Zantac Lawsuit

Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Thursday, March 24, 2016

Seroxat (Paxil) and Noise Intolerance

Hyperacusis is a condition that arises from a problem in the way the brain’s central auditory processing center perceives noise. Common causes include, but are not limited to, ear damage from toxins or medication.

During my time on GlaxoSmithKline's Seroxat I noticed I could not tolerate sounds that I used to be able to tolerate. Sudden loud noises not only startled me but they made me feel agitated. This problem continued through the whole withdrawal process of Seroxat and still exists today. I wouldn't say that my condition is hyperacusis as many of those who suffer from that particular ailment have difficulty with every day noises, such as;  running tap water, riding in a car, walking on leaves, dishwasher, fan on the refrigerator, shuffling papers.

I would, however, suggest, that Seroxat, known as Paxil in the US and Canada and Aropax in Australia, does something to the central auditory processing center as many people have experienced an intolerance to sudden loud noises during their time on Seroxat, withdrawing from Seroxat and years after taking it.

For me, it's sudden loud noises - an example would be a busy restaurant or coffee shop, the clinking of crockery or the clogged filter from the coffee machine being banged. Babies crying on public transport is also troublesome for me. Ironically, I love music so people may say why can you tolerate the likes of AC/DC yet cringe at the sound of breaking glass or random banging? Well, the answer is simple, music has a beat, a rhythm, I kind of know what is in store.

In my book, The evidence, however, is clear, the Seroxat scandal, I describe an incident with my three children and nephew. It relates to the noise issue associated with Seroxat and is something that I found extremely difficult to write about. Basically, my three children and nephew were being boisterous, as kids are, whilst playing on a games console - I told them to keep the noise down - they didn't. I flew into a rage, swore at them and told them to get out. Directly after this incident I went walking through a country park - my intention was to seek confrontation.

Maybe I have a mild form of hyperacusis, one that will, seemingly, stay with me for the rest of my life - a condition I never had before taking GlaxoSmithKline's antidepressant.

With this in mind I reached out to some forums on Facebook where Seroxat patients discuss the problems they face, and have faced, whilst taking Seroxat.

I asked the following...

Has anyone ever suffered with an intolerance to sudden loud noises when withdrawing from Paxil/Seroxat/Aropax and has this intolerance continued after you successfully tapered from Paxil?

Unsurprisingly, I got a good response.

Here's some of the replies that are followed by GlaxoSmithKline's 2014 product monograph for Seroxat. A product monograph is what your doctor gets to see but you don't. Here's some comments first...

I'm still on Paxil and trying to slowly taper, but I can tell you though when I have been in withdrawal all the noises seem to be intensified and I jump out of my skin when anything bangs. I have children so it's very difficult , their sudden tantrums can send me in a spin. I think I'm more on edge with noise and other things since tapering. I'm not off them yet and it's going to take a long time till I'm finished. ~ Giovanna Lee - Sydney, Australia
I became intolerant but it wasn't only loud sudden noise.  For me, even the sound of the toilet flushing sounds like an aeroplane, it gets on my nerves so bad and makes me really angry. I actually had my brother by the throat because he kept running the hot water and the sound of the boiler firing up sent me into a rage. Loud music is really bad as well the neighbours playing music or cars passing makes me wants to throttle them. I have bad insomnia but even when I do sleep the slightest noise wakes me up and really upsets me. I was on Seroxat for 15 yrs and looking back noises irritated me whilst on it but became much worse when I started to wean. I have been off it for 10 months and still hate noise but I don't actually so violently towards it now. ~ Anne Marie McMillan, 47, Scotland
If someone knocks on my car window, I've been known to hit myself in the face when they're out of sight, the same if someone makes me jump. My mum is deaf in one ear so she talks rather loud, sometimes I have to go into the toilet to dig my nails into my palms as a distraction then calm down. It can also be chatter in a supermarket, packaging being handled, gates opening etc. I know we all get distracted by noises, but the rage I feel really worries me. ~ Jane Teece, 52, East Sussex
I didn't notice that I was sensitive to loud noises at first, it is especially sudden loud noises that make me anxious and jittery, when I was on Seroxat it was hard to wake me up and I would sleep through the alarm clock. Off it now for 2 years 4 months and it has caused so many arguments with husband & family members, when sudden noises happen they make me anxious and verbally aggressive and I go into the fight or flight mode, it's as if I'm on high alert and everything is amplified and I'm on edge, it is only recently that my husband has stopped using the alarm due to the issues I was having with it. ~ Julie Anson-Boynton, 46, West Midlands
What I can remember is that when I tapered down from 20mg to 10mg too fast loud noises made my whole body shake. I did not know that this was due to withdrawal, thank God I know a lot more now. ~ Miranda Springer, 43, Holland
Sudden noises during withdrawal but as withdrawal didn't work with me after three attempts, the anxiety of sudden noises (not necessarily loud) have been left with me i.e. thunder, a tap on the shoulder, someone saying my name unexpectedly, car/bike backfire, balloons, fireworks .. the list goes on. ~ Anon, UK
I am in the middle of a pretty significant wave right now and the noise thing is really bothering me. I keep turning the tv down and startle to any noise ie; Kids dropping a fork. ~ Jodie Chinn

Now to Glaxo's product monograph which I spoke about at the head of the patient comments. Glaxo are careful not to let us know if the side effects happened during withdrawal. They also cover themselves by claiming, "It is important to emphasize that although the experiences reported did occur during treatment with PAXIL®, they were not necessarily caused by it."

Events Observed During the Clinical Development of Paroxetine.

Special Senses

  • Ear pain
  • Otitis media (a group of inflammatory diseases of the middle ear)
  • Tinnitus (the perception of noise or ringing in the ears)
  • Hyperacusis (a collapsed tolerance to usual environmental sound)
  • Otitis externa (inflammation of the outer ear and ear canal)
  • Deafness
I bet your doctor never told you about these adverse events related to Seroxat, huh?

Why would he/she? The product monograph for Seroxat is 57 pages long, we surely don't expect doctors to read all of it, do we? In any event, Glaxo make it crystal clear, "It is important to emphasize that although the experiences reported did occur during treatment with PAXIL®, they were not necessarily caused by it."

Furthermore, those limp-wristed medicine regulators, the MHRA have had 36 yellow card reports regarding paroxetine and hyperacusis - see page 11/67

David Healy's RXisk website database shows 163 reported events for hyperacusis, which has a Proportional reporting ratio (PRR) of 15.6% (Link)

So, folks, the next time you jump out of your skin because your child is playing noisily or someone drops a plate on the floor or bangs a coffee filter against a metal container to unclog it, just remember that Glaxo are aware of these problems but claim that they were not necessarily caused by their product.

The Glaxo mission statement has never changed, it's still, "At GSK our mission is to improve the quality of human life by enabling people to do more, feel better and live longer."

GlaxoSmithKline, doncha just love them!

Special thanks to those who took time to email me with their stories. Apologies to those who never made this blog post.

Bob Fiddaman.

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