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MHRA Drug safety updates

Medication in pregnancy

  • Following reports on the safety of valproate in pregnancy, the Commission on Human Medicines confirmed in January that lamotrigine and levetiracetam are the safer of the medicines reviewed during pregnancy
  • A partnership of 16 leading organisations has established a Safer Medicines in Pregnancy and Breastfeeding Consortium to improve the medicines health information available to women who are thinking about becoming pregnant, are pregnant, or are breastfeeding. Look out for reports from this group
  • Selective serotonin reuptake inhibitors/serotonin and norepinephrine reuptake inhibitor: Data from observational studies suggest that taking these antidepressants during the month before delivery may result in a small increased risk of postpartum haemorrhage. This should be considered in the context of an individual patient’s bleeding and thrombotic risk assessment during the peripartum period and the benefits of antidepressants for the patient’s mental health.

Pregabalin

  • In February, it was noted that pregabalin (Lyrica) was linked with infrequent reports of severe respiratory depression, including some cases without the concomitant use of opioid medicines. Patients with respiratory disease, neurological disease, renal impairment, those using concomitant CNS depressants and people older than 65 are considered at higher risk, so adjustments in dose or dosing regimen may be necessary.

Levothyroxine

  • In May, the MHRA advised that some patients may need to be prescribed a specific thyroxine product rather than a generic. This is because some patients report persistent symptoms when switching between different levothyroxine tablet formulations. A thyroid function test should be considered if a patient reports symptoms after a switch, and if a specific brand is known to be well tolerated then prescribers must select the correct product. 

Chloramphenicol eye drops

  • A warning was issued about the maximum daily limit regarding boron exposure in chloramphenicol eye drops containing borax or boric acid (as buffers) for children less than two years of age. In July, an MHRA review stated that the benefits outweigh the risks and that the product information would be updated accordingly. A typical dose of one drop three to four times a day in both eyes would result in daily exposure below the safety limit.
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