Medicine recall - Vioxx (Rofecoxib)Medicine recall - Vioxx (Rofecoxib) ... Reason: The company has decided to recall VIOXX based on new information from a recent clinical study which showed ...
http://www.tga.gov.au/recalls/2004/vioxx.htm -


Reason: The company has decided to recall VIOXX based on new information from a recent clinical study which showed that there was an increased risk of cardiovascular events such as heart attack and stroke beginning after 18 months of treatment, in the patients taking Vioxx at a dose of 25 mg once daily.

Vioxx Recallvioxx.jpg You will no doubt have heard of the Vioxx Recall in the news in ... Vioxx Recall May Bring Flood of Suits to Merck - 'Last week's decision by ...
Vioxx was withdrawn from the worldwide market by its manufacturer, Merck USA at the end of September, 2004.

Roughly 20 million Americans have used Vioxx by the time of the recall and it is estimated in Australia that over 300,000 people have taken the drug. There have been numerous studies that have been available for the last 3 to 5 years suggesting that Vioxx, a heavily advertised arthritis drug, commonly referred to as non steroidal and anti-inflammatory drug causes heart attack, stroke, sudden and unexplained death as well as significant increases in the risk of serious thrombotic cardiovascular adverse events.

A study was published in the August, 2004 issue of the American Medical Association Journal which came to the conclusion that Vioxx (also known as Celebrex) caused a significant increase in these cardiovascular events.

Our firm is perusing compensation for victims and has undertaken significant investigations and also aligned itself with a well known leading American legal firm to assist potential litigants who may have suffered significant disabilities as a result of taking Vioxx to take appropriate legal action for damages.

The company producing Vioxx, Merck USA is a pharmaceutical giant. Out of sales of the drug Vioxx the company turns over approximately 2.5 billion US per annum. The company is valued conservatively at $100 billion US.

Early reports of heart attack risks among Vioxx users apparently emerged in 2001. At that stage law suits were being filed in the United States with some of these cases currently being heard. It was only until very recently that the drug company withdrew the drug and very arguably was aware of the ongoing medical disabilities associated with Vioxx for at least 3 to 4 years.

It will ultimately be a matter of finding medical experts who will testify to a causal connection between the drug which precipitated heart attack/strokes our investigations have discovered that some people were seemingly healthy, vigorous, non smoking with no history of heart disease inexplicably drop dead and/or suffered a stroke after keeping a daily regime of Vioxx. A person who was on the drug for approximately 12 to 18 months would have a much better chance of establishing a claim against the drug company Merck than someone who was only on it for a short period of time although each case depends on its own special facts.

No doubt the drug manufacturer, Merck will argue that they acted responsibly and that the risks associated with the drug were minimal. There is, however. significant evidence that the drugs cause cardiovascular risks as early as 1996 and further more that Merck used direct to consumer advertising to push patients into using Vioxx when cheaper off patent medicines like Ibuprofen work as well for most people without the risks.

In the United States the drug company marketed Vioxx directly to the public through general advertising. Thus arguably making it more difficult for Merck to argue that it had provided adequate warnings.

As a consequence of such action against the company if successful, a Plaintiff would expect to receive significant sums of money for :-
Pain and suffering;

Physical and psychological incapacity

Past and future wage loss;

Home care needs such as supervision, assistance with household/domestic duties;

Ongoing requirements for medical treatment, physiotherapy and the like.
In cases where people have died and the cause is related on the balance of probability to Vioxx, family members may have a claim for pain and suffering, anxiety as well as any wage loss associated with such anxiety, pain and suffering.

Merck pharmaceutical was still running safety trials concerning Vioxx after its introduction into the market some years ago until recently. Obviously they were still not certain as to its safety.

Questions that need to be looked at when assessing the merits of a claim involving Vioxx are as follows:-
The dosage prescribed (12.5, 25 or 50 milligrams) and the number of times taken per day;

Who prescribed Vioxx for, was it the General Practitioner, Specialist or otherwise?;

Prior health concerns including heart, respiratory, liver, kidney disorders;

Whether or not the patient smokes and if so how much;

Whether or during the course of taking Vioxx the patient had a heart attack, stroke, gastrointestinal bleeding, kidney disease, liver disease or otherwise;

Other drugs taken whilst on Vioxx, for example aspirin, Ibuprofin or blood thinning agents such as Warfarin

You will no doubt have heard of the Vioxx Recall in the news in previous weeks. Below are a list of helpful resources related to the recall and some information to help you wade through the Vioxx Recall news.

Despite VIOXX’s treatment of a wide range of pain-inducing health problems, the list of potential side effects in substantially longer. While the occurrence of each side effect no doubt varies from person to person, the extensiveness of the list, combined with recent corroborating evidence, is quite telling: VIOXX can be very dangerous.

Merck Sharp & Dohme has decided to recall Vioxx based on new information from a recent clinical study which showed that there was an increased risk of cardiovascular events such as heart attack and stroke beginning after 18 months of treatment, in the patients taking Vioxx at a dose of 25 mg once daily.
The new information is the result of analysis of data from a three-year study of patients taking rofecoxib for recurrent colon polyps. The study was called the APPROVe (Adenomatous Polyp Prevention on VIOXX) trial. It commenced in 2000 and included 2,600 patients aged 40-96 with approximately 62% male.
The results from the study for the first 18 months did not show any increased risk of confirmed cardiovascular events.
There is no evidence currently to suggest that other COX-2 selective inhibitors will have the same effects - but also data from long-term studies are not currently available for the other agents.

The following side effects of Vioxx are less severe, but occur more frequently:
- Respiratory infections
- Headache
- Dizziness
- Diarrhea
- Nausea, vomiting and upset stomach
- Heartburn
- Stomach pain
- Swelling of the legs and/or feet
- High blood pressure