Consumer News Weekly » HEALTH

Medtronic SC catheters recall – serious injury or death possible

allenh — Fri, 25 Sep 2009 20:12:39 +0000

Certain Medtronic SC Catheters and Revision Kit Models may pose a risk of serious injury or death to patients when paired with the Medtronic IsoMed Pump Model 8472 according to the FDA.

Here is a list of models issued for the Class 1 recall by the FDA:

8709SC
8731SC
8578
8596SC

This is because of a design compatibility issue causing a physical interference between the SC catheter connector and the IsoMed pump.

This may prevent the SC catheter from completely connecting to the IsoMed pump, even though it may appear to be connected and feel secure and may lead to disruptions of therapy and revision surgery, which pose a risk of serious injury or death.

Related Topics

Medtronic Recall Information

Defective Device Information

Mesothelioma Attorney

Pain pump Lawsuit

Januvia side effects could include pancreatitis according to FDA

Jay Genkins — Fri, 25 Sep 2009 19:49:30 +0000

Diabetes treatment Januvia and Janumet ( sitagliptin / metformin ) could be linked to occurrences of acute pancreatitis, According to the FDA.

This is the same problem that sunk sales of Amylin Pharmaceuticals Inc.’s Byetta.

88 cases of acute pancreatitis were reported to the fda in Januvia patients between 10/06 and 02/09.

The agency is working with Merck to include new warning information on the drug’s label.
“It is recommended that health care professionals monitor patients carefully for the development of pancreatitis after initiation or dose increases,” the agency said, in a statement.

Patients who take these drugs are advised by the FDA to discuss this news with thier doctor and advice that healthcare professionals monitor patients carefully for the development of pancreatitis after initiation or dose increases of sitagliptin or sitagliptin/metformin.

Still, the agency said it is unknown whether these patients are at an increased risk for developing pancreatitis and the medication should be used with caution and with appropriate monitoring in patients with a history of the condition.

“Because acute pancreatitis is associated with considerable morbidity and mortality, and early recognition is important in reducing adverse health outcomes, FDA is recommending revisions to the prescribing information to alert health care professionals to this potentially serious adverse drug event,” the agency said.

What is sitagliptin?

Sitagliptin is an oral diabetes medicine that helps control blood sugar levels. It works by regulating the levels of insulin your body produces after eating.

Sitagliptin is for people with type 2 diabetes (non-insulin-dependent) diabetes. Sitagliptin is sometimes used in combination with other diabetes medications, but is not for treating type 1 diabetes.

Sitagliptin may also be used for other purposes not listed in this medication guide.

If you or someone you care about has taken a medication and suffered adverse side effects, we urge you to contact our law offices today. You may have actually injected or ingested a defective drug; if so, you could be entitled to monetary compensation for any pain and suffering that resulted from your experiences with the product.

More topics
Byetta Settlement

Fixodent Class Action Lawsuit

Nephrogenic systemic fibrosis NFS From Gadolinium

Ocella Lawsuit Information

slonge — Tue, 22 Sep 2009 21:02:32 +0000

Ocella class action lawsuits starting with possible case settlements for Ocella victims.

Birth control pills have been around for quite some time and in fact are being used by thousands who try to prevent themselves from getting pregnant. A birth control pill is an oral contraceptive which contains hormones that try to stop ovulation so that the female will be unable to produce an egg for the male sperm to fertilize.

There are many types of birth control pills that are circulating in the market today although one has to be very careful in choosing which birth control pill to use and whether it is safe for your body or not.

One of these is Ocella.

The same brand of pill may cause side effects in most women but it may have only a slight adverse effect on others. These side effects may generally depend on the overall health condition of the woman taking the contraceptives. But most of the times, however, the side effects caused by taking oral contraceptives or birth control pills may go unnoticed for a little while and the woman taking it would usually overlook the changes that is happening to her.

Some of the changes that may not be noticed for a short time would be mood changes, headaches and weight gain.

Mood changes are also one of the side effects that may go unnoticed by the woman taking birth control pills. This change can only be noticed by the people around her but not by the woman herself.

These things may only be considered as somewhat probably minor changes, but still, this should be a cause for concern already because it might lead to something serious since some of the more serious side effects of birth control pills are blood clots, heart diseases, breast and liver cancer.

Ocella Attorneys are interested in hearing from any women that has suffered the above side effects.

Chinese Drywall Lawsuit by Florida Homeowners

Jay Genkins — Thu, 12 Mar 2009 23:12:16 +0000

Florida Home owners have filed another Chinese Drywall Lawsuit. This is the latest of four lawsuits filed so far and allege that tens of thousands of florida homes could be built with the defective Drywall from China.

Several homeowners have complained of “rotten egg” smells coming from the drywall. Drywall is usually manufactured in the United States but due to recent shortages, many contractors were forced to use the Chinese made Drywall.

The company behind the supply of the defective products is Knauf Plasterboard Tianjin Co. Ltd. of China, a subsidiary of German-based manufacturer Knauf Group.

The health department said that most of the homes being investigated were built after 2004, but one home that is the subject of complaints was built in 2001.

The U.S. Consumer Product Safety Commission and Florida Department of Health have announced their own investigations to determine whether the Chinese drywall poses a threat to public safety or health.

The U.S. Consumer Product Safety Commission said last week it was investigating complaints that Chinese-made drywall was emitting odors and causing appliance problems in homes.

Several people have come forward and many more are expected to as Florida homeowners find out that issues are related to the Chinese Drywall.

BPA baby bottle Ban – NY Law Makers Vote

Jay Genkins — Thu, 05 Mar 2009 01:17:38 +0000

NY county lawmakers vote to ban GARDEN CITY, N.Y. (AP) — Lawmakers in a Long Island county have voted to approve what would be the nation’s first ban on baby bottles and toddler sippy cups made with a chemical that some studies suggest may be harmful to infants.

The ban on Bisphenol-A (BPA) was approved unanimously by the Suffolk County Legislature on Tuesday. It will take effect if County Executive Steve Levy signs it, but he has not indicated whether he will do so.

The FDA had said last fall that BPA was safe, but after an independent report found deep flaws in its study the agency announced in December that it was planning more research.

Bill would Strengthen the FDA with more Authority

Jay Genkins — Thu, 05 Mar 2009 01:07:41 +0000

The legislation would expand FDA access to food company records and tests, give it authority to order mandatory food recalls, and increase funding.

Lawmakers and critics say this bill is a step in the right direction, but a step that should have been taken years ago.

Industry is open to change, said Scott Faber, a top lobbyist for the Grocery Manufacturers Association, which represents large food and beverage companies.

“The food industry recognizes that we need to give FDA new powers and new resources to address new challenges,” Faber said.

Businesses are concerned about reorganizing the entire system. The priority should be strengthening the current agencies before rearranging them, he said.

The GAO, the investigative arm of Congress, recommended two years ago that Congress re-examine the system. It said 76 million people are sickened by food-borne illness each year, and 5,000 die.

But few changes have been made. And despite the salmonella outbreak, even the lawmakers urging changes say a streamlined new agency is unlikely any time soon.

In related News, a study suggests that the FDA should have more oversight on supliments. More than half of all American adults, or at least 114 million people, use dietary supplements like vitamin pills, diet pills, herbs and energy drinks. But the Food and Drug Administration does not have enough authority to ensure that the products are safe, and it should seek more oversight power, according to a government audit released Tuesday.

In January, the Food and Drug Administration issued a warning on 69 weight-loss products. The agency, however, cannot require manufacturers to remove supplements from shelves.

The new report from the federal Government Accountability Office acknowledged that the F.D.A. had taken some steps in the last few years to supervise the supplement industry more closely — but the report said those steps did not go far enough.

In the first 10 months of last year, for example, the audit said the F.D.A. received 948 reports of health problems associated with dietary supplements, but not necessarily directly caused by them. Those included 9 deaths, 64 life-threatening illnesses and 234 hospitalizations.

Congress requested the evaluation of how the FDA regulates these popular products. The Nutrition Business Journal reports that 79% of adult Americans take dietary supplements.

VITAMINS: Give ‘em an ‘F’ in cancer prevention

BETTER LIFE: Vitamin use common in kids

The GAO listed a number of areas in which the FDA has little oversight. For example, supplement companies don’t have to tell the FDA what products they sell or ingredients they use.

Raptiva and PML Side Effects Brain Infection Lawyer

Fixodent, Polident Denture Cream Zinc Poisoning & Neuropathy

Complete List Peanut Butter Products Recalled to Date

Jay Genkins — Wed, 11 Feb 2009 19:44:40 +0000

Please see below for the complete list of recalled peanut butter products as of Feb 10 2009.

For the current list and more information, the best place to go is the FDA page dedicated to this.
http://www.fda.gov/oc/opacom/hottopics/salmonellatyph.html

Peanut Butter Recall List – Feburary 2009 FDA Press Releases

Peanut Butter Recall List – January 2009 FDA Press Releases

January 2009 Press Releases

—————-More information from the CDC———————-

Update for February 9, 2009 (next web update will be available Thursday, February 12)

Today’s Highlights

Case count is 600 in 44 states with latest confirmed, most recent reported illness beginning on January 23, 2009
Major national brands of jarred peanut butter found in grocery stores are NOT affected by the Peanut Corporation of America (PCA) recall.
Consumers may use FDA’s online database* to see if foods are on the recall list. Those without Internet access may call 1-800-CDC-INFO (available 24 hours a day, seven days a week) for product recall information.
Additional Advice for Consumers
Salmonella Signs and Symptoms
Pets: Questions and Answers Related to the Salmonella Typhimurium Outbreak and Pets
Multistate Outbreak of Salmonella Infections Associated with Peanut Butter and Peanut Butter-Containing Products — United States, 2008–2009. Morbidity and Mortality Weekly Report, January 29, 2009 / 58 (Early Release);1-6.
Salmonella Strains Tables for Outbreak Related to Peanut Butter and Peanut-Containing Products
CDC Podcast – What Kids Need to Know About Peanut Butter and Salmonella
CDC Podcast – Salmonella Serotype Typhimurium Outbreak in Peanut Butter and Peanut Butter-Containing Products
CDC’s Role During a Multi-State Foodborne Outbreak Investigation
CDC’s Role in Food Safety
CDC E-cards Related to Salmonella Outbreak

Outbreak Investigation | Recommendations/Advice to Consumers | Clinical Features/Signs and Symptoms | CDC’s Role in Food Safety | Previous Updates

Why has Salmonella been in the news recently?

The Centers for Disease Control and Prevention (CDC) has been receiving reports, from many states, of illnesses caused by a type of Salmonella called Salmonella Typhimurium. Several deaths may also be associated with this outbreak. Tests indicate that the people who became sick may have eaten the same contaminated food, because they were infected with the same strain of Salmonella Typhimurium (i.e., the strain of Salmonella shared the same genetic “fingerprint”). Additional information on the numbers of illness and the states in which they occurred can be found at www.cdc.gov/salmonella/typhimurium/.

Is the salmonellosis outbreak definitely linked to peanut butter?

A combination of epidemiological analysis and laboratory testing by state officials in Minnesota and Connecticut, the Food and Drug Administration (FDA), and CDC enabled FDA to confirm that the sources of the outbreak were peanut butter and peanut paste produced by the Peanut Corporation of America (PCA) at its Blakely, Georgia, processing plant. Peanut paste is a concentrated product consisting of ground, roasted peanuts that is distributed to food manufacturers to be used as an ingredient in many commercially produced products including cakes, cookies, crackers, candies, cereal and ice cream.

FDA- Consumer Medication Information Not Always Useful

Jay Genkins — Tue, 16 Dec 2008 21:38:31 +0000

12/15/07 – Study Finds Much of Private-Sector Consumer Medication Information Not Consistently Useful

A study released today by the U.S. Food and Drug Administration found that the printed consumer medication information (CMI) voluntarily provided with new prescriptions by retail pharmacies does not consistently provide easy-to-read, understandable information about the use and risks of medications.

The study, Expert and Consumer Evaluation of Consumer Medication Information, showed that while most consumers (94 percent) received CMI with new prescriptions, only about 75 percent of this information met the minimum criteria for usefulness as defined by a panel of stakeholders. In 1996, Congress called for 95 percent of all new prescriptions to be accompanied by useful CMI by 2006.

“The current voluntary system has failed to provide consumers with the quality information they need in order to use medicines effectively and safely,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Because the congressional goals have not been met, the FDA intends to seek public comment on initiatives that can be used to meet the goals.”

CMI has been defined as being useful if it includes scientifically accurate, unbiased information that is presented in an understandable and legible format. Specifically, CMI should include the drug name and uses, how to monitor for improvement in the condition being treated, contraindications (situations when the medicine should not be used), symptoms of serious or frequent adverse reactions and what to do, and certain general information, including statements encouraging patients to talk to their health care professional.

“We need to work with pharmacy operators, drug manufacturers, health care professionals, and consumers to come up with a sensible, comprehensive and more effective solution,” said Woodcock.

In early 2009, the FDA Risk Communication Advisory Committee will hold a public meeting to discuss the study’s findings. In addition, the FDA has created a Web site to receive public comment on the study and solicit feedback on the best ways to provide useful prescription information to consumers.

If you or someone you love was injured by the severe side effects of Defective Drugs you may be entitled to pursue financial compensation for your pain and suffering, but if you wait too long laws called statutes of limitations could prevent you from pressing your case. Let a dedicated and experienced defective drug attorney help you get you the restitution you deserve.

Contact a Defective Drug lawyer today

Call 1-888-775-3779 or fill out our FREE CASE REVIEW form.

Previous FDA Stories-

Byetta Diabetes Drug Warning by FDA

Jay Genkins — Mon, 18 Aug 2008 23:18:53 +0000

The FDA has received reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta.

Update Aug. 27 The makers of the type 2 diabetes drug Byetta reported Tuesday the deaths of four more people who’d been taking the medication.

Byetta is a medicine given by subcutaneous injection to help treat adults with type 2 diabetes. Of the 6 cases of hemorrhagic or necrotizing pancreatitis, all patients required hospitalization, two patients died and four patients were recovering at time of reporting. Byetta was discontinued in all 6 cases.

Byetta and other potentially suspect drugs should be promptly discontinued if pancreatitis is suspected. There are no signs or symptoms that distinguish acute hemorrhagic or necrotizing pancreatitis associated with Byetta from the less severe form of pancreatitis.

The FDA is warning patients taking Byetta that there have been “very rare case reports of pancreatitis with complications or with a fatal outcome.”

Six more reports of patients developing pancreatitis while taking Byetta. Two patients died and 4 were recovering.

Regulators stressed that patients should stop taking Byetta immediately if they develop signs of acute pancreatitis, a swelling of the pancreas that can cause nausea, vomiting and abdominal pain. The FDA warned that it is very difficult to distinguish acute pancreatitis from less dangerous forms of the condition.

The FDA announcement updated an October alert about 30 reports of Byetta patients developing pancreas problems. At that time Byetta’s makers agreed to add information about the reports to the drug’s label.

However, the FDA made clear Monday that it is seeking a stronger, more prominent warning about the risks.

Amylin and Eli Lilly said in a statement that patients taking Byetta have shown “very rare case reports of pancreatitis with complications or with a fatal outcome.” The companies added that diabetes patients are already at increased risk of pancreatitis compared with healthy patients.

The pancreas produces several important biological fluids, including insulin — the sugar-regulating hormone that most diabetics lack.

If pancreatitis is confirmed, initiate appropriate treatment and carefully monitor the patient until recovery. Byetta should not be restarted. Consider antidiabetic therapies other than Byetta in patients with a history of pancreatitis.

Read the complete MedWatch 2008 Safety Summary, including a link to the ‘”Information for Healthcare Professionals”

Byetta Lawyers are available for free consultations for people who have been affected by the side effects of this drug.

Carbatrol Lawsuit filed

Jay Genkins — Thu, 17 Jul 2008 01:02:04 +0000

Generic versus brand name drugs are always an issue for pharmaceutical companies. If there are drug companies producing generic versions of drugs illegally, then it should very well be an issue.

This is the case with Shire who has a track record of filing lawsuits against other drug companies. This time they are filing patent infringement lawsuits against Nostrum Pharmaceuticals and Apotex for attempting to apply to be able to market versions of its anti-seizure drug Carbatrol.

Carbatrol is used to treat patients who suffer seizures disorders and trigeminal neuralgia. Trigeminal neuralgia is described as episodes of “sudden, brief, recurrent, stabbing facial pain.”

There are rules and regulations that must be followed when producing generic drugs some of which are in place to protect consumers. If a company is not following these rules they can be detrimental to the public health.

This is the cause of some pharmaceutical drug recalls. Consumers use the recalled drug ignorant of its recall status and consequently suffer extreme adverse effects and sometimes death.

If you have taken a drug and have experienced any adverse side effects consult with one of our attorneys as well as visit our website at www.kerrysteigerwalt.com. (Always seek the medical attention you need first.)

Cipro Side Effects draw Black Box Warning by FDA

Jay Genkins — Tue, 15 Jul 2008 07:26:50 +0000

The (FDA) anounced to the makers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary.

Through its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA), the agency also determined that it is necessary for manufacturers of the drugs to provide a Medication Guide to patients about possible side effects.

Many people agree that the FDA is simply not doing enough about drugs like this.

Fluoroquinolones are drugs approved for the treatment or prevention of certain bacterial infections. Like other antibacterial drugs, fluoroquinolones do not treat viral infections such as colds or flu.

“Fluoroquinolones are effective in treating certain bacterial infections, but health care professionals and patients need to be aware of the increased risk associated with the use of these drugs of developing tendinitis and tendon rupture, particularly for certain patient populations,” said Edward Cox, M.D., director, Office of Antimicrobial Products, Center for Drug Evaluation and Research.

“The FDA believes it is important to highlight and strengthen information regarding possible side effects of fluoroquinolones because it may affect decisions about the relative risks and benefits associated with these products.”