Medtronic SC catheters recall – serious injury or death possible

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.

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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.

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Ocella Lawsuit Information

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.

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Yasmin Lawsuit Information
Yasmin side effectsYasmin side effects

Yasmin Lawsuit Information

Law firms recently have started taking inquires from people who may have a potential  yasmin lawsuit due to injury from side effects.

The FDA issued a letter to Bayer AG and strongly suggested that they talk about the numerous side effects. The FDA felt that the ads were misleading These claims are misleading because they suggest that Yasmin’s “different kind of hormone” offers unique “chemistry” benefits and that this difference contributes to the high rate of drug efficacy.

Yasmin is a type of birth control pill marketed and manufactured by the German company Bayer Schering Pharma AG Yasmin first entered the American market in 2001 and has generated close to 500 million in sales to date.Yasmin is an oral contraceptive and is a synthetic spironolactone analogue known in the medical world as drospirenone.

Drospirenone binds to the progesterone receptor, the resulting complex becomes activated and binds to specific sites on DNA. This leads to an increased difficulty of sperm entry into the uterus and implantation.

When the Yasmin TV advertising started the FDA took issue with the television commercials which featured women discussing the benefits of the product. The ads had a music score and dialog between the actors.

While there has been no official Yasmin recall, the U.S. Food and Drug Administration (FDA) has warned Bayer AG that the advertising campaign for Yasmin and Yaz were misleading, namely that the ads suggested a broad useage of the medication, minimized potentially serious side effects, and overstated the efficacy of the pill.

Twice have letters been sent to Bayer AG, and once has Bayer AG been ordered to correct its ads, costing the company a total of $20 million. Bayer AG is also under obligation to submit future ad campaigns to the FDA for approval before it launches them in the U.S.

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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