PRAC starts review of Xeljanz (tofacitnib) and introduces temporary prescribing restrictions for patients at high risk of blood clots in the lungs.

PRAC starts review of Xeljanz (tofacitnib) and introduces temporary prescribing restrictions for patients at high risk of blood clots in the lungs.

PRAC starts review of Xeljanz (tofacitnib) and introduces temporary prescribing restrictions for patients at high risk of blood clots in the lungs. Following an earlier review on heart rhythm problems being caused by fenspiride, the PRAC  recommended revoking  MAs for any cough medicines containing the drug. 

EU referral procedures for finalisation:

  • Fenspiride (NAP) EMEA/H/A -107i/1480

New signals detected from EU spontaneous reporting systems

  • Direct-acting antivirals (DAAV) – signal of autoimmune hepatitis
  • Febuxostat – ADENURIC (CAP); FEBUXOSTAT MYLAN (CAP) – signal of gynaecomastia
  • Ferric carboxymaltose (NAP) – signal of arteriospasm
  • Ibuprofen and fixed-dose combinations – signal of acute generalised exanthematous pustulosis (AGEP)
  • Mesalazine (NAP) – signal of nephrolithiasis
  • Sebelipase alfa – KANUMA (CAP) – signal of nephrotic syndrome
  • Tigecycline – TYGACIL (CAP) – signal of bradycardia

New signals detected from OTHER sources

  • 5 alfa – reductase inhibitors (5ARIs) – signal of Type 2 diabetes mellitus
  • Amino acid, lipid combinations with vitamins or trace elements – signal of adverse outcomes in neonates treated with solutions not protected from light
  • Ibuprofen (NAP) – signal of serious exacerbation of infections
  • Lithium – signal of drug induced lichenoid reaction

 

Signals follow-up and prioritisation

  • Clomipramine – signal of persistent sexual dysfunction after drug withdrawal
  • Clopidogrel – signal of interaction with ritonavir boosted antiviral HIV therapy leading to insufficient inhibition of platelet aggregation
  • Pantoprazole – signal of colitis microscopic
  • Sertraline – signal of maculopathy
  • Tocilizumab – ROACTMRA (CAP) – signal of facial paralysis
  • Tofacitinib – XELJANZ (CAP) – signal of increased pulmonary embolism and overall mortality arising from a post-authorisation safety study in patients with CV risk factors treated for RA with tofacitinib 10 mg twice daily.