This post was written by Dr Irene Campbell-Taylor, a former Clinical Neuroscientist and Assistant Professor of Medicine at the University of Toronto.
It is essential to read the marketing copy of pharmaceutical companies with care and attention for critical hidden details. It is rare to find an announcement with such obvious errors and dangerous suggestions up front as those contained in the latest media material on Pfizer’s Lyrica (pregabalin), an anticonvulsant drug used for neuropathic pain, partial seizures and generalized anxiety disorder.
In June 2007, Lyrica became the first medication approved by the U.S. Food and Drug Administration for the treatment of fibromyalgia. Sales reached a record $3.1 billion in 2010.
In 2009, Lyrica was one of four drugs, along with Bextra, Geodon and Zyvox, which a subsidiary of Pfizer pleaded guilty to misbranding “with the intent to defraud or mislead”. Pfizer agreed to pay $2.3 billion in settlement, and entered a corporate integrity agreement. The investigation was triggered by allegations made by six whistle-blowers.
“to put issues that diminish trust behind us”
A spokesperson for Pfizer said earlier this year that it would pay the fine “to put issues that diminish trust behind us”.
Now, in the EU, Pfizer announces that it is producing a liquid form of Lyrica for patients with dysphagia. This term applies to people who, usually as a result of neurological impairment, have difficulty swallowing. There are two types of dysphagia: oropharyngeal, caused by damage to the nerves and muscles of the mouth and throat and esophageal dysphagia in which there are problems passing food down the esophagus and into the stomach.
Pfizer appears to be directing its campaign toward oropharyngeal dysphagia but clearly has not consulted anyone with knowledge of the condition. Berkeley Phillips, Medical Director of Pfizer Ltd declared:
“By bringing pregabalin oral solution to the UK market, we can provide patients who are candidates for treatment but experience difficulty swallowing, with an alternative option. The difficulties associated with dysphagia for those who are required to take medicines orally are widely accepted. It is our hope that this new oral solution formulation will provide an appropriate alternative, which will be more convenient for these patients…..Dysphagia is linked to certain diseases and disorders, such as diabetes, epilepsy, multiple sclerosis (MS) and Parkinson’s disease (PD) and can also occur as a side effect to some types of medication. The risk of dysphagia increases with age and the condition can make it difficult for patients to swallow medications that are in solid form.”
American pie
This sounds American as apple pie – what could be wrong? The critically important detail is that these patients have difficulty swallowing liquids – not solids. Contrary to popular belief, the most difficult consistency to swallow is thin liquid because the damaged muscles within the mouth cannot control it and aspiration into the lungs becomes highly probable. Some companies such as Sandoz make millions selling “thickeners” for liquids to be ingested by people with dysphagia. Many of these products in fact do little other than cause dehydration.
But now we have Pfizer proposing that a medication be provided in a form that will increase the likelihood of its ending up in the lungs instead of the stomach.
The company goes on to state: “5% of over 79 year olds and 16% of those aged over 87 years are reported to suffer from symptoms of dysphagia. These figures rise to up to 60% amongst the elderly who live in nursing homes or sheltered accommodation. 24% of patients who are mildly impaired due to MS suffer from permanent dysphagia, however, the prevalence increases progressively together with rising disability, with 65% of severely disabled MS sufferers experiencing permanent dysphagia. According to estimates, almost 40% of patients who suffered a stroke also suffer from swallowing problems.….”
“According to research,” they continue, “patients who experience difficulty in swallowing pills have poorer health outcomes and higher health care costs.” After 25 years of treating dysphagic patients, I have no knowledge of any such research.
Martin Johnson, GP and RCGP Pain Champion explained:
“A wide range of patients with dysphagia will benefit from the introduction of the new oral formulation. The introduction of the oral solution will help us in our treatment of peripheral and central neuropathic pain in the elderly, those with epilepsy, diabetes, multiple sclerosis, stroke and Parkinson’s disease, and of course palliative patients as well.”
Breathless
This is such a potentially dangerous statement that it leaves me breathless.
“According to recommendations from the National Electronic Library for Medicine, doctors should wherever available administer licensed alternatives, like oral solutions to those patients who are unable to take medicines in solid oral dosage forms.”
The suggestion for dysphagic patients is to change to suppository, or topical (on the skin) format, or medications that melt on the tongue but never to oral solution.
The known adverse effects of Lyrica are frightening
Our story, however, gets worse. The known adverse effects of Lyrica are frightening. Remember that this drug is recommended for people who already have neurological disorders. The admitted adverse effects include:
- Mood or behavior changes, depression, anxiety, agitation, hostility, restlessness, hyperactivity (mentally or physically), thoughts about suicide or self-harm.
Patients are advised to: “Call your doctor at once if you have any of these serious side effects”:
- Muscle pain, weakness, or tenderness (especially if you also have a fever and feel tired); easy bruising or bleeding; or swelling in your hands or feet, rapid weight gain.
Less serious side effects may include:
- Dizziness or drowsiness, anxiety, blurred vision, loss of balance or coordination, problems with memory or concentration, dry mouth, skin rash or itching, constipation, stomach pain; increased appetite; or joint or muscle pain.
What is the most important information I should know about pregabalin (Lyrica)?
“You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments. This is not a complete list of side effects and others may occur.”
A spoonful of liquid helps the medicine go down – in the most delightful way
The advertising so far has been aimed at adults and elderly patients. But the availability of a liquid formulation makes it easier to give a medication to people who don’t like pills. How long before we see it offered to infants and children as has happened with multiple other drugs never intended for paediatrics.
There appears to be no end to the number of dangers that the gullibility of both the public and physicians can enable companies to sell for enormous profits. For Pfizer a billion dollar fine is just the cost of doing business. A civilization earns the name by its readiness to protect and care for the vulnerable and the needy – by the quality of its healthcare. Sometimes it seems like the barbarians are at the gates.
This is not all good. I am in the U.S., but I belong to a Face Book group called “Lyrica Survivors Support Group”. This is made up of people who’s health & life have been destroyed by Pfizers latest wonder drug, Lyrica. It also helps people who need info on Lyrica but can’t find it anywhere else, as Pfizer neglected to report a lot about Lyrica leaving people all over the world hung out to dry. It’s very sad. My use of Lyrica stemmed from nerve damage to nerves after surgery. I don’t think my primary doc would have offered this nasty drug to me had he known, what I know now. It has a nasty, nasty, Withdrawla syndrome upon cessation of drug. Severe insomnia leading to sleep paralysis,
muscle twitching, heart palpitations, racing heart & mind, anxiety, depression,tinnitus, pins & needles anywhere, eye disorders & pain, & relevant to this article dysphagia. I had difficulty swallowing starting on day 3 of withdrawal. So bad I stopped eating. Now I read they are offering it to people who have this problem already. What the HELL, Pfizer. Haven’t you done enough damage ? People in the U.K, now think you are promoting this drug so they can taper slower from Lyrica capsules, which don’t come in mg. doses consistent with dropping the recommended 10% at a time by mental health professionals. Your drug Lyrica causes the symptoms you are prescribing it for. Now this. It is ” INSIDIOUS”, and irresponsible. How about helping us first that you have already damaged. I guess it’s like the writer of this article says, for Pfizer, it’s just the cost of doing business.
How long after withdrawal did the swallowing problem last? I read you stated it started 3 days after you stopped but how long before you were able to swallow comfortable/normal again?
I take lyrica along with tramadol because i broke my neck and damaged my spine. The only major effects I’m seeing after years is every now and then i can’t swallow. It happened tonight, so i did a search to see what it was a side effect of. As long as i stay very calm and get a drink or exhale and move the food back jnto my mouth, I’m fine . It feels like food is stuck in my throat. I get neck head aches that are very hard to explain other than an ache that is so bad its an intense pain. So far after at least 5 years the side effects are better than the constant pain. I find if i want a clear head i have to take my morning dose and not sleep until at least 6 hours later. If i do sleep i find i am in a haze all day. It’s not a pleasant drug. But, for me, it’s better than constant pain. It took 2 to 3 years to find a drug that had few major side effects but stopped the pain. Thanks for posting your experience as it helped make sense of mine. ☺
Wow wow what can I say. Also a lyrica survivor who never had depression or anxiety till I encountered lyrica. Sleeplessness insomnia gut problems sexual dysfunction the list goes on. Contact Pfizer about withdrawing they read from their books. If u did what they said u would be dead. Thankfully I found the survivors group and weaned properly over 4 months
Please note that Facebook and Pfizer have now blocked searches on FB for Pfizer’s name brand drugs. Search for Pregabalin on Facebook to find the Lyrica Survivors (Pregabalin Support) group or use a search engine like Google.
https://www.facebook.com/groups/LyricaSurvivors/
THANK YOU for posting this! I am currently going through the nasty Lyrica withdrawals, so someone suggested I look for the Lyrica survivors group on Facebook and connect with others going through the same thing. I searched for it and nothing would come up…. NOW I KNOW WHY!
Thank you Amy, for reminding folks that Pfizer has blocked the use of the name LYRICA in the support group’s name. Pregabalin Survivors has helped so many, including myself, and I have made true friends and I go there whenever I need support or just human words of wisdom. The group you started has saved so many. You need a gold medal for the good you have done. Please, if you are thinking about starting pregabalin or you are on it and want off…please join this group. It will save you! You just have to be dedicated. Open to all !
I am also a survivor of the maximum dose of pregabalin. I was on 600 mg for several years and was put on it for herniated and broken back lower lumbar disks and radiculopathy. So bad that I am unable to walk, move or sleep due to the constant pain. Only after the horrible side effects started and my pain actually was made WORSE by this medication did I research and read that Pfizer had gotten in a legal action and was forced to publish a statement saying pregabalin should never be prescribed for any type of lower back pain…as it gas proved ineffective. But many doctors never read that recall message. My dose was upped and upped and upped. So now I found myself in the position of having to get off this wicked drug. I had to use a liquid tapering program, because it is so dangerous to stop this drug at once. To do so would mean high heart rate, high blood pressure, increased anxiety, suicidal thoughts, total ( and I mean total) insomnia and, most importantly…the chance of seizures that can not be stopped by normal seizure medications or benzodiazepines. Status Epileptics. That’s some serious stuff. I even had two seizures tapering slowly. This medication destroys both your body and your mind. I’ve been off for over a year and complications continue. You will lose “ you” on this med.
Pfizer needs to be held responsible for all of its false claims that this drug helps “ everything.” I am also a member of the Facebook group Pregabalin survivors ( Pfizer has blocked the use of the word LYRICA in the title ) and have received and try to give incredible support, help and understanding. I would ask anyone struggling with this medication to join this first class support group…we would love to have you. Getting off is a marathon, not a sprint. Compared to opioids, this drug causes way more side effects, is more addictive, takes about ten times as long to get off of and leaves permanent damage to the brain and mental health that simple low lever opioids don’t. Perhaps if enough doctors hear this, they will not be afraid to prescribe the RIGHT medication for severe lower back issues ( my orthopedic surgeon will not touch my back because there is too high a chance of paralysis ), yet the opioid I was on was yanked from me in favor of this disgusting drug.
My life would have continued normally if I had been left on it ! And if you have kidney problems, this drug will make them worse ( which I admit they do warn of in their written warnings but doctors just don’t read them ) and docs give it to kidney patients anyway ( they just don’t care about reading through the side effects of this “ miracle drug.” ). If you are on it and things have not started going bad yet….they will…trust the thousands of people who have experienced them….and now is the perfect time to join the Facebook support group and learn about natural alternatives and the safest way to get off this drug before it takes your life from you. I have years I can never get back. Years. Don’t let this happen to you.
Shame on you, Pfizer ! ( Funny ending, I had tons of stock in Pfizer pre-LYRICA …after I decided to get off, I dumped them all…they’ll be getting no investment from me ). I may have taken a financial hit….but they owe everyone involved so much more than financially. This drug needs to be taken off the market. People are dying…check the statistics, in Ireland the death rate of people on pregabalin is double that of people on opioid therapy. If the US would take a survey, they would find the same thing.