Safety warnings, alerts and recalls

• drug alerts on defective medicines; 
• medical device alerts and their predecessors; and
• safety warnings and messages about medicines, including letters sent to health professionals.
  

Latest safety warnings, alerts and recalls

• 08 Feb 2010 | Medical Device Alert: Servo 300 and 900 ventilators (SV300 and SV900) manufactured by Siemens (now Maquet) (MDA/2010/011)
  

  This Medical Device Alert has been issued due to excessive negative pressures (eg using closed suction systems), which can damage the inspiratory and expiratory pressure measurement transducers. Such damage has led to high gas flows that subsequently caused bilateral pneumothoraces.

• 01 Feb 2010 | Monthly list of MDAs - 2010
  

  A month-by-month list of Medical Device Alerts that we have issued in 2010.

• 01 Feb 2010 | Nicotine replacement therapy: New extended indication and consultation
  

  We have today announced an extended indication for nicotine replacement therapy (NRT) to include harm reduction, which has been granted for an (NRT) inhalator, available through general sales outlets.

• 01 Feb 2010 | Medical Device Alert: C-Max U/2 stair climbers manufactured by Alber Antriebstechnik GmbH (AAT) (MDA/2010/010)
  

  This Medical Device Alert (MDA) has been issued due to a risk of injury to the attendant's hand when using the climbing mechanism on C-Max U/2 stair climbers manufactured by Alber Antriebstechnik GmbH (AAT).

• 01 Feb 2010 | Information sent to healthcare professionals in January 2010 about the safety of medicines
  

  A list of letters sent to healthcare professionals in January 2010, to inform of new safety information and advice.

• 28 Jan 2010 | Class 3 Drug Alert (Action within 5 days): Schering-Plough Ltd - IntronA 18, 30 and 60 million IU solution for injection (Recombinant interferon alfa-2b) - EL (10)A/02
  

  Schering-Plough Ltd is recalling certain batches, which have an expiry date of 18 months, as a precautionary measure because the stability of the products after 15 months cannot be assured.

• 28 Jan 2010 | Medical Device Alert: T-piece connector incorporated into various breathing systems manufactured by Intersurgical Ltd (MDA/2010/009)
  

  This Medical Device Alert (MDA) has been issued due to a possible blockage of the connector by a plastic membrane, which has been caused by a moulding fault during manufacture. This fault could prevent or restrict the gas flow to the patient.

• 21 Jan 2010 | Sibutramine: Suspension of marketing authorisation as risks outweigh benefits
  

  The European Medicines Agency (EMA) has completed a review of the obesity medicine sibutramine (Reductil). The review has found that the cardiovascular risks of sibutramine outweigh its benefits.

• 21 Jan 2010 |  Questions and answers for recommendation to suspend sibutramine (Reductil) (15Kb)
  

• 21 Jan 2010 |  Sibutramine: Direct Healthcare Professional Communication (68Kb)