Sanofi to withdraw Lasix Retard 60 mg worldwide, leaving Estonia without long-acting furosemide
Ravimiamet says Sanofi Winthrop Industrie is ending production and sale of the furosemide prolonged-release capsules globally, with no new deliveries to Estonia and pharmacy stocks running low.
Estonia's medicines agency, Ravimiamet, has been told that Lasix Retard 60 mg prolonged-release hard capsules are to be discontinued. The marketing authorisation holder, Sanofi Winthrop Industrie, says production and marketing of the product will stop worldwide.
No further shipments to Estonia are expected, according to the agency, and pharmacy stocks are close to running out. The active substance is furosemide, a diuretic used to treat oedema and hypertension.
Ravimiamet notes that no other 60 mg prolonged-release oral furosemide medicines are marketed in Estonia or elsewhere in Europe, so the withdrawal removes the only product of its kind from the market.
An alternative is already in place. At the request of the Estonian Society of Cardiology, furosemide 40 mg tablets have previously been permitted for use as an unauthorised medicine in heart failure, renal failure, liver cirrhosis and hypervolaemia or oedema of other origin. These tablets are currently available in Estonia, and the health insurance fund, Tervisekassa, reimburses them automatically as an exception. Diuretics with other active substances are also marketed in Estonia for oedema and hypertension.
The agency asks patients to consult their doctor to find a suitable replacement. It says it publishes information on marketing discontinuations in the medicines register.
What it means for your team
- Market-access and supply teams should note that no authorised prolonged-release furosemide 60 mg alternative exists in Estonia or elsewhere in Europe, according to Ravimiamet.
- Furosemide 40 mg tablets, an unauthorised medicine permitted at the Estonian Society of Cardiology's request, are available and automatically reimbursed by Tervisekassa as an exception.
- Pharmacovigilance and medical information teams may see queries from patients and prescribers switching therapy, since the agency is directing patients to their doctors for substitutes.
Official source: Ravimiamet ↗
Article written by VigiEye from the official source (Ravimiamet). AI-assisted; check the source before acting.