Cipla Medpro faces claims over side effects of antibiotic
Cipla Medpro faces claims that it failed to adequately warn patients about the potentially severe side effects of a common antibiotic. These claims arose after a Johannesburg man suffered four life-altering tendon ruptures.
A man in his 40s is now considering legal action against the company. He was prescribed Tavaloxx, a fluoroquinolone antibiotic, and alleges the warnings provided inside the medicine’s box were severely outdated. This led to claims omitting critical information about risks known globally for years.
The case shines a spotlight on the gap between regulatory compliance and the information readily available to patients at the point of dispensing.
After surgery on his right arm, his left bicep ruptured just weeks later while performing light exercises. The surgeon noted the tendon was in such poor condition that cowhide was needed for the repair. The patient has since suffered two further tendon ruptures, adding to the number of claims against Cipla Medpro.
A History of Global Safety Alerts
The potential for fluoroquinolone antibiotics to cause disabling side effects is not new. Between 2015 and 2018, the US Food and Drug Administration (FDA) issued multiple warnings about risks ranging from tendon ruptures to aortic aneurysms. In 2015, the FDA mandated its strongest “black box warning” for all drugs in this class.
In the US, pharmaceutical company Johnson & Johnson faced an $800 million class-action lawsuit. This lawsuit involved users of a similar drug who suffered severe reactions. The company eventually settled hundreds of cases.
Locally, in January 2019, Cipla and other pharmaceutical firms collaborated with the South African Health Products Regulatory Authority (Sahpra) on a letter to medical practitioners. This letter advised against prescribing the drug for a range of mild-to-moderate or self-limiting infections. This collaboration perhaps influenced how Cipla Medpro faces claims.
Despite this, the package insert found inside the Tavaloxx box was dated October 2007. It had not been revised to include these critical warnings.
Cipla and Sahpra Respond to Allegations
Cipla maintains it has acted responsibly. In a statement, spokesperson Fidelia van der Linde confirmed the company co-signed the 2019 letter to healthcare professionals. She stated that “doctors and pharmacists are aware of the updates”.
She explained that the updated package insert is available on the Sahpra website. Additionally, the regulator recommended an “overlabel” for the product box.
She said the overlabel refers patients and healthcare professionals to the Sahpra website. Here, they can find the latest package insert and leaflet information.
Sahpra spokesperson Yuven Gounden stated that Cipla has complied with the regulator’s requirements. This is based on an approved package insert for Tavaloxx dated 16 August 2020. She said that if Sahpra is aware of any violation of the Medicines and Related Substances Act, it can take action. However, in this instance, this is not relevant for Cipla Medpro.
However, for the patient, a website link or a sticker on a box was not sufficient. As he considers his next steps, his case raises important questions. These questions concern a company’s obligation to ensure that the most up-to-date safety warnings are provided. They should be provided directly to the patients who need them most, further demonstrating how Cipla Medpro faces claims.
