GSK’s Raxar Was Withdrawn In 1999.. So Why Won’t They Withdraw Seroxat?


I have been campaigning for almost a decade now about Seroxat and GSK, and as each year passes I am still astonished that GSK have been allowed to keep Seroxat/Paxil (Aropax/Paroxetine) on the market. It is simply a killer drug with risks that far outweigh any perceived benefit. GSK’s Raxar drug was withdrawn in 1999 because of a supposedly very rare risk, and GSK’s Seroxat PIL (patient information leaflet) has grown into a litany of side effects, many of which are not rare, but are actually very common. GSK’s Raxar was apparently linked to 13 deaths, however GSK’s Seroxat has a body count which is far far greater, and the worst thing is, many tens of thousands are trapped on this killer drug because of its addictive properties. The link between Seroxat and birth defects has been established for some years now also.

Seroxat has been banned for use in under 18’s because it makes them want to kill themselves, and it causes self harm. There have also been reports of risks of suicide etc in ‘young adults‘. Those of us who have extensive experience with Seroxat (and those who have been harmed by Seroxat) know that these serious side effects occur regardless of age- so why is Seroxat still on the market? How can the regulators justify the continued sale of this deadly drug when other drugs have been withdrawn for a lot less?

http://www.fda.gov/ohrms/dockets/ac/00/backgrd/3634b1a_tab5b.htm

November 1, 1999

Dear Health Care Provider:

Withdrawal of Product: RAXAR( (grepafloxacin HCl) 600 mg Tablets, 400 mg Tablets, and 200 mg Tablets

Glaxo Wellcome has voluntarily withdrawn all licensed formulations of RAXAR and the product is no longer available from pharmacies.

RAXAR is a fluoroquinolone antibiotic indicated for the treatment of infections caused by strains of bacteria susceptible to grepafloxacin in the following diseases: community-acquired pneumonia; acute bacterial exacerbations of chronic bronchitis; uncomplicated gonorrhea (urethral in males and endocervical and rectal in females); non-gonococcal urethritis and cervicitis.

Glaxo Wellcome has recently concluded an extensive review of the safety of RAXAR and determined that due to an effect of RAXAR on cardiac repolarization, manifested as QT interval prolongation on the electrocardiogram (ECG), some patients may be at risk of a very rare but serious ventricular arrhythmia known as torsade de pointes when treated with the product.

Although torsade de pointes has been reported very rarely in patients taking RAXAR, it is considered by the Company that the therapeutic benefit of treatment with RAXAR may be outweighed by the potential risk to patient safety, especially given the availability of alternative treatments.

For patients already commenced on a course of RAXAR, careful consideration should be given to switching the patient to an alternative antibiotic therapy.

If you have any samples of RAXAR in your possession, you may either contact Glaxo Wellcome to request self-addressed, postage-paid boxes to facilitate returning samples to Glaxo Wellcome, or you may dispose of any remaining RAXAR samples in the usual and customary way that you dispose of expired or damaged samples.

If you would like to request boxes, or for more information, please contact the Glaxo Wellcome Customer Response Center at telephone number 1-888-TALK-2-GW (888-825-5249).

Sincerely,

Richard S. Kent, MD
Vice President – US Medical Operations
Glaxo Wellcome Inc.

Raxar

Raxar, also known as Grepafloxacin hydrochloride, is used to treat bacterial infections such as pneumonia and gonorrhea. It is marketed by GlaxoSmithKline. The FDA approved the drug in November 1997. Raxar was withdrawn from the market in October 1999 because of its effect on QT interval prolongation which can lead to cardiac events and sudden death. Severe side effects include difficulty breathing, closing of the throat, hallucinations, irregular or slow heartbeats, muscle or joint pain, and liver damage. Common side effects include headache, nausea, diarrhea, ringing of the ears, drowsiness or insomnia. Sales in the U.S. generated $23.5 million in total revenue for the GlaxoSmithKline. Clinical trials indicated heart arrhythmia in patients using 600-milligram doses which resulted in death; however, patients using 400-milligram doses did not manifest the irregularities. Individual lawsuits were filed as a result of 13 deaths attributing to the use of Raxar. Settlements were reached with the individual plaintiffs in the fall of 2000.

https://www.shunnarah.com/practice-areas/drugs/raxar/

Raxar (Grepafloxacin)

Development and Release

Raxar was developed by Otsuka Pharmaceuticals and licensed for sale to GlaxoWellcome (which became GlaxoSmithKline in 2000) as an antibiotic used to treat certain bacterial infections such as pneumonia and gonorrhea. The U.S. Food and Drug Administration (FDA) approved Raxar for sale to the general public in November of 1997. In the short time it was on the market before it was deemed too dangerous for sale, the product generated $23.5 million in sales in the United States.

Health Problems Associated With Raxar

In reports presented to the FDA at the time of Raxar’s approval, there were concerns that the drug caused heart-rhythm disturbances in patients. Although such irregularities did not occur in patients who took the 400-milligram dose of Raxar during the clinical trials, four of the subjects taking 600-milligram doses died as a result of a heart arrhythmia soon after withdrawing from the clinical trial. Glaxo and the FDA then sought to minimize the risk of harm to any individual through precautionary labeling.

Glaxo’s Response

While it was not clear at the time that Raxar was the culprit at the time of approval, one FDA medical officer noted that the question was “open.” Still, Glaxo maintained that the heart arrhythmia was not caused by Raxar and highlighted the fact that there were no “deaths or permanent disabilities” to patients who took the drug at 400-milligram doses. Conspicuously missing from the warning label, however, were the deaths that occurred in clinical trials to patients taking the 600-milligram dose.

According to the FDA, an estimated 13 people died as a result of their Raxar prescription. Most of the fatalities associated with Raxar were in patients under 70 years of age, with no reported prior heart irregularities. In October of 1999, almost two years after the product came to market, Glaxo pulled Raxar from shelves. The company issued an accompanying statement that it was “no longer convinced that the benefits of Raxar outweigh the potential risk to patients.”

Legal Response

Because so relatively few were exposed to Raxar’s risks, just 13 deaths were attributed to the drug—a relatively small number in the context of dangerous drug litigation. Glaxo reportedly reached individual settlements with the plaintiffs in the fall of 2000.

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2 comments

  1. kiwi

    “Those of us who have extensive experience with Seroxat (and those who have been harmed by Seroxat) know that these serious side effects occur regardless of age.”
    Exactly.
    Yet what i cannot understand is when i reported drug induced suicidal ideations (i would have been the last person in the world to do something like this yet it was overwhelming, never experienced that prior to my druggery by a doctor) and horrific side effects in trying to get off this drug my doctor for some reason had no interest in reporting these adverse events to the nations centre for adverse reactions management CARM. I had to do it because he refused to. This lack of action by a doctor is totally unacceptable. Its a moral and ethical failure.
    What the heck is going on out there! or perhaps what the heck is not going on.
    If my experience is anything to go by the black box warning should be raised to those 50 years of age and under. Yet i know 60 yr olds who have had exactly the same experience.

    • The Evidencer

      I had the suicide urges on Chantix. Scary, and very convinicng.

      The wording they are allowed to use, at least in the states, is maddening too.

      “EFFEXOR XR and other antidepressant medicines may increase suicidal thoughts or actions” is weakened by “and other antidepressant medicines”

      Since they get to call their unpredictable pills anti-depressants, which is a pretty firm lie in a lot of cases, they should have to use the same certainty on the downsides, too. “EFFEXOR XR causes suicide.”

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