Drug Injury Attorney Blog

In February, I wrote about the Senate's report on their investigation of the diabetes drug Avandia (rosiglitazone) and allegedly unethical behavior by the drug's manufacturer, GlaxoSmithKline. As a dangerous prescription drug lawyer, I keep a close watch when drug manufacturers face allegations of unethical behavior, as does GlaxoSmithKline, the maker of Avandia. Now, a Reuters report reveals that the FDA is considering ending a study of Avandia's safety earlier than planned because subjecting study participants to this drug's substantial risk of causing heart attack could be unethical.

A 2007 study by Dr. Steven Nissen of the Cleveland Clinic, published in the New England Journal of Medicine, showed that taking Avandia increased a patient's heart attack risk by 64%. This is a frightening risk for Type II diabetes patients already at high risk for heart attack. University of Washington researcher Bruce M. Psaty, MD, PhD, said, "There is little evidence for using this drug…. The purpose of reducing blood sugar is to prevent cardiovascular events. Now the possibility of cardiovascular benefit associated with Avandia appears remote -- indeed, it appears linked to harm." Avandia already carries a black box warning, the strongest kind of warning from the FDA, about patients' increased risk of heart failure. Two FDA drug safety reviewers recommended pulling the drug from the U.S. market in 2008, and in late March 2010, Saudi Arabia's Food and Drug Authority suspended Avandia for six months.

Meanwhile, GlaxoSmithKline maintains that the evidence does not establish that Avandia increases the risk of heart attack, citing its own long-term study, which of course may not be completely objective. The February Senate report alleged that GlaxoSmithKline also tried to quash information damaging to Avandia by intimidating doctors and downplaying evidence of its dangers. Yet the Senate investigation found that privately, GlaxoSmithKline's own scientists acknowledged that Dr. Nissen's study was sound. As a defective prescription drug attorney, I think it's important that patients be made aware of scientists' and regulators' concerns about Avandia.

By refusing to acknowledge the concerns of the FDA and the Senate, GlaxoSmithKline may be trying to protect its sales of Avandia, which reached $2.8 billion in 2006. But GlaxoSmithKline may pay a big price for doing so. Drug manufacturers can be held legally responsible for the harmful effects of their drugs if they fail to warn the public and government regulators about them. The FDA's decision to consider ending the current Avandia study because of the heart attack risk, along with the Saudia Arabian FDA's suspension of Avandia, suggests that everyone is convinced of Avandia's risks -- but GlaxoSmithKline simply won't acknowledge them until it's forced to. This is a dangerous game to play with patients' health and lives.

Continue reading " Avandia Study May End Early Due to High Risk of Patient Heart Attack " »

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According to pharmaceutical industry journal PharmaLive, the U.S. Food and Drug Administration has rebuked GlaxoSmithKline for false advertising about its chronic lymphocytic leukemia (CLL) drug Arzerra (ofatumumab). In a letter to the company, the FDA says that an advertisement for Arzerra in the Journal of Clinical Oncology fails to mention any of the risks associated with the drug or the limitations on the drug's use. Because of these omissions, the FDA says that the ad implies that Arzerra is safer and more effective than evidence says it is. As a dangerous drugs attorney, I took note of this article because numerous drug companies have been discovered making similar intentional violations, exposing millions of patients to serious risks.

The FDA also upbraided GlaxoSmithKline for failing to submit its Journal of Clinical Oncology ad for the FDA’s review before publication. Because Arzerra was within 120 days of being approved by the FDA for marketing, its promotional materials were supposed to be vetted by the FDA. GlaxoSmithKline had framed the advertisement as a “disease awareness” ad, which purports to inform people about a disease without mentioning a particular drug, so no disclosure of drug side effects would have been required. But the FDA said that the ad's allusions to Arzerra were transparent, and that the ad should have described the adverse reactions to Arzerra that patients could suffer. For example, Arzerra can increase the risk of an often fatal viral infection of the brain, progressive multifocal leukoencephalopathy, which resembles a speeded-up version of multiple sclerosis. Arzerra can also be harmful to patients who have a history of hepatitis.

Drug manufacturers have a legal responsibility to warn doctors and patients of the risks associated with their drugs. As a defective prescription drug attorney, I am glad that the FDA is taking GlaxoSmithKline to task for trying to sidestep its responsibility to inform the public of all relevant safety information about Arzerra. A number of drug manufacturers have been held liable in lawsuits over false advertising of their drugs' effectiveness and safety. Patients with serious illnesses like CLL have enough to worry about without also having to research faulty claims about their medications, or worry about undisclosed safety information. Unfortunately, as the FDA's letter to GlaxoSmithKline shows, drug manufacturers often place their own financial interests ahead of patients' safety.

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Patients being treated for epilepsy, depression, migraine, chronic pain, bipolar disorder, and other conditions may need to be vigilant about suicide-related side effects of their treatment. A recent report on CNN.com details the results of a study just published in the Journal of the American Medical Association (JAMA). It found that taking antiseizure drugs to treat epilepsy and other conditions roughly doubles the risk of suicidal thoughts and suicide attempts, compared with other drugs in the same class. The medications in question are the antiseizure and nerve pain relief drug gabapentin (Neurontin), the antiseizure and bipolar disorder drug lamotrigine (Lamictal), and the antiseizure drugs oxcarbazepine (Trileptal), tiagabine (Gabitril), and the seizure, bipolar disorder, and migraine treatment valproate (Depakote). I see a lot of people who have experienced unexpected negative effects from prescription drugs in my work as a defective prescription drug attorney, and I am glad that news outlets like CNN are making the public aware of these dangers.

In 2008, the U.S Food and Drug found that people who took any of eleven anticonvulsants, as these drugs are called, approximately doubled the risk of suicidal thoughts and suicide attempts. The risk is less than half of one percent -- about one in 230 patients will have suicidal behavior or thoughts. Experts say patients need to be aware of this risk, so that they'll be more likely to notice if they are that one in 230. The FDA required these drugs to carry a warning label about this risk, but did not require a “black box” warning, the most serious kind of warning.

The new study published in JAMA looked at people taking thirteen anticonvulsants over five years and tracked suicide attempts, suicides and violent deaths. It found that five of the drugs increased the risk of suicidal behavior compared with topiramate (Topamax), a widely prescribed and versatile drug in the same class. Aware that many of the anticonvulsants they looked at were used to treat mental illnesses, the authors of the study accounted for the increased risk of suicide because of mental illness as they analyzed the data. They still found that "the risk was derived from the specific drug that the patient was taking and not their underlying conditions," said Dr. Elisabetta Patorno of the Brigham and Women's Hospital in Boston, the lead author of the study. Dr. Andres Kanner of Rush Medical College in Chicago, who did not work on the study, said that patients taking anticonvulsants should tell their doctors if they or a family member have a history of mental illness. Patients should not stop taking the drugs without discussing the issue with their doctors, and they should tell their doctors if they feel depressed or have thoughts of suicide.

As a dangerous prescription drug lawyer, I am glad that patients are gaining access to better information about the drugs that they take, but I am concerned that this information is not coming from the drug manufacturers. The risk of suicide is a well known side effect of certain antidepressants, and it’s not unlikely that the manufacturers could have been aware of it before the JAMA study came out. In fact, the drugmaker Pfizer just settled a wrongful death lawsuit with the widow of a man who committed suicide while taking Neurontin. Pfizer still faces many similar lawsuits and also pleaded guilty to criminal charges in 2004 and agreed to pay $430 million because of how it promoted Neurontin. Neurontin had been one of the company's best selling drugs before it lost patent protection and generic versions became available. These circumstances suggest that some drug manufacturers might have worried that warning people about the increased risk of suicide would harm their profits.

Continue reading " Study Links Epilepsy and Depression Drugs to Suicidal Thoughts and Attempts " »

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As a dangerous prescription drug attorney, I was interested in this story about a St. Louis drug manufacturer's guilty plea to two felony counts of criminal fraud. Ethex Corp, a wholly owned subsidiary of KV Pharmaceutical, admitted that it had failed to report to the FDA that it had been producing generic prescription medications that contained up to double the dose they should have had. Company leaders admit that they knew about the problem in the spring of 2008, but kept quiet about most of the drugs until an FDA order shut down production in January of 2009. They blame the problem on bad managers who have since been pushed out. Despite 15 months of no production or sales, KV faces at least 30 lawsuits, 15 of which are wrongful death claims.

In May 2008, pharmacists in California and Canada discovered that morphine sulfate tablets produced by Ethex were much larger than they should have been. Overdoses of morphine, an opiate, can cause a person to stop breathing and go into a coma. KV Pharmaceuticals recalled the defective morphine tablets the next month. However, they decided not to do anything in response to reports of similarly oversized tablets of other drugs like propafenone, a medication for irregular heartbeat, and dextroamphetamine sulfate, a component of Adderall, the attention-deficit disorder drug. Propafenone overdose can lead to coma and seizures, and dextroamphetamine sulfate overdose can, in extreme cases, lead to amphetamine psychosis, in which a person experiences hallucinations and goes for long periods of time without sleep.

Assistant U.S. Attorney Andrew Lay wrote in court papers that a KV executive knew about these problems and decided that since there was low probability that more oversize tablets would be found, the company should do nothing, even though other employees objected to this approach. This executive told employees to avoid discussing the problem in writing as much as possible, and to limit the number of people who would find out about it. In other words, the executive orchestrated a cover-up. KV employees said that they were encouraged regularly to falsify records so that the FDA would think that KV was in compliance with FDA standards on chemical tests and cleanliness of the equipment used to produce the drugs.

In the end, the company's emphasis on production over safety has already severely affected its bottom line -- industry watchers say KV could be bankrupt within the year. It is no surprise to me, as a drug defect attorney, KV is facing so many lawsuits over defects in its drugs. Over 200 more pending claims have not yet made it to court, and 26 of those involve a patient's death. CVS Pharmacies is also suing KV for $100 million for allegedly breaking a supply contract.

Continue reading " Drug Manufacturer Admits It Ignored Duty to Warn FDA of Its Defective Products " »

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