Posts filed under ‘Pharmaceuticals’
Diabetes drug linked to macular edema
A popular class of drugs used to treat Type 2 diabetes may increase the risk of vision problems, a new study suggests, underlining the importance of regular eye exams for anyone with diabetes.
The study is one of the largest to investigate vision loss associated with thiazolidinediones, a group of drugs that includes the well-known medications Actos and Avandia. While the drugs can help to protect against the many complications of diabetes, small trials and case reports had suggested they may increase the risk of macular edema, or swelling in the central part of the retina, which can result in blindness in one or both eyes.
The new study, published in The Archives of Internal Medicine, involved over 103,000 people with Type 2 diabetes who were followed for about a decade. Those who were using one of the medications were found to have a roughly two to three times higher risk of macular edema, though the likelihood of disease was relatively small. About 1.3 percent of people taking one of the drugs developed diabetic macular edema, compared to a rate of 0.2 percent among those who were not on one of the medications. Combining the drugs with insulin, a common practice, seemed to heighten the risk further.
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Study Affirms Actos Bladder Cancer Risk
Use of the anti-diabetic agent pioglitazone (Actos) is associated with an increased risk of bladder cancer, a nested case-control study confirmed.
Patients with type 2 diabetes who were ever treated with pioglitazone had an 83% higher risk for bladder cancer (adjusted rate ratio 1.83, 95% CI 1.10 to 3.05) than those who had never used the thiazolidinedione, according to Laurent Azoulay, PhD, of McGill University in Montreal, and colleagues.
This was a drug-specific effect, because patients taking rosiglitazone (Avandia) did not have an elevated risk (RR 1.14, 95% CI 0.78 to 1.68), the researchers reported online in BMJ.
The results of this analysis differed from those of a study being presented this week at the annual meeting of the American Society of Clinical Oncology, which suggested that the bladder cancer risk was a class effect for glitazones.
Alli and Xenical cause serious injury to kidney, liver, and/or pancreas
Alli and Xenical are diet pills used to promote weight loss. They decrease absorption of fat by the intestines, which can reduce the number of calories a person absorbs. The Food and Drug Administration (FDA) has received reports of serious injury to the liver, kidney, and/or pancreas in people taking Alli/Xenical.
If you or anyone you know has suffered from injury to the liver, kidney, or pancreas while taking Alli or Xenical, please CONTACT US for a free case evaluation.
Multaq / Dronedarone causing liver failure amongst its users
The French pharmaceutical company Sanofi-Aventis, has confirmed that two users of its atrial fibrillation drug, Multaq ( Dronedarone) now require transplants following liver failure. The drug was first approved for use in the United States in July of 2009.
Dronedarone is used to treat abnormal heart rhythm in patients who have had atrial fibrillation or atrial flutter during the past six months. Dronedarone can reduce the risk of being hospitalized for these conditions, according to the FDA. The agent was approved with a Risk Evaluation and Mitigation Strategy with a goal of preventing its use in patients with severe heart failure or who have recently been in the hospital for heart failure. In a study of patients with these conditions, patients given dronedarone had a greater than two-fold increase in risk of death. Link
Link to the Wall Street Journal Article
If you, or someone you know, has taken Multaq / Dronedarone and suffered any sort of complication, it is important to know your rights. Please CONTACT an attorney to evaluate your case and advise you as to how you may proceed.
If you or someone you know is currently taking Multaq ( Dronedarone ) please advise them to contact their doctor immediately to discuss their situation. If you have been injured while taking Multaq ( Dronedarone ), please CONTACT us immediately for a free case consultation. The Ronan Law Firm has over 25 years of litigation experience and we have successfully represented clients all across the nation in pharmaceutical cases such as Vioxx, Fen-Phen, Avandia and more.
Why let uncertainty prevent you from proper recovery for your injury? CONTACT the Ronan Law Firm with any questions or concerns that you may have.
Darvon and Darvocet withdrawals continue to affect the pharmaceutical market
On Monday, Cornerstone Therapeutics Inc, withdrew three of its generic products per FDA recommendation. Cornerstone’s affected products include Balacet 325 CIV, Propoxyphene Napsylate and Acetaminophen Tablets CIV and Propoxyphene Napsylate and Acetaminophen Tablets CIV. (link)
Last week, the FDA ordered Xanodyne Pharmaceuticals to withdraw the name-brand versions propoxyphene, a drug used to treat mild to moderate pain. Issues arose with propoxyphene after a study revealed that the drug places patients, from healthy to those weakened by illness, at risk for serious to sometimes fatal arrhythmias.
Propoxyphene was first approved in 1957. Since 1978, the FDA has received two requests to remove propoxyphene from the market. Until now, the FDA had concluded that the benefits of propoxyphene for pain relief at recommended doses outweighed the safety risks of the drug. (link) The efficacy and safety of propoxyphene, first approved by the FDA in 1957, was the subject of a January 2009 FDA advisory committee meeting. After considering the data submitted with the drug’s original application and subsequent medical literature and post-market databases, the committee voted 14 to 12 against continued marketing of propoxyphene products. In making this recommendation, the committee noted that additional information about the drug’s cardiac events would be relevant in weighing its risks and benefits, based on the release. (link) News of the withdrawals came as no shock to the European markets as they had ordered the withdrawal of propoxyphene in 2009.
American Council on Science and Health Doctor Gilbert Ross is happy with this withdrawal.
I do, however, agree that Darvon needed to be removed from the market–let’s just say public health will not suffer as a result of its withdrawal. LINK
If you or someone you know is currently taking Darvon, Darvocet, or a some generic form, please advise them to contact their doctor immediately to discuss their situation. If you have been injured while taking Darvon, Darvocet, or any generic, please CONTACT us immediately for a free case consultation. The Ronan Law Firm has over 25 years of litigation experience. The Ronan Law Firm has successfully represented clients all across the nation in pharmaceutical cases such as Vioxx, Fen-Phen, Avandia and more. Why let uncertainty prevent you from proper recovery for your injury? CONTACT the Ronan Law Firm with any questions or concerns that you may have.
Darvon and Darvocet ( propoxyphene )pulled from the market because of serious heart risks
The FDA has ordered the immediate stoppage of any marketing pertaining to the pain relief medication, Darvon and Darvocet. LA Times Xanodyne Pharmaceuticals has withdrawn Darvon, a pain reliever used to treat mild to moderate pain. Darvocet mixes propoxyphene with acetaminophen to help relieve pain. The core element of the drugs, propoxyphene, hasbeen shown to cause serious toxicity to the heart, even when used at therapeutic doses.
Additionally, these heart problems are not limited to patients weakened by illness; rather, even healthy patients are at risk. Risks include, but are not limited to: Significant changes in the electrical activity of the heart, prolonged PR interval, widened QRS complex and prolonged QT interval. These changes increase the risk for serious abnormal heart rhythms.
The FDA has recommended that healthcare professionals stop prescribing propoxyphene-containing products to patients and then, contact patients currently taking propoxyphene-containing products and ask them to discontinue he drug.
The FDA estimates that 10 million people have been given either Darvon or Darvocet since 2009.
If you or someone you know is currently taking Darvon, Darvocet, or a generic therein, please advise them to contact their doctor immediately to discuss their situation. If you have been injured while taking Darvon, Darvocet, or any generic, please CONTACT us immediately for a free case consultation. Why let uncertainty prevent you from proper recovery for your injury? CONTACT the Ronan Law Firm with any questions or concerns that you may have.
French Diabetes Drug Mediator may have contributed to 500 deaths
The French medical watchdog agency l’Afssaps has recommended that patients who took Mediator, a drug designed to treat diabetes and obesity in Europe, get checked for heart valve damage.
A report conducted by France’s national health insurance entity CNAM revealed that in about 30 years, as many as 500 patients may have died from complications directly related to Mediator. Link
This news crosses the pond just as litigation mounts against GlaxoSmithKline, manufacturer of Avandia. Europe has already pulled Avandia off it’s shelves while in the US, the FDA has implemented warnings and restrictions for the Type 2 Diabetes drug.
The new focus of the litigation circles around how much information GlaxoSmithKline had prior to the 2007 Nissen study( New England Journal of Medicine) regarding potential risks and dangers. The Nissen study reveals an increase in the risk of heart attacks, stroke, or death amongst Avandia patients while reports allege that GSK knew about these risks and failed to warn the public about them. Link
The Ronan Law Firm is currently representing people all across the country with their claims against the drug manufacturer. If you have any questions regarding the Avandia litigation and/or how your rights as a patient may be affected, do not hesitate to CONTACT us. Why let your uncertainty preclude you from potential monetary damages? CONTACT US for a free case consultation.
Yaz birth control still causing health problems for its users.
Where you see advertisements for Yaz, you’ll see bright colors and smiling faces. But now there’s also an added emphasis on the serious side effects of this contraceptive — results of a $20 million corrective marketing campaign by its manufacturer, Bayer, getting a message out that thousands of women now claim was missing when their pills were prescribed.
While Bayer has indeed been forced to correct its marketing, claims against the birth control manufacturer continue to rise as women suffer life-threatening injuries due to Yaz / Yasmin. Complaints of blood clots, gall bladder disease, heart attacks and strokes are the major issues affecting Yaz and/or Yasmin users.
If you or a loved thinks they may have been harmed while taking either Yaz or Yasmin, please CONTACT an attorney immediately. Why risk compensation for your injury because of uncertainty? It doesn’t matter if you’re in Kansas, Missouri, California, New York or anywhere in between. The Ronan Law firm has experience representing clients all across the country. CONTACT us for a free consultation regarding your claim.
What is Accutane and what are the problems associated with the acne medication?
Accutane was manufactured by Hoffmann-La Roche. Due to dwindling sales, Roche Pharmaceuticals stopped making Accutane in 2009. Accutane was one of the most popular medicines used to combat acne. Accutane came under fire after reports of serious physical adverse events came to light.
These reports tie Accutane to Irritable Bowel Syndrome, Ulcerative Colitis and Crohn’s Disease. Even though the drug is no longer being manufactured, legal recourse is still available to those harmed by this medication. The Statute of Limitations in this case is very important as it may be running without the patient’s knowledge. If you or someone you know took Accutane in the past, do not hesitate to CONTACT us with any questions and/or concerns. At The Ronan Law Firm, we’ll offer you a free consultation and advise you of your rights as it may pertain to your specific case.
Meridia recall signals potential litigation
Following a FDA recommendation, Abbott Laboratories has removed it’s diet pill Meridia (sibutramine) from the market. Following an extensive study, the FDA found Meridia gave users a 16 percent higher chance of suffering from heart disease, stroke and even death. Dr. John Jenkins went so far as to say that “there was no identifiable population of patients for whom the benefits of Meridia outweighed its risks.”
The F.D.A.’s action stems from the results of a clinical trial involving more than 10,000 patients that were announced late last year. In that trial, 11.4 percent of people who took Meridia suffered a heart attack, stroke or other major cardiac problem, compared with 10 percent of those taking a placebo — a 16 percent increase in relative risk. The trial, which had been requested by European regulators, found that those on the drug lost only about 2.5 percentage points of their weight more than those on the placebo. NY TIMES
Meridia, initially approved for use in 1997, was supposed to be the replacement for the popular, yet dangerous Fen-Phen. People who used Meridia to help with weight loss and regulate their metabolisms are urged to stop using the drug immediately.
Do you think you’ve suffered an injury as a result of your Meridia use? Do you know someone who has? The statute of limitations may already be running on potential cases. Do not lose out on a chance to obtain compensation for your injury because you were uncertain of the cause. CONTACT us for a free consultation regarding your case
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