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Press releases Saturday 29 March 2008

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(1) Being born bottom first is inherited
(2) Risks of increased access to over-the-counter medicines may outweigh benefits

(1) Being born bottom first is inherited
(Maternal and paternal contribution to intergenerational recurrence of breech delivery: population based cohort study)
http://www.bmj.com/cgi/content/short/bmj.39505.436539.BEv1
(Editorial: Intergenerational recurrence of breech delivery)
http://www.bmj.com/cgi/content/short/bmj.39527.608542.80v1

A baby is twice as likely to be born bottom first if either or both the parents were themselves breech deliveries, according to a study published ahead of print on bmj.com. The results suggest genes are a contributing factor.

The vast majority of babies are delivered head first. Fewer than one in twenty are delivered the other way round - what is known as a breech delivery. Such deliveries carry significantly greater risks for the baby: they are more likely to die or suffer from health problems.

Factors such as premature delivery and low birth weight are also known risk factors associated with a breech delivery but these only account for up to one in seven of all such breech births. Until now knowledge of whether genes could also be a factor has been lacking.

The researchers from the University of Bergen in Norway looked at data covering all the births in Norway between 1967 and 2004. They studied the information available on men and women and their first born children - a total of 387,555 parent and child units.

They found that men and women who had been delivered full-term in breech had more than twice the risk of breech delivery in their own first pregnancies. Furthermore, babies delivered naturally, not by caesarean, were at the biggest risk of a breech delivery.

The risk was equally strong for male and female parents. This result was emphasized when researchers studied the 35,056 men who had children with two different women. The authors suggest that genes predisposing to a breech delivery are transferred to the foetus which then increases the risk of the mother having a breech delivery.

Breech delivered parents, born prematurely, had no increased risk of breech delivered offspring - the result of the prematurity rather than genes predisposing towards a breech delivery in these cases.

Despite the suggestion of a genetic trait for breech presentation some of the results suggest an environmental factor or interaction, caution the researchers in accompany editorial. Further research is needed before advising mothers of a high risk of breech delivery if their parents had a breech delivery.

Contacts:
Tone Nordtveit, University of Bergen, Norway
Email: tone.nordtveit@isf.uib.no
Editorial: Janet Hardy, University of Massachusetts Medical School, USA
Email: janet.hardy@umassmed.edu

(2) Risks of increased access to over-the-counter medicines may outweigh benefits
(Over-the-counter medicines: proceed with caution)
http://www.bmj.com/cgi/content/short/336/7646/694

The risks of increasing people's access to over-the-counter medicines may outweigh the benefits, warn experts in this week's BMJ.

They suggest that the safety of over-the-counter medicines should be kept under close review and that patients should be urged to report any adverse reactions.

Medicines are currently divided into classes that do or do not require prescription, write Robin Ferner, Director at the West Midlands Centre for Adverse Drug Reactions and Keith Beard, Consultant Physician at the Victoria Infirmary Glasgow.

Prescription only medicines are subject to a range of controls that are relaxed when medicines are made more freely available over the counter.

When deciding if a medicine should be reclassified to make it available over the counter, regulatory authorities must balance the benefits of easier access against the potential harm from unsupervised or inappropriate use.

Once medicines have been reclassified, they remain subject to safety review.

Patients, doctors and pharmacists can all benefit if medicines are available over the counter. For example, patients can call at a pharmacy any time rather than waiting to see a doctor, general practitioners no longer need to write prescriptions for minor ailments, and pharmacists can make better use of their professional skills.

Drug companies and retail pharmacies can also expect to benefit commercially from reclassification of medicines as over the counter.

However, there are worries about over-the-counter medicines, say the authors. For instance, a patient who makes the wrong diagnosis and uses an inappropriate over-the-counter medicine may present late with a potentially serous but treatable condition. Prescribers also have no opportunity to reinforce instructions for safe use as they can with prescribed medicines.

Regulators can reduce the potential for harm of over-the-counter medicines by specifying the concentration, dose, or pack size that a pharmacist can supply without prescription. However some drugs, such as statins, are probably less effective in low doses than in the higher doses usually prescribed.

Internet shopping now also makes it straightforward, if risky, to order medicines without involving a doctor or pharmacist in the decision. The Royal Pharmaceutical Society of Great Britain estimates that two million Britons obtain their medicines that way.

So what needs to be done to increase the safety of over-the-counter medicines, ask the authors?

The safety of over-the-counter medicines has to be continually reviewed, even though this is difficult in practice, they say. Since healthcare professionals may not be involved, we have to rely on patients to report adverse effects. A new website allowing patients to report adverse drug reactions to the UK Yellow Card scheme* could be helpful.

Regulators should also ask for clearer evidence of benefit at the over-the-counter dose if this is lower than the dose usually prescribed, they conclude.

Notes to editors
*The Yellow Card Scheme helps The Medicines and Healthcare products Regulatory Agency (MHRA) monitor the safety of medicines that are on the market. http://yellowcard.mhra.gov.uk

Contact:
Robin Ferner, Director, West Midlands Centre for Adverse Drug Reactions, City Hospital, Birmingham, UK
Email: r.e.ferner@bham.ac.uk

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