Losartan: a new batch recalled, what side effects?

Losartan, alone or with hydrochlorothiazide, is a medicine for high blood pressure. Several batches were withdrawn from the market in 2021 and one batch in 2022 (printing error on the blister). What are the side effects ? What drug to replace it? Conduct and alternatives.

[Mis à jour le jeudi 2 juin 2022 à 17h37] A new batch of drugs containing Losartan (treatment indicated for high blood pressure) from the laboratory Biogaran has been withdrawn from the market because of a printing error on the blisters, informed the Medicines Agency (ANSM) on June 1, 2022. On the boxes of this batch, it may be written: “Atorvastatin Cristers Pharma 40 mg film-coated tablet” instead of “Losartan / hydrochlorothiazide BGR 100 mg / 25 mg coated tablet”. In this context, the laboratory has asked community pharmacists to contact patients to whom they would have delivered this batch between May 12 and May 25, 2022 in order to reassure them and explain to them that the tablets are compliant despite this error, and also to make an exchange with a box from another batch, reports the Daily Pharmacist. The Biogaran laboratory made a point of specifying thatno case of pharmacovigilance has been reported to date in connection with this quality defect. What is losartan? What are its indications? What other batches are affected by a recall?

Definition: what is losartan?

Losartan, alone or in combination withhydrochlorothiazide (a diuretic used in the treatment of hypertension), is a antihypertensive drug. It belongs to the family of receptor antagonists angiotensin IIa substance present in the body capable of causing a contraction of the arteries and increase blood pressure, which ultimately weary the heart.

What are the indications for losartan?

Losartan medicines (alone or in combination) are commonly used in:

  • The treatment ofhigh blood pressure (hypertension)
  • The treatment ofheart failure
  • Prevention of kidney failure linked to type 2 diabetes
  • Prevention of cardiovascular morbidity after myocardial infarction.

What are the side effects and risks of losartan medications?

Investigations are still ongoing. But as a precautionary measure, several batches of drugs, affected by the presence of this impurity, have been the subject of a so-called preventive recall. “there is no immediate risk linked to the presence of this impurityinsists the ANSM. On the other hand, the risks in the event of abrupt cessation of treatment are real: hypertensive flare-ups (significant elevation of diastolic blood pressure)destabilization of cardiovascular disease.“Investigations are currently being carried out to assess whether the impurity present in these drugs is mutagenic or not. A mutagenic substance can produce hereditary genetic defects or increase their frequency, defines ANSES.

>> You can report any adverse effect suspected of being due to a drug to your Regional Pharmacovigilance Center or on www.signalement-sante.gouv.fr.

What drugs are affected by the recall?

Since October 2021, losartan medicationsshown in treatment of high blood pressurewere the subject ofa preventive reminderwhich leads to significant supply tensions (out of stock), reported the Medicines Agency (ANSM) in a press release. Several laboratories have proceeded, in agreement with the ANSM, and as a precautionary measure, with the recall of batches of the specialties mentioned below:

What is the procedure for patients?

The ANSM has issued a series of recommendations which are applicable in this context of tension and until a return to a satisfactory level of supply of losartan, potentially in 2022.

  • You should not stop your treatment without medical advice. If you have any losartan tablets left, you can finish the pack before taking the other sartan medicine given to you by your pharmacist.
  • When renewing your prescription, if the treatment initially prescribed is no longer available, the pharmacist can give you directly another medicine of the same family (sartan) without you having to consult your doctor immediately. There are 5 different sartans: losartan, irbesartan, candesartan, telmisartan and valsartan. This replacement is done on an exceptional and temporary basis, until the next medical consultation. The pharmacist should inform the doctor.
  • Consult your doctor as part of your usual medical follow-up or before, if you feel the need.
  • If you are allergic or intolerant to any sartan, contact your doctor. The latter will offer you another sartan that you may well tolerate. There are indeed 4 which are alternatives to losartan: irbesartan, candesartan, telmisartan and valsartan.

What are the alternatives to losartan?

Only the sartan and its dosage may change in the substitution of these drugs.

For replacement of losartan and hydrochlorothiazide medications, the dose of hydrochlorothiazide should remain the same. Only the sartan and its dosage may change in the substitution of these drugs. The ANSM recalls that specialties based on losartan/hydrochlorothiazide are only indicated in arterial hypertension.

Alternatives to Losartan
Alternatives to Losartan: Dosage and Indications © ANSM

What are the generics of Losartan?

Some examples of generic drugs based on Losartan: Losartan Accord, Losartan Arrow, Losartan Biogaran, Losartan Cristers, Losartan EG, Losartan Sandoz, Losartan Evolugen…

Sources: Medicines containing losartan (alone or in combination): what to do in a context of supply tensions, ANSM, October 27, 2021 / Public database of medicines

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