Drug Injury Attorney Blog

A panel of experts convened by the U.S. Food and Drug Administration has voted to lower the maximum dosage of pain reliever acetaminophen, HealthDay reported June 30. The vote made big news because acetaminophen is an extremely common ingredient in over-the-counter cold and flu medicines taken by millions of Americans each year, including Tylenol and Excedrin. The panel acted out of concerns about liver damage, a known side effect of acetaminophen overdose. The FDA is not required to follow its panel’s recommendations, but it typically does.

Doctors have known for years that an acetaminophen overdose can cause liver damage. In fact, the FDA says acetaminophen is the leading cause of liver failure in the U.S., contributing to 200 deaths a year and sending 56,000 to emergency rooms. Acetaminophen is safe for most people at recommended doses, but an FDA report issued in May says many consumers don’t realize they’re endangered when they go over the recommended dosage, or combine multiple medications containing acetaminophen. That concern drove the vote to lower the recommended dosage, which is currently 4 grams daily and 1,000 milligrams in any individual pill. The panel did not set a daily maximum, but reduced the per-pill maximum to 650 milligrams for over-the-counter medicines.

This video from the Associated Press explains the issue:
Video from the Associated Press:

Of course, the pharmaceutical industry resisted the panel’s efforts to further regulate acetaminophen, arguing that the high doses currently allowed are necessary for patients treating chronic pain. According to the AP, acetaminophen-containing drugs saw $2.6 billion in sales last year, with over-the-counter medicines representing 80% of those sales. However, as a dangerous drug lawyer, I’m pleased that the panel took steps to keep American consumers safe. Many millions of Americans keep these medications in their homes as medicine-cabinet staples, and some use acetaminophen every single day. That means millions of people are exposed to injuries from acetaminophen overdose. Even if only a fraction of these end up accidentally overdosing, they could still represent thousands of unnecessary and preventable deaths.

When most people think of dangerous drugs, they think of medications that are defective by design or manufacture, like Vioxx -- that is, the medicine is dangerous no matter how it’s used. But manufacturers of drugs (and other consumer products) can also be legally liable if they fail to give consumers sufficient warning of a serious safety problem with their products. Consumers need clear information to make informed decisions about what medications are safe for them. If manufacturers fail to warn patients about the dangers of their products in a way that meets FDA standards, and patients are hurt as a result, those patients have the right to hold the manufacturer legally responsible with a defective drug lawsuit.

Continue reading "FDA Calls for Reduced Maximum Dosage of Common Pain Reliever Acetaminophen" »

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On Thursday, by order of the U.S. Food and Drug Administration, U.S. Marshals raided generic drug company Caraco's factories and seized more than 30 of the 40-odd medications it markets. The seizure was ordered after the FDA found manufacturing problems at all three of the company’s plants in Detroit, Michigan.

Caraco is no stranger to FDA-related controversy. Indeed, it has had several high-profile recalls of its medications just in the past year, all of which exposed it to multiple dangerous drug lawsuits. These recalls included the popular diabetes drug metformin (generic for Glucophage), and the heart drug digoxin, the latter of which allows Caraco to hold a fifth of the U.S. market. Both products were recalled due to concerns about accidental variations in the pills' sizes.

Despite the FDA's drastic measures, the director of its drug division's office of compliance has said that patients taking generic drugs made by Caraco should continue to take them, because all of the defective drugs had been recalled or seized. This seems an interesting instruction, considering how great the damage could be if she is wrong. Digoxin, a derivative of the poisonous plant foxglove, is known to be toxic and has a narrow margin between beneficial and lethal amounts. Improperly sized digoxin tablets can cause heart instability and even death, particularly in patients with kidney failure. Last year, a different generic drug company, Actavis Group, recalled its generic digoxin medication due to concerns that some of the tablets had been manufactured twice as thick as the company intended. According to the FDA, "several reports of illness and injuries" were linked to Activis pills last year.

Caraco's products also include a generic form of epilepsy drug Tegretol, a pain reliever called tramadol/APAP, and many others. A full list of the company's defective products can be found on the FDA's website. Generic defective drugs can be even more dangerous than their brand-name counterparts, as the manufacturer's name does not call attention to itself. However, it should always be listed, so please check the labels of all your generic medications. If you or someone you love has experienced serious ill effects or untimely death after taking a Caraco-manufactured product, please contact a St. Louis pharmaceutical liability lawyer to learn more about your rights and your potential legal claim. Innocent consumers who fall victim to mistakes by Caraco or any other drug company should be heard -- and, if appropriate, compensated for their physical, emotional and financial losses.

Based in St. Louis, Missouri, The Lowe Law Firm's pharmaceutical injury lawyers represent clients in Missouri, southern Illinois and across the country who have been hurt by defective prescription and over-the-counter medications. If you or someone you care about has been harmed by a dangerous drug, and you would like to learn more about your rights and options, please contact the Lowe Law Firm online, or call us toll-free at 1-877-678-3400 for a free, confidential consultation.

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On Tuesday, the FDA shocked thousands of consumers with an advisement to stop using Zicam cold remedies. The announcement cited links between three Zicam products -- Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs and Zicam Cold Remedy Swabs, Kids' Size -- with the loss of sense of smell. The culprit ingredient in these so-called "natural" Zicam Products is zinc, a mineral that scientists say has been known since 1938 to damage nerves in the nose needed for smell. According to the Washington Post, zinc also has apparently been used to destroy sense of smell in laboratory animals.

Also called anosmia, the loss of sense of smell can be permanent. This amounts to the loss of one of your five basic senses. Without sense of smell, not only are you unable to experience full quality of life by smelling pleasant scents, but your ability to detect dangerous fumes or smoke is also greatly impaired -- in other words, a properly functioning nose could save your life. Your sense of taste is also greatly diminished when you can't smell, making you much more likely to ingest spoiled food, or food tainted with harmful substances.

The advisement came after more than 130 reports had been submitted to the FDA about a loss of sense of smell in patients who used one of the three Zicam products. Some reports came after several doses of Zicam, but many of these people said their anosmia occurred suddenly, after just one dose. In response to this alarming body of evidence, the FDA sent Matrixx Initiatives, manufacturer of Zicam products, a letter of warning stating that the products could no longer be marketed without FDA approval.

The FDA has stated that Zicam Cold Remedy was never formally approved because it is part of a group of remedies called homeopathic products, formulations that typically use small doses of "natural" active ingredients including herbs, minerals and flowers. This may be the FDA's policy, but as a southern Illinois product liability lawyer I would like to point out that this is no excuse for laxity in product testing. "Natural" is a far cry from "harmless."

The letter also stated that the products were not properly labeled to reflect the risk of anosmia that has been associated with them. You might think this was all news to Matrixx, or that they thought that 130 cases somehow weren't enough to merit labeling their product with a safety advisement. The fact is that they have already settled more than 400 lawsuits about this very thing, including a giant $12 million lawsuit in 2006. The company also has received more than 800 anosmia complaints, which the FDA recently asked them to surrender. The company did not comply.Speaking as a St. Louis pharmaceutical liability attorney and as a human being, a company neglecting to account for that many injuries in the name of profit is positively appalling.

The FDA says it is especially concerned about intranasal zinc use in children, since children might lose sense of smell but be less likely to communicate the condition to an adult. Fortunately, the Kids' Size Cold Remedy Swabs had already been discontinued prior to the FDA's announcement. Matrixx has said it will withdraw its dangerous products from stores, but extensive damage has already been done. With Zicam sales in the millions, the chances are good that someone close to you has used this product, or considered using it, at least once. Worse, reports are now surfacing that Zicam products are not the only "homeopathic" products out there that are causing serious side effects. These problems could affect millions of Americans -- all of whom would have a legal claim against the products’ manufacturers

Zicam products reeled in about 40 percent of Matrixx's $111.6 million in sales last year. While Matrixx decides what its next move will be, the FDA has advised people who have experienced any sense of smell loss or other problems after use of any of the three Zicam products to consult their health care professional. I would add that they should consult a Missouri dangerous drug attorney directly after. The loss of one of life's most basic and crucial senses is a possibility no one -- not even Matrixx -- can afford to ignore.

If you or someone you love has experienced a loss of sense of smell and has used Zicam products, or has experienced serious side effects after taking any product labeled as "homeopathic," please contact The Lowe Law Firm right away. In a dangerous drug injury lawsuit, you can claim payment for all the medical treatment related to the supplement’s defects, plus lost wages and compensation for your injuries.

Based in St. Louis, Missouri, our pharmaceutical liability lawyers represent clients across the nation who have been hurt by defective medications and over-the-counter remedies. If you would like to learn more about your rights and options, please contact the Lowe Law Firm online, or call toll-free at 1-877-678-3400 for a free, confidential consultation.

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The FDA made an official statement today, saying it has requested class of asthma drugs called leukotriene modifiers be labeled with a "precaution" warning of potential psychiatric side effects, including suicidal thoughts and behavior. This family of drugs includes zileuton, marketed by Cornerstone as Zyflo and Zyflo CR; zarfirlukast, marketed by AstraZeneca as Accolate; and montelukast, marketed as Singulair, Merck & Co.'s number-one-selling drug.

In March of last year, the FDA began an ongoing safety review of a possible association between suicidal tendencies and leukotriene modifiers. In early January, the FDA said clinical trial data suggested that the products were not associated with an increased risk of mood changes or suicidal behavior. But in April, as the agency completed a review including not only clinical trial data but also post-marketing reports, it began to change its tune. The post-marketing reports included cases of neuropsychiatric events including agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior including suicide, and tremors.

Singulair has been associated with psychiatric side effects for some time; Merck began labeling Singulair to reflect those possible side effects in March 2007. In response to today's FDA request, Merck stated that precautionary language is already included in Singulair's labeling, and that the language will simply be moved from a section labeled as "side effects" to a higher section labeled as "precautions." Merck also says it will provide health care providers with informative leaflets and communicate these latest findings to prescribing professionals face-to-face. Speaking as a St. Louis defective drug lawyer, I believe Merck not only should be held to these claims, but also should be held accountable for keeping consumers informed. AstraZeneca and Cornerstone have also said they will add precautionary language to their drugs' labeling; they too should be held to their claims.

According to Reuters, analysts from Morningstar and BMO Capital Markets say the distinction between side effect advisements and precaution labeling will have little effect on sales. As a Southern Illinois harmful drug attorney, I say this is all the more reason for consumers to remain vigilant. That same article says Singulair's U.S. sales are estimated at $4.4 billion for 2009; if the FDA is reporting an association between suicidal thoughts and these drugs in documented cases, imagine how many undocumented cases exist in the U.S. today.

If you or a loved one have had suicidal thoughts or other psychiatric side effects while taking Singulair, Accolate, Zyflo, Zyflo CR, or any of their generic equivalents, you have rights, and the Lowe Law Offices can help you protect them. With offices in St. Louis, Missouri and Belleville, Illinois, our pharmaceutical liability lawyers represent people who have suffered serious illnesses or injuries because they took a dangerous medication. In a defective drug lawsuit, you can win back the cost of the drug and all of the treatment it necessitated, as well as compensation for serious injury, permanent disability or the loss of a loved one. If this sounds like your situation, we can help you learn what your options are at a free, confidential consultation. To set one up, please contact the Lowe Law Firm online or call us toll-free at 1-877-678-3400.

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On June 4, the U.S. Food and Drug Administration issued a warning to healthcare professionals associating the risk of liver damage and failure with the use of the anti-thyroid drug propylthiouracil. The drug is prescribed for the treatment of Graves' disease, an autoimmune disorder that leads to overactivity of the thyroid gland. The FDA's notification linked the use of propylthiouracil to serious liver injury, including liver failure and death, in both adult and pediatric patients.

"After analyzing adverse event reports, the FDA has identified an increased risk of liver injury with propylthiouracil when compared to an alternative treatment for Graves' disease, methimazole," said Amy Egan, M.D., deputy director for safety, Division of Metabolism and Endocrinology Products, in the FDA’s Center for Drug Evaluation and Research, in the report. "Health care professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves' disease. If propylthiouracil therapy is chosen, the patient should be closely monitored for symptoms and signs of liver injury, especially during the first six months after initiating therapy."

The FDA discussed these findings on April 19, 2009 with the American Thyroid Association (ATA) at a public workshop on propylthiouracil-related liver toxicity in Washington, D.C. According to the FDA, a total of 32 cases of serious liver injury associated with the use of propylthiouracil were reported to the FDA's Adverse Event Reporting System, from when the system was established in 1969 through October 2008. Of the 22 adult cases, the FDA identified 12 deaths and five liver transplants. Of the 10 pediatric cases, there was one death and six reports of liver transplant. In contrast, only five cases of serious liver injury were identified for methimazole, which was approved for marketing in 1950. All five cases were in adult patients, and three resulted in death.

The report did not definitively conclude that there was a causal relationship between propylthiouracil and liver toxicity, nor did it advise healthcare professionals to stop prescribing the product. However, the FDA did advise caution in prescribing the drug, and that each case should be examined individually. For example, because a rare birth defect has been reported with methimazole and not with propylthiouracil, propylthiouracil may be more appropriate for patients with Graves' disease who are in the first trimester of pregnancy, the report said.

I am pleased that the FDA has brought this issue to the attention of the ATA and issued an official public warning on its website. However, as a Missouri dangerous drug attorney, I must stress that these are only the first steps of many that should be taken to protect patients from the potential negative effects of this drug. Drug companies bear a great responsibility to take the initiative in keeping consumers current on the risks of the products they sell. This means proper labeling, warnings and marketing that properly reflects the risk entailed in using their product. If they fail to do those things, they can be held legally responsible for any injuries that result, through a pharmaceutical injury lawsuit.

The FDA said it is continuing to monitor these serious reported adverse events, and is working to make changes to the propylthiouracil prescribing information, particularly for use in pediatric patients. It also said that it intends to update its information on this issue when additional information or analyses become available. In the meantime, FDA says, adverse reactions or quality problems experienced with use of the propylthiouracil may be reported to the FDA's MedWatch Adverse Event Reporting program. Their contact information is available online.

Speaking as a Missouri dangerous drug lawyer, I feel it is especially important to address injuries caused by drugs, including those in generic circulation, as soon as possible. Since this particular medication has been marketed for quite some time -- since 1947, according to the FDA -- millions of Americans could have suffered these adverse effects already. It is important for those people to know what their rights are. That's why, even if there already is an existing class action suit against a particular drug that may have harmed you, you should contact The Lowe Law Firm immediately for a free, confidential consultation. The personalized attention you receive will help you to determine your specific rights and any potential case you may have.

Based in St. Louis, The Lowe Law Firm is a national law firm that specializes in representing people who have been injured by, or lost a loved one to, dangerous prescription drugs. Our Missouri defective drug attorneys represent people in the Midwest and across the United States. To set up an appointment with an experienced defective prescription drug attorney, please contact us today through our website, or call us toll-free at 1-877-678-3400.

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In a meta-analysis of 17 studies, researchers have found that the cancer drug Avastin substantially increases the risk of developing holes in the stomach and intestines, U.S. News & World Report said May 25. Researchers looked at 17 studies of Avastin, none of which have proven a significant association between the drug and perforations in the gastrointestinal tract. However, in their analysis, the researchers at Stony Brook University Cancer Center in New York found that patients were twice as likely to develop perforations when they took Avastin, and that the rate of perforations went up as the dosage did.

Avastin (bevacizumab) is approved in the United States to treat several types of cancer. In fact, the FDA in early May approved the drug for treatment of brain cancer. It attacks cancerous tumors by preventing new blood vessels, which keep cancer tissue alive, from forming. In the Stony Brook study, researchers looked at 17 studies involving nearly 13,000 patients who received Avastin along with chemotherapy. Those who received 2.5 milligrams of Avastin were 61% more likely to develop perforations than those not taking Avastin. At twice that dose, 5 milligrams, patients were 167% more likely to develop a perforation. The risk was highest in patients with coleorectal and renal cancer and lowest in those with pancreatic cancer.

Perforations in the stomach and bowels are a serious and potentially life-threatening medical emergency. When these holes develop, they allow stomach acids, food and feces to leak from the organs where they belong into the abdomen. This leads to a bacterial infection of the abdomen called peritonitis. Patients feel abdominal pain that gets worse when they move, nausea, vomiting and sometimes fever. Doctors generally must perform surgery to close the hole and wash away the matter that leaked.

As a Missouri prescription drug injury attorney, I am disappointed to learn that there’s accuracy to reports of Avastin’s dangers. This is the first strong evidence connecting Avastin to stomach and bowel perforations, but other studies have turned up evidence for the association. In fact, the drug was approved for use in breast cancer patients over the objections of the FDA’s own panel of experts. Avastin didn’t seem to prolong lives, they argued, so those and other side effects may not be worthwhile. Nonetheless, it was approved and now carries a black box warning, the strongest available, about its potential to cause gastrointestinal problems.

If you are taking Avastin and you believe it’s responsible for holes in your digestive tract that led to a medical emergency, you should call The Lowe Law Offices as soon as possible. People should never be injured or killed by prescription drugs that are supposed to help. If the drug’s manufacturer failed to warn patients and the public about this risk, patients who were harmed have the right to sue the drug manufacturer for all of their physical, financial and emotional injuries. That includes the cost of more medical care and all other costs related to the injury, as well as the physical pain, emotional trauma and any death or disability caused by the defective drug.

Based in St. Louis, the Lowe Law Offices is a national law firm specializing in representing people who were hurt by dangerous prescription drugs or lost a loved one. Our Illinois defective drug lawyers represent people in the Midwest and around the United States. And we offer free, confidential consultations, so you risk nothing to learn more about your rights and any potential case. To set up an appointment with an experienced dangerous prescription drug attorney, please contact us online or call toll-free at 1-877-678-3400 today.

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Consumer advocacy group Public Citizen has asked federal regulators to require a black box warning on the label of a drug it says may induce miscarriage or premature labor, the Associated Press reported May 6. Amitiza (lubiprostone) is prescribed to people who suffer from chronic constipation, but it is chemically similar to misoprostol, which can induce labor and miscarriage in pregnant women. Amitiza’s label currently warns that the drug has not been tested in pregnant women and that they should use it only if the benefits outweigh the risk to the fetus, but Public Citizen wants a stronger label. Neither the FDA nor the drug’s maker, Sucampo Pharmaceuticals, commented for the story.

Amitzia, which is considered less addictive and easier to tolerate than older laxatives, was prescribed more than a million times in 2008. Its chemical cousin, misoprostol, is approved for treatment of gastric ulcers in the United States. However, misoprostol also causes uterine contractions and thins the cervix, which is why it is widely used off-label, and approved in other countries, to induce labor and end pregnancies. In fact, it may be prescribed with the abortion drug RU-486. It is also used when a natural miscarriage or other obstetric problem leaves tissues in the uterus.

It is unclear whether Amitzia has similar effects. No studies have been done examining the drug’s effect on human pregnancies, but studies with Guinea pigs have shown a 4% miscarriage rate. For that reason, it is still available to pregnant women, although its label suggests that they weigh the risks of using Amitzia against its benefits. A spokesman for Public Citizen called that label “grossly inadequate” and lacking in useful information.

As a defective prescription drug attorney, I agree. While I am sure most patients will do what’s best for their unborn children, they must be armed with good information to do so. As things currently stand, they must rely on a doctor or their own self-directed research to find that information. History has shown over and over again that pharmaceutical companies cannot be trusted to disclose information that might hurt their drugs’ sales. Pregnant women taking Amitzia could run extremely serious risks -- inducing a miscarriage or giving birth prematurely, which can cause death and serious birth defects in the baby and is also extremely expensive. Until quality studies in humans establish that Amitzia is safe, women should at least be clearly warned of the risks.

The dangerous pharmaceutical lawyers at The Lowe Law Firm represent victims of just this kind of oversight -- people who were hurt by a drug that was supposed to help. Based in St. Louis, we handle defective medication lawsuits for victims in Missouri, the Midwest and around the United States. If you’ve been seriously harmed or lost a loved one to a defective prescription drug, we would like to help. To learn more, please contact us online today or call toll-free at 1-877-678-3400.

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Federal regulators and pharmaceutical company Baxter International are investigating the cause of two deaths linked to blood-thinning drug heparin, the Wall Street Journal reported May 11. Two patients at a hospital in Lewes, Delaware died after using the heparin, and a third suffered unspecified medical problems; a spokeswoman for Baxter said their symptoms include intracranial bleeding. A hospital administrator told the newspaper that the problem had not yet been identified, but the use of heparin was the only thing they found tying the three cases together.

This is the second serious safety problem in two years for heparin and Baxter. Heparin is a blood thinner, used to treat dangerous blood clots, certain heart problems and people on life support. Contaminated heparin imported from China killed 81 people and sickened 785 more in 2008, sending them into shock and dangerously lowering blood pressure. The culprit was oversulfated chondroitin sulfate -- a supplement that is cheaper than heparin but mimics its effects, suggesting that it was used intentionally to cut costs. In response, Baxter and other manufacturers were forced to recall their versions of the drug. However, the article noted, the drug in the current outbreak comes from a North American source and patients’ symptoms are different.

As a dangerous prescription drug attorney, I hope regulators can find the problem and recall any tainted medication before more patients fall ill. The symptom mentioned in the article, intracranial bleeding, is the medical term for a hemorrhage inside the skull, including in the brain. This is considered a medical emergency because it can create pressure inside the skull that leads to brain damage -- and thanks to the heparin, the bleeding won’t be stopped by the body’s natural blood clotting ability. Patients with the serious medical problems treated with heparin are already weak, and they tend to be older -- those who died in Delaware were 64 and 71. A drug that causes severe pressure on the brains of these patients could kill them or leave them with permanent brain damage.

Based in St. Louis, The Lowe Law Firm represents clients throughout the Midwest and the United States who have been seriously harmed by a defective pharmaceutical product. Our defective medication lawyers help people who fell ill or lost a loved one to a dangerous drug hold pharmaceutical companies legally responsible for their actions. In a drug injury lawsuit, you can claim compensation for a death, serious illness or permanent disability, as well as compensation for all of the medical costs caused by the drug’s flaws. To learn more about how you can take action at a free, confidential consultation, please contact The Lowe Law Firm online today or call us toll-free at 1-877-678-3400 from anywhere in the United States.

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The U.S. Food and Drug Administration has warned consumers that they should immediately stop using an over-the-counter diet aid called Hydroxycut, the Associated Press reported May 1. The dietary supplement is associated with serious liver problems, the article said, including the death of a teenaged boy. Its maker, Iovate Health Sciences, has agreed to recall all 14 Hydroxycut products. Consumers who have any of those products should return them to the store where they were purchased, an FDA press release said, and report any negative effects of using the supplement to their doctors and the FDA. More information from Iovate can be found at HydroxycutInformation.com.

Hydroxycut is one of the most popular weight-loss supplements on the market, selling 9 million packages last year according to the Associated Press. The FDA recalled it after receiving 23 reports of serious liver problems in otherwise healthy people, including the death of a 19-year-old young man from liver failure. (Iovate disputes that Hydroxycut was responsible for the death.) Patients using the recommended amount of the supplement have reported jaundice (a yellowing of the skin), seizures, heart problems and a form of muscle damage called rhabdomyolysis, which can lead to kidney failure. Symptoms of serious liver problems include jaundice, brown urine, excessive tiredness, nausea and vomiting, itching and loss of appetite.

It is unclear which ingredient in Hydroxycut is behind the liver problems, the Associated Press said. The FDA does not have the power to review or test supplements before they go on the market, and Iovate has changed the supplement’s formula several times. However, a safety researcher interviewed by the Associated Press said the problem may be a fruit enzyme called hydroxycitric acid, which has been linked to liver problems in a scientific study.

As a Missouri dangerous drug attorney, I fear that this may only be the beginning of larger problems with this supplement. Hydroxycut is one of the most popular weight-loss supplements on the market, selling tens of millions of units over seven years. With so many users, it’s possible that far more than 23 users have encountered problems, but not connected them to using the supplement. Unfortunately, this is especially likely because the FDA has little regulatory power over dietary supplements. Instead, it must rely on post-consumption reports of problems from users of the supplements, and many consumers -- or their doctors -- don’t think to report their problems right away. In fact, the death believed to be related to Hydroxycut took place in 2007, but was reported only in March.

If you are one of the thousands of Americans who has used Hydroxycut and you now believe it’s responsible for serious health problems, you have legal rights. In a dangerous drug injury lawsuit, you can claim payment for all the medical treatment related to the supplement’s defects, as well as lost wages and compensation for your injuries. The Lowe Law Firm can help. Based in St. Louis, Missouri, our pharmaceutical liability lawyers represent clients around the nation who have been hurt by defective medications and dietary supplements.

If you would like to learn more about your rights and your options at a free, confidential consultation, please contact the Lowe Law Firm online or call toll-free at 1-877-678-3400 today.

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In a decision that affects nearly every home in the United States, the U.S. Food and Drug Administration required stronger warnings Tuesday for labels on several common over-the-counter painkillers. According to Forbes magazine, the rules require pharmaceutical companies to display the chemical name of the product prominently on its label and warn of any potential interactions with other drugs or common consumables like alcohol. Products containing acetaminophen must also warn about the risk of severe liver damage, and products containing non-steroidal anti-inflammatory drugs must warn about the risk of stomach bleeding. Manufacturers have one year to change their labeling to comply.

The labeling change affects multiple common over-the-counter pain relievers, including Advil, Tylenol, Bayer, Aleve, Excedrin and Motrin. The generic names of the affected products include aspirin, acetaminophen, ibuprofen, naproxen and ketoprofen. All of those drugs but acetaminophen are in a category of drugs called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs are associated with an increased risk of bleeding in the stomach, particularly in people over 60, those who are taking blood thinners or steroids or people with ulcers or other stomach problems. Heavy use of NSAIDs also contributes. Labels will soon warn consumers about the potential for stomach problems and common risk factors.

Acetaminophen, which is in a category of drugs by itself, does not carry a risk of stomach bleeding. Rather, the new FDA rule will warn consumers of the increase risk of severe liver damage from taking acetaminophen, especially for exceeding the maximum recommended does. According to an FDA press release, research shows that some people take more acetaminophen than the label recommends, while others may take several acetaminophen-containing products at once without realizing the risk. Having three or more alcoholic drinks on the same day can also increase the risk of liver damage. In addition, taking acetaminophen with the blood thinner warfarin may increase the chances of serious bleeding problems. An FDA advisory committee plans to meet in late June to discuss

As an dangerous drug injury attorney, I am pleased at the FDA’s announcement. The problems with both kinds of medicines have been understood for decades, and in fact, acetaminophen overdose is the most common cause of acute liver failure in the United States. Unfortunately, many consumers don’t realize this, so they feel free to take another dose if the first does not work to relieve their pain. As the FDA press release notes, manufacturers have voluntarily added some amount of safety labeling to address the issues, but not as many as the agency now requires. With literally millions of Americans of all backgrounds and states of health taking these medications every day (at a cost of billions of dollars annually), we need clear safety information on their labels.

The pharmaceutical liability lawyers at The Lowe Law Firm represent people who have suffered serious illnesses or injuries because they took a dangerous over-the-counter or prescription medication. In a defective drug lawsuit you can win back the cost of the drug and all of the treatment it necessitated, as well as compensation for a serious injury, permanent disability or the loss of someone you love. If this sounds like your situation and you’re ready to take the next step, you can learn more about your rights and your options at a free, confidential consultation. To set one up, please contact our main St. Louis office or call toll-free at 1-877-678-3400.

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A court has ordered Neligen Pharmaceuticals and its parent company, Advent Pharmaceuticals, to immediately cease distributing more than 50 of its drugs. According to an April 10 Associated Press story, the U.S. Food and Drug Administration has a permanent injunction against the companies, barring them from manufacturing and distributing drugs that are adulterated, misbranded or not approved by the FDA. The drugs are mainly prescription cough and cold medicines -- but none have gone through the FDA approval process, so their safety, labeling and effectiveness are all in doubt.

According to the FDA press release, the companies (which also do business as Unigen Pharmaceuticals Inc.) agreed to a consent decree that requires them to destroy all of the drugs they currently have and stop manufacturing any new medications without FDA approval. They must hire outside experts to advise them on complying with regulatory standards, and may not resume operations until they have written permission from the FDA. After they do, the FDA may order them to stop their operations at any time if it finds a regulatory violation. The agency may fine the companies $1,000 per violation and up to $5,000 per day for any continuing legal violations.

As a defective prescription drug attorney, I am pleased to see the FDA cracking down on drug companies that abuse the public’s trust. Most of us assume that a drug wouldn’t even be on the market without FDA approval, so we trust that prescription medications are safe to use and adequately labeled. Companies that illegally bypass the FDA approval process betray that trust and expose consumers to potential serious injury from defective drugs or unannounced drug interactions. As a dangerous prescription medication lawyer, I have seen too many pharmaceutical companies’ cynical marketing tactics to believe that they would all be immune from the temptation to cut costs if they were not held accountable.

Based in St. Louis, The Lowe Law Firm represents people in Missouri, southern Illinois and throughout the United States. Our pharmaceutical liability lawyers sue on behalf of people who have lost a loved one or been seriously harmed because of a prescription or over-the-counter medication they thought they could trust. In these defective drug lawsuits, victims can win the money they need to pay for medical care or other bills related to the tainted medication; replace lost wages while they are out of work; and compensate them for a serious injury or illness, permanent disability or loss of a loved one. To learn more at a free, confidential consultation, please contact the Lowe Law Firm today.

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Last year’s Supreme Court ruling in Riegel v. Medtronic took away patients’ right to sue makers of defective medical devices that seriously harmed them or their loved ones. The court said in the 2008 ruling that patients may not file these legal claims because they are explicitly preempted by language in federal law. In response, Congress introduced the Medical Device Safety Act of 2009, which would correct that decision with language that explicitly says federal law does not preempt state-court lawsuits against makers of dangerous medical devices. On April 9, the New England Journal of Medicine published an editorial supporting the legislation, on the belief that it would make patients safer.

The editorial noted that thousands of medical device lawsuits have been thrown out of court since Riegel, regardless of how deserving the injured patients might be. In particular, it cited dismissal of more than 1,000 lawsuits filed by victims of the defective Medtronic Sprint Fidelis defibrillator, which is surgically implanted directly into the patient’s chest. The device has a defective wire that’s unreasonably likely to break, causing it to stop working or shock the patient internally at random times until it can be surgically removed. As the New York Times noted April 7, that surgery is very risky and should ideally be performed by a doctor who specializes in removing the wires. Medtronic itself notes that there have been 13 related deaths so far -- but thanks to Riegel, victims and their families have no legal recourse.

The editorial called for the Medical Device Safety Act’s passage for two major reasons, most importantly, patient safety. The decision shielded medical device makers from the potential consequences of not disclosing risks -- and as a defective medical device lawyer, I know all too well that some pharmaceutical companies are willing to hide risks in order to protect their profits. Restoring the right to sue would remove that risk and improve safety. It would also bring the law on dangerous medical devices in line with the law on defective drugs, the editorial said. The Supreme Court recently ruled in Wyeth v. Levine that federal law does not preempt state-court claims that a medication is defective, a decision the writers find inconsistent with Riegel. The proposed bill would level the playing field between drugs and devices, they wrote.

I strongly agree, and not just because this issue affects my practice as a defective drug and medical device attorney. Medical device safety, effectiveness and disclosure are literally life-or-death situations for many patients. The high-profile cases of drugs like Vioxx and Seroquel make it clear that not all manufacturers are putting safety ahead of profits, and mistakes or lax regulation by the FDA show that we can’t rely on that agency as our only safeguard. Allowing litigation in the cases that slip through the regulatory cracks would give medical device companies the accountability that American patients deserve. As the editorial said, “lawsuits by injured patients... have been an important part of the regulatory framework and very effective in keeping medical devices safe.”

Based in St. Louis, the Lowe Law Firm represents clients throughout the United States who have been seriously harmed or lost a loved one because of a defective prescription drug or medical device. If you or a loved one was hurt after taking a drug, and you believe the manufacturer failed to disclose important safety information about it, our Missouri defective pharmaceutical lawyers can help. To speak to us about your situation and your legal rights, please contact us online as soon as possible or call toll-free from anywhere in America at 1-877-678-3400.

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Posted In: Dangerous Medical Devices

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