South Carolina Lawyer Blog

Side effects of Pfizer's stop-smoking drug, Champix (known as Chantix in the United States) has caused Health Canada to issue strong warnings, reports NewsInferno.

The warning was issued following concerns of mood changes, hostility, suicidal behavior, and sometimes fatal skin reactions in some patients taking the popular drug. The drug must now carry a boxed warning about the serious safety issues.

Last year the U.S. FDA issued a similar warning saying psychiatric side effects seen among Chantix users at that time included 98 reports of suicide and 188 reports of attempted suicide. Although there was speculation some psychiatric problems could have been from nicotine withdrawal, the FDA found many of the reported problems occurred while Chantix users were still smoking.

Pfizer still maintains the safety of Chantix/Campix claiming the serious effects are often seen in people who try to stop smoking, calling it nicotine withdrawal. The controversy over the safety of Chantix continues, as do numerous lawsuits over Chantix's association with psychiatric problems.

Prescription drugs can have serious side effects. The Louthian Law Firm has pursued prescription drug injury and other personal injury lawsuits in South Carolina since 1959. If you or someone you care about has been injured or killed by an unsafe prescription drug, call us today at 1-800-410-5656 for a free evaluation of your unique case.

Chantix/Champix Drug Warning

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Bloomberg Business Week reports the largest drug maker in the U.K., GlaxoSmithKline (Glaxo), has agreed to pay $60 million in the first settlements of lawsuits over their drug, Avandia. This diabetes drug has been cited as causing heart attacks and strokes in some of the users.

This settlement will resolve more than 700 Avandia lawsuits, paying out about $86,000 for each case. Glaxo is scheduled to face its first Avandia trial in July in Philadelphia. More than 4,000 lawsuits have already been filed with more expected.

Avandia was approved for sale in the U.S. in 1999 and was the world's best-selling diabetes pill before the safety concerns came out. Glaxo says the users who suffered heart attacks cannot link them to Avandia and no health risks were hidden.

Prescription drugs can have serious side effects. The Louthian Law Firm has pursued prescription drug injury and other personal injury lawsuits in South Carolina since 1959. If you or someone you care about has been injured or killed by an unsafe prescription drug, call us today at 1-800-410-5656 for a free evaluation of your unique case.

Dangerous Drugs

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Chantix is an anti-smoking drug made by Pfizer and approved by the FDA on May of 2006. Since that time many users have reported serious side effects such as depression, suicidal thoughts and other psychotic episodes. According to the FDA, blackouts and unconsciousness leading to car accidents have also been linked to Chantix use.

Due to the reported problems from Chantix users, the FDA sought a "Black Box" warning for the drug. This warning is required for any drug that can cause a serious threat of significant or life-threatening side effects.

If you have used Chantix and have suffered some of the dangerous side effects caused by this drug, you have the option to seek justice for your pain and suffering, states a recent press release.

The Louthian Law Firm continues to investigate cases of injuries caused by Chantix and to assist those who have been harmed. If you or a loved one believes you have been harmed by your use of Chantix, contact the Louthian Law Firm today through the firm’s Web site or by telephone at 1-866-410-5656.

Chantix

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AstraZeneca, the U.K.’s second-largest drug maker, faces over 14,000 lawsuits claiming its antipsychotic drug Seroquel causes diabetes.

A U.S. District Judge said she will recommend sending all the cases back to their home courts for trial. AstraZeneca wanted the judge to send only 60 cases back to their home courts for trial as test cases in order not to needlessly burden other judges across the country.

The lawsuits allege the London-based company downplayed the diabetes risks of Seroquel. AstraZeneca has spent $623 million to date in legal defense costs defending Seroquel, the company's second largest selling drug after Nexium. The judge also ordered attorneys for both sides to meet with a mediator to seek the possibility for a settlement.

Prescription drugs can have serious side effects. The Louthian Law Firm has pursued prescription drug injury and other personal injury lawsuits in South Carolina since 1959. If you or someone you care about has been injured or killed by an unsafe prescription drug, call us today at 1-800-410-5656 for a free evaluation of your unique case.

AstraZeneca Faces Lawsuits

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A Philadelphia jury has awarded $75 million in punitive damages to an Illinois woman who developed cancer after taking one of Pfizer's menopause drugs. The punitive award is about 20 times greater than the $3.7 million awarded in actual damages.

More than 6 million women have taken Prempro, a hormone replacement drug used to treat symptoms such as hot flashes, night sweats and mood swings during menopause. A study in 2002 by the Women's Health Initiative suggested women who use hormone replacement drugs are at higher risk for developing breast cancer.

According to news reports, the Illinois woman took Prempro for five years before she developed breast cancer in 2002. Since the lawsuits against Pfizer's Wyeth unit began in 2006, the company has lost five of the eight cases with 33 more scheduled for trial.

In an earlier case, three Nevada women were awarded $99 million in punitive damages, which was later reduced to $35 million and is now being appealed.

Prescription drugs can have serious side effects. The Louthian Law Firm has pursued prescription drug injury and other personal injury lawsuits in South Carolina since 1959. If you or someone you care about has been injured or killed by an unsafe prescription drug, call us today at 1-800-410-5656 for a free evaluation of your unique case.

Pfizer Held Liable In Prempro Trial

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After the story broke this week about a North Carolina factory tied to bacteria-tainted syringes that killed five patients, criminal investigators revealed a startling fact -- the company’s "chief microbiologist" was a teenage high school dropout.

The case raises a glaring question: As this pharmaceutical tragedy was taking shape, where was the FDA, the agency charged with protecting U.S. citizens from deadly medicines?

If you or someone you care about has been injured or killed by an unsafe medical product, contact our prescription drug injury lawyers today. For a free consultation, call Louthian Law at (866) 410-5656 or use our online contact form.

Tainted Syringe Story

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With the increasing reports of suicidal thoughts and other serious neuropsychiatric symptoms tied to the anti-smoking drug Chantix, the drug's maker has launched a new ad that does not even mention the product by name.

Consumer Reports says such ads are known as "help-seeking" ads come in handy for drugs "that have a particularly nasty list of side effects."

Chantix became available August 2006. Since that time, over 6 million people have been prescribed the drug. In the last quarter of 2007, Chantix had the most serious incidents of any drug during that time – a total of 988. The director of the Health Research Group at Public Citizen has warned people not to take the drug until there is more information about its safety and the increased psychiatric adverse events connected with taking this medication.

More information about the side effects of Chantix is available here.

Prescription drugs make many people’s lives better, but unfortunately the Journal of the American Medical Association reports 51% of all prescription drugs have serious side effects not recognized before they gained FDA approval. If you or someone you care about has been injured or killed by an unsafe prescription drug, contact the Louthian Law Firm today at 1-866-410-5656 for a free evaluation of your case.

Chantix Ad Story

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A New Jersey jury has awarded nearly $13 million to three acne drug users who developed severe inflammatory bowel disease after taking the medication.

The three plaintiffs are Florida residents who used the drug to treat adolescent acne. All three developed bowel disorders, including ulcerative colitis and Crohn's disease.

If you or someone you care about was seriously injured by a prescription drug, you should speak with a South Carolina pharmaceutical litigation attorney at the Louthian Law Firm as soon as possible. We have won justice for South Carolinians since 1959, and recovered millions of dollars to help sick and injured people heal and move on. For a free consultation, call us today at 1-866-410-5656.

Acne Drug Verdict

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The drug Trasylol was used during open-heart surgery to reduce blood loss in thousands of patients. However, the FDA suspended sales of the drug in 2007 over a possible link to kidney failures, heart attacks and strokes.

Because so many heart surgery patients received Trasylol during the 14 years it was on the market, attorneys told legal newspaper Lawyers USA that litigation is likely to develop into a mass tort.

If you or someone you care about has been injured by a dangerous pharmaceutical product like Trasylol, you should speak with an experienced South Carolina personal injury attorney like the ones at the Louthian Law Firm as soon as possible. Our attorneys can help you evaluate your case; protect your legal right to the courts; stand by your side throughout the legal process; and get you the best possible results. For a free consultation, call the Columbia SC Defective Drug Lawyers at Louthian Law Firm today at 1-866-410-5656.

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The Food and Drug Administration will begin a quarterly posting of drugs whose safety is under investigation because of complaints filed by drug companies, physicians and patients.

The FDA will name the drug and the nature of the "adverse events" but will not describe the number of complaints or how serious the events were, FDA officials said.

The FDA has an Adverse Event Reporting System that last year logged 482,154 unsolicited reports of potential reactions to drugs. Many of the reported problems had nothing to do with the medication a patient was taking, the agency said.

If you or someone you care about was seriously injured by a prescription drug, you should speak with a South Carolina pharmaceutical litigation attorney at the Louthian Law Firm as soon as possible. We have won justice for South Carolinians since 1959, and recovered millions of dollars to help sick and injured people heal and move on. And because we know injured people are often suffering financially as well as physically, we never charge for an initial case evaluation. For a free consultation, call us today at 1-866-410-5656.

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An Indiana woman whose husband committed suicide in January 2008 has filed a lawsuit against Pfizer, the manufacturer of Chantix, a smoking-cessation drug her husband was taking.

The woman alleges that the company failed to warn consumers that the prescription medication might cause serious psychiatric symptoms such as suicidal thoughts.

If you or someone you care about was seriously injured by a prescription drug, you should speak with a South Carolina pharmaceutical litigation attorney at the Louthian Law Firm as soon as possible. We have won justice for South Carolinians since 1959, and recovered millions of dollars to help sick and injured people heal and move on. And because we know injured people are often suffering financially as well as physically, we never charge for an initial case evaluation. For a free consultation, call us today at 1-866-410-5656.

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The FDA is warning doctors about severe skin reactions in alcoholism patients who use Vivitrol, an injectable treatment made and marketed by Cephalon Inc. Doctors and patients should watch for swelling, infection, and other complications where the drug is injected. The FDA emphasized that the proper needle must be used when administering Vivitrol. Also, the drug should be injected into muscle, not fatty tissue.

More than 200 reports of skin problems have been reported among patients. A Cephalon spokeswoman said the company believes some problems stem from improper injections.

If you or someone you care about was seriously injured by a prescription drug, you should speak with a South Carolina pharmaceutical litigation attorney at the Louthian Law Firm as soon as possible. For a free consultation, call us today at 1-866-410-5656.

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Trasylol, a defective drug manufactured by Bayer AG, may have claimed as many as “1,000 lives per month” in the time before it was recalled, according to a doctor who presented a study to the FDA in September 2006. It wasn’t until November 2007, however, when the Canadian Data Safety Monitoring Board had stopped a Trasylol trial after a data analysis indicated that the 30-day mortality risk in the study’s patients was nearing “statistical significance”, that Bayer suspended sales of the drug in the US at the FDA’s request.

Trasylol is a drug used to prevent bleeding during heart bypass surgery, and before it was removed from the market, about a third of all bypass patients had received Trasylol. The initial reports from the Canadian study suggested an increased risk of death for Trasylol users compared with two other antifibrinolytic drugs. There had also been reports linking Trasylol with kidney problems, amputations, heart attacks and strokes.

Dr. Dennis Mangano, who presented his study to the FDA which found that Trasylol increased the risk of kidney failure requiring dialysis, as well as death, believes Trasylol should have been taken off the market when he published his study in 2006. Bayer executives, in fact, attended Mangano’s presentation in order to defend Trasylol. What they did not tell the FDA was that their own Trasylol study, known as the 13 drug report, confirmed Mangano’s findings. That study, which analyzed a database of hospital patients who were given the drug, suggested the drug’s use could also increase the likelihood of serious kidney damage, congestive heart failure and strokes. Even after learning about the 13 drug report, however, the FDA allowed Trasylol to remain on the market, adding only a warning label to its packaging explaining that the drug placed patients at high risk of kidney failure. Between the study’s publication and November 2007 when Bayer removed Trasylol, close to half a million patients received the drug.

Continue reading "FDA Suspends Marketing of Trasylol" »

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Merck & Co., manufacturer of the painkiller Vioxx, said Friday November 9th that it will pay $4.85 billion to end thousands of state and federal lawsuits over its painkiller Vioxx in one of the largest drug settlements ever.

Vioxx was developed to treat arthritis, but was pulled from the market on September 30, 2004 after its researchers determined that continued use of the product doubled risk of heart attacks and strokes. At the time that the medication was recalled, Merck & Co. was pulling in about $2.5 billion a year in sales of the drug. To qualify for a settlement, plaintiffs must have filed claims by a certain date and meet several criteria, including medical proof that they suffered a heart attack or stroke, that they received at least 30 Vioxx pills and that they received enough pills to support a presumption that they were ingested within two weeks before injury.

Company officials stressed that the agreement is not a class action settlement and that it is not admitting fault. They estimated the deal, if accepted, would end 45,000 to 50,000 personal injury lawsuits involving U.S. Vioxx users who suffered a heart attack or ischemic stroke, the type in which blood flow to the brain is blocked.

The agreement becomes binding only if 85 percent of the plaintiffs in key categories agree to the deal: all pending heart attack and ischemic stroke cases, all cases involving deaths and all cases alleging more than 12 months of Vioxx use. Potential claimants will have to have prior medical documentation of a heart attack or stroke, and they will not be able to later opt out of the settlement. Also, all law firms involved in the “steering committees” directing pretrial discovery and other coordination of both state and federal cases must get every one of their clients to settle.

The numbers involved in this settlement are staggering. While $4.85 Billion may seem like an astronomical number, it is interesting to note that upon announcement of the terms of the agreement, Merck & Co. stock went up 2 percent, to $55.90 – trading near their 52 week high of $58.36. The Food and Drug Administration approved Vioxx in 1999, and in the years following its release, the drug was used by over 84 million people around the world. Although studies conducted around the time that the drug was approved for distribution showed that there were hypertension related side effects associated with Vioxx, the drug was made available across the globe.

The South Carolina prescription drug lawyers at the Louthian Law Firm can help you if you or a loved one has suffered any serious side effects as the result of a taking prescription drugs. Contact us immediately to discuss your case with a dedicated legal professional. Our attorneys can begin helping you as soon as you contact us, and may be able to recover for you the monetary compensation that you deserve for your serious injuries.

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After hearing testimony that the drug increases the risk of suicidal thoughts, even in patients without a history of depression, Federal health officials unanimously rejected the weight loss drug, rimonabant, manufactured by Sanofi-Aventis SA. The panel said that the company failed to show the drug is safe.

Judging from the back-to-back 14-0 votes by the expert panel it is unlikely the Food and Drug Administration will approve the drug. The agency usually follows its panel’s advice, but it isn’t required to do so.

“There is a reasonable suspicion we better learn some more and watch this affair more closely before we launch into massive use of this drug,” said panelist Dr. Jules Hirsch, a senior physician at New York’s Rockefeller University.

Continue reading "Federal Health Advisors Reject New Weight-loss Drug" »

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FDA Commissioner Andrew von Eschenbach said at a congressional hearing Wednesday that
the FDA is going to require stronger warnings about heart failure on the diabetes drugs Avandia and Actos.

The FDA is directing GlaxoSmithKline to add a "black box" warning to Avandia and ordering Takeda Pharmaceuticals to do the same for its competing diabetes drug Actos, strengthening existing warnings about a condition in which the heart does not adequately pump blood. The issue is separate from an analysis in the New England Journal of Medicine that said Avandia increased the risk of heart attack.

The concerns about Avandia prompted Democratic lawmakers to call for increased regulation of the pharmaceutical industry. Rep. Henry Waxman, D-Calif criticized the FDA for not alerting consumers sooner about the drug's potential dangers.

Continue reading "FDA to Require Avandia to Carry Stronger Warnings" »

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Chicago Tribune staff reporter Bruce Japsen reported that gifts which are showered on doctors by drug and medical device makers have become so pervasive that they are a standard part of virtually every United States physician’s practice.
“Despite self-policing initiatives launched by organized medical groups and the drug and device makers to curb the cozy relationship between physicians and industry, 94 percent or virtually all physicians have at least one type of relationship with the drug industry, according to a study which was scheduled to be published in the New England Journal of Medicine.”
Drug marketing and conflict of interest between doctors and medical product companies have come under scrutiny because of their impact on cost and because of safety issues involving heavily promoted drugs. Eric Campbell, the studies lead researcher and co-author who is an associate professor of medicine at the Institute for Health Policy at Massachusetts General Hospital and Harvard Medical School, says that “relationships with industry are a fundamental part of the way medicine is practiced today.” He went on to say that consumers have a reason to be concerned about what the study found.
The American Medical Association guidelines, which are voluntary, say that any gift to a physician should “primarily entail a benefit to patients and should not be of substantial value”. When physicians accept gifts they should be worth less than $100 and “benefit patients.” Studies suggest that many doctors do not always follow the AMA guidelines.

Continue reading " Free Drugs for Doctors from Drug Makers Can Lead to Harm for Patients" »

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