 - Pregnancy test kits – Clinitest hCG Cassette, lot numbers 97552 and 97574 (professional use only), manufactured by Siemens Healthcare Diagnostics

  This Medical Device Alert has been issued as there is a risk that women in very early stages of pregnancy may have had a false negative test and go on to have treatment contraindicated in pregnancy.