Antihypertensive drug withdrawn. Important message for patients

The Chief Pharmaceutical Inspector announced the withdrawal from the market and the ban on placing on the market a series of a drug used mainly in patients with hypertension. Unknown impurities have appeared in the medicine.

These are specific series of a drug called Corsib. These are tablets used, among others, in patients with hypertension. The medicine is available on prescription. The reasons for withdrawal include: unidentified impurities that have been detected in the medicine.

Discontinued Corsib – details

GIF provided details about the recalled Corsibu series in its announcement:

Corsib, (Bisoprolol fumaras), 2.5 mg, tablets,
series number 7ME023A, expiry date: March 31, 2026,
responsible entity: Medreg sro based in the Czech Republic.

At the same time, the office issued a decision to ban two batches of this drug on the Polish market:

series number 7ME023A, expiry date: March 31, 2026,
series number P28033, expiration date: March 31, 2026.

Why was Corsib discontinued?

During drug testing, it turned out that one of the mentioned batches of the drug was contaminated. It also turned out that the drug did not maintain adequate stability. “The cause of the deviation was overheating of the tableting mixture during the manufacturing process,” we read in the announcement. Two batches of the drug were produced from the same raw material, therefore both are covered by the decisions.

“There is therefore a risk that the batches placed on the market will not meet the quality requirements set for them by the end of their expiry date. Corsib (…) belongs to a group of medicines called beta-blockers. These medicines affect the body’s response to certain nerve impulses, especially in the heart. As a result, bisoprolol slows down the heart rate and thus increases the efficiency of the heart in pumping blood inside the body. Corsib is also used to treat high blood pressure (hypertension) and angina (chest pain caused by blockage of the arteries supplying the heart muscle). Due to the unconfirmed nature of the contamination, a threat to the patient’s health and life cannot be ruled out,” the press release emphasized.

Both decisions regarding the drug are immediately enforceable.