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FDA recently issued a Public Health Advisory describing reports of sudden unexplained death in children taking Adderall and Adderall XR, which are used to treat ADHD. Sudden death has been reported in children with underlying cardiac abnormalities who are taking recommended doses of amphetamines, including Adderall and Adderall XR. A very small number of cases of sudden death have been reported in children without cardiac abnormalities taking Adderall. At this time, it doesn't appear that the number of sudden deaths in children taking Adderall is greater than the number that would be expected in this population without treatment. But it's possible that patients with underlying heart defects might be especially at risk, and so the advisory reemphasizes the warning in the product labeling that these patients should ordinarily not be treated with Adderall products.

Tags: FDA Advisory Adderall Sudden Unexplained Death Children Patient Safety ADHD Cardiac Abnormalities Drug Reaction

FDA recently provided health care practitioners and patients with updated information about the risks and benefits of Crestor (rosuvastatin calcium), a cholesterol-lowering drug made by Astra-Zeneca Pharmaceuticals. Crestor, like all other statins, has been associated with rhabdomyolysis. The incidence of this effect is low, and the risk of serious muscle damage doesn't appear to be greater for Crestor than for other statins. But as with all statins, the risk of myopathy increases with higher drug levels. So Crestor's labeling has been changed to re-emphasize the risk of myopathy, particularly at the highest approved dose of 40 mg. The labeling also stresses the need to consider using lower starting doses in some patients. This may be particularly important when treating Asian Americans, since a large pharmacokinetic study found that this group of patients had drug levels about twice as high as a Caucasian control group, and that could increase their risk for myopathy. The revised labeling now recommends that the 5 mg dose of Crestor be considered as the starting dose for Asian-Americans, and also for others with predisposing factors for myopathy, including patients on cyclosporine and those with severe renal insufficiency.

Tags: Updated Safety Information Crestor Cholesterol-Lowering Drug FDA Statins Rhabdomyolysis Myopathy Asian Americans

Here's a warning about certain enclosed beds that could be hazardous to patients. They're made by Vail Products Inc. of Toledo, Ohio. On March 22, the FDA and the Justice Department initiated a seizure of all Vail model 500, 1000, and 2000 enclosed bed systems, because patients can become entrapped in the beds and suffocate. These canopy-like padded beds are used for at-risk patients with cognitive impairment, unpredictable behavior, spasms, seizures, and other disorders. They're advertised as an alternative to using a physical restraint or medication to reduce falls and prevent wandering. About 30 adverse events, including at least 7 deaths, have occurred from entrapments, falls, and other incidents with these beds. More than half of these events involved children age 16 and under. FDA recommends that hospitals, nursing homes, and consumers who have a Vail enclosed bed system stop using it immediately and move the patient to an alternate bed. If the only option for the patient is to continue using the Vail bed, FDA currently recommends that users follow these safety precautions, recommended by Vail: - Use only the mattress recommended by the company. - Always leave the side rails in the "up" position except when moving the patient from the bed. - If the bed has a Hi-Lo feature that raises and lowers the entire bed surface, never leave the feature in the "Hi" position while the patient is unattended, because the patient can become entrapped. The company may take additional steps to address these safety issues. Check our web site for additional information and for updates as they become available.

Tags: Warning Vail Patient Beds FDA Enclosed Safety Death Suffocation Nursing Homes Hospitals

FDA is requiring that a new Bolded Warning be added to the labeling for Gabitril (tiagabine) an antiepileptic drug that's approved as adjunctive therapy in treating partial seizures. The warning is being issued because of reports that Gabitril has been associated with seizures in more than 30 patients who received it for conditions other than epilepsy. Although Gabitril is approved only for treating epilepsy, it's been used off-label for treating other conditions, mainly psychiatric illnesses and chronic pain, and it's those uses where the seizures have occurred. This could pose a confusing situation for practitioners: a drug that's used to control seizures in patients with epilepsy that could be causing seizures in other patients. In fact, an FDA Advisory notes that in some cases, prescribers have actually increased the dose of Gabitril when their patients without epilepsy started having seizures. Presumably they weren't aware that it was the Gabitril that might be causing the seizures, and they may have thought that since the drug is an anti-epileptic, it might control the seizures in these other patients. Gabitril's manufacturer is changing the labeling to reflect this risk, and they've also agreed to undertake an educational campaign for both physicians and patients, making people aware of the risks and discouraging off-label use. The FDA Advisory reminds practitioners that Gabitril has not been approved for conditions other than epilepsy, and that using it for these conditions constitutes an off-label use. The Advisory says that if a practitioner does decide to use the drug off-label, the risk of seizures should be explained to the patient.

Tags: Warning Gabitril Patients Without Epilepsy FDA Seizures Patient Safety Off-Label

HeartSine Technologies is recalling some of its samaritan® Automatic External Defibrillators. The affected devices may shut down before delivering a shock, which could delay treatment or even lead to death of a viable patient. We've received several user complaints that the device shut down during an attempted charge, but no injuries have been reported to date. This recall includes models SAM-001, SAM-002, and SAM-003 with certain serial numbers within the range of 1270 - 2324. The HeartSine samaritan® PAD automatic external defibrillator is not affected by this recall. HeartSine Technologies notified its distributors and customers by letter on February 14, 2005, and the company is providing a software upgrade for the affected devices. If you have a device within this serial number range, but have not yet received an upgrade kit, you should contact the company as soon as possible to see if your product is affected and to get the kit. Go to our web site for details on how to contact the company.

Tags: Recall Heartsine AEDs FDA Samaritan Automatic External Defibrillators SAM-001 SAM-002 SAM-003 Patient Safety

FDA recently approved a new injectable drug to help control blood sugar in adult patients with Type 1 and Type 2 diabetes. It's called Symlin, or pramlintide acetate, and it's manufactured by Amylin Pharmaceuticals. Symlin is used in addition to insulin to help reduce postprandial blood sugar levels in patients who can't achieve adequate control despite optimal insulin therapy. Tighter control of blood sugar may help reduce the risk of long-term renal, cardiovascular and ocular events in these patients. Although patients with Type 2 diabetes already have drug therapy other than insulin to help control blood sugar, Symlin will be the only therapy available other than insulin for Type 1 patients. The FDA and the manufacturer have some safety concerns about Symlin. First, the drug may increase the risk of hypoglycemia. This risk is greatest in Type 1 diabetics and in those with gastroparesis. Second, patients might mix Symlin with insulin in the same syringe, which can alter the activity of the insulin. And third, the drug might be used inappropriately in patient populations where the risk / benefit profile hasn't been established. To help resolve these concerns, FDA is requiring that patients receive a Medication Guide with each prescription that explains the risks and how to use the drug properly. The guide tells patients they must be using their insulin as prescribed, must follow their doctor's instructions on using the drug, must be followed up frequently, and that they must test their blood sugar before and after every meal and at bedtime. The labeling for physicians will specify that Symlin not be used in patients with gastroparesis, or those allergic to any of the drug's ingredients.

Tags: Drug Treat Type Diabetes FDA Injectable Symlin Blood Sugar Insulin

FDA is notifying physicians and pharmacists that a Medication Guide for patients must be distributed with each prescription for Cordarone tablets, or generic amiodorone. This is an anti-arrhythmic drug used to treat severe ventricular arrhythmias. FDA requires these guides for drugs that pose a serious public health concern. The guide explains to patients that Cordarone can cause lung damage and liver damage, and in some cases can worsen the heart rhythm problems that the drug is intended to treat. It describes the warning symptoms that should lead patients to seek medical attention, and explains that the drug should only be used when other agents did not work. In a letter to health care professionals, Cordarone's manufacturer, Wyeth Laboratories, cautions that the Medication Guide should not be used as a substitute for talking to patients about the risks and benefits of the drug.

Tags: Medication Guide Cordarone (amiodarone HCl) FDA Anti-Arrhythmic Drug Ventricular Patient Safety Lung Liver Damage

In April 2005, PharMEDium Services of Houston, Texas announced a recall of some of its Magnesium Sulfate solution because of a possible sterility problem. All strengths of 50 ml admixtures of Magnesium Sulfate in 5% Dextrose solution are affected by this recall. Two lots of this product have been associated with outbreaks of Serratia marcescens infection. This can cause serious or life-threatening conditions, particularly among immuno-compromised patients. The company has stopped producing and distributing this product until it can determine and correct the source of this problem. Hospitals with questions should contact the company at 1-847-457-2300.

Tags: Recall Magnesium Sulfate Solutions FDA 50 ml Admixtures 5% Dextrose Solution Serratia Marcescens Infection Fatal

In a recent letter, Wyeth Pharmaceuticals alerted health professionals about changes in the tuberculosis drug Trecator (ethionamide tablets, USP) which may make it necessary to retitrate patient dosages. The older, sugar-coated version of the drug, called Trecator-SC, has been replaced by a film-coated version called Trecator. The new formulation is more rapidly absorbed, leading to higher peak concentrations and could result in patient intolerance if given at the same dose as Trecator-SC. So it's important that patients switching from Trecator-SC to Trecator be monitored and have their dosages adjusted.

Tags: Trecator Formulation Requires Dosing Adjustment FDA Tuberculosis

Roche Pharmaceuticals has notified health care professionals about new information that reinforces a contraindication when prescribing combination antiretroviral therapy for treating HIV infection.. Rifampin has been contraindicated with saquinavir, because the rifampin will reduce plasma levels of saquinavir. A study was recently performed to see whether boosting saquinavir with ritonavir would overcome this problem. But when healthy volunteers in the study were given rifampin along with the combination of saquinavir and ritonavir, 39 percent developed significant hepatocellular toxicity. As a result, Roche Pharmaceuticals is cautioning that rifampin should not be given to patients who are also receiving a combination of saquinavir and ritonavir.

Tags: Drug-Induced Hepatitis Rifampin Ritonavir/Saquinavir Combination FDA Antiretroviral HIV Hepatocellular Toxicity

Novartis has notified healthcare professionals about new warnings and dosing recommendations for the company's bisphosphonate drug, Zometa (zoledronic acid). Zometa is used to treat multiple myeloma and metastatic bone lesions from solid tumors, and hypercalcemia of malignancy. The changes are intended to improve the renal safety of Zometa. The revised labeling includes an additional warning regarding patients with preexisting renal impairment who are undergoing multiple treatments with Zometa and other bisphosphonates, because they may be at increased risk of renal deterioration. The new dosing recommendations are intended for patients with advanced cancer who also have reduced renal function, that is, those patients whose baseline creatinine clearance is 60 ml/min or lower. The revised labeling stratifies the recommended Zometa doses for patients with mild and moderate renal impairment according the baseline creatinine clearance rates. The company recommends that during Zometa treatment, serum creatinine be measured before each dose, and that treatment should be withheld when there's evidence of renal deterioration.

Tags: Zometa Dosing Patients Renal Impairments Bisphosphonate FDA Multiple Myeloma Metastatic Bone Lesions Solid Tumors

FDA has issued an alert about increased mortality when using "atypical" antipsychotic drugs to treat behavioral disorders in elderly patients with dementia. The alert applies to drugs such as Abilify (aripiprazole), Zyprexa (olanzapine), Seroquel (quetiapine), Risperdal (risperidone), Clozaril (clozapine) and Geodon (ziprasidone). Symbyax (olanzapine and fluoxetine HCl), an antidepressant, is also covered by the advisory. These drugs are not approved for treating behavioral disorders in patients with dementia. In fact, they're approved only for treating schizophrenia and mania. So this constitutes an unapproved, "off-label" use. The situation came to light when these drugs were being tested in clinical trials on elderly patients with dementia. Those treated with the drugs had a higher mortality rate than those receiving placebo. The causes of death were varied, but most of them appeared to be either cardiovascular or due to infection, such as pneumonia. FDA has asked the manufacturers of these drugs to add a boxed warning to the labeling describing the increased mortality risk. The labeling will also state that these drugs are not approved for treating behavioral symptoms in elderly patients with dementia. FDA is also considering adding a warning to the labeling of older antipsychotic medications, because limited data suggest that there may be a similar increase in mortality for these drugs.

Tags: Atypical Antipsychotics FDA Dementia Abilify Zyprexa Seroquel Risperdal Clozaril Geodon Symbyax Schizophrenia Safety

Biogen Idec has notified healthcare professionals about safety changes in the labeling for Avonex (interferon beta-1a), which is used to treat relapsing forms of MS. The labeling now warns that severe hepatic injury, including hepatic failure, hepatitis, and elevated serum hepatic enzyme levels, have been reported in patients on Avonex. Patients have also experienced asymptomatic elevation of hepatic transaminases, and this recurred in some patients when they were rechallenged with Avonex. In some cases, these events occurred when the patient was taking other drugs that are associated with hepatic injury. The company says consider the potential for injury when Avonex is used in combination with other hepatotoxic products such as alcohol, or when new agents are added to the regimen of patients already on Avonex. The company also says that patients on Avonex should be monitored for signs of hepatic injury.

Tags: Warning Liver Injury Avonex (interferon beta-1a) FDA Multiple Sclerosis Hepatic Hepatitis Patient Safety

On April 7, 2005, FDA announced several important changes that pertain to the marketing of non-steroidal anti-inflammatory drugs (NSAIDs). FDA has asked that one product be withdrawn from the market, and is requiring stronger warnings in the labeling for the other products. This is a continuation of the process that began several months ago with Vioxx (rofecoxib), when Merck withdrew that product from the market because of concerns about adverse cardiovascular events. These later actions are being taken because of concerns about other NSAIDs. It's important to understand that the new actions don't just apply to the COX-2 selective inhibitors. They apply to both the COX-2 inhibitors and to other, non-selective NSAIDs, and they apply to both prescription and non-prescription products. FDA asked the manufacturer of one of the COX-2 inhibitors, Bextra (valdecoxib), to withdraw it from the market based on concerns about cardiovascular events, and serious skin reactions. In its decision about Bextra, FDA noted the lack of adequate data on the cardiovascular safety of this drug when it's used chronically, and also reports of serious skin reactions, including deaths. Another factor was the lack of demonstrated advantages of Bextra over other NSAIDs. That leaves just one COX-2 inhibitor, Celebrex (celecoxib), still on the market. FDA decided that the benefits of Celebrex outweigh the risks, provided that patients are properly selected and informed. But FDA is requiring that certain actions be taken to minimize the risk with Celebrex. For example, there will be a boxed warning in the labeling about CV and GI risks, and the labeling will encourage physicians to discuss benefits and risks with the patient. In addition, a Medication Guide will be given to the patient each time the drug is dispensed, informing them of the risks and the importance of using the lowest effective dose for the shortest time possible. Non-selective NSAIDs, such as ibuprofen and naproxen, are also subject to new requirements. For prescription-only products, the requirements are similar to those for Celebrex, including the boxed warning in the labeling and the Medication Guide for patients. For OTC products, FDA is asking manufacturers of ibuprofen, naproxen and ketoprofen to change their labeling to give more information on CV and GI risks and provide other warnings.

Tags: Recent FDA Actions NSAIDS Vioxx (rofecoxib) COX-2 Selective Inhibitors Bextra (valdecoxib) Patient Safety Skin

FDA recently approved a new cranial sealing system for dura mater surgery to prevent cerebrospinal fluid (CSF) leakage from the incision site. The product, which is used as an adjunct to suturing, is called the Dura Seal Sealant System, and it's manufactured by Confluent Surgical, Inc. This is the first device specifically approved for this purpose. Until now surgeons have used a variety of approaches to prevent spinal fluid leakage, such as oversewing the area, or packing the area with other tissue. The Dura Seal system consists of two solutions and an applicator. The solutions mix in the tip of the applicator as the product is being applied, forming a hydrogel that seals the dura mater. The gel biodegrades in four to eight weeks, which is enough time for healing to take place. DuraSeal should not be used in confined bony structures where nerves are present, since the swelling of the hydrogel can result in neural compression. The manufacturer will continue to study the DuraSeal system to further investigate infection rates, and to compare the device to existing methods of preventing CSF leakage.

Tags: Sealing System Dura Mater Surgery FDA Cranial Cerebrospinal Fluid (CSF) Hydrogel

FDA recently approved the first device to prevent ruptures of descending thoracic aneurysms. It's an endovascular graft called the GORE TAG Endoprosthesis System, and it's made by W.L. Gore and Associates. Descending thoracic aneurysms have traditionally been managed either with anti-hypertensive drugs or by open surgical repair. This GORE TAG graft can provide an alternative to these treatments. Using the device is less invasive than conventional surgery, but it still requires regular follow-up and testing to monitor the success of the treatment over time. The GORE TAG System consists of an endovascular graft made of expanded polytetrafluoro-ethylene and an outer metal stent. The endovascular graft is delivered by a catheter inserted into the femoral artery in the groin. At the site of the aneurysm, the graft is deployed and then self-expands to the diameter of the aorta, excluding the aneurysm and relining the artery wall. This can prevent further growth and possible rupture of the aneurysm. FDA approved the device based on review of two clinical studies of approximately 200 people. Study results showed that aneurysm-related deaths were lower in patients who had received the endoprosthesis than in the surgical control group. FDA is requiring the company to conduct additional studies to evaluate its long-term clinical performance and to assure that when the device is used in the large general population, its safety and effectiveness will be comparable to the clinical trials.

Tags: Device Treat Descending Thoracic Aneurysms Endovascular Graft GORE TAG Endoprosthesis System FDA Anti-Hypertensive Drugs

Bedford Laboratories, a division of Ben Venue Laboratories, is recalling one lot of Famotidine Injection, 20 mg/2 mL, because the company could not assure the sterility of the product. Famotidine injection is used in some patients with pathological hypersecretory conditions or intractable ulcers, or as a short term alternative for patients who can't take oral famotidine. The affected lot is # 609336, with an expiration date of April 2006. This lot was distributed in August 2004 to wholesalers and distributors, and they distributed the product to hospitals. If you have any vials of this lot of Famotidine Injection, stop using it. Contact Bedford Laboratories at 1-800-562-4797 to return the product.

Tags: Recall Injectable Famotidine Sterile FDA Pathological Hypersecretory Conditions Intractable Ulcers Patient Safety

FDA recently issued a notification to health care professionals which warned about the possibility of serious injury if patients with implanted neurological stimulators undergo MRI exams. The injuries reported to FDA have included coma and permanent neurological damage. They were likely caused by heating of the electrodes at the tip of the leads. Neurological stimulators include a fairly wide variety of products i.e., neuromuscular stimulators, deep brain stimulators, spinal cord stimulators, vagus nerve stimulators and peripheral nerve stimulators. Physicians who either implant these stimulators or monitor patients who have them should warn patients that if an MRI procedure was prescribed, they should check back with the monitoring physician and make sure it can be performed safely. In addition, radiology personnel should screen patients for the presence of implants before performing an MRI exam. It's important to ask about both present and past implants. That's because sometimes when an implant is removed, the pulse generator is explanted but the leads remain in place in the patient. These leads can be heated by the MRI and cause a problem as well. If the patient does have an implanted neurological stimulator, then consider consulting with the referring physician about other imaging options. If it's decided that an MRI procedure is indicated, be sure to review the labeling for the specific model stimulator, and pay particular attention to warnings and precautions. For some stimulators, the labeling may specify the types or strengths of MRI equipment that can be used. But with other stimulators, certain MRI procedures simply can't be performed.

Tags: MRI-Caused Injuries Patients Implanted Neurological Stimulators Coma Permanent Damage FDA Patient Safety

Kingswood Laboratories is recalling its Moi-Stir Oral Swabsticks because the product may be contaminated with molds, including Aspergillus and Penicillium. Using the contaminated swab sticks could result in respiratory infections, especially in patients with compromised immune systems. These swabsticks, which are used to moisten the mouths of patients, were distributed to hospitals, wholesalers, pharmacies, nursing homes, medical and dental offices, and consumers. Some were given as free samples. The swabsticks are packaged as three sticks in a white foil pouch, with the name "Moi-Stir" in green letters on the front of the pouch. The recall includes Moi-Stir Swabsticks with lot numbers A2, 1193, 1209, 1233, 1260 and 1725. The lot numbers are embossed on the pouch. If you have swabsticks in the recalled lots, you should stop using them immediately and return them to the point of purchase. And if you know of patients who are using this product, you should warn them to stop doing so.

Tags: Recall Moi-Stir Oral Swabsticks FDA Mold Contamination Aspergillus Penicillium Infection Patient Safety