Recently the slow release version of Metformin has been recalled by the FDA and several manufacturers in the USA due to higher than accepted levels of something called N-Nitrosodimethylamine (NDMA). This has been shown to be carcinogenic (cancer-causing) in lab animals.
Members of our community who rely on this medication to help manage their PCOS have understandably been concerned about this so we reached out to the Medicines and Healthcare Products Regulatory Agency (MHRA):
We are aware that the FDA has recommended, but not mandated, the recall of certain lots of Metformin tablets in the USA. The affected products were not on the UK market.
The MHRA, along with other Global Regulators, continue to investigate the issue. Companies have been asked to develop tests for nitrosamines, analyse their medicines and provide the results to the MHRA and other European regulators by October this year.
In the meantime, the consequences of patients not having access to this lifesaving medicine far outweigh the very small risk posed by the presence of nitrosamines exceeding the ‘acceptable daily intake’ indicated in the FDA notification. The advice to patients is therefore to continue to take your metformin medicines. If you still have concerns regarding the product itself, please contact your GP for advice.
We understand that some may still feel uncomfortable with this and medication and on the flip side, some patients have looked at buying metformin and other medications from the internet due to delays in being able to access their GP or secondary care clinicians who can initiate a prescription. We spoke to Dr Judith Ibison from our medical advisory panel for advice:
Metformin can be a valuable medicine for the management of polycystic ovarian syndrome and is a keystone medication for many people with Type II diabetes.To date, there is no identified metformin preparation available in the UK, which has higher than recommended levels of nitrosamines.
This may not be the case for medicines sold over the internet, which are not quality assured by the UK Medicines and Health Regulator Authority. Medications sold over the internet can vary from having inactive content e.g. chalk, to containing effective quality controlled medications, to preparations containing harmful substances. Which of these categories a product is in, is difficult for the purchaser to detect. For this reason, women should use only medications prescribed by their GP or Consultant, and provided by the NHS.
For women with diabetes, in particular, stopping metformin will cause impairment of diabetes control, which leads to tissue damage: so please don’t stop your medication without discussing it with your GP.
If modified-release metformin preparations are not available, women can revert to instant release metformin. If they have had gastrointestinal symptoms using the Instant Release preparations in the past, then again they could discuss with their GP a slow transition over to the Instant Release preparation to accommodate to the preparation or discuss trying a lower dose.