Epidural Steroid Injection and Meningitis
The Centers for Disease Control and the FDA are investigating cases of fungal meningitis among patients who received an epidural steroid injection for back pain. Several of these patients suffered strokes that are believed to have resulted from the ingredients in the epidural steroid injection. The meningitis cases are thought to be associated with a potentially contaminated medication used in the epidural steroid injection. Interim data shows that all infected patients received injections with an ingredient prepared by a particular compounding center.
Forty-seven people in seven states are now confirmed to have fungal meningitis, the Centers for Disease Control and Prevention reported Friday, 12 more than the day before…
Physicians and clinics in 23 states are reviewing patient records to determine which patients may have received injections contaminated with a fungus. The Greenspring Surgery Center in Baltimore, Maryland, has determined that 300 patients received injections with the recalled drug — manufactured by New England Compounding Center in Framingham, Massachusetts. CNN
If you have suffered meningitis after receiving an epidural steroid injection please call for a free case evaluation.
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.
Contact us with any questions, concerns, or for a free consultation regarding your specific case.
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.
FDA knew of problem yet tainted alcohol pads still caused serious problems
Blurbs from an MSNBC article discussing the harms associated with products released from a plant run by Triad Group. The products include such materials as alcohol pads used for sterilization, creams and ointments, lubricating jelly, swabs, etc: Link
The death of a 2-year-old Houston boy from a rare infection blamed on contaminated alcohol wipes may be only the first casualty tied to allegedly shoddy sterilization practices by a Wisconsin medical products firm….
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“Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed,” officials wrote in inspection reports. But there’s no record that the FDA sent warning letters typically used to force firms to comply….
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Reported injuries range from superficial skin infections to serious complications, and even one claim of another death….
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Another 100 reports of problems with alcohol prep pads have been logged by the FDA since the Jan. 5 recall of Triad products because of potential contamination with the bacteria Bacillus Cereus, an agency spokesman said.
And a Tennessee man has filed his own $30 million lawsuit against Triad, claiming he developed an infection from Bacillus Cereus from the wipes and had to undergo open-heart surgery as a result.
“That was the most scared I’ve been in my life,” said Donovan Joseph Postich, a 55-year-old ironworker from Madisonville, Tenn., who is permanently disabled after the surgery. “They told me about the tainted pads and you just kind of put two and two together.”
Triad’s recall covers all lots of its alcohol prep pads, wipes and swabs, totaling perhaps hundreds of millions of products sold in the U.S., Canada and Europe.
H&P Industries, which does business as the Triad Group, is among the largest providers in the U.S. of generic medical products often sold under private labels of grocery stores such as Safeway and Kroger and drugstores such as CVS and Walgreens….
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Problems with sterilization, contamination
Documents show that FDA officials expressed concerns following visits to the Triad plant from July 15 to July 17, 2009, and again from April 19 to May 18, 2010. Inspectors reported that the company could not validate the processes used to ensure quality or sterility not only of alcohol prep pads and wipes, but also other products used for intimate care.Those include hemorrhoid creams, infant and adult glycerin suppositories and sterile lubricating jelly widely used in homes, as well as in clinics and hospitals for medical exams.
The inspection documents, known as FDA Form 483s, were obtained by msnbc.com from a confidential source and confirmed by FDAzilla.com, an independent Web site that monitors the FDA. Copies of the documents were sent to the FDA for review; the agency did not deny their authenticity.
In the documents, inspectors cited Triad’s sterilization process for alcohol prep products, questioning dosages of the gamma radiation process that ensures sterility.
“Specifically, there is no validation of the gamma radiation sterilization process for the Alcohol Swabsticks labeled as sterile,” the report said.
In addition, shipments of Triad Plus BZK prep pads that failed to meet specifications were released for distribution, inspectors said.
The documents did not mention specific contamination of the swabs or pads with Bacillus Cereus.
However, inspectors said Triad’s processes “may not be adequate to sterilize” the lubricating jelly and charged that Triad had failed to address “high microbial bioburden levels” previously detected in the purportedly sterile jelly. Information about the specific type of contamination was redacted in the documents.Inspectors reported worn and broken manufacturing equipment, misidentified batches of hemorrhoid cream, and instances where if a single batch of hemorrhoid ointment or glycerin suppositories failed quality standards, others weren’t tested for the same problem and were released for distribution.
In one case, inspectors noted that a batch of lubricating jelly failed viscosity tests on Jan. 28, 2010, but was released anyway with the specific consent of Triad’s president, David Haertle. A week later, the decision to release the jelly per Haertle’s authority was revised and cases of the jelly were scrapped, but some already had been distributed, according to the report.
“No action was taken on the distributed cases,” inspectors wrote.
Overall, officials concluded the company had no procedures in place for reporting or acting on manufacturing problems….
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Before the recall, FDA had received no reports of adverse events related to Triad alcohol prep products, Kelly said. From Jan. 5 to Jan. 31, the company received about 100 reports of problems with alcohol prep products, which Kelly said was typical of the number of reports received after most recalls are posted. They included about 50 reports of infection and one death, which could not be tied to contaminated wipes.
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If you or someone you know thinks they have been injured by one of Triad’s products, please advise them to contact their doctor immediately to discuss their situation. After the health concerns are taken care of, 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 obtaining proper recovery for your injury? CONTACT the Ronan Law Firm with any questions or concerns that you may have.
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.
GM Recals Cadillac DTS and Buick Lucerne Sedans
GM has recalled 2010 and 2011 Cadillac DTS and Buick Lucerne sedans that use a V8 engine. The issue involves alternator cables that have the potential to wear through the line carrying your power steering fluid. Given enough time, this wear and tear could create a leak resulting in your loss of steering fluid, thus creating a loss of power steering and increasing the potential for a crash.
GM Dealers have offered to repair this defect at no cost to the owners. Please contact your nearest dealership immediately to get this problem resolved. You never know who may be in your car or where you may be if/when the steering gives out.
If you have any questions regarding this recall, or you or someone you know has been in an accident involving one of these models, please do not hesitate to CONTACT the Ronan Law Firm. We would be happy to answer any questions and/or give you a free consultation regarding your case.
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