Fluoroquinolones: An FDA advisory panel urge drug companies for clearer and prominent label warnings on side effects
A US Food and Drug Administration (FDA) joint advisory panel on 5 November agreed that stronger warning labels for the popular prescribed fluoroquinolone antibiotics is needed.
The fluoroquinolones are marketed as generic antibiotic drugs with the well-known brand names that include Bayer AG’s Cipro — generically called ciprofloxacin — and Johnson & Johnson’s Levaquin, or levofloxacin.
With rising number of patients suffering from adverse reactions, with sometimes permanent disability, an open and public FDA review was held to discuss the safety and effectiveness for fluoroquinolone drug use in “uncomplicated” infections.
A 21-member joint panel of the Antimicrobial Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee were asked to consider the drug’s therapeutic intervention in sinus infections, urinary-tract infections and bronchitis.
The panel unanimously voted that there was lack of evidence in the effectiveness and safety for sinusitis. For bronchitis, the vote was 18–2, with insufficient evidence and with one abstention. For urinary tract infections, the vote was 20–1.
The Advisory Committee’s decision followed a day of emotional testimony from over 30 patients affected by the fluoroquinolone drugs suffering with profound and harmful effects to their health and cognitive ability.
Amongst those who gave testimony was Rachel Brummert of the Quinolone Vigilance Foundation.
She was prescribed the fluoroquinolone Levaquin for a routine sinus infection in 2006. Weeks later, her achilles tendon ruptured — the first of ten tendon ruptures she suffered during the next nine years — as well as other severe adverse reactions — some life-threatening.
Brummert testified before the panel:
“These antibiotics have the power to destroy lives when they are prescribed for routine infections like sinus infections and UTIs that don’t need their strength. Just as it is irresponsible to squelch a kitchen fire with the defenses we would mount against a wildfire, likewise, it is reckless to use a fluoroquinolone antibiotic to squelch a routine infection. There are safer, effective antibiotics for the treatment of routine infections in the event that an antibiotic is even necessary.”
Tobias Gerhard, PhD, of Rutgers University in New Brunswick, N.J. said:
“It was very apparent in the testimonials today that the current labelling does not communicate the risks clearly.”
Label warnings in the UK
While the FDA advisory panel may be calling for better warning labels to the class of flouroquinolones in the US, the Medical Healthcare and Regulatory Agency (MHRA), who oversees the use of prescription drugs in the UK, has historically not followed FDA rulings for stronger label warnings for the Quinolones (UK).
In Britain, doctors regularly prescribe Ciprofloxacin, sold as Ciproxin by drug giant Bayer plc, to treat a range of common infections such as urinary tract infections, respiratory conditions, prostatitis and sinusitis.
In 2008, US manufacturers were directed by the FDA to update their drug labels to highlight the risk of ‘tendon rupture and tendonitis’. The FDA issued a further alert in 2013 for ‘permanent nerve damage.’
Although the MHRA has confirmed 61 deaths potentially linked to these antibiotics since 2000 and a further 1,855 ‘spontaneous’ adverse events in the UK, the MHRA has stated there are no plans for research or further action.
A spokesperson for the MHRA said: “Ciprofloxacin and other fluoroquinolones are acceptably safe and effective medicines to treat a range of infections. The potential risks are clearly described in the product information and it is for the doctors to talk to patients of any risks.”
Amongst those known to have been affected by the drug include Dick Decent, keyboardist of the rock group Def Leppard, who in September 2012 wrote in his suicide note: “I didn’t kill myself, Bayer killed me.”
At the inquest, Decent’s suicide was put down to ‘depression.’ His widow, Sara Beardes, said this was ‘misleading’ and failed to acknowledge the true cause of his suffering brought on by a drug that left him disabled in his final year.
“It was not fair what happened to my husband — his life was taken from him because of this terrible drug. I do not want my husband to have suffered three years of torture for nothing. I would want, if nothing else, for awareness, recognition and action to be taken regarding the fluoroquinolone group of antibiotics.” said Beardes.
Decent’s harrowing story is not an isolated case.
There are a number of British victims of the drug Ciprofloxacin who have suffered severe ‘neurological disorder’ side effects — some for many years — and say that the medical profession has abandoned them.
Jane Allan, 49 from Essex, has been forced to take early retirement because of disability from Ciprofloxacin for a persistent cough in 2012.
Allan, along with other British “floxed” victims, has campaigned tirelessly for the public to be better informed of “fluoroquinolone toxicity syndrome” and “fluoroquinolone-associated disability.”
Robert Oldfield, 62, from Stafford, former teacher who was prescribed Ciprofloxacin for a non-bacterial prostatitis in 2009 — has been admitted into A&E 18 times where he says the NHS is ‘at a loss’ to know how to treat him.
“I really don’t believe there is much that can done for me but there needs to be greater publicity of this massive problem — it is an ‘antibiotic time bomb set to explode’ — because there are so many people taking this stuff.
I believe there are number of people out there who don’t know why they might be ill — they should check if they have ever been prescribed Ciprofloxacin.”
The “myriad” range of symptoms include excruciating pain, “electrical type shocks” numbness, tingling, ruptured tendons, tendonitis, hypersensitivity — to name but a few.
It is uncertain how widespread the problem extends in the UK. But British “floxed” victims are calling for greater safeguards and more prominent warnings following the recent developments for clearer label warnings in the US.