The pharmaceutical sector is on alert with the return of Lucartan.

Voldemort Barreto / Cenado Agency

Invisa’s decision to demand a collection of lasartans, published in the Official Gazette this Thursday (23rd), alarmed pharmaceutical manufacturers, distributors and retailers. Leading organizations in the sector claim that the agency ignored the sector’s concerns and acted hastily, which could affect the access of 25 million people to the treatment of high blood pressure.

The agency banned and withheld batches of drugs containing active ingredients due to suspicions of the presence of “azido” impurities in acceptable safe concentrations. While this does not affect all pharmaceutical companies, Anvisa’s decision compromises most of the pharmaceutical industry. The list includes Aché, Biolab, Brainfarma, Cimed, Eurofarma, Geolab, Prati-Donaduzzi and Teuto.

Withdrawal of lasartan: possible effect on treatment restriction

“The biggest problem with mass recall is the suspicion of the active ingredient, losartan, which is the safest and most affordable in terms of the cost of treatment. Yes, and at the same time discourage treatment, which is already a serious problem in Brazil, “he added.

IQVIA data show that the lasartan molecule equivalent to 78% of prescriptions for antihypertensive drugs in the last 12 months to April. With 192.7 million units sold, lasartan accounted for 92.5% of sales in the category during the same period, four times lower than the second – olmesortana meloxomide.

The industry also questions the recall of Lucerne.

Sindusfarma also issued an official statement criticizing the agency. Check out the full document.

Regarding the decision by the National Health Surveillance Agency (Anvisa) to determine the return of high blood pressure medication losartan, the Pharmaceutical Products Industry Union (Sindusfarma) provides the following explanations:

1 – “The scale is precautionary and treatment should not be interrupted.”As Anvisa has shed light on.

2 – Interruption of treatment can harm patients, as stated by Anvisa.

3 – Lucartan, manufactured and distributed in Brazil, is of the highest quality, matching the best formulations in the world.

4 – To better serve the population, as always, the pharmaceutical industry has arranged to replace the synthesis of lasartan with the producers of active pharmaceutical ingredients (APIs), in order to avoid the above-mentioned impurities. can go.

5 – “There is no immediate risk of using this drug.”As Anvisa himself informs, as there is no data that indicates an increase in the number of negative incidents related to impurity.

6 – “Lasartan is considered a safe and effective medicine.As Anvisa explains, controlling the treatment of high blood pressure and heart failure significantly reduces the risk of stroke and heart attack.

7 – All Losartan presentations at Invisa continue with the correct registration.;

8. Lucartan manufacturing companies affiliated with Sindhus Pharma are taking all possible steps to address the shortage of this important drug.

9. The pharmaceutical sector is committed to the highest standards while maintaining the efficacy and safety of medicines available to the Brazilian population.

Source: Panorama Farmacêutico Newsroom

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