Britain Warns of Stroke Risk With Zyprexa® and Resperdal

A UK Department of Health study has found three times more risk of stroke in older patients who take Zyprexa and Risperdal. The Eli Lilly and Johnson & Johnson medications are used to treat acute psychosis and schizophrenia.

According to Reuters News, the British Department of Health issued a statement warning that Zyprexa and Risperdal should not be used to treat “off label” behavioral problems in older patients with dementia because of the risk of stroke. “Off label” use refers to the practice of permitting physicians to prescribe approved medications for use other than their intended indications. In February of 2004, Eli Lilly issued a voluntary similar warning in a letter to doctors and psychiatrists in the U.S. An Eli Lilly spokesperson stated that the pharmaceutical giant will not seek FDA approval Zyprexa to treat older patients with dementia.

In other Zyprexa-related news, the drug is undergoing a patent challenge from companies that seek to introduce generic knockoffs of the drug. Zyprexa is also under competitive pressure from new drug rivals Geodon and Abilify.

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FDA Warns Glaxo Over Paxil Ads; New York Files Lawsuit

6/22/04 – The Food and Drug Administration (FDA) has asked drug maker GlaxoSmithKline to halt certain advertisements for Paxil Controlled-Release medication because they are vague and misleading about safety issues. The FDA also gave GlaxoSmithKline until June 23 to respond to the charges that a TV ad excludes information on certain side-effects and distracts viewers with “compelling and attention-grabbing visuals” while risk information is being presented.

Glaxo touts Paxil as an anti-anxiety drug that is safe for use in a broader range of patients than the FDA has approved. The FDA contends that the TV ad for Paxil Controlled-Release is “false or misleading” and that it implies that the drug is safer than actually proven.

This latest controversy comes on the heels of New York Attorney General Eliot Sptizer’s lawsuit against Glaxo over the alleged concealment of information that challenges the safety and effectiveness of Paxil when given to children.

The request was made public just over a week after New York Attorney General Eliot Spitzer filed a lawsuit against Glaxo over the alleged concealment of data that would challenge the safety and efficacy of Paxil when given to children. Spitzer accuses Glaxo of “repeated and persistent fraud” and that Glaxo hid the fact that in some trials involving children, Paxil failed to demonstrate better efficacy that a placebo. The suit further alleges that in some cases Paxil was more likely to cause suicidal thinking. Paxil has not been approved for treatment in children under the age of 18.

Glaxo maintains that its data is made available to health-care professionals "through publication in peer-reviewed journals, poster presentations at scientific meetings, and medical letters to physicians.”

In a separate case, GlaxoSmithKline is being sued by three Paxil users who charge that the pharmaceutical maker suppressed their evidence that proved that the majority of Paxil users experience the return of anxiety and panic attacks.

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Family Files $25 Million Suit in Leaking Duragesic Patch Death

April 2004 - Johnson & Johnson and their subsidiary Janssen Pharmaceutica Products LP has been sued by the family of a woman who drowned in her bathtub after using a Duragesic pain patch. The suit alleges that the patch leaked dangerous levels of the opiate fentanyl into her body. The family claims that the patch was part of a recall of Duragesic patches which had the potential to leak medication along its edge. The recall came after the victim died.

The suit charges that fifty-one year old Patricia C. Wroten was washing her hair in the bathtub when she was rendered unconscious and drowned as a result of an overdose of the powerful pain medication.

Duragesic is a prescription medication to treat “moderate to severe chronic pain” and the drug can function for up to three days. Alza Corporation, a wholly-owned subsidiary of Johnson & Johnson is also a co-defendant in the suit.

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$20 Million Awarded in “Popcorn Packers’ Lung” Case
In March of 2004, a jury awarded a former popcorn-factory worker $20 million in the first "Popcorn Packers' Lung" trial. Eric Peoples is the first of 30 former workers at a factory in Jasper, MO who filed a lawsuit claiming that his severe breathing problems and damaged lungs were caused by a chemical in the butter flavoring used in microwave popcorn. The judgment was made against New York-based International Fragrances, the manufacturer of the buttery flavoring.

After developing a severe cough in 1998, Mr. Peoples now functions at only a 20 percent lung capacity according to USA Today.

The Environmental Protection Agency (EPA) and the Centers for Disease Control and Prevention (CDC) are investigating other workers' claims against International Fragrances, but says that microwave popcorn is safe for consumption.

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Lawsuit Charges HRT Caused Breast Cancer and Debilitating Stroke
Ten Ohio women filed a negligence lawsuit at the end of May charging several pharmaceutical giants with causing their breast cancer and at least one stroke. Wyeth and Wyeth Pharmaceuticals, Inc. of Columbus, OH; Pharmacia, Pharmacia Inc., Solvay Pharmaceuticals and Upjohn Corp. of Cleveland, OH; Cincinnati’s Pfizer Inc., Duramed Pharmaceuticals and Greenstone Ltd. were all named in the hormone replacement therapy (HRT) suit.

Prempro, the once-a-day pill that combines estrogen and progestin is at the heart of the case. The FDA approved Prempro in 1994. The lawsuit contends that "Through its marketing and advertising efforts, Wyeth convinced doctors and patients that menopause was not the natural process of aging, but instead turned this process into a disease in need of drug treatment.” According to the lawsuit, “Manufacturing defendants minimized the risks of these drugs to the prescribing physicians and ultimate users while simultaneously exaggerating the purported benefits.”

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NIH Sends 11,000 Letters to Estrogen-Alone Study Participants
The National Institutes of Health (NIH) has advised participants in the Women’s Health Initiative (WHI) to stop taking their estrogen-alone study pills due to stroke risk and other findings in otherwise healthy women. The follow-up phase of the study is now set to begin. Letters were sent to all 11,000 participants in early March of 2004.

In their study of healthy postmenopausal women who have undergone hysterectomies, the NIH found that estrogen alone does not appear to increase or decrease heart disease. However, estrogen alone seems to increase the risk of stroke while decreasing the risk of hip fractures.

An earlier study by the WHI had found that older women receiving the Prempro combination hormone replacement therapy (HRT) experienced almost double the rate of dementia compared to women not receiving therapy. Wyeth Pharmaceuticals, the makers of Prempro, had reiterated the FDA’s opinion that women should use the lowest effective dose of HRT for the shortest duration.

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ASEA Sues Pfizer Over Neurontin 'Off-Label' Marketing Scheme
06/07/04 – The Alaska State Employees Association Health Benefit Trust filed a lawsuit against Pfizer Inc. and its subsidiary Warner-Lambert Co. over its off-label marketing scheme of its top selling epilepsy drug Neurontin.

The lawsuit was filed on behalf of health plans and others that have paid for Neurontin for so-called "off-label" uses since Jan. 1, 1994. Once approved, drugs may not be marketed or promoted for any used not in their application or approval by the FDA (off-label). Neurontin was approved in 1993 for treatment of epileptic partial seizures.

In May of 2004, Pfizer plead guilty in May and agreed to pay $427 million to settle all criminal charges and civil liabilities related to the illegal and fraudulent promotion of unapproved uses for Neurontin.

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FDA Approves Generic OxyContin
Even though many pharmacies have limited access (or none) to the generic form of the powerful painkiller OxyContin, it is already available on the black market in Appalachia. In March of 2004, the FDA gave approval to Teva Pharmaceuticals of North Wales, PA and Endo Pharmaceuticals of Chadds Ford, PA to sell the generic version of the drug. The drug will bear the government’s strongest warning label since Oxycontin and its generic form may be as addictive as morphine.

OxyContin is a long-lasting, time-release drug containing oxycodone that is generally prescribed for patients suffering from chronic pain. When swallowed whole, it can provide up to 12 hours of pain relief. Abusers crush the tablets and then inject, chew or snort the drug to gain a potentially lethal high.

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Brown & Crouppen win $19M in medical malpractice case
A federal judge found the government liable for millions of dollars in damages related to botched birth procedures at Touchette Regional Hospital in Centreville. Brown & Crouppen filed the medical malpractice suit on behalf of a five year-old-boy who suffered brain damage after a doctor used a vacuum extractor 15 times when the manufacturer recommended it be used no more than three. 

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Brown & Crouppen represent couple in precedent setting lawsuit against manufactures of ephedra-containing products
Gov. Blagojevich of Illinois signed the first statewide law banning the sale of ephedra supplements on May 25, 2003. This action is a direct result of the combined efforts of Sen. Durbin and the couple Brown & Crouppen represent in a lawsuit following the death of their son after taking a product containing ephedra. 

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