Cheap generic drug stops fatal bleeding but gets little use

Generics/Research | Posted 13/04/2012 post-comment0 Post your comment

According to a systematic review of data, use of a cheap generic drug could potentially save many trauma patients every year [1].

picture 69

The drug in question, tranexamic acid, is made by Pfizer in injectable form and by many generics companies in other forms. It is a synthetic derivative of the amino acid lysine and is used to treat or prevent excessive blood loss during surgery and in various other medical conditions. It works by blocking plasmin, an enzyme that dissolves blood clots.

The drug has been used in Afghanistan and Iraq to reduce bleeding in wounded soldiers and is even sold over the counter as a treatment for heavy menstrual bleeding in Japan and UK. Although in the UK it is carried in ambulances, outside of the UK it is used in few civilian hospitals, according to The New York Times.

Eighteen studies were included in the systematic review. Studies were conducted in 13 countries; Africa, Australia, Brazil, Canada, Denmark, France, India, Mozambique, Norway, South Italy, Spain, UK and US. In addition, data from the CRASH-2 trial, which recruited 20,211 patients from 274 hospitals in 40 countries throughout the world, was used. The CRASH-2 trial was an international randomised controlled trial of the early administration of tranexamic acid to bleeding trauma patients.

From the collected data it was estimated that worldwide every year an estimated six million people die of trauma, with approximately 400,000 of those patients dying in the hospital from bleeding.

If all of these patients received tranexamic acid within one hour of injury approximately 128,000 deaths could be averted, if the drug was administered within three hours of injury this reduces to approximately 112,000 deaths, see Figure 1.

Figure 1: Deaths averted by use of tranexamic acid (TXA)

GW 943B figure 1

Source: Ker et al [1]

The largest number of deaths from haemorrhage and consequently the largest number of deaths averted are in India and China, where more than 17,000 lives could be saved in each country with use of the drug. However, significant deaths could also be averted in developed nations, such as the US, where it was estimated that 4,000 lives could be saved.

In the face of such evidence, some hospitals in the US are now using it, and others are looking into its effectiveness. The drug started getting heavy use by the US on the battlefield after some military medical officials saw it was being used successfully on British soldiers.

References

1.  Ker K, et al. Avoidable mortality from giving tranexamic acid to bleeding trauma patients: an estimation based on WHO mortality data, a systematic literature review and data from the CRASH-2 trial. BMC Emergency Medicine 2012;12:3.

2.  McNeil DG. Cheap Drug Is Found to Save Bleeding Victims. The New York Times. 20 March 2012. [cited 2012 Apr 13]. Available from: www.nytimes.com/2012/03/21/health/tranexamic-acid-cheap-drug-is-found-to-staunch-bleeding.html?_r=1&ref=health

comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010