|
 |
 |
| 11 entries found. Viewing page 1 of 1. |
| |
| February 11, 2011 |
| Recall of Nexgen Complete Knee Solution Knee Replacement Components |
| Posted By DeCarli Law |
 |
Zimmer Inc. has initiated a Class 2 recall of the Nexgen Complete Knee Solution MIS tibial components, locking screw and stem extensions. The U.S. Food and Drug Administration issued a notice regarding the recall on September 13, 2010. The FDA Notice may be found HERE, which lists the specific codes for the recalled devices.
As of the date of the notice, there had been 114 reports filed with the FDA reporting that the device loosened, requiring patients to undergo surgery to replace the device. Immediately after the recall, Zimmer sent an “URGENT DEVICE CORRECTION” letter to orthopedic surgeons who had used the device. Zimmer warned surgeons to destroy or disregard all previous versions of the surgical technique and to review and familiarize themselves with the revised technique in light of the recall.
If you or a loved one underwent knee replacement surgery in which a Nexgen device was used, you ultimately may need to undergo surgery to replace the defective Nexgen device. Symptoms that may indicate a failure of the device include knee and joint pain, difficulty standing or walking, decreased range of motion, and soreness or stiffness.
|
|
| Continue reading "Recall of Nexgen Complete Knee Solution Knee Replacement Components" » |
|
Permalink  |
| |
| February 03, 2011 |
| More Information on Association Between Anaplastic Large Cell Lymphoma (ALCL) and Breast Implants |
| Posted By DeCarli Law |
|
More information is available on the link between Anaplastic Large Cell Lymphoma (ALCL) and breast implants. As noted in an earlier blog post, the U.S. Food and Drug Administration announced last week the
link between ALCL and breast implants.
It is important to note that ALCL is not breast cancer. ALCL is a type of lymphoma, a cancer of the cells of the immune system. In the cases where women with breast implants developed ALCL, ALCL was not found in the breast tissue itself, but in the fibrous scar capsule surrounding the implant. Over time, a fibrous scar tissue called a capsule develops around a breast implant, separating the implant from the rest of the breast. The ALCL is found within this fibrous capsule.
ALCL has been diagnosed most frequently in women undergoing implant revision operations for late onset, persistent seroma (collection of fluid). Most patients are diagnosed when they seek medical treatment for implant related symptoms such as pain, lumps, swelling, or asymmetry that developed long after their initial surgical sites were fully healed. These symptoms were due to persistent seroma, hardening of breast area around the implant (capsular contraction), or masses surrounding the breast implant.
Importantly, the FDA is NOT recommending prophylactic breast implant removal in patients without symptoms or other abnormalities. However, the risk of ALCL should be considered by any woman considering whether to undergo breast implant surgery.
The FDA is requesting that healthcare professionals and patients report any confirmed cases of ALCL in women with breast implants. You may report a confirmed case to the FDA online HERE.
|
|
| Continue reading "More Information on Association Between Anaplastic Large Cell Lymphoma (ALCL) and Breast Implants" » |
|
| Permalink |
| |
| January 27, 2011 |
| Anaplastic Large Cell Lymphoma (ALCL) Linked to Breast Implants |
| Posted By DeCarli Law |
|
The U.S. Food and Drug Administration announced yesterday a possible association between saline and silicone gel-filled breast implants, and anaplastic large cell lymphoma (ALCL). Data suggests that patients with breast implants have a very small, but significant, risk of ALCL in the scar capsule adjacent to the implant.
ALCL is a relatively uncommon type of non-Hodgkin’s lymphoma that arises from T-cells. ALCL is diagnosed in about 1 out of 500,000 women in the United States each year. ALCL located in breast tissue is even less common. The FDA is aware of only about 60 cases of ALCL worldwide in women with breast implants. However, the exact number is uncertain because it is likely that not all cases have been reported.
At present, breast implant manufacturers do not warn of the risk of ALCL. However, in an effort to ensure that patients receiving breast implants are informed of this risk, the FDA will be working with manufacturers in the coming months to update their product labeling materials to add a warning.
The FDA is requesting that healthcare professionals and patients report any confirmed cases of ALCL in women with breast implants. You may report a confirmed case to the FDA online HERE
.
|
|
| Continue reading "Anaplastic Large Cell Lymphoma (ALCL) Linked to Breast Implants" » |
|
| Permalink |
| |
| January 12, 2011 |
| Drug Companies Hide Side Effects From Investors As Well As Consumers |
| Posted By DeCarli Law |
|
From our work representing people injured by dangerous drugs, we’ve learned the hard way that drug companies often conceal drug side effects from consumers. According to a lawsuit now on appeal to the Supreme Court of the United States, they also sometimes hide them from their own investors, which underscores the importance of reporting drug side effects to the FDA.
A posting on the Wall Street Journal’s Law Blog reports on a lawsuit filed by investors against Matrixx Initiatives, Inc., whose wholly-owned subsidiary manufacturers Zicam. Investors brought a securities-fraud class-action lawsuit against Matrixx. The lawsuit alleges the company failed to disclose reports from consumers that they lost their sense of smell after using Zicam Cold Remedy nasal gel and swabs. Matrixx received at least a dozen reports between 1999 and 2003, but did not disclose this to potential investors.
The fact that pharmaceutical companies do not disclose reports of drug side effects to their own investors, as well as to the consumers who use their products, reinforces the importance of reporting injuries to the FDA. If you experience a side effect after using a prescription or over-the-counter drug, you should immediately report it to your physician and to the drug manufacturer, but ALSO report it to the FDA. You can easily do this online HERE.
|
|
| Continue reading "Drug Companies Hide Side Effects From Investors As Well As Consumers" » |
|
| Permalink |
| |
| September 13, 2010 |
| Recalled Diet Drug Solo Slim Contains Synephrine |
| Posted By DeCarli Law |
|
The FDA recently ordered the recall of diet drug Solo Slim because it contains an undeclared drug ingredient, Didesmethyl Sibutramine, a risk for people with a history of heart disease. However, Solo Slim also contains Synephrine, another potentially dangerous drug that can cause heart attacks, heart palpitations, strokes, and even death.
Synephrine (or oxydrine) has a chemical structure similar to ephedrine. Because of its similarity to ephedrine, Synephrine can cause similar side effects. Based on the potential for cardiovascular toxicity of Synephrine, Health Canada in January 2010 issued guidelines limiting the maximum dose of Synephrine, and prohibiting the sale of health products containing both Synephrine and caffeine without prior submission of clinical evidence of the product’s safety.
Thus, Solo Slim contains two different drugs that can cause heart attacks and strokes. Further, Solo Slim also contains caffeine, which in combination with Synephrine was regarded as potentially dangerous in itself by the Canadian health agency. This chemical makeup makes Solo Slim particularly dangerous for people with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
As we reported in an earlier post, consumers should return Solo Slim immediately to the place of purchase for a full refund, and contact their physician if they experience any side effects as a result of taking the product. |
|
| Continue reading "Recalled Diet Drug Solo Slim Contains Synephrine" » |
|
| Permalink |
| |
| September 09, 2010 |
| FDA Orders Label Changes for Gadolinium-Based Contrast Agents |
| Posted By DeCarli Law |
|
The U.S. Food and Drug Administration (FDA) announced today that it will require significant label changes for gadolinium-based contrast agents (GBCAs) in order to reduce the risk of nephrogenic systemic fibrosis (NSF).
The most significant label change is the recommendation that Omniscan, Magnevist and Optimark NOT be used on people with chronic, severe kidney disease, such as dialysis patients, or those with acute kidney injury (AKI). This follows the determination by FDA staff last fall that Omniscan, Magnevist and Optimark are the gadolinium-based contrast agents most likely to cause NSF.
The new labeling also recommends that healthcare professionals:
-
Screen patients prior to administration of a GBCA to identify those with AKI or chronic, severe, kidney disease. These patients appear to be at highest risk for NSF.
- Use the clinical history to screen patients for features of AKI or risk factors for chronically reduced kidney function.
- Avoid use of GBCAs in patients suspected or known to have impaired drug elimination unless the need for the diagnostic information is essential and not available with non-contrasted MRI or other alternative imaging modalities.
-
Monitor for signs and symptoms of NSF after a GBCA is administered to a patient suspected or known to have impaired elimination of the drug.
- Not repeat administration of any GBCA during a single imaging session.
The complete text of the FDA's Safety Announcement may be found HERE.
Unfortunately, this label change comes too late for some people with kidney disease or AKI who were injected with Omniscan, Magnevist and Optimark and as a result, developed NSF. Symptoms of NSF include scaling, hardening and tightening of the skin; red or dark patches on the skin; and joint stiffness. NSF can also cause fibrosis of internal organs that may lead to death. There is no effective treatment for NSF.
If you or a loved one developed any of the NSF symptoms listed above after treatment with a gadolinium-based contrast agent, you may have a legal claim. However, these and all personal injury claims are subject to statutes of limitations -- laws that place deadlines on when a claim may be made. Call the NSF lawyers at DeCarli Law for a free, no-obligation telephone consultation to learn your legal options. We are experienced helping people stricken with NSF, and can provide you with additional information about NSF and your legal rights. |
|
| Continue reading "FDA Orders Label Changes for Gadolinium-Based Contrast Agents" » |
|
| Permalink |
| |
| August 13, 2010 |
| FDA Orders Label Change for Lamictal (lamotrigine) to Disclose Risk of Aseptic Meningitis |
| Posted By DeCarli Law |
|
The FDA has issued a safety alert disclosing that Lamictal (lamotrigine) can cause aseptic meningitis. Lamictal (lamotrigine) is a medication commonly used to treat seizures in children two years and older, and bipolar disorder in adults. Symptoms of meningitis may include headache, fever, stiff neck, nausea, vomiting, rash, and sensitivity to light. In cases of meningitis, it is important to rapidly diagnose the underlying cause so that the correct treatment can be promptly begun.
The label change to disclose the risk of aseptic meningitis came after the FDA identified 40 cases of aseptic meningitis in patients who took Lamictal between December 1994 and November 2009.
Patients should immediately contact their healthcare professional if they experience signs and symptoms of meningitis while taking Lamictal. Patients or their parents can report Lamictal side effects to the FDA online HERE.
|
|
| Continue reading "FDA Orders Label Change for Lamictal (lamotrigine) to Disclose Risk of Aseptic Meningitis" » |
|
| Permalink |
| |
| August 12, 2010 |
| After Years of Delay, Bayer Asks the FDA for Approval of Gadovist, its Safer Gadolinium-Based Contrast Long Available in Europe |
| Posted By DeCarli Law |
|
The FDA has just accepted Bayer Schering Pharma's New Drug Application for Gadovist, a gadolinium-based contrast agent currently sold in Europe and other parts of the world, but not in the United States. A New Drug Application is the procedure a drug company uses to formally request the FDA to allow it to sell a drug in the United States.
Although Bayer's application for Gadovist is new, Gadovist itself is not. Gadovist has been approved for sale in the European Union since 1998. However, until recently, Bayer has not sought approval for selling it in the United States. This decision -- whatever its basis -- has put Americans at risk.
Gadovist has a macrocyclic molecular structure, which means the gadolinium ion is surrounded by an organic chelate. In contrast, Magnevist, the Bayer contrast agent sold in the United States, has a linear ionic molecular structure. Magnevist's molecular structure is less stable than Gadovist's macrocyclic structure. As a result, European regulatory agencies recognize than Magnevist is less safe than Gadovist. The EU equivalent of the FDA requires the Magnevist label to state that it is contraindicated (not recommended) for use on people with severe renal impairment. Gadovist does not have this restriction.
A gadolinium-based contrast agent's molecular stability has dire health consequences, especially for people with impaired renal function, like those on dialysis. If a gadolinium-based contrast agent breaks down within the human body, the person is at risk of developing nephrogenic systemic fibrosis (NSF). NSF, also known as nephrogenic fibrosing dermopathy (NFD), is an incurable disease characterized by hardening of the skin and other body tissues. The only known cause of NSF/NFD is the use of gadolinium-based contrast agents in medical procedures such as MRI, MRA and CT scans (CAT scans).
|
|
| Continue reading "After Years of Delay, Bayer Asks the FDA for Approval of Gadovist, its Safer Gadolinium-Based Contrast Long Available in Europe" » |
|
| Permalink |
| |
| August 09, 2010 |
| Recall of Appetite Suppressant “Solo Slim” |
| Posted By DeCarli Law |
|
The FDA announced today the recall of appetite suppressants “Solo Slim” and “Solo Slim Extra Strength.” FDA lab analysis revealed that Solo Slim contains an undeclared drug ingredient, Didesmethyl Sibutramine. Sibutramine is an FDA-approved drug used as an appetite suppressant for weight loss. Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients, and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
Solo Slim Extra Strength is packaged in a white plastic bottle with a blue screw-on cap, as pictured to the left. Each bottle contains 30 capsules, and bears UPC 8 35470 00220 5. All lots of these products with expiration dates including and prior to August 2013 currently available on the market are being recalled. The products were sold to distributors and retail stores nationwide, and on the internet.
Consumers should return the product immediately to the place of purchase for a full refund, and contact their physician if they have experienced any side effects as a result of taking the product.
|
|
| Continue reading "Recall of Appetite Suppressant “Solo Slim”" » |
|
| Permalink |
| |
| May 11, 2010 |
| FDA Announces “Bad Ad Program” to Help Health Care Providers Detect and Report Misleading Drug Ads |
| Posted By DeCarli Law |
|
Today, the U.S. Food and Drug Administration announced the launch of what it calls the “Bad Ad Program.” The program is designed to educate health care providers about their role in ensuring that prescription drug advertising and promotion is truthful and not misleading.
The program is aimed at drug ads that target doctors and other health care providers. The pharmaceutical industry spends three times as much on advertising directed at health care professionals as it spends on advertising directed at consumers. Advertising directly to health care professionals is called “detailing,” and most frequently occurs in locations such as medical offices, hospitals, and pharmacies, as well as at medical meetings and symposia.
A document released today by the FDA describes the main purpose of the Bad Ad Program as raising “awareness among health care professionals about the importance of helping FDA in its efforts to prevent misleading promotion of prescription drugs.” According to Thomas Abrams, director of the FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC), “the Bad Ad Program will help health care providers recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency.”
When reports of misleading ads are filed, the DDMAC will determine whether it meets the criteria necessary for taking regulatory action. If the DDMAC determines the ad to be a violation, it will move forward with an appropriate enforcement action, which could include sending a Warning Letter or referring the matter to law enforcement for a criminal investigation.
Although the Bad Ad Program is mainly aimed at health care professionals, anyone can submit a complaint to the FDA. The FDA has a similar educational campaign designed to educate consumers about misleading drugs advertisements. This program is called EthicAd and may be accessed on the internet HERE.
If you believe you have been injured by a prescription drug or over-the-counter drug, you also can report this to the FDA HERE. This is not necessary to preserve your legal rights, but it is the right thing to do, because it can bring dangerous drug side effects to the attention of the FDA, and make sure the FDA is aware how dangerous a particular drug is.
FDA Documents on the Bad Ad Program:
|
|
| Continue reading "FDA Announces “Bad Ad Program” to Help Health Care Providers Detect and Report Misleading Drug Ads" » |
|
| Permalink |
| |
| November 17, 2009 |
| FDA Staff: Omniscan, Magnevist and OptiMARK Gadolinium-Based Contrast Agents Most Likely to Cause NSF |
| Posted By DeCarli Law |
|
In a recently-prepared FDA document, staff members conclude that Omniscan, Magnevist, and OptiMARK are the gadolinium-based contrast agents with the highest risk of causing Nephrogenic Systemic Fibrosis (NSF). A much lower NSF risk is associated with Prohance and Multihance. These conclusions are contained in a briefing document prepared for an upcoming FDA committee meeting that will consider changing the warning labels to reflect these differing risks.
The briefing document was prepared for an Advisory Committee meeting to be held on December 8, 2009, which will re-evaluate the current warnings required for gadolinium-based contrast agents. Currently, all gadolinium-based contrast agents must have the same warning, regardless of brand. This decision was made in 2007, based on the information available at that time about NSF. However, the warning labels may change if the recommendations of FDA staff members are adopted.
Various FDA staff reports contained in the briefing document recommend heightened warning labels for the three more dangerous contrast agents: Omniscan, Magnevist, and OptiMARK. A lesser warning would be required for Prohance and Multihance, which are associated with fewer cases of NSF. In fact, the makers of Optimark have already changed their warning label on their own, as reported in a previous blog post, contraindicating use of their product for patients with severe renal disease and those awaiting a liver transplant.
The FDA documents provide further support for what has already become apparent in NSF lawsuits: most people develop NSF after exposure to Omniscan, Magnevist, and OptiMARK.
If you or someone you know has developed Nephrogenic Systemic Fibrosis (NSF) after exposure to gadolinium-based contrast agents during an MRI or other medical procedure, consider contacting the MRI lawyers at DeCarli Law for a free, no obligation consultation.
|
|
| Continue reading "FDA Staff: Omniscan, Magnevist and OptiMARK Gadolinium-Based Contrast Agents Most Likely to Cause NSF" » |
|
| Permalink |
| |
| 11 entries found. Viewing page 1 of 1. |
| | |
|
 |