Drug for heart patients suspended from circulation. GIF alarms

Drug for heart patients suspended from circulation.  GIF alarms

GIF issued another announcement. The statement concerns a preparation used to treat patients with cardiac problems. Find out the details of the decision.

This is about Qutiro. The product is used to treat patients with cardiovascular diseases, such as ischemic heart disease, myocardial infarction or acute coronary syndromes. The preparation inhibits the sticking together (aggregation) of blood platelets, which reduces the risk of clots and facilitates blood flow to the heart.

Qutiro – GIF decision details

The Chief Pharmaceutical Inspector released a message containing more information about the suspended drug: Qutiro 5mg/100ml, tirofiban (as tirofiban hydrochloride) infusion 5mg/100ml

  • packaging: 100 ml,

  • batch number: GL23G-03, expiration date: 30/06/2025,

  • responsible entity: QUESTUS PHARMA PRIVATE LIMITED based in India;

  • entity that has obtained consent to temporarily admit the above-mentioned product to trading. medicinal product:

  • Genesis Pharm sp. z o. o. limited partnership, ul. Obywatelska 128/152, 94-104 Łódź.

Why has Qutiro been suspended?

The Provincial Pharmaceutical Inspector sent a report to GIF about a suspected quality defect of the indicated medicinal product. Adverse reactions such as chills and chest pain were observed in eight hospitalized patients who took the drug. On this basis, it was concluded that Qutiro probably did not meet its quality requirements and was contaminated. Therefore, its use poses a real threat to the health and life of patients.

“The ground for suspending the trade in a medicinal product is therefore a justified suspicion that the product does not meet the requirements set for it. However, there is no doubt that the side effects occurring in patients after administration of the medicinal product (…) justify the suspicion of irregularities in the quality of this medicinal product. Additionally, clarifying and verifying activities undertaken by the hospital staff, i.e. blood cultures of patients in which the presence of Klebsiella Pneumoniae ESBL bacteria was confirmed and that microbiological purity tests in the field of staff hand hygiene, environmental tests: surfaces of equipment, tools and materials did not reveal any the presence of Klebsiella Pneumoniae ESBL bacteria constitute an additional circumstance indicating a potential quality defect of the medicinal product,” we read in the announcement of the Chief Pharmaceutical Inspector.

GIF, taking into account the health and life of patients, decided to suspend the sale of Qutiro throughout the country until further investigation is carried out. The decision was made immediately enforceable.

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