South Carolina Lawyer Blog

A low country pain clinic was one of the healthcare facilities that received a batch of tainted steroids linked to the deadly meningitis outbreak.

Intervene MD, with locations in Mount Pleasant and North Charleston, posted the following on its blog:

“Unfortunately, our practice was one of those provided medications from the manufacturer [New England Compounding Center]. We were notified by the South Carolina Department of Health and Environmental Control (DHEC) on Friday, September 21st that we had received suspect medicines from lots produced between July 31 and September 16. We immediately removed all vials of the medication from use and returned them to the manufacturer.

“Because we are concerned, we have made every effort to determine each and every patient who may have received epidural treatment with this medication. We have personally spoken with almost all of the 189 people affected. We continue to call and work to get in touch with each person who received this medication by epidural injection. There are a few patients we’ve not been able to reach by telephone, despite multiple attempts, and we are sending follow-up letters that detail signs and symptoms to watch for until the possibility of illness passes. Each person has been asked to seek immediate emergency treatment if they have any symptoms. According to the Centers for Disease Control (CDC), this illness takes from one week to one month following exposure to develop.

“It is a relief that none of our patients are showing any signs or symptoms of meningitis. Two — at our urging — have gone to the emergency room for further examination. Tests determined that they do not have meningitis.

“We have been and continue to be available to speak with our patients. We invite them to phone us with any questions, issues or anxiety. We are providing medical counseling and following all CDC recommendations.

“We urge anyone who has recently had epidural treatment for back pain to contact their doctor. If you are our patient and have questions, we want you to call us. Epidural steroid injections for the management of pain have been used for many years and have relieved pain in thousands. This treatment has allowed many individuals to experience an improved quality of life and be more productive.”

If you or a loved one has been directly affected by the meningitis crisis, the South Carolina drug injury lawyers at the Louthian Law Firm in Columbia are available to answer legal questions about your rights and options.

Meanwhile, the first of an anticipated wave of lawsuits over the fatal outbreak was filed October 11 in Minnesota.

According to Reuters news:

“The lawsuit [Barbe Puro v. New England Compounding Pharmacy Inc, U.S. District Court, District of Minnesota, No. 12-2605] was filed in a Minnesota federal court on Thursday by a woman who said she was given a steroid injection for back pain and has experienced symptoms consistent with meningitis. She is awaiting the results of tests.”

The number of people nationwide who have contracted meningitis from an injection of tainted steroids had exceeded 215 as of October 15. More than a dozen have died.

View an infection map from the Centers for Disease Control and Prevention here.

Patients who received a steroid injection at Intervene MD between July and September 2012 are urged to contact a healthcare provider immediately.

View a CDC map of all affected healthcare facilities here.

Get Answers From A South Carolina Drug Injury Lawyer

The Columbia drug accident attorneys of the Louthian Law Firm are available to evaluate cases of injury or death in light of the meningitis outbreak. If you or a loved one received a steroid injection for back pain between July and September 2012, you should first seek medical attention. Once you have done that, our dedicated pharmaceutical attorneys are available to discuss your legal options. Call us today at 888-616-4339. The call is confidential and toll free.

Researchers have uncovered a possible link between a common drug used to treat diabetes and an increased risk of vision problems, according to a HealthDay report. According to the study, which first appeared in the online edition of the Archives of Internal Medicine, users of thiazolidinediones may be two or three times more at risk of a serious problem with their vision, called macular edema. Macular edema, according to the National Eye Institute, is a condition in which fluid leaks into the macula, or the part of the eye where sharp, straight-ahead vision happens. The fluid then makes this part of the eye swell, which causes blurry vision.

This means more trouble for users of Actos, Avandia and similar drugs, since thiazolidinediones are in both Avandia and Actos, and are used to help control blood sugar in people with diabetes. We’ve written before about the bladder cancer risk linked to Actos, and the HealthDay report mentions the links between Avandia and serious risks of heart problems.

For the study, which was carried out in England, lead researcher Dr. Iskandar Idris and his team looked at data from more than 100,000 people with type 2 diabetes. At the start of the study, none of those 100,000 people had macular edema. After one year, however, diabetes patients in the study who were taking Actos, Avandia, or other thiazolidinediones developed the eye problem more than six times as often as the diabetes patients who didn’t take those drugs.

According to researchers, about 20 percent of people with diabetes suffer from macular edema, which is one sign of a serious vision illness. An editorial that appeared with the study in the Archives of Internal Medicine said that the study adds to a growing concern about the possibility of drugs like Avandia or Actos causing fluid buildup in the eyes of people who use the drugs. Dr. Sonal Singh, who co-wrote the editorial, said diabetes patients who take Avandia or Actos should see an eye doctor promptly if they experience visual symptoms.

Contact Our South Carolina Prescription Drug Injury Lawyers Today
Prescription drug injuries can be very serious. In many cases, medical professionals may not realize that a patient's illness was caused by a drug, causing them to lose precious treatment time. Indeed, the causes of some prescription drug injuries may not be apparent until months or years later, when independent scientists discover problems with the drug. Some of the most serious injuries caused by recently discredited prescription drugs include heart attacks and myocardial infarction, heightened or lowered blood pressure, blood clots, rapid changes in blood sugar and other potentially fatal conditions.

If you or someone you care about has been injured or killed by an unsafe prescription drug, contact the South Carolina personal injury attorneys at the Louthian Law Firm today. Call toll free at 888-662-9821 or locally at 803-454-1200 or use our online for a free evaluation of your case.

Drug company giant GlaxoSmithKline made U.S. history recently in an agreement with U.S. authorities requiring the company to pay a $3 billion healthcare fraud settlement. The GlaxoSmithKline deal with the U.S. Department of Justice also has the drug maker pleading guilty to three misdemeanor criminal counts.

The criminal counts are linked to three different GlaxoSmithKline drugs: Paxil, Wellbutrin and Avandia.

News about the settlement says that $1 billion will go toward settling criminal complaints leveled against the company, and the other $2 billion will go toward settling civil fines.

A large part of the settlement focuses on attempts by GlaxoSmithKline to get doctors to prescribe certain of its drugs in ‘off-label’ uses. As the American Cancer Society summarizes, an off-label drug use is when “a drug is used in a way that is different from...the FDA-approved drug label.”

According to the FDA, the decision to use drugs in an off-label prescription is left up to doctors in most cases. However, while it may be legal for doctors to prescribe drugs for off-label uses, it’s not legal for drug companies to advertise or promote those off-label uses.

According to a Reuters article about the settlement, the Department of Justice says that’s exactly what GlaxoSmithKline did. Some of the off-label uses that U.S. officials say GlaxoSmithKline promoted include prescribing the antidepressant drug Paxil to treat patients under the age of 18 and prescribing the antidepressant drug Wellbutrin for weight loss.

According to the investigation, which the Department of Justice spearheaded, GlaxoSmithKline encouraged doctors to prescribe these drugs off-label to their patients by treating doctors to spa programs, special dinners and other activities.

A different sort of controversy surrounds the charges relating to the diabetes drug Avandia. In the case of Avandia, prosecutors say, GlaxoSmithKline didn’t give important safety information to the Food and Drug Administration. The data, the Department of Justice says, has led to so-called ‘black box’ warnings on Avandia, advising doctors and patients about the increased risk of heart attack and heart failure linked to the drug.

As Reuters coverage of the drug settlements points out, the size of the $3 billion settlement and extent of the criminal charges is a new level of victory for U.S. drug and health regulators. As James Cole, with the U.S. Justice Department said, the GlaxoSmithKline medical fraud settlement is, “a clear warning to any company that chooses to break the law.”

About The Louthian Law Firm
The Louthian Law Firm, P.A., of Columbia, S.C., has been obtaining fair compensation for personal injury victims since 1959. The firm was founded by Herbert Louthian, who has more than 50 years of trial experience and is licensed to practice in all courts in South Carolina. The Louthian Law Firm focuses on personal injury cases involving medical malpractice; car, truck and motorcycle accidents; and other serious and catastrophic injuries throughout South Carolina. For a free, confidential case evaluation, contact the firm by phone at 888-662-9820 or through its online form.

It seems medical research linking diabetes drug Actos to bladder cancer just keeps piling up. A new study from Canada, recently published in the Canadian Medical Association Journal, found that the common diabetes treatment may be involved in raising bladder cancer risks for users by as much as 22 percent.

The authors of the new study say that they still aren’t sure how or why pioglitazone, the drug in Actos, is linked with the higher cancer risk. Senior study author Jeffrey A. Johnson says that recent studies of the drug’s effects in animals show that Actos may cause crystals to form, which might then irritate the bladder and trigger the increased cancer risk.

Current studies show that, overall, people with type 2 diabetes have about a 40 percent higher risk of developing bladder cancer than other people. Doctors think this may be because people with this type of diabetes have increased levels of insulin, a chemical produced by the body to help digest food, in their bodies.

According to the National Institutes of Health, diabetes affects 25.8 million people in the U.S., or just over 8 percent of people. Type 2 diabetes is the most common form of diabetes in the U.S., and diabetes is responsible for $116 billion in medical costs in the U.S. each year.

We’ve written before about the growing evidence linking Actos to cancer dangers. The drug in Actos is also a part of diabetes medications sold under the names Actoplus Met, Actoplus Met XR, and Duetact. According to the Food and Drug Administration (FDA), 2.3 million people filled prescriptions for pioglitazone drugs in the first 10 months of 2010.

The findings from the Canadian study reinforce findings by an earlier French study and a five-year study by the FDA, which all found links between the Actos drug and higher risks of bladder cancer. The FDA has said that it will continue to monitor data from patients prescribed diabetes drugs with pioglitazone in them.

According to the FDA, people who’ve taken pioglitazone drugs—whether under the name Actos, or in another form like Duetact—should be aware of the increased bladder cancer risk, as well as potential symptoms of bladder cancer. Symptoms includepain in the lower back and abdomen, the appearance of blood or a red color in urine, pain while urinating, or an urgent need to urinate. Experts still don’t agree about how best to safeguard patients—France suspended the drug, and Germany recommended that doctors not prescribe it for any new diabetes cases. In the U.S., some doctors say they have stopped prescribing the drug. Others say they look at a patient’s overall background and cancer risk, and may still prescribe the drug if the risk of cancer seems low enough. For the millions of American patients taking the pioglitazone drug, however, this new study may just show that the risk is never low enough.

About The Louthian Law Firm

The Louthian Law Firm, P.A., of Columbia, S.C., has been obtaining fair compensation for personal injury victims since 1959. The firm was founded by Herbert Louthian, who has more than 50 years of trial experience and is licensed to practice in all courts in South Carolina. The Louthian Law Firm focuses on personal injury cases involving medical malpractice; car, truck and motorcycle accidents; and other serious and catastrophic injuries throughout South Carolina. For a free, confidential case evaluation, contact the firm by phone at 888-662-9820 or through its online form.

After a five-year study, the U.S. Food and Drug Administration (FDA) recently announced that patients who took certain medications for diabetes may now have a much greater risk of bladder cancer.

According to the FDA safety announcement, those who took the prescription drug pioglitazone, sold under the brand name Actos, may be at risk. The drug is also a part of diabetes medications sold under the names Actoplus Met, Actoplus Met XR, and Duetact. These prescriptions are used most often in the treatment and control of type 2 diabetes in adults.

Also according to the FDA, 2.3 million patients filled prescriptions for medications containing the drug pioglitazone in the first 10 months of 2010. The FDA safety announcement is the result of both the five-year data review by the FDA and a recent study in France, which showed that exposure to pioglitazone increases the risk of bladder cancer over time.

No studies have yet to show a direct link between the drug and bladder cancer, but experts do agree that studies have shown that use of the drug over an extended period of time puts patients at risk. According to the FDA review, patients exposed for a period of 12 months or more had a 40 percent increase in risk of bladder cancer. The French study showed that an increased risk was particularly associated with male patients.

The FDA has said that it will continue to monitor data from patients prescribed diabetes drugs like Actos. France has suspended use of pioglitazone, and Germany has recommended its physicians not prescribe the drug for use in new diabetes patients.

People who are currently taking or have taken diabetes medications containing the drug should be aware of the increased bladder cancer risk, as well as potential symptoms of bladder cancer, according to the FDA. Problems such as pain while urinating, an urgent need to urinate, pain in the lower back and abdomen, or appearance of blood or a red color in urine may indicate the presence of bladder cancer.

The FDA also recommends that patients talk to their doctors about any problems or concerns about diabetes prescription drugs.

The South Carolina prescription drug injury attorneys at Louthian Law Firm are here for you if you or a loved one has suffered life-threatening side effects from Actos or any other drug. Contact us at today at (888) 926-0056, or locally at (803) 454-1200. You can also use our online contact form. We'll give you a free evaluation of your case.

A former University of Utah football player has filed a product liability lawsuit against the makers of the Stryker pain pump after claiming use of the pump after shoulder surgery resulted in permanent shoulder damage.

The man developed chondrolysis, severe loss of cartilage in the joint, and his lawsuit claims Stryker Corp. should have known about the risk of cartilage problems associated with the use of their pain pumps. The suit claims that the treating doctor would not have used the pump for pain management had he been aware of the risk of chondrolysis.

In 2009 FDA required manufacturers of pain pumps to add warnings about the risk of chondrolysis from shoulder pain pumps. Several other shoulder pain pump lawsuits have been filed claiming chondrolysis-related injuries.

If you have suffered a personal injury or lost a loved one due to a defective product, the attorneys at Louthian Law Firm can help. Call us for a free consultation at 866-454-1200.

Dangerous Pharmaceutical Product

A Canadian study has revealed that the popular smoking cessation drug, Chantix, increases the risk of heart problems in smokers who take the medication.

In the study, published in the Canadian Medical Association Journal, researchers concluded that the drug’s long list of dangerous side effects also includes heart attacks and irregular heartbeats.

Prior to this study, patients reported that the drug caused changes in behavior, hostility, agitation, depressed mood, and suicidal thoughts or actions. Our South Carolina injury attorneys have been reporting on the drug's side effects for years.

The authors of the study concluded that their results, and those of other studies, suggest a 72% increased risk of heart attack while using Chantix (varenicline). Dr. Sonal Singh, an assistant professor of general internal medicine at the Johns Hopkins University School of Medicine was one of the study’s authors and said he would not recommend that his patients take the drug. When quitting smoking, "you want to decrease your risk of a heart attack, instead of increasing a heart attack by 72%," Singh said.

The results prompted the U.S. Food and Drug Administration (FDA) to issue a warning in June stating, “If you have cardiovascular disease, taking Chantix may increase your risk of certain cardiovascular adverse events.” The agency also encouraged patients to report side effects from the use of Chantix to the FDA MedWatch program. The latest warning is in addition to the boxed warning on the Chantix packages citing the risk of “psychological events.”

The drug company Pfizer, which makes Chantix, argues that the study’s results are flawed but is working with the FDA to evaluate the existing claims.

The South Carolina injury attorneys at Louthian Law Firm are here for you if you or a loved one has suffered life threatening side effects from Chantix (varenicline) or any other drug. Contact us at today at (866) 454-1200, or locally at (803) 454-1200. You can also use our online contact form. We'll give you a free evaluation of your case.

An 18-year-old college student died of cardiac arrest in September after she took YAZ to treat her acne. The student’s mother has filed a wrongful death lawsuit against Bayer, the maker of YAZ, also known as Yasmin or Ocella.

The lawsuit alleges YAZ is a “dangerous prescription drug sold without adequate warnings about the risks of serious and fatal injuries.”

Following two studies, the British Medical Journal last month published findings that drugs containing the hormone drospirenone were 2-3 times more likely to increase the risk of serious blood clots than earlier-generations of oral contraceptives. YAZ contains drospirenone.

While Bayer claims this side effect is rare, the YAZ website does warn against the increased risks of blood clots, stoke, and heart attack. In 2008, the U.S. Food and Drug Administration sent Bayer Healthcare Pharmaceuticals, Inc. a warning letter citing the company for running two misleading television ads which overstated its benefits and minimized serious side effects.

If you believe you or a member of your family has been harmed by an unsafe prescription drug, contact the Louthian Law Firm today at 1-866-410-5656 or contact us online for a free evaluation of your case

Dangerous Prescription Drugs

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.

Read More...

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.

Read More...

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

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

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

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

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

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

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; and stand by your side throughout the legal process. 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.

Full story - Click here.

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.

Full story - Click here.

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" »

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.

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" »

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" »

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.

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