Januvia side effects could include pancreatitis according to FDA

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

Pfizer hit with a record-breaking $2.3 billion in fines

Federal prosecutors hit Pfizer Inc. with a record-breaking $2.3 billion in fines Wednesday and called the world’s largest drug maker a repeating corporate cheat for illegal drug promotions that plied doctors with free golf, massages, and resort junkets.

Announcing the penalty as a warning to all drug manufacturers, Justice Department officials said the overall settlement is the largest ever paid by a drug company for alleged violations of federal drug rules, and the $1.2 billion criminal fine is the largest ever in any U.S. criminal case. The total includes $1 billion in civil penalties and a $100 million criminal forfeiture.

Authorities called Pfizer a repeat offender, noting it is the company’s fourth such settlement of government charges in the last decade. The allegations surround the marketing of 13 different drugs, including big sellers such as Viagra, Zoloft, and Lipitor.

As part of its illegal marketing, Pfizer invited doctors to consultant meetings at resort locations, paying their expenses and providing perks, prosecutors said.

“They were entertained with golf, massages, and other activities,” said Mike Loucks, the U.S. attorney in Massachusetts.

Loucks said that even as Pfizer was negotiating deals on past misconduct, they were continuing to violate the very same laws with other drugs.

To prevent backsliding this time, Pfizer’s conduct will be specially monitored by the Health and Human Service Department inspector general for five years.

In an unusual twist, the head of the Justice Department, Attorney General Eric Holder, did not participate in the record settlement, because he had represented Pfizer on these issues while in private practice.

Associate Attorney General Thomas Perrelli said the settlement illustrates ways the Justice Department “can help the American public at a time when budgets are tight and health care costs are rising.”

Perrelli announced the settlement terms at a news conference with federal prosecutors and FBI, and Health and Human Services Department officials.

The settlement ends an investigation that also resulted in guilty pleas from two former Pfizer sales managers.

Officials said the U.S. industry has paid out more than $11 billion in such settlements over the past decade, but one consumer advocate voiced hope that Wednesday’s penalty was so big it would curb the abuses.

“There’s so much money in selling pills, that there’s a tremendous temptation to cheat,” said Bill Vaughan, an analyst at Consumers Union, the nonprofit publisher of Consumer Reports.

“There’s a kind of mentality in this sector that (settlements) are the cost of doing business and we can cheat. This penalty is so huge I think consumers can have some hope that maybe these guys will tighten up and run a better ship.”

The government said the company promoted four prescription drugs, including the pain killer Bextra, as treatments for medical conditions different from those the drugs had been approved for by federal regulators. Authorities said Pfizer’s salesmen and women created phony doctor requests for medical information in order to send unsolicited information to doctors about unapproved uses and dosages.

Use of drugs for so-called “off-label” medical conditions is not uncommon, but drug manufacturers are prohibited from marketing drugs for uses that have not been approved by the Food and Drug Administration. They said the junkets and other company-paid perks were designed to promote Bextra and other drugs, to doctors for unapproved uses and dosages, backed by false and misleading claims about safety and effectiveness.

Bextra, for instance, was approved for arthritis, but Pfizer promoted it for acute pain and surgical pain, and in dosages above the approved maximum. In 2005, Bextra, one of a class of painkillers known as Cox-2 inhibitors, was pulled from the U.S. market amid mounting evidence it raised the risk of heart attack, stroke and death.

A Pfizer subsidiary, Pharmacia and Upjohn Inc., which was acquired in 2003, has entered an agreement to plead guilty to one count of felony misbranding. The criminal case applied only to Bextra.

The $1 billion in civil penalties was related to Bextra and a number of other medicines.

A portion of the civil penalty will be distributed to 49 states and the District of Columbia, according to agreements with each state’s Medicaid program.

Pfizer’s top lawyer, Amy Schulman, said the settlements “bring final closure to significant legal matters and help to enhance our focus on what we do best — discovering, developing and delivering innovative medicines.”

In her statement, Schulman said: “We regret certain actions taken in the past, but are proud of the action we’ve taken to strengthen our internal controls and pioneer new procedures.”

In financial filings in January, the company had indicated that it would pay $2.3 billion over the allegations.

The civil settlement announced Wednesday covered Pfizer’s promotions of Bextra, blockbuster nerve pain and epilepsy treatment Lyrica, schizophrenia medicine Geodon, antibiotic Zyvox and nine other medicines. The agreement with the Justice Department resolves the investigation into promotion of all those drugs, Pfizer said.

The government said Pfizer also paid kickbacks to market a host of big-name drugs: Aricept, Celebrex, Lipitor, Norvasc, Relpax, Viagra, Zithromax, Zoloft, and Zyrtec.

The allegations came to light thanks largely to five Pfizer employees and one Pennsylvania doctor, who will now share $102 million of the settlement money.

FBI Assistant Director Kevin Perkins praised the whistleblowers who decided to “speak out against a corporate giant that was blatantly violating the law and misleading the public through false marketing claims.”

AP

Stabilet Infant Warmer Recall-Draeger

Stabilet Infant Warmer Draeger: Class 1 recall due to the reasonable probability that use of these products will cause serious injury or death.

The FDA issued a Class 1 recall models of the Stabilet infant warmer because they may cause serious injury to infants and caregivers due to the possibility that the warmer might be the ignition source for a fire.

On July 20, 2009, Draeger sent a recall letter to all known customers, requested customers remove the affected devices from service, remove the heating element and the power cord to make the device unusable once removed from service and emphasized these devices are not to be used, donated or sold for any other purpose.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

Stabilet Infant Warmer models 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200 [Dräeger/Hill-Rom]

Acetaminophen Liver Failure Side Effects

Acetaminophen Liver Failure

Research has shown that hundreds of Americans each year experience acute liver failure as a result of taking acetaminophen — widely known under the brand name Tylenol — and about 100 people die annually from overdosing on the painkiller, either intentionally or unintentionally.

Although researchers have found that the drug is safe if taken at recommended levels, its prevalence in a variety of pain relievers, fever reducers and cough medicines as a somewhat hidden ingredient means patients don’t realize they are taking several drugs that all contain acetaminophen.

History of  Acetaminophen Liver Failure

In the late 1990s, research began to show that acetaminophen was a major cause of acute liver failure in the United States, with up to half of the cases due to accidental overdose. Responding to these concerns, FDA took a number of steps to reduce the incidence of liver injury related to acetaminophen.

In 1998, FDA finalized a regulation that required all OTC acetaminophen products to include an alcohol warning in labeling.

The warning stated: Acetaminophen. ‘‘Alcohol Warning’’: ‘‘If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.’’

In 2002, FDA convened an Advisory Committee meeting to discuss unintentional liver toxicity related to the use of OTC acetaminophen.7 The Advisory Committee recommended a specific liver toxicity warning and distinctive labeling on OTC packages so that products containing acetaminophen could be more easily identified. FDA and manufacturers were also advised to educate consumers and health professionals about the risk of liver injury from acetaminophen.

In early 2004, FDA launched a public education campaign to help consumers use acetaminophen more safely. By most standards, the campaign would be considered small, due to budgetary constraints. It was also limited by reluctance on the part of some commercial outlets to provide a venue for FDA’s message about acetaminophen toxicity as the product was sold or promoted in those outlets. Nonetheless, FDA has continued to expand efforts to improve public education about acetaminophen overdosing and liver injury and has recently updated the acetaminophen information on FDA’s Web site.

In 2004, FDA sent letters to every state board of pharmacy asking them to consider requiring labeling on the immediate container of Rx products containing acetaminophen that: (1) uses the term acetaminophen, not APAP, (2) instructs patients to avoid concurrent use of other acetaminophen containing drugs, (3) instructs patients not to exceed the maximum daily recommended acetaminophen dose, and (4) instructs patients to avoid drinking alcohol during prescription use.8 FDA was informed by the National Association of Boards of Pharmacy that, as of February 2008, no states had implemented regulations related to the request.

In December 2006, FDA issued proposed regulations for OTC labeling for acetaminophen containing products to require inclusion of new safety information and that the container and outer carton identify acetaminophen when it is an ingredient.9 The final version of the regulation is currently under review.

In 2007, the Director of FDA’s Center for Drug Evaluation and Research (CDER) convened a multidisciplinary working group in CDER to continue to evaluate the issues associated with acetaminophen-related liver injury and consider additional steps FDA could take to decrease the number of cases of acetaminophen-related liver injury. The working group considered detailed reviews of the issues from the Office of Nonprescription Products, the Office of Surveillance and Epidemiology and the Division of Anesthesia and Analgesic and Rheumatology Drug Products as part of its deliberations.

Source: FDA 2009 Meeting Materials web page

Related:
Childrens Cold Medicine Recall
Defective Drug Lawyers

acetaminophen liver damage
acetaminophen liver failure
acetaminophen liver transplant
acetaminophen serious liver injury
acetaminophen death

Bard IVC Filter Injury Report

Inferior Vena Cava (IVC) filters are Medical devices which are meant to help prevent blood clots from getting to the lungs.They are placed in patients who are at high risk for blood clots in the lungs.

Defective IVC Filters:
The two defective products are:

• Bard Peripheral Vascular Recovery (Recovery TM)
• G2 Filter (G2TM).

Why are they considered defective?
The IVC filters are said to have caused severe injuries and side effects including:

• Filter Movement
• Fracture of the Filter
• Lung and Heart Puncture
• A few cases resulting in death

Reports by the FDA and Bard indicate that Bard IVC filters higher incidents of these injuries than any other IVC filters.

Zicam Warning by FDA – Consumers Should Stop Taking

Federal drug regulators warned consumers to stop using Zicam, a popular homeopathic cold remedy, because it could damage or destroy their sense of smell.

The action is an early indication that the Obama administration is likely to take far more aggressive enforcement actions againstdrug companies than the Bush administration did.

The Food and Drug Administration received 130 reports from consumers and doctors of people losing their sense of smell after using one of the Zicam nasal products, which include Zicam Cold Remedy and Zicam Cold Remedy Swabs. The reports date to 1999, when Matrixx Initiatives of Scottsdale, Ariz., first introduced the products.

In 2006, Matrixx paid $12 million to settle 340 lawsuits from Zicam users who claimed that the product destroyed their sense of smell, a condition known as anosmia. Hundreds more such suits have since been filed.

Although the F.D.A. took no action during the Bush administration, Dr. Margaret A. Hamburg, who was named the agency commissioner by President Obama, said the incidence of anosmia associated with Zicam “strikes us as a fairly large problem.”

The agency issued its consumer alert even though Matrixx refused to recall its products, a highly unusual event. In a news release, Matrixx said it had suspended shipments of Zicam and would reimburse customers who wanted a refund.

“Matrixx Initiatives stands behind the science of its products and its belief that there is no causal link between its intranasal gel products and anosmia,” the release said. “For this reason, Matrixx Initiatives believes that the F.D.A. action is unwarranted and will seek a meeting with the F.D.A. to review the company’s product safety data.”

Matrixx had $101 million in sales last year, of which $40 million came from Zicam products. Because Matrixx has called Zicam a homeopathic product, the company was not required to seek agency approval before selling it.

The F.D.A. does not have the power to order product recalls but must rely on manufacturers to do so voluntarily. Bills now moving through Congress would give the agency that power. Bush administration appointees said the F.D.A. did not need mandatory recall authority because companies always withdrew unsafe products when asked.

But the government sometimes negotiated for days or weeks before companies agreed to recalls, leading many more consumers to be put at risk. And the Zicam case demonstrates that aggressive enforcement action can lead to disagreements.

An F.D.A. warning letter sent to Matrixx on Tuesday states that Zicam Cold Remedy intranasal products “may pose a serious risk to consumers who use them” and are “misbranded.” Such language would normally describe a recall alert. The products have no proven benefits.

Matrixx has received more than 800 reports of Zicam users losing their sense of smell but did not provide those reports to the F.D.A., said Deborah M. Autor, director of compliance in the agency’s drug center. The law requires producers of approved drugs to forward to the F.D.A. all reports of product-related injuries, but Ms. Autor declined to say whether this reporting requirement applied to Matrixx.

“This disabling loss of one of the five senses may be long lasting or even permanent in some people,” Ms. Autor said. “People without the sense of smell may not be able to detect dangers such as gas leaks or smoke. They could lose much of the pleasure of eating, adversely impacting the quality of life.”

Dr. Charles E. Lee, a compliance officer in the agency’s drug center, said zinc could be toxic to nerve receptors in the nose. In the 1930s, intranasal zinc was tested as a polio preventative, and some patients suffered anosmia, Dr. Lee said.

Blair Robes Recall- 162,000 women’s robes recalled after 6 deaths

Consumers are being urged to immediately stop wearing a certain type of chenille robe made by Blair LLC due to a fire hazard that is believed to have killed at least six people.

The Consumer Product Safety Commission and Blair LLC, based in Warren, Pa., on Thursday said they were issuing the second recall notice in two months after receiving reports of six deaths due to the robes catching on fire. In five of the six cases, the victims were women who were cooking at the time; three of the victims were in their 80s. The recall applied to 162,000 robes.

“CPSC urges all consumers to report any incidents or injuries involving consumer products, even after a recall has been announced,” said acting CPSC Chairman Thomas Moore. “Contact the CPSC so that we may help prevent tragic deaths or injuries like those that might be related to the Blair robes.”
CPSC and Blair initially announced their voluntary recall in April, citing three reports of the robes catching on fire, including one report of second-degree burns.

The robes, made in Pakistan, have the following item numbers: 3093111, 3093112, 3093113, 3093114, 3093115, and 3093116. They are a one-piece garment made of plush sculpted chenille, a shaped stand collar, and horizontal chenille front and back yolks and cuffs. The robes have a full-button front with seven matching button closures.

The robes were sold in Blair catalogs and on the company Web site, as well as Blair stores in Warren, Pa., Grove City, Pa., and Wilmington, Del., from January 2003 through March 2009. Consumers may return the robe to Blair and receive a refund or a $50 gift card by contacting the company at (877) 392-7095 between 9 a.m. and 9 p.m. ET Monday through Saturday, via the firm’s Web site at Blair.com/recall, or by e-mail at blairproductrecall(at)blair.com.

Propylthiouracil PTU Liver Failure FDA WARNING

June 3, 2009 – FDA Alert: Propylthiouracil -Induced Liver Failure

According to the FDA Propylthiouracil (PTU) can cause serious liver injury, including liver failure and death.

PTU is used to manage hyperthyroidism associated with Grave’s disease. It is also used to decrease symptoms of hyperthyroidism in preparation for surgically removing the thyroid gland or before inactivating the thyroid gland with radioactive iodine therapy

Reports to FDA’s Adverse Event Reporting System (AERS) suggest there is an increased risk of hepatotoxicity with PTU when compared with methimazole (MMI).

The FDA has identified 32 AERS cases (22 adult and 10 paediatric) of serious liver injury associated with PTU use. Of the adult cases, 12 deaths and 5 liver transplants occurred. Among the paediatric patients, 1 case resulted in death and 6 in liver transplants.

In contrast, for MMI only 5 AERS cases of serious liver injury were identified. All five cases were in adult patients and 3 resulted in death.

Although both PTU and MMI are indicated for the treatment of hyperthyroidism due to Graves’ disease, healthcare professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves’ disease. PTU may also be used when it is not advisable to remove the thyroid gland.

Physicians should closely monitor patients on PTU therapy for symptoms and signs of liver injury, especially during the first 6 months after initiation of therapy (fatigue, weakness, vague abdominal pain, loss of appetite, itching, easy bruising or yellowing of the eyes or skin).

In general, PTU is considered second-line drug therapy except in patients who are allergic to or intolerant of methimazole. Rare cases of embryopathy, including aplasia cutis, have been reported with use of MMI during pregnancy, while no such cases have been reported with PTU use. Thus, PTU may be more appropriate for patients with Graves’ disease who are in their first trimester of pregnancy.

Agranulocytosis is potentially the most serious side effect of Propylthiouracil therapy. Patients should be instructed to report any symptoms of agranulocytosis, such as fever or sore throat. Leukopenia, thrombocytopenia, and aplastic anemia (pancytopenia) may also occur. The drug should be discontinued in the presence of agranulocytosis, aplastic anemia (pancytopenia), ANCA-positive vasculitis, hepatitis, interstitial pneumonitis, fever, or exfoliative dermatitis. The patient’s bone marrow function should be monitored. Propylthiouracil can cause fetal harm when administered to a pregnant woman.

Because the drug readily crosses placental membranes and can induce goiter and even cretinism in the developing fetus, it is important that a sufficient, but not excessive, dose be given. In many pregnant women, the thyroid dysfunction diminishes as the pregnancy proceeds; consequently a reduction of dosage may be possible. In some instances, Propylthiouracil can be withdrawn 2 or 3 weeks before delivery.

On April 18, 2009, the FDA held a public workshop with the American Thyroid Association (ATA) to discuss PTU-related hepatotoxicity. The FDA is continuing to monitor these serious reported adverse events and working to make changes to the PTU prescribing information, particularly for use in paediatric patients. Also, the ATA plans to update its treatment guidelines for Graves’ disease in the upcoming months.

Reports to FDA’s Adverse Event Reporting System (AERS) suggest there is an increased risk of hepatotoxicity with PTU when compared to methimazole (MMI). Although both PTU and MMI are indicated for the treatment of hyperthyroidism due to Graves’ disease, healthcare professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves’ disease. Physicians should closely monitor patients on PTU therapy for symptoms and signs of liver injury, especially during the first six months after initiation of therapy. PTU and MMI were approved in 1947 and 1950, respectively.

Hydroxycut Recall Information – 5/2/2009

Products included in the Hydroxycut Recall

• Hydroxycut Regular Rapid Release Caplets
• Hydroxycut Caffeine-Free Rapid Release Caplets
• Hydroxycut Liquid Shots
• Hydroxycut Hardcore RTDs (Ready-to-Drink)
• Hydroxycut Max Aqua Shed
• Hydroxycut Hardcore Liquid Capsules
• Hydroxycut Max Liquid Capsules
• Hydroxycut Regular Drink Packets
• Hydroxycut Caffeine-Free Drink Packets
• Hydroxycut Hardcore Drink Packets (Ignition Stix)
• Hydroxycut Max Drink Packets
• Hydroxycut 24
• Hydroxycut Carb Control
• Hydroxycut Natural

Users of Hydroxycut should be aware of symptoms of possible liver damage from hydroxycut, including, jaundice, brown urine, nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite.

Hydroxycut liver failure, injury and death – FDA Warning

May 1 , 2009 – FDA Recall of Hydroxycut due to kidney and liver failure, cardiovascular disorders and even death

As millions of people in the United States attempt to lose weight for a plethora of reasons, many are turning to different products to help them do so. As a result, companies are beginning to research, develop and market these products as a way to accomplish the weight loss they desire in a fast and safe manner.

Unfortunately, some of these weight loss aids are proving to be dangerous, and that appears to be the case with one of the most popular product lines on the market – Hydroxycut products by Iovate Health Sciences, Inc. Below is a brief overview of the burgeoning issue with these products:

The Products

The products at issue are the line of Hydroxycut weight loss aids that are marketed to help consumers weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss, all of which are meant to promote better health because of less weight. These products sold in huge numbers since hitting the market, and they are seen as cost-effective and efficient.

The Problems

The problems that have arisen in response to using them have been not only numerous, but serious in nature.

Specifically, these problems include:

• Seizures
• Cardiovascular disorders
• Rhabdomyolysis – A type of muscle damage that can lead to other serious health problems such as kidney failure.

Perhaps most serious is the trend that points towards different forms of liver damage. These different forms of damage include jaundice and elevated liver enzymes, which can lead to the immediate need for a liver transplant.

At this point, at least 23 reports of serious side effects developing as a result of using these products and one death has been reported. Given the small sample pool and the relatively short amount of time in which they have been generated, the US Food and Drug Administration (FDA) has decided to act now.

FDA’s Response

The FDA has recently issued a public warning to all consumers that they should immediately stop using any of these products until additional investigations can be completed regarding Hydroxycut weight loss products. This investigation centers on the ingredients present in the products and other factors included with their usage.

If you or someone you love has been harmed as a result of using Hydroxycut weight loss products, contact a defective drugs lawyer as soon as possible to schedule a free initial consultation.

Bone Screw Recall – Calaxo Screws

Smith & Nephew Inc. is recalling all lot numbers and all item codes of CALAXO screws which were
first distributed in the UK in 2006. This screw is used to secure the graft in anterior cruciate
ligament (ACL) reconstruction.

Worldwide, 0.3% of patients have developed pre-tibial soft tissue swelling, which can mimic the
appearance of an infection between 2 and 36 weeks after implantation. The manufacturer is
currently investigating the cause of this problem.

Most cases resolved without intervention. A small number of cases needed local debridement and
removal of any remaining screw fragments, or replacement with an alternative screw or bone graft.
The manufacturer estimates that about 2,550 devices have been used in the UK since 2006.
The manufacturer is aware of seven reported cases of inflammation in the UK of which two
required implant revision.

The manufacturer wrote to chief executive officers of trusts, theatre managers, and surgeons who
were known to use CALAXO about this product recall in August 2007 (see MHRA website). This
notice is to facilitate the recall.

Digoxin Recall – Caraco Brand

Caraco Pharmaceutical Laboratories and FDA notified healthcare professionals of a consumer-level recall of Caraco brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of September, 2011.

The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin, a drug product used to treat heart failure and abnormal heart rhythms. The drug has a narrow therapeutic index and the existence of higher than labeled dose may pose a risk of digoxin toxicity in patients with renal failure.

Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and bradycardia. Death can also result from excessive digoxin intake. A lower than labeled dose may pose a risk of lack of efficacy potentially resulting in cardiac instability.

Consumers with the recalled product should return these products to their pharmacy or place of purchase.

Pistachios Recall Salmonella Warning

A California pistachio processor issued a nationwide voluntary recall on Tuesday of pistachios due to potential salmonella contamination.

The U.S. Food and Drug Administration and the California Dept. of Public Health are investigating the matter. Thus far, several illnesses have been reported by consumers that may be associated with the pistachios, the FDA said.

The recalled nuts were shipped on or after Sept. 1, 2008 by Setton Pistachio of Terra Bella Inc.

Propafenone HCL Tablets Recall

Propafenone HCL Tablets 225 mg Recall

Recalled lot number: 112680A, expiration date July 31, 2010
Product Name: Propafenone HCL tablets
Shipped: Between October 15, 2008 and November 26, 2008.

The lot is being recalled because some tablets may contain slightly higher levels of the active ingredient than specified. The recalled tablets were manufactured by Watson Laboratories, Inc.

Because it has a narrow therapeutic index, some patients who are particularly sensitive to small variations in dose may experience potentially , including arrhythmias (irregular heartbeat) or low blood pressure.

Propafenone is a drug product used to treat cardiac arrhythmias (irregular heartbeats). It has a narrow therapeutic index, so some patients who are particularly sensitive to small variations in dose may experience potentially serious side effects, including arrhythmias (irregular heartbeat) or low blood pressure. Consequently, as a precautionary measure, Watson is recalling this one lot to the consumer level to minimize any potential risk to patients.

Anyone who has 225 mg Propafenone HCL tablets should check the bottle for the lot number and expiration date to see if they have tablets being recalled. Anyone with 225 mg Propafenone HCL tablets being recalled should call (888) 352-9616, Monday through Friday, 8:00 a.m.-5:00 p.m. EDT, for instructions on how to return affected product.

Patients using 225 mg Propafenone HCL tablets who have medical questions should contact their health-care provider.

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch

FDA Warns of Health Risk for Sharing Insulin Pens

According to the FDA, sharing insulin pens can put patients at risk of transmitting hepatitis viruses, HIV, and other blood-borne pathogens.

Insulin pens are not designed, and are not safe, for one pen to be used for more than one patient, even if needles are changed between patients because any blood contamination of the pen reservoir could result in transmission of already existing blood-borne pathogens from the previous user.

The FDA is working with the Centers for Disease Control and Prevention, professional societies and health care organizations to reinforce patient and health care provider education about proper and safe use of insulin pens.

Baxter Infusion Pump Recall

A Class 1 Recall of  Baxter infusion pumps by the FDA.

Colleague Single and Triple Channel Volumetric Infusion Pumps by Baxter
The Model numbers are:

• Mono 2M8151 and 2M8153

• CX 2M8161 and 2M8163

• CXE 2M9161 and 2M9163

The defective Pumps were manufactured and distributed from February, 1997 through December, 2008.

The company identified software and battery usage failures that result in a delay in or interruption of infusion that may cause serious injury and/or death. Baxter sent a letter to all of its customers, which included advice and instructions to institutions using the infusion pumps.

Chinese Drywall Lawsuit by Florida Homeowners

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.

Next Page »