New Delhi: The Drug Controller General of India (DCGI) has ordered the withdrawal of AstraZeneca’s anti-cancer drug Olaparib tablets from the market citing potential adverse effects. Olaparib is mainly used to treat patients with gBRCA mutation and advanced ovarian and breast cancer, but it has been found to pose risks to patients.
Olaparib is a polyadenosine 5′-diphosphoribose polymerase (PARP) enzyme inhibitor. It works by blocking the PARP enzyme, which helps fix DNA damage in cells. By doing this, it specifically targets and kills cancer cells with certain genetic mutations like BRCA1 and BRCA2, slowing down the spread of cancer. This drug is usually given to patients with advanced cancers that haven’t improved with other treatments. Common side effects include nausea, tiredness, and anaemia.
On May 16, the DCGI said that AstraZeneca Pharma India Limited has applied for the withdrawal of Olaparib Tablets 100mg and 150mg to treat patients with gBRCA mutation and advanced ovarian cancer who have had three or more rounds of chemotherapy.
As a response, the DCGI told state drug regulators, “In view of the above circumstances, you are requested to direct all the manufacturers of said drug under your jurisdiction to withdraw marketing of the product Olaparib Tablets 100mg and 150mg approved by your office… and submit the revised package insert.” The drug will still be available for other approved uses.
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