Januvia Recall

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Cautions about the use of Januvua

Users of the diabetes drugs Januvia or Janumet should be aware that the medications have been associated with a number of cases of pancreatitis, which may be caused by side effects of Januvia. The FDA issued an alert to notify doctors and consumers about revisions to the warning label regarding post-marketing reports of acute pancreatitis, including severe forms, hemorrhagic pancreatitis and necrotizing pancreatitis.

Between October 2006 and February 2009, the FDA’s Adverse Event Reporting System has identified at least 88 cases of acute pancreatitis associated with the use of Januvia (sitagliptin) and Janumet, which combines Januvia with metformin. The actual number of Januvia pancreatitis cases is likely substantially higher, as reported events usually only account for between 1% and 10% of all occurrences.

Some concerning information provided by the FDA about the Januvia pancreatitis side effects include:

• 66% of the cases resulted in hospitalization for pancreatitis
• 4 cases required treatment in an intensive care unit (ICU)
• 2 cases involved severe cases of hemorrhagic or necrotizing pancreatitis, which can be fatal in many cases
• 21% of the cases had pancreatitis develop within 30 days of starting Januvia or Janumet
• 53% of the cases resolved once the medication was stopped
• 49% of the cases were not associated with other risk factors for developing pancreatitis
• The most common pancreatitis symptoms from Januvia were abdominal pain, nausea and vomiting

According to the information provided to healthcare professions about the Januvia pancreatitis warning, the FDA concluded:

Based on the temporal relationship of initiating sitagliptin (Januvia) or sitagliptin/metformin (Janumet) and development of acute pancreatitis in reviewed cases, FDA believes there may be an association between these events. 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 healthcare professionals to this potentially serious adverse drug event.

Januvia Pancreatitis Lawsuit Attorneys

The experienced attorneys at Sanders Phillips Grossman are examining the information provided by the FDA and evaluating whether users of these diabetes drugs who have experienced a severe injury may be entitled to compensation through a Januvia lawsuit as a result of the drug maker’s failure to adequately warn about this serious and potentially life-threatening side effects.

The FDA has not indicated that any users of Januvia or Janumet should stop taking their medication, and no medication (especially a diabetes drug) should be discontinued without the supervision of a physician. Any concerns about the potential for Januvia pancreatitis side effects should be reviewed with a doctor.

Symptoms of pancreatitis could include:

• Severe upper abdominal pain which may radiate through the back
• Nausea and Vomiting
• High or Low Blood Pressure
• Elevated Heart or Respiratory Rates

Contact Sanders Phillips Grossman for a Free Case Review

Sanders Phillips Grossman is accepting cases for those injured by this product nationally. If you or someone you love has suffered a major complication due to the use of this product, it is important to know that you are not alone. Fill out the free case review and we will contact you to discuss your claim. Sanders Phillips Grossman has experienced lawyers ready to help you with your questions to get you the compensation you deserve. We have a no fee promise. If we do not win, you do not owe an attorney fee.

FDA studies possible pre-cancerous link with diabetes drugs

By Ransdell Pierson

Thu Mar 14, 2013 12:22pm EDT

(Reuters) – The U.S. Food and Drug Administration is studying unconfirmed reports that a widely used class of diabetes drugs, which includes Merck & Co’s Januvia, may cause inflammation of the pancreas and pre-cancerous changes to the pancreas.

The agency, in a notice on its website on Thursday, said it is the first time it has communicated potential pre-cancerous links to the medicines, known as incretin mimetics. The oral treatments also include Onglyza from Bristol-Myers Squibb Co and AstraZeneca PLC.

Patients should continue taking their medicines as directed until speaking with health care professionals, the agency said. The FDA said it is investigating findings from academic researchers that highlighted the potential risk.

“These findings were based on examination of a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes,” the agency said.

The FDA has asked the researchers to explain how they collected and studied the specimens and to provide tissue samples so the agency can further assess any possible risks.

In the meantime, the FDA said it has not reached any new conclusions about safety risks of the class of drugs.

The agency noted it has previously warned the public about acute pancreatitis, including fatal and nonfatal cases, seen with the medicines. Package insert labels for the class of drugs already warn about risk of the potentially dangerous inflammation.

“It’s too early to tell, but we’ll keep an eye on it,” Edward Jones analyst Judson Clark said, when asked about the significance of the potential safety issues in Thursday’s FDA advisory.

But Clark said he did not expect any immediate changes in prescribing habits for the drugs because the pancreatitis risk is already noted on the drug labels.

Merck’s Januvia and its related drug called Janumet, had combined sales last year of almost $6 billion, making them by far the company’s biggest product franchise. Onglyza and a related drug called Kombiglyze had sales last year of $709 million.

Shares of Merck were down 0.9 percent, while Bristol-Myers slipped 0.5 percent, in midday trading on the New York Stock Exchange. Shares of AstraZeneca were up 0.6 percent, also on the NYSE.

(Reporting By Ransdell Pierson; editing by Sofina Mirza-Reid)

http://www.reuters.com/article/2013/03/14/us-diabetes-pancreas-fda-idUSBRE92D0S920130314