Fresenius says tighter EU rules could trigger antibiotic shortage

By PharmaCompass

2019-06-13

Impressions: 82 Article

German drugmaker Fresenius has sent out a warning to the European drug regulator that stricter production norms being considered by it could exacerbate shortages of a life-saving antibiotic — piperacillin-tazobactam — that is used by about 25 million patients globally each year.

Piperacillin, given in combination with efficiency-booster tazobactam, is a broad-spectrum antibiotic used to combat serious infections such as sepsis or pneumonia.

The market for piperacillin-tazobactam is highly concentrated with Fresenius and Chinese rival Qilu supplying almost the entire European market between them. Production outages at Qilu have resulted in repeated stock shortages over the past three years.

The European Medicines Agency (EMA) is working on a revision of good manufacturing practices (GMP) that govern the production of sterile drugs such as infusions and injections to take into account the latest technology developments.

Though the GMP review is an important initiative, piperacillin shortages should be avoided because second-choice drugs would put patients’ lives at risk from avoidable infections, Marc-Alexander Mahl, in charge of generic drugs and complex formulations at the Kabi division of Fresenius, said.

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