(1) The Most Scandalous Case In Pharma: GSK’s Manufacturing Cover Up Puts Millions At Risk Of Harm.


(you can download the evidence from the publicly available site- Pacer- or from here – from Exhibit 25)Exhibit 25

There’s a case brewing in the US (that I have been following attentively), which I think could be one of the most scandalous cover-ups in Big Pharma history. The documents I am about to reveal (all publicly available and downloadable through the Pacer Website) are absolutely damning for GlaxoSmithKline. However the public must be warned because lives are at risk.

The case basically involves a whistle-blower called Thomas Reilly who has taken a  wrongful termination case against GSK. Reilly was head of GSK’s Global IT systems (the computer systems that run GSK’s product manufacturing globally). In 2015- When Reilly tried to warn the CEO at the time- Andrew Witty- that there are serious problems, Witty seemed to brush him off (see excerpts below). If Thomas Reilly’s allegations of serious problems with GSK’s manufacturing are true (and I have no reason to believe that they are untrue, particularly considering the dozens of recalls – that I have documented- of their various products- over the years) then this essentially means that no GSK product can be trusted to be safe.

It also means that many millions of people globally, are at risk, of ingesting either a defective, contaminated, or just shoddily produced GSK product at any time. We are all at risk here, because we all need drugs/treatments from time to time, due to illness or injury etc, and GSK are one of the biggest suppliers of Pharmaceuticals/consumer health products in the world. Even those who work for GSK are at risk (they take meds too), and their family/friends etc are at risk also- because due to their dodgy manufacturing/defunct IT processes within their global supply chain- we simply do not know if a GSK product is ever safe or not (for a long, but not extensive, list – of GSK recalls- see this link)

Read from Exhibit 25 (page 4) –  screen grab below.

Link here-

https://www.pacermonitor.com/public/case/21357104/REILLY_v_GLAXOSMITHKLINE,_LLC

And see how GSK’s Andrew Witty (CEO at the time- 2005) glibly and nonchalantly dismissed IT Expert (and GSK employee at the time) Thomas Reilly’s serious concerns about GSK’s global manufacturing/IT systems.

Bear in mind, that GSK have had many criminal investigations against them over the past decades, and that they have previously been fined (as a felon) in a 3 Billion lawsuit – instigated by the Department of Justice and Whistle-blower Greg Thorpe in 2012.

They were also fined in China in 2014 for similar damning corruption and fraud allegations.

GSK has a long history of breaking ethics/morals and harming consumers (see the Seroxat and Avandia debacles for a taste of how bad GSK treat users of their products).

We have no reason to trust them in any sense whatsoever.  They have given us absolutely no reason to trust them- ever.

I have documented many dozens of their recalls, from various products – ranging from asbestos contamination, to splinters in toothpaste. (see here)

how many cases like this of bad batches of drugs/products slip through oversight and go unreported? how bad are GSK’s manufacturing processes? and how many people get harmed from using GSK products without even realizing it?

How many Cidra‘s has GSK got?

And why are the authorities allowing them to operate?

(if any  journalists/whistle-blowers are interested in this scandal – please contact me by email)

I will cover more of these publicly available and downloadable documents over the coming days.

This is just the beginning of another GSK scandal; a scandal that illustrates how everyone (across the globe)is at risk of harm from a dodgy GSK product because of their defunct manufacturing cover up.

GSK is no stranger to scandal, and no stranger to harming people with dodgy meds, but the sheer scale of harm to consumers from this current massive cover-up is staggering.


TR1TR2TR3TR4tr5TR6TR7TR8TR9TR10

TR111.png

TR12Tr13Tr14

Advertisements

GSK’s Dodgy Lamictal…


GSK Hides Dangerous Side-effects of Epilepsy Drug, Lamictal

Share this…
Share on FacebookTweet about this on Twitter

GSK Hides Dangerous Side-effects of Epilepsy Drug, Lamictal

While we all know that any drug comes with side-effects, it’s critical that drug companies and foundations tell the public the truth about those side-effects.

In this Video:

  • Learn how drug giant GlaxoSmithKline lied to the FDA and withheld critical information tying their seizure medication Lamictal to a devastating condition known as Steven Johnson Syndrome (SJS) and even toxic epidermal necrolysis (TEN).
  • How their Drug increases suicide and suicidality by more than 3 fold.
  • How the Epilepsy Foundation fails to mention the corruption/fraud behind this drug and the real risks of life altering permanent side-effects.

Watch as Dr. Dale breaks down the problems with Big Pharma fraud and The Epilepsy Foundation’s misinformation regarding the true risk of Lamictal.

It is my hope that as a community and nation we can drive real change and end corruption within medicine.

References:
https://www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report
http://www.huffingtonpost.com/bruce-e-levine/just-how-corrupted-has-am_b_157145.html
http://www.epilepsy.com/medications/lamotrigine

GSK’s Murky Experiments On Babies In Ireland…


I reported on GSK’s involvement in the Tuam (Irish) baby trials several years ago on this blog, so it’s good to see that others have taken up the baton and now there is a lot online about these very dodgy trials. Great research from whoever wrote the article below and an interesting slant also when comparing GSK’s past trials on Irish orphans with its not so long ago- Study 329 Paxil (Seroxat) Trial-

 

“….In Study 329 you were informed that participation in the trial would not lead to any different treatment from standard clinical care. Well standard clinical care for the use of imipramine in adults at that time would have been to use doses of around 150 mg or less. In their adult trials running at the same time, GSK were using a 150 mg dose. But in Study 329, the protocol from the get go mandated pushing every child who got imipramine up to 300 mg if possible. It’s difficult to see any rationale for this other than by making imipramine look so toxic, Paxil might look good by contrast….”

Check out tuambabies.org for more on these hideous experiments.


 

 

 

GSK’s Tafenoquine…


https://tendaily.com.au/news/politics/a181204blz/soldiers-anticipate-long-awaited-inquiry-report-into-anti-malarial-drugs-20181204

Soldiers Anticipate Long-Awaited Report Into Anti-Malarial Drugs

Defence force personnel left with debilitating psychological effects from taking anti-malarial drugs are looking forward to the release of a long-anticipated report into the use of two separate medications.

Anti-malarial products mefloquine and tafenoquine have been prescribed for Australian defence personnel — as well as general civilians — for many years.

While mefloquine was registered with the Therapeutic Goods Administration as early as 1988, with tens of millions of prescriptions globally, recent years have shone a light on the drug’s potential side-effects.

A months-long federal government inquiry into the use of the two drugs, and any “adverse health effects” of their use, is due to report this week after being twice delayed.

The Department of Defence outlines that most symptoms are “minor”, and can include sleep problems, vivid dreams, anxiety and depression. In around 10 percent of cases, the department said, users can experience dizziness or headaches.

In one percent of cases, the department noted, side-effects can include “agitation, restlessness, mood swings, panic attacks, confusion, hallucinations, aggression, psychosis and suicidal ideation”, as well as balance problems and seizures.

(Getty Images)

The American Food and Drug Administration (FDA) added warning labels to mefloquine products in 2013, warning of possible psychological issues including dizziness, balance issues or ringing ears.

Much attention has been paid to the use of the drugs by defence force personnel around the world, including in the US and UK, with countless members sharing personal stories with journalists.

More than 1300 ADF members were prescribed mefloquine in a trial in Timor Leste in the early 2000s, while others — including retired army officer Stuart McCarthy — were given the drug, and another called tafenoquine, in other overseas missions to developing countries to combat malaria.

(Getty Images)

“I had a lot of chronic health issues that I could never really get to the bottom of. I was given tefenoquine in Bougainville in 1999, and I didn’t really think much of it connected to the subsequent health problems I had,” McCarthy told 10 daily.

“Even though I was given a very high dose during the trial, and the purpose was to eradicate malaria, I still got malaria regardless.”

McCarthy said he also later developed a range of serious psychological conditions, including depression, and other “subtle but noticeable” issues like vertigo and what he classed as general “cognitive decline”.

He claimed up to 3000 people may have been affected by these drugs, saying he had spoken to “hundreds” of families and was aware of some suicides allegedly linked to the use of the anti-malarial drugs.

“The evidence now is these drugs can cause a permanent brain injury. There’s a very distinctive set of symptoms including psychiatric ones, like depression, anxiety, and neurological symptoms,” he told 10 daily.

“The drug trial I was involved in, tafenoquine, my experience was there was very little if any info on side effects, other than you might have some gastro for a few days. There was no mention of possibility of brain damage.”

(Getty Images)

Around 140 Australian personnel were prescribed mefloquine between 2010 and 2016, according to the defence department.

“A Senate report will be released today on the use of anti-malarial drugs, which has had direct input from veterans throughout Australia and I look forward to reading the findings,” Veterans Affairs minister Darren Chester told 10 daily on Tuesday.

“I am focussed on putting veterans and their families first and delivering the essential services they rely on, with more than $11 billion provided each year.”

The Senate inquiry into ‘Use of the Quinoline anti-malarial drugs Mefloquine and Tafenoquine in the Australian Defence Force’ attracted nearly 140 submissions.

Those who used the drugs have complained the drug trials were incorrectly administered, and that the government has not provided appropriate access to health or support services to deal with ongoing side-effects.

“There is clear, extensive evidence of the harmful effects of mefloquine and tafenoquine, including lasting impact on many hundreds of Australian quinoline veterans and their families,” the Quinoline Veterans and Families Association (QVFA) said in its submission.

“Despite claims by Commonwealth officials that adequate help is available, the government has consistently denied the fact that these drugs are able to cause permanent brain damage resulting in widespread chronic neuropsychiatric illness and in some cases suicide.”

“There is a compelling need for the Commonwealth to implement a comprehensive program of outreach, rehabilitation and research, led by experts in ABI and clinical neurotoxicology.”

(Getty Images)

In its own submission, the Department of Defence defended the use of mefloquine, saying it was not commonly used and only as a “third-line” treatment when people could not use two other more popular treatments.

But it acknowledged side-effects had been experienced by some personnel.

“Defence has always acknowledged that mefloquine can cause side effects, including neuropsychiatric problems, while individuals are taking the drug,” the department wrote.

“Generally, symptoms will disappear when the individual stops taking the drug but they can persist for some time afterwards due to the drug’s long half-life of two to four weeks. Defence also acknowledges that neuropsychiatric side effects have been known to continue and become long term in a small number of individuals.”

The Senate report is due to be delivered this week.

McCarthy acknowledged concerns raised by himself and others affected by the drugs had been well-received by federal officials, but said the government needed to take action.

“There needs to be a royal commission,” he told 10 daily.

“Most important, we need dedicated outreach and rehab programs for people affected by these drugs. We want the government to set up a program of referrals, so anyone with these symptoms can be referred to the appropriate medical specialist, and also appropriate social support.”

Widow asks SCOTUS to toss GSK’s win in lawsuit over Paxil labeling, lawyer’s suicide


GlaxoSmithKline  

Asserting a Chicago federal appeals panel wrongly invalidated a jury’s verdict, attorneys for the widow of a Chicago lawyer who committed suicide after taking the generic version of the antidepressant drug Paxil, have asked the U.S. Supreme Court to throw out the appellate ruling and order more proceedings on whether pharmaceutical company GlaxoSmithKline should be made to pay for allegedly not revising their drug’s warning label to reflect an increased risk of suicide.

On Dec. 19, attorneys for Wendy Dolin filed a petition with the U.S. Supreme Court, asking the nation’s high court to take up their appeal of the decision from the U.S. Seventh Circuit Court of Appeals in Chicago, which had found a federal jury was wrong to order drugmaker GSK to pay Dolin $3 million. In that decision, the appellate judges had essentially found GSK could not be held liable for the content of the warning label on its medication, because those labels were controlled by the U.S. Food and Drug Administration.

“The Seventh Circuit’s decision creates a world where a drug manufacturer is permitted under the First Amendment to promote its drug for non-FDA approved indications, … but a drug manufacturer is prohibited from issuing warnings concerning life threatening risks associated with its drug,” Dolin’s attorneys wrote in their petition.

The petition was filed about four months after a panel of three Seventh Circuit judges threw out the verdict in favor of Dolin, widow of lawyer Stewart Dolin, who killed himself in 2010 in a downtown Chicago transit station. Wendy Dolin alleged her husband was taking paroxetine, the generic version of GSK’s Paxil. She alleged the drug’s label, which was written by GSK and is identical for the name brand and generic versions, did not adequately warn the drug could increase the risk of suicide. Dolin alleged GSK knew of the alleged increased risk, yet chose not to revise the warning label.


Bijan Esfandiari   Baum Hedlund Aristei & Goldman P.C.

GSK, however, said it tried several times to secure approval from the FDA to revise the label, but the FDA declined.

After years of proceedings in federal district court in Chicago, a jury found in favor of Dolin at trial. GSK appealed, and the Seventh Circuit overturned the verdict.

In the appellate decision, the judges, led by Circuit Judge David Hamilton, found GSK had asked the FDA four times to change the labels, but the FDA had ordered GSK to use standard language the FDA approved for paroxetine and other antidepressants. This showed GSK had no control over the labels, Hamilton said.

In their petition to the Supreme Court, however, Dolin’s lawyers said this finding represented a misreading of the case. They asserted the FDA had not disallowed the revisions, but rather had directed GSK to publish suicide risk warnings as a supplemental warning, known as a Changes Being Effected, or CBE, provision.

Dolin’s attorneys further argued the Seventh Circuit’s decision ignored key legal precedents, including the Supreme Court’s 2009 ruling in Wyeth v Levine, which held drug companies can revise labels to enhance warnings, without FDA approval.

Dolin’s attorneys painted the Seventh Circuit ruling as “unreasonable,” as it came despite contrary findings from “nine jurors and two distinguished district court judges reviewing the same facts” who “found that GSK was not prohibited from issuing stronger warnings.”

“There is no evidence the FDA ever rejected a paroxetine-specific adult suicide warning,” Dolin’s lawyers claimed. “The FDA’s invitation to GSK to use the CBE (which GSK could use unilaterally without the FDA’s invitation) to issue a paroxetine-specific adult suicidality warning in a place within the label that is outside the class labeling section can hardly be considered or interpreted as a rejection of a paroxetine-specific adult suicide warning.

“…It is akin to being invited to dance but construing that invitation as clear evidence of rejection.”

Dolin’s lawyers noted the Supreme Court is scheduled to hear arguments in a similar case, Merck v Albrecht.

In that case, the U.S. Third Circuit Court of Appeals came down on the question opposite the Seventh Circuit. In their decision, Dolin’s lawyers assert, the Third Circuit judges determined such labeling questions were appropriate for a jury, and “a reasonable juror could conclude that ‘the ball was in (drugmaker) Merck’s court’ to submit a revised CBE for the correct enhanced warning.”

Dolin’s lawyers asked the Supreme Court to delay action on their petition until resolving the Albrecht case. But after Albrecht, the lawyers asked the high court to vacate the Seventh Circuit decision and remand the case for new proceedings.

The petition was filed by attorneys Bijan Esfandiari, of the firm of Baum Hedlund Aristei & Goldman P.C., of Los Angeles, and David E. Rapoport and Mathew S. Sims, of the Rapoport Law Offices P.C., of Chicago.

GSK has been represented by attorney Lisa Blatt, of Arnold & Porter Kaye Scholer, of Washington, D.C., and by the firms of Dentons US LLP, of Chicago, and King & Spalding, of Atlanta.

GSK CEO, Emma Walmsley, Resigns To Pursue Career As Stand-Up Comedienne


Emma1

 

It seems that Glaxo CEO, Emma Walmsley, has perhaps quit her job at Glaxo to become a stand up comic? (as evidenced by the screen-shots).

However, there’s nothing funny about Glaxo’s 3 Billion Dollar Fine with the US department of justice (How many people were killed from dodgy off label prescribing from fraudulent behavior for this fine alone?)

There’s nothing funny either about concealing data, which results in the deaths or disablement of unsuspecting patients.

Nothing humorous in any of Glaxo’s crimes.

There is however, something very funny about the images of Emma Walmsley sprouting on about trust, particularly when you consider Glaxo are still currently under investigation by the serious fraud office in the UK, and also in light of Thomas Reilly’s case against them (currently pending).

It seems along with Glaxo’s ethics, its humanity and its morals, its entire manufacturing system is also not fit for purpose too (how many people are unknowingly being harmed from that fact alone?). How many dodgy meds end up maiming unsuspecting patients from Glaxo’s long list of product recalls?

See here for an extensive list..

It seems that Glaxo is a very tragic comedy act indeed.


“…..A senior whistleblower at GlaxoSmithKline is suing the drugs giant over claims his warnings about allegedly dangerous botched IT projects were hushed up by his superiors who eventually ended his 16-year career at the company.

Thomas Reilly worked around the world designing, installing and troubleshooting major IT projects at GSK production plants and at its UK and US data centres. 

He claims he warned for years of serious issues in IT systems in many countries that caused numerous factory shutdowns.

Yet, in a lawsuit filed against the firm in the US, he says his concerns were not properly acted upon by his superiors in Britain. In one case, he says his warnings about a Latin American plant were covered up by his manager for fear of alerting auditor PricewaterhouseCoopers….”

 

https://www.standard.co.uk/business/glaxosmithkline-faces-new-whistleblower-claims-over-unfair-dismissal-a3842706.html

 

Emma2

 

 

Mom’s Emotional Warning: Talk to Your Doctor Before Taking Antidepressants While Pregnant


Mom’s Emotional Warning: Talk to Your Doctor Before Taking Antidepressants While Pregnant

Photograph by Meg Boggs and Matilda Berrelez

From weight gain to postpartum depression, Meghan Boggs has been sharing her struggles, fears, failures and successes on Instagram for quite some time. Five days ago, she shared another. Only this time, it wasn’t her story to tell— it was her sister’s.

meg.boggs

Meet my sister, Tilly. Her #iam1in5 story is one that has changed her, our family, and so many people around the world. Tilly has been on medication since she was 15 years old. During her second pregnancy, she was told that it was safe to continue taking her antidepressants (Paxil). She then discovered at an ultrasound just four weeks before her due date that Adrian, her son, had several heart defects. Adrian had open heart surgery at just 8 days old. Tilly found out just a few months later that this was all caused by the antidepressants she was on during her pregnancy and sued the company. Adrian was one of the very first cases, and she won. The labels were then changed to reflect the dangers of taking them while pregnant. But even though she won the case, she was left with a child who would never live a normal life. She was left with the guilt that came with her decision to continue the medication even though she was told it was safe. . It’s now been 14 years since she had Adrian, and he’s had 5 open heart surgeries, 3 pacemaker changers, countless heart catheterizations and will eventually need a heart transplant. She is the definition of strength and I have always looked up to her because she is an unbelievable mother. She is also 1 in 5, but even through all that she has been through, she has always done whatever it takes to be the best mother to all three of her children. She is a warrior and I am so thankful she agreed to share her story. * To read her full story and her advice for anyone who is struggling to cope with being off medication during their pregnancy, head over to my blog. And watch my stories to see photos of Adrian throughout his journey. ♥️ * Disclaimer: This post is not meant to provide medical advice. Always consult your doctor about any questions about your health, medications, and pregnancy. You have options. Let your voice be heard.

“Meet my sister, Tilly,” she wrote. “Her #iam1in5 story is one that has changed her, our family, and so many people around the world.”

Boggs’ sister, Matilda (Tilly) Berrelez, has been on antidepressants since she was 15 years old. She was 21 in 2003 when she found out she was pregnant with her second child.

At the time, Berrelez (then Vasquez) was told it was safe to continue taking Paxil—an SSRI (selective serotonin reuptake inhibitors) drug she’d been taking to treat depression and anxiety. So, she did as she was told and continued taking the medication, unaware of any risk to her unborn child.

Four weeks prior to her due date, however, an ultrasound revealed that her baby had several heart defects.

Adrian Vasquez, born April 19, 2004, was only 8 days old when he underwent his first heart surgery. Five months later, news broke that taking Paxil during early pregnancy could cause heart defects, lung defects, clubfeet and cranial defects in newborns.

Paxil during early pregnancy could cause heart defects, lung defects, clubfeet and cranial defects in newborns.

Boggs told Mom.me that Adrian’s case was “the very first one to go against a pharmaceutical company.” In fact, she added, “CNN covered this and came out to our house to film.”

After winning the case against GlaxoSmithKline—the makers of Paxil—Boggs said companies began changing their labels to reflect the risks and dangers of taking SSRI drugs while pregnant.

“But even though she won the case, she was left with a child who would never live a normal life. She was left with the guilt that came with her decision to continue the medication even though she was told it was safe.”

In a full story on Meg Boggs, Berrelez (now 36), recalls the moment she learned her son was in trouble. After waiting nearly 45 minutes for a technician to finish taking an ultrasound, she asked if there was something wrong.

“She stopped the ultrasound, looked me in the eyes for a split second, looked down, then told me she would be right back with me and left the room,” she wrote. A few minutes later, she returned with the doctor, who said, “I’m sorry to tell you this, honey, but there is something wrong with your baby’s heart.”

A month later, Berrelez was told that her son had a double outlet right ventricle, patent ductus arteriosus, and pulmonary stenosis. That was 14 years ago.

Since then, Adrian has had five open-heart surgeries, three pacemaker changers and countless heart catheterizations. A heart transplant is almost inevitable.

“We are estimating this will occur sometime in his teenage years,” wrote Berrelez, who says she wouldn’t wish this for anyone—mother, child or family.

“There is no greater worry, pain, anxiety or nauseating sensation that compares to what my little boy has gone through since the day he was born,” she wrote.

“If there is a chance of your child being harmed by the medication you are taking, do all you can to discontinue the medication for as long as possible.”

Where is the outrage?


https://www.bmj.com/content/362/bmj.k3948/rr-1

Pandemrix and narcolepsy

Where is the outrage? GlaxoSmithKline suppressed clear danger signals from vaccination with Pandemrix. The result, to begin with, was the suffering of a large number of children and adolescents who developed narcolepsy. Peter Doshi is to be commended for dispassionate reporting of the facts, but I am frustrated by his cool rhetoric in the face of what I believe are acts of greed and cruelty.

The facts reported by Doshi are new, but the pattern of behavior is not. The manufacturers and their professional surrogates are past masters at doing research that shows short-term vaccine efficacy but that does not reveal serious adverse effects. They always end up saying, as in this case, that “there is no proof of a causal association.” Such behavior might be forgiven if influenza vaccines were real lifesavers, but we still do not know if they have done more good than harm in the long run. I am not alone in making this assertion.

Not long ago Gaffney and Lexchin said that US and Canadian pharmaceutical systems, “…are dysfunctional. Costs are exorbitant, commercial goals distort drug development, misleading promotion fosters misuse, and medications are too often unaffordable for patients.” (BMJ 2018;361:k1039) Much the same can be said for the development and promotion of vaccines in the last 10-15 years.

I get frustrated and angry about the promotion of some drugs and vaccines, but I am saved from despair by the efforts of professionals like Doshi and his colleagues who keep plugging away at the facts.

Allan S. Cunningham

Competing interests: No competing interests

24 September 2018
Allan S. Cunningham
Retired pediatrician
Cooperstown NY 13326, USA

GSK’s Recent Drug Recalls..


Those who keep a finely tuned eye on GSK won’t fail to notice that they are involved in a lot of product recalls (see here) . Of course the Reilly versus GSK lawsuit is obviously related to GSK’s manufacturing (or lack of good manufacturing) and this malfunctioning system leads to substandard drugs being released. GSK were fined for their Cidra debacle, but how many more Cidra’s are there out there? who knows? Perhaps we will find out through another lawsuit- the blue-cross blue shield one?

In the meantime, more GSK products are recalled..

http://publicaffairs-sme.com/productrecalls/?p=1573

18-026 QA PRODUCT RECALL – GLAXO SMITH KLINE RECALLS 24 HR PREVACID DUE TO POSSIBLE MICROBIAL CONTAMINATION

Date:  4 OCT 2018                                                                                     Recall: # 18-026

Scope: WORLDWIDE RETAIL FACILITIES, DCs & ECOMMERCE

Out of abundance of caution, Glaxo Smith Kline announced a voluntary recall of Prevacid 24 Hr capsules due to possible microbial contamination. The Exchange currently sells the 14ct. capsules.

Hazard: Healthy people can develop mild illnesses from contact with some forms of microbial contamination, however; serious infections may occur in people in the hospital and/or with weakened immune systems.

Incidents/Injuries: To date, no illnesses have been reported in connection with this problem.  This recall is being conductined out of abundance of caution.

Description: The following product is affected.

Remedy: Customers who purchased the product are encouraged to return it to the store where it was purchased for a full refund.

Consumer Contact: Customers who have additional questions or concerns should contact the GSK Customer Service team at 1-800-743-4014, Option 5 for PREVACID® 24HR 15 mg Lansoprazole Capsules, Recall Event Number 134PREV18.

Sold at: Worldwide Exchange facilities, Online E-commerce and other retailers.

Manufacturer(s): Glaxo Smith Kline


 

https://www.staterbros.com/product-recalls-catalog/prevacid-24hr-capsules/

Prevacid 24HR Capsules

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC Voluntary Recal Prevacid 24HR Capsules

For Immediate Release

Items affected at Stater Bros Markets are:

PREVACID 24HR CAPSULES  14 CT   3-00676-28614-3  *SP ITEM     

PREVACID 24HR CAPSULES  42 CT  3-00676-28642-6   *SP ITEM

 

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC Date: September 26, 2018

184 Liberty Corner Drive
Warren, NJ 07059

Consumer Contact:

GSK Customer Service team at 1-800-743-4014, Option “5”, for PREVACID® 24HR 15 mg Lansoprazole Capsules, Recall Event Number 134PREV18.

Dear GSK Customer:

This letter is to inform you that GSK Consumer Healthcare is conducting a voluntary retail level recall of:

Prevacid® 24HR Capsules, 15 mg lansoprazole (14, 28, and 42 counts)

UCC: Please refer to Attachment 1 for full list of impacted UCC codes

UPC: Please refer to Attachment 1 for full list of impacted UPC codes

This recall is being conducted with the knowledge of the US Food and Drug Administration (FDA).

In keeping with our commitment to quality, GSK Consumer Healthcare has made the precautionary decision to voluntarily recall all Prevacid® 24HR Capsules lots within expiry at the retail distribution level. This decision is based on microbiological out of specification results obtained for one lot of Prevacid® 24HR Capsules that remains within GSK control and has not been distributed. Although all lots on the market and within expiry have met all release test specifications, current available data cannot exclude potential impact to released product. There is no evidence of a consumer safety concern based on a completed medical assessment that concludes the use of, or exposure to, the affected product is not likely to cause adverse health consequence.

Please note that product is being recalled at the retail level. This is not a consumer level recall.

Affected lots (within expiry) were manufactured between October 8th, 2015, and March 26, 2018, and distributed in the timeframe between January 7th, 2016 and September 2nd, 2018.

GSK Consumer Healthcare is committed to providing the highest quality products to our customers. We regret any inconvenience this recall may cause and appreciate your cooperation.

If you have any questions, please contact our GSK Customer Service team at 1-800-743-4014, Option “5”, for PREVACID® 24HR 15 mg Lansoprazole Capsules, Recall Event Number 134PREV18.

 

GSK Pandemrix jab fears reported two years before Irish recall..


Swine flu jab fears reported two years before Irish recall

Group fighting for narcolepsy sufferers ‘shocked and appalled’ by British Medical Journal report

The new UK study revealed that even in 2009 there were indications Pandemrix had a rate of adverse reactions far higher than other vaccines. Photo: PA
The new UK study revealed that even in 2009 there were indications Pandemrix had a rate of adverse reactions far higher than other vaccines. Photo: PA

Ralph Riegel and Eilish O’Regan

A leading medical journal has warned that serious safety “indicators” were raised over the swine flu vaccine Pandemrix in 2009 – almost two years before the vaccine was finally suspended from use in Ireland.

 

‘The British Medical Journal’ published a major investigation into the use of the drug across Europe where it is now linked to cases of narcolepsy or severe sleep disorders in children.

Last night, one solicitor acting for Irish children who developed narcolepsy said it was “a scandal” families have been fighting for justice for seven years while the State was aware of such data.

Support group Sufferers of Unique Narcolepsy Disorder (SOUND) said the report was “shocking and utterly appalling.”

The British report relies on multiple European investigations and ongoing legal actions over the drug, manufactured by GlaxoSmithKline (GSK).

Last August, a major Irish Independent investigation revealed some children received a double dose of Pandemrix when stocks of the vaccine were used from January 2011 amid fears there would be a shortfall for the normal winter flu jab.

Solicitor: Michael Boylan is handling many of the narcolepsy cases. Photo: Collins Courts
Solicitor: Michael Boylan is handling many of the narcolepsy cases. Photo: Collins Courts

Thousands of children received a single vaccine dose in 2009/2010 at the height of swine flu scare.

But the 2011 re-issue was almost two years after research data showed indicators that Pandemrix had a far higher rate of adverse incidents than other comparable vaccines.

Pandemrix was re-issued to GPs nationwide in 2011 despite the fact major studies were already under way in Sweden and Finland into potential links with narcolepsy.

Re-issued in Ireland on January 7, 2011, the vaccine was recalled on March 28, 2011 when both studies indicated there was a likely link to narcolepsy.

The new UK study revealed that even in 2009 there were indications Pandemrix had a rate of adverse reactions far higher than other vaccines.

ADVERTISEMENT

It calculated Pandemrix had a 500pc greater rate of “adverse events” reported than another swine flu vaccine.

In Ireland, Pandemrix was only made available before it had completed its testing protocols because the Government had offered GSK a full indemnity.

Almost 100 families are now suing the Government, Health Service Executive and GSK.

Many of the narcolepsy cases are being handled by solicitors Michael Boylan and Gillian O’Connor.

“The fact that the general public were not made aware by the Minister for Health or the HSE that Pandemrix was untested prior to or even during the vaccination programme as adverse data emerged is one of the reasons why we have now served the State defendants with claims for aggravated and exemplary damages,” Ms O’Connor said.

“It is a scandal and totally unacceptable that our clients have had to fight tooth and nail for accountability and appropriate redress for the dreadful injuries caused for the past seven years given that this information has been within the defendants knowledge all this time.”

GSK declined to comment given ongoing legal action.

SOUND said the group was “shocked and appalled” at the report.

“These revelations now present very serious questions for the State, the HSE and GSK as to what exactly happened with Pandemrix.

“These shocking revelations require immediate answers to who knew what and when. We need accountability now,” SOUND co-founder Tom Matthews warned.

The HSE insisted its vaccine selections in 2009 were on the basis of expert medical advice supported by an external panel of experts.