Yaz birth control pill is linked with risk of blood clots, heart attack, stroke and gallbladder disease
The Yaz birth control pill has been linked with serious adverse heart problems. The FDA sent a letter to the manufacturer of Yaz that reiterates the risk of blood clots, heart attack, stroke and gallbladder disease in Yaz users. The FDA also states that Yaz has additional risks because it contains the progestin, drospirenone that can lead to hyperkalemia in high risk patients, which may result in potentially serious heart and health problems. Women taking Yaz must be on heightened alert about drug interactions that can increase potassium, in addition to drug interactions common to all combination oral contraceptives. These adverse reactions can included fatal arrhythmias which results from abnormal potassium levels. Yaz and other oral contraceptives have an increased risk of heart attack, and there is a link between oral contraceptives and blood clots and stroke. In January 2009, the FDA reprimanded the manufacturer of Yaz for marketing it to treat headaches and acne, which are uses that are not approved by the FDA. If you or a family member took Yaz and suffered a blood clot, stroke or heart attack, we urge you to contact our office to obtain additional information about recovering financial compensation for your injuries.
Influend Cough and Cold Products Linked to Heart Problems
ION Labs and FDA notified consumers and healthcare professionals of the recall of all Influend Cough and Cold products sold on or after May 30, 2008 due to the possibility that the products may be superpotent with possible complications ranging from tachycardia, palpitations, arrhythmias, and cardiovascular collapse with hypotension to headaches, dizziness, anxiety, restlessness and nervousness. The FDA stated that customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product. If you or a family member took Influend Cough and Cold products and suffered tachycardia, arrhythmias, or cardiovascular collapse, we urge you to contact our office to obtain additional information about recovering financial compensation for your injuries.
N&E headline:Digoxin Linked to Heart Problems
Caraco Pharmaceutical Laboratories and FDA notified healthcare professionals of a consumer-level recall of Caraco brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of September, 2011. The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin, a drug product used to treat heart failure and abnormal heart rhythms. The drug has a narrow therapeutic index and the existence of higher than labeled dose may pose a risk of digoxin toxicity in patients with renal failure. Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and bradycardia. Death can also result from excessive digoxin intake. A lower than labeled dose may pose a risk of lack of efficacy potentially resulting in cardiac instability. If you or a family member took Digoxin and suffered a cardiac related injury, we urge you to contact our office to obtain additional information about recovering financial compensation for your injuries.
Rythmol Linked to Heart Problems
FDA and Watson Pharmaceuticals notified healthcare professionals and patients of a recall of Propafenone HCL 225 mg tablets, also known as Rythmol, a drug product used to treat cardiac arrhythmias. The drug is being recalled because some tablets may contain slightly higher levels of the active ingredient than specified. Because it has a narrow therapeutic index, some patients who are particularly sensitive to small variations in dose may experience potentially serious side effects, including arrhythmias (irregular heartbeat) or low blood pressure. The affected lot [lot number 112680A, expiration date July 31, 2010] of Propafenone HCL tablets was shipped to customers between October 15, 2008 and November 26, 2008. The Press Release includes instructions for identifying and returning the affected product. If you or a family member took Rythmol and suffered a serious side effect, we urge you to contact our office to obtain additional information about recovering financial compensation for your injuries.
Zencore Linked to Heart Problems
Bodee LLC and FDA notified consumers and healthcare professionals of a nationwide recall of all the company's supplement product sold under the name Zencore Plus. FDA lab analysis of Zencore Plus samples found the product contains benzamidenafil, an undeclared drug product and a PDE5 inhibitor. The use of Zencore Plus by an unsuspecting user of organic nitrates may pose a life-threatening risk of sudden and profound drop of blood pressure due to potential interaction between benzamidenafil and organic nitrates. Zencore Plus is sold in health food stores and by mail order on internet nationwide. The FDA advised that consumers who have this product in their possession should stop using it immediately. If you or a family member took Zencore and suffered a serious side effect, we urge you to contact our office to obtain additional information about recovering financial compensation for your injuries.
Reglan Linked to Development of Tardive Dyskinesia
FDA notified healthcare professionals that manufacturers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a boxed warning to their drug labels about the risk of its long-term or high-dose use. Chronic use of metoclopramide has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken. These symptoms are rarely reversible and there is no known treatment. Metoclopramide is available in a variety of formulations including tablets, syrups and injections. Names of metoclopramide-containing products include Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution, and Reglan Injection. Manufacturers will be required to implement a risk evaluation and mitigation strategy [REMS] to ensure patients are provided with a medication guide that discusses this risk. If you or a family member took Reglan and suffer from tardive dyskinesia, we urge you to contact our office to obtain additional information about recovering financial compensation for your injuries.
Zonegran Linked to Development of Metabolic Acidosis
The FDA notified healthcare professionals that updated clinical data has determined that treatment with zonisamide, indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy, can cause metabolic acidosis in some patients. Patients with predisposing conditions or therapies may be at greater risk for developing metabolic acidosis and the risk of zonisamide-induced metabolic acidosis appears to be more frequent and severe in younger patients. FDA recommends that healthcare professionals measure serum bicarbonate before starting treatment and periodically during treatment with zonisamide, even in the absence of symptoms and is working with the makers of zonisamide to revise the product labeling to reflect this new safety information. The notification includes recommendations for healthcare providers, information for patients, and a data summary. If you or a family member took Zonegran and developed metabolic acidosis, we urge you to contact our office to obtain additional information about recovering financial compensation for your injuries.
Raptiva Linked to Progressive Multifocal Leukoencephalopathy
Genentech and FDA notified healthcare professionals of the voluntary, phased withdrawal of Raptiva, a medication for treatment of psoriasis, from the U.S. market due to a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML). By June 8, 2009, Raptiva will no longer be available in the United States. Prescribers are being asked not to initiate Raptiva treatment for any new patients. Prescribers should immediately begin discussing with patients currently using Raptiva how to transition to alternative therapies. The FDA strongly recommends that patients work with their health care professional to transition to alternative therapies for psoriasis.
[Posted 02/19/2009] FDA issued a Public Health Advisory to notify healthcare professionals of three confirmed, and one possible report of progressive multifocal leukoencephalopathy (PML), a rare brain infection, in patients using the psoriasis drug Raptiva. In October 2008, the labeling for Raptiva was changed to highlight, in a Boxed Warning, the risks of life-threatening infections, including PML. In addition, FDA directed Genentech, the manufacturer of Raptiva, to develop a Risk Evaluation and Mitigation Strategy, or REMS, to ensure that patients receive risk information about Raptiva. The FDA is reviewing this latest information. The agency will take appropriate steps to ensure that the risks of Raptiva do not outweigh its benefits that patients prescribed Raptiva are clearly informed of the signs and symptoms of PML, and that health care professionals carefully monitor patients for the possible development of PML. The Public Health Advisory provides recommendations for healthcare providers and patients when treatment with this product is considered. If you or a family member took Raptiva and developed PML, we urge you to contact our office to obtain additional information about recovering financial compensation for your injuries.
Fleet is linked to a risk of kidney injury called acute phosophate nephropathy
Following the issuance of FDA's safety alert on Thursday stating that oral sodium phosphates bowel cleansing solutions should be available by prescription only, C.B. Fleet Company immediately announced a voluntary recall of its over-the-counter products Fleet® Phospho-soda® and Fleet® Phospho-soda® EZ-Prep® Bowel Cleansing System.
According to the FDA, such cleansers may cause kidney damage.
The voluntary recall is directed to retailers and wholesalers.
The recall decision was made to address FDA's determination that oral sodium phosphatesolutions used for bowel preparation prior to medical procedures (such as a colonoscopy) should only be available by prescription, and that consumers should not use over-the-counter products for bowel cleansing.
Fosamax® Information
Fosamax® belongs to a class of drugs known as bisphosphonates, which are prescribed for the treatment of osteoporosis and for the management of advanced cancers. It is one of the most commonly used medications in the United States. Fosamax® is linked to the development of osteonecrosis of the jaw, or ONJ, a rare and serious condition that causes breakdown and death of the jawbone. ONJ typically develops after minor dental work. Because Fosamax® stays in the body for months or years, patients who are no longer using Fosamax® are also at an increased risk for ONJ.
Individuals suffering from ONJ can experience severe infections with painful symptoms such as facial discomfort or numbness, gum swelling, drainage, and poor gum healing. Patients with ONJ also experience tooth loss and other disfiguring side effects. Treatment can include long-term antibiotic use, surgical reduction of damaged bone, or similar alternatives. However, ONJ is extremely resistant to most treatments and careful planning is required because as invasive surgical techniques can worsen the condition.
Fosamax® was recently shown to have a higher incidence of ONJ than other bisphosphonates in a study conducted by the United States Food and Drug Administration. Evidence suggests that its manufacturer, Merck, failed to update the Fosamax® label to reflect the danger in a timely manner, exposing millions of users to potential injury unnecessarily. Attorneys at The Levensten Law Firm, P.C. have the experience, knowledge, and resources to successfully represent ONJ victims against Merck. Our firm offers a free case evaluation and our team will help you understand your legal rights. Please contact us today for more information or to speak with an attorney about your Fosamax® injury.
Ketek® Information
Ketek® belongs to the category of drugs called “antibiotics.” Ketek® tablets contain telithromycin, a semi synthetic antibacterial in the ketolide class for oral ingestion. The drug was approved in April 2004 to treat various bacterial infections of the lungs and sinuses including sinusitis, bronchitis, and pneumonia.
Ketek® has recently been linked to severe liver problems, including liver failure, and several deaths by the Food and Drug Association and the Canadian Department of Health. On February 12, 2007, the Food and Drug Administration restricted the use of Ketek® to patients with serious cases of pneumonia because of the drug’s dangerous side-effects.
The Food and Drug Administration reported the antibiotic will remain on the market but that its new label will bear a new black-box warning. If you would like additional information concerning Ketek®, its side-effects, or pursuing a claim, please contact our office.
Kugel® Hernia Patch
The Bard® Composix® Kugel® Mesh Patch is used to repair ventral hernias caused by thinning or stretching of scar tissue that forms after surgery. The patch is placed behind the hernia defect through a small incision. It is then held open by a “memory recoil ring” that allows the patch to be folded for insertion and later spring open and lay flat once it is in place.
The "memory recoil ring" that opens the Bard® Composix® Kugel® Mesh Patch can break under the stress of placement of the large sized products in the intra-abdominal space. This can lead to bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).
On January 10, 2007, Davol, Inc., a subsidiary of C.R. Bard, sent letters to health care professionals and distributors notifying them of the most recent expansion of this recall of specific lots of Bard® Composix® Kugel® Large Oval and Large Circle Mesh Patches for product codes 0010202 and 0010204. Surgeons and hospitals should stop using the recalled product and return unused units to the company.
Patients who have been implanted with one of the recalled devices should feel free to contact The Levensten Law Firm concerning your legal rights.
Ortho Evra® Information
Ortho Evra® birth control patch that was prescribed to more than five million women. Through aggressive marketing to consumers and doctors as a safe and convenient alternative to oral birth control pills, Ortho Evra® became the most popular prescribed form of birth control in the United States. Manufactured by Ortho-McNeil Pharmaceutical, Inc., a division of Johnson & Johnson, the patch is associated with a significantly higher rate of serious health risks than other forms of birth control.
Approximately 4 million women used the Ortho Evra® birth control patch since it went on sale in 2002. Now there are reports that the Ortho Evra® patch has caused life-threatening blood clots, fatal heart attacks, strokes, pulmonary embolisms, and other serious medical problems in Ortho Evra® birth control patch users. On July 17th, 2005, the Associated Press International (API) reported that they knew of at least a dozen women, most in their late teens and twenties who died last year due to blood clots that are believed to be related to the use of the Ortho Evra® patch. Dozens more survived strokes and other blood clot related side effects according to the 16,000 federal drug reports filed with the Food and Drug Administration, which also found 23 different fatalities associated with the patch. However the primary cause of death in each case was not always clear. If you or a loved-one has been harmed by the Ortho Evra® birth control patch, please contact our office for more information.
Seroquel® Information
AstraZeneca Plc., a London-based pharaceutical manufacturer is being sued in the United States for injuries resulting from Seroquel®, also known as "quetiapine tablets." Seroquel® is an atypical antipsychiotic drug approved by the Food and Drug Administration to treat Schizophrenia and Bi-polar I disorder.
Patients allege that AstraZeneca did not properly warn them about possible side-effects, including dramatic weight gain and diabetes. In addition, the aggressive marketing Seroquel®, which has made the drug AstraZeneca's second largest seller, over-promoted the drug's uses and benefits while concealing the drug's dangerous risks. Plaintiffs allege that AstraZeneca knew about these side-effects, but failed to include adequate label warnings until the F.D.A required them to do so.
Approximately 10,000 lawsuits are currently filed against AstraZeneca across the nation. If would like more information about Seroquel®, its side-effects, or a free consultation to discuss your use of the drug, please contact our office.
Stent Implants
Stents are used to hold open an artery that has become too narrow due to atherosclerosis. In atherosclerosis, plaque builds up on the inner walls of arteries. As the artery walls thicken, the pathway for blood narrows. This can slow or block blood flow.
The stent is first collapsed to a small diameter and put over a balloon catheter. It is then moved into the area of the blockage and the balloon is inflated. As the stent expands, it locks in place inside the artery keeping it open. It becomes a permanent fixture inside the artery, allowing blood to flow. Within a few weeks of the time the stent was placed, the inside lining of the artery grows over the metal surface of the stent.
The stent placement procedure can cause infection, blood clots, or bleeding. Other rare complications of coronary stents include chest pain, heart attack, or tearing of the blood vessel. The stent also can move out of place, called stent migration. In some cases, plaque can reappear in the stented artery, this is called in-stent restenosis.
Zelnorm Information
Zelnorm, or "tegaserod maleate", is used by women for the short-term treatment of irritable bowel syndrome (IBS). IBS is a disorder that interferes with the normal functions of the large intestine. Symptoms may include cramps, abdominal pain, bloating, constipation, and/or diarrhea.
On March 30, 2007, Novartis announced that it is complying with the FDA's request to suspend marketing of Zelnorm. A recent analysis of Zelnorm's clinical trial data identified a significant number of cardiovascular ischemic events from heart attacks, strokes, and unstable angina. They occurred primarily in patients who had pre-existing cardiovascular disease and/or cardiovascular risk factors.
· YAZ
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· Fleet
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· Influend
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· Fosamax
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· Digoxin
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· Ketek
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· Rythmol
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· Kugel Hernia Patch
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· Zencore
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· Ortho-Evra
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· Reglan
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· Seroquel
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· Zonegran
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· Stent Implants
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· Raptive
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· Zelnorm
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