Discussions that mention vioxx

Drug Interactions / Side Effects board


Hi Dale, if i were you i would throw this drug in the bin where it belongs. I was taking it for a couple of weeks & i suffered the exact same effects as you, also chest pains. I took very little time in getting rid of it & i did not seek a replacement for fear of getting landed with something harmful again.
I had been taking Vioxx for a few weeks a couple of years ago, this caused me to have bad chest pains & tingling in my arms etc, i told my Doctor at the time & he said this should not happen & he gave me a prescription for 100 more of the same. I got the tablets took them home & threw them in the bin, then not so long ago i read where this Vioxx drug was being withdrawn as it had been discovered how several hundred people had died from heart attacks & strokes after taking the tablets over a period. Another was Opren, i used to take that some years ago & that caused me to have bad chest pains, i discarded it & again it was later withdrawn when it was discovered hundreds of patients had died from perforated stomachs due to that drug. At the moment i take 14 different prescribed drugs daily & if i were to get any pains or tingling or nausea or whatever from any of them they would go straight into the bin also. Better to be safe than sorry, i am sure people are being experimented on & being used as Guinea Pigs when taking certain tablets, if proper trials had been held before releasing certain drugs onto the market, then these cases of hundreds of people dying would not take place, & these drugs would not have to be withdrawn. When a brand is withdrawn there is a small mention of this in the Media, where it is also said how so many people died from taking the drug, & that is then the end of the matter. Hundreds, maybe thousands of people are being killed by these drugs & nobody is held to account, because its big business & those that should care dont give a damn. So throw them in the bin each & every time you get a bad feeling from a drug, because if you dont you will be gambling with your life. Regards John
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United States of America v. Pfizer, Civil Action No. 96-11651
Neurontin Product Information

Pfizer Inc., the world's largest pharmaceutical company, on May 13, 2004 plead guilty and agreed to pay $430 million to resolve all criminal charges and civil liabilities related to the illegal and fraudulent marketing of its top selling epilepsy drug Neurontin by Warner-Lambert's Parke-Davis Division.
The U.S. Food and Drug Administration approved Neurontin in 1993 for the treatment of partial seizures with and without secondary generalization in adults with epilepsy.

OFF-LABEL USES

But, Neurontin was aggressively marketed to treat a wide array of ailments for which the drug was not approved for:

Bipolar Disorder
Various Pain Disorders
Lou Gehrig's Disease
Attention Deficit Disorder
Migraines
Drug and Alcohol Withdrawal Seizures
Restless Leg Syndrome
First-line monotherapy treatment for epilepsy




For Example, the company falsely promoted Neurontin as effective for treating bipolar disease, even when a scientific study demonstrated that a placebo worked as well or better than the drug.

CONSEQUENCE OF ILLEGAL MARKETING SCHEME
As a consequence of the unlawful promotion scheme, patients who received the drug for unapproved and unproven uses had no assurance that their doctors were exercising their independent and fully-informed medical judgment, or whether the doctor was instead influenced by misleading statements made by, or inducements provided by, Warner-Lambert, the Justice Department said. Potential problems that can arise from off-label use without the benefit of careful FDA oversight include the occurrence of unforeseen adverse effects because the drug was not studied in the type of patient it is being used for off-label and the appropriate dosage and course of treatment have not been established.

ILLEGAL MARKETING TACTICS
Warner-Lambert used a number of tactics to achieve its marketing goals, including encouraging sales representatives to provide one-on-one sales pitches to physicians about off-label uses of Neurontin without prior inquiry by doctors, the Justice Department said. The company's agents also made false or misleading statements to health care professionals regarding Neurontin's effectiveness. The company also utilized "Medical Liaisons," who represented themselves (often falsely) as scientific experts in a particular disease, to promote off-label uses for Neurontin.

The company paid doctors to attend so-called "consultants meetings" in which physicians received a fee for attending expensive dinners or conferences during which presentations about off-label uses of Neurontin were made, the Justice Department said. These events included lavish weekends and trips to Florida, the 1996 Atlanta Olympics and Hawaii. There was little or no significant consulting provided by the physicians.

Warner-Lambert paid physicians to allow a sales representative to accompany them while he or she saw patients, with the representative offering advice regarding the patient's treatment, which was biased towards the use of Neurontin, the Justice Department said.

These tactics were part of a widespread, coordinated national effort to implement an off-label marketing plan.

BUILDING A BLOCKBUSTER DRUG
Neurontin was launched into the marketplace in February of 1994; from mid-1995 to at least 2001, the growth of off-label sales was tremendous. While not all of these sales were the consequence of Warner-Lambert's illegal marketing, the marketing scheme was very successful in increasing Neurontin prescriptions for unapproved uses, the Justice Department said.

Pfizer had $2.4 billion in U.S. sales of Neurontin in 2003.

THE WHISTLE-BLOWER
The investigation was commenced in the District of Massachusetts when a former medical liaison for Warner-Lambert, Dr. David Franklin, filed a suit on behalf of the U.S. government. Private individuals like Dr. Franklin are allowed to file whistleblower suits under the federal False Claims Act to bring the United States information about wrongdoing. If the United States is successful in resolving or litigating the whistleblower's claims, the whistleblower may share in part of the recovery. As a part of the resolution, Dr. Franklin will receive approximately $24.64 million of the civil recovery.


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