One of South Africa's leading pharmaceutical firms is accused of deliberately not disclosing full possible adverse events associated with a common antibiotic that it markets and sells.
The US Food and Drug Administration (FDA) between 2015 and 2018, issued numerous warnings that fluoroquinolone's possible toxic side effects range from tendon ruptures to aortic aneurysms.
In 2015, the FDA called for a black box warning, the agency’s strongest, for all fluoroquinolones.
Pharmaceutical company Johnson & Johnson, which faced an $800m class lawsuit from flouroquinolone users who suffered severe adverse reactions, settled hundreds of the cases.
In January 2019, Cipla was one of the pharmaceutical companies that signed “important medical safety information” that TimesLIVE Premium has seen, which advised medical practitioners not to prescribe the drug for “non-bacterial [chronic] prostatitis for mild to moderate infections, including uncomplicated cystitis and acute exacerbation of chronic bronchitis, among others”.
The letter issued in collaboration with the South African Health Products Regulatory Authority (Sahpra), stated that “healthcare professionals are advised that for the indications listed, only to prescribe quinolone/fluoroquinolone antibiotics where other antimicrobials are considered not to be an appropriate treatment option, have failed, are contraindicated or not tolerated”.
Doctors were advised in that letter not to prescribe the drug for “treating non-severe or self-limiting infections (such as pharyngitis, tonsillitis and acute bronchitis), preventing travellers' diarrhoea or recurrent lower urinary tract infections, non-bacterial infections”.
Despite this warning and commitments to update insert packaging leaflets, Cipla's package insert inside Tavaloxx's box, seen by TimesLIVE Premium, does not contain warnings about some of the latest side effects.
The insert package found in the Tavaloxx box was published in October 2007, and had not been revised.
Cipla spokesperson Fidelia van der Linde said the updated package insert or leaflet can be found on the Sahpra website and shared its link with TimesLIVE Premium.
She also confirmed that the company signed the January 2019 letter to alert healthcare professionals of the adverse side effects and warning related to the prescription of the drug.
“Therefore doctors and pharmacists are aware of the updates. Please note that Cipla has been in constant engagement with Sahpra regarding this matter. Sahpra have recommend that we do an overlabel, referencing the latest package inserts/leaflet information on the Sahpra website that is accessible to the public,” Van der Linde said.
On why the warning was not on the package insert in the box, she said: “We have overlabeled all Tavaloxx product on hand accordingly. The overlabel refers patients and healthcare professionals to the Sahpra website for the latest package insert and leaflet information.”
She said all healthcare professionals are well aware “of these above-mentioned changes and should ensure they take the necessary precautions for this class of medicine”.
Asked if omitting updating the leaflet inside the drug's box may have been influenced by fears of loss of income, Van der Linde said: “We do not agree with the unsubstantiated allegation.”
“The package insert has been updated on the Sahpra website, and we refer patients to this,” she said.
Sahpra spokesperson Yuven Gounden said based on an “approved package insert dated 16 August 2020 for Tavaloxx, Cipla Medpro has complied with Sahpra's requirements”.
Gounden said Sahpra as the medicine’s regulator, takes the necessary steps to ensure that all health products meet the criteria of safety, quality and efficacy.
“If Sahpra is aware of any violation of the Medicines and Related Substances Act, then Sahpra can take action. However, in this instance, this is not relevant for Cipla Medpro,” Gounden said.
Anton van den Heever, a Johannesburg man in his 40s, is considering his legal options after experiencing four tendon ruptures after he was prescribed Cipla Medpro's Tavaloxx, a drug which treats sinus, urinary tract and respiratory infections.
Van den Heever said he wanted to launch a legal challenge against the company as his life “has now changed forever”.
“Having been fit and strong my whole life — how did it all come undone by taking a commonly prescribed antibiotic?” Van den Heever asked.
The outdoor enthusiast who regularly played polo cross, was prescribed the drug by his doctor after developing an infection following a kidney stone removal procedure in 2018.
“I didn’t know that this drug was going to change my life forever ... a couple of weeks after recovering from the infection I was back in the routine of my life and exercising,” he said.
While taking a breather after exercise, his right elbow collapsed without warning.
“I wasn’t even picking anything up. My right bicep had ruptured without any warning. This was a huge shock. I consulted a surgeon and was operated on,” Van den Heever said.
However, following the operation, he had to use a sling which he said was restrictive and impaired his fitness routine.
After a few weeks of light exercises, his left bicep ruptured.
“This was incredible ... again back to the surgeon, who said that in this case the tendon was so poor that they would need to add cowhide to fix the rupture. Now [I have] two arms in slings,” he said.
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