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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