Onglyza – Emerging Litigation

Onglyza (Saxagliptin) – Case Review – Focus blocks

Onglyza belongs to a class of drugs known as Incretin Mimetics, which stimulate the production of insulin in the pancreas to help regulate blood sugar levels in patients with Type-2 diabetes. It was approved for the treatment of Type-2 diabetes in 2009.

Specifically, they belong to a class of drugs called Dipeptidyl peptidase-4 (DPP-4) inhibitors. These medicines help the pancreas secrete more insulin and stop the liver from making excess sugar and help the body produce more insulin after meals.

Manufacturer: Bristol-Myers and AstraZeneca

Dosage Forms and Strengths:

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Contraindications:

  • Type 1 Diabetes Mellitus
  • Diabetic Ketoacidosis
  • History of a serious hypersensitivity reaction (E.g., anaphylaxis, angioedema, exfoliative skin conditions) to Onglyza

FDA Drug Safety Communication

The FDA has been investigating a link between incretin mimetics such as Onglyza and a heightened risk for thyroid cancer since 2009.

Pancreatitis:

In November 2011, information about pancreatitis was added to Onglyza’s warnings and precautions. Pancreatitis is inflammation of the pancreas; serious cases require hospitalization and can lead to death. Pancreatitis can also lead to pancreatic cancer.

Heart Failure:

[02-11-2014] The U.S. Food and Drug Administration requested a clinical trial data from the manufacturer of Saxagliptin to investigate a possible association between use of the type 2 diabetes drug and heart failure. The request resulted from a study published in the New England Journal of Medicine (NEJM), which reported an increased rate of hospitalization for heart failure, when the heart does not pump blood well enough, with use of Saxagliptin (Marketed as Onglyza and Kombiglyze XR) compared to an inactive treatment. The study did not find increased rates of death or other major cardiovascular risks, including heart attack or stroke, in patients who received Saxagliptin. The manufacturer is expected to submit the trial data to FDA by early March 2014, after which we will conduct a thorough analysis and report our findings publicly.

April 14, 2015: Study reveals a 27% increase in the rate of hospitalizations for heart failure in Onglyza-treated subjects.

FDA Public Warning Issued for Increase of Acute Pancreatitis, Pancreatic Cancer

Heart failure is not the only potentially fatal condition with a documented link to Onglyza. In 2013, the FDA warned that people taking Onglyza and similar drugs may be more likely to develop pancreatic cancer.

Onglyza is what’s known as a DPP-4 inhibitor. The FDA has warned that these drugs appear to increase the risk of cancerous growth in the pancreas. The warning was prompted by a 2011 study in Gastroenterology which linked a similar drug to a 2.7 times increased risk of pancreatic cancer.

Heart failure and pancreatic cancer are potentially fatal conditions, and the risks should not be taken lightly. The makers of Onglyza should have warned the public of these life-threatening complications

Serious Side Effects:

·         Heart Failure

·         Pancreatic Cancer

·         Pancreatitis

·         Thyroid cancer

Common side effects

  • Diarrhea
  • Headache
  • Nausea and vomiting
  • Stuffy or runny nose
  • Sore throat
  • Upper respiratory tract infection
  • Urinary tract infection
  • Low blood sugar
  • Swelling or fluid retention

 

CASE REVIEW FOCUS AREAS:

1. Whether the patient was prescribed Onglyza?

2. Reason for Onglyza Prescription?

3. Dosage and Intake details

Critical Review of

  • Physician Drug Prescription Details
  • Pharmacy Dispensing Details
  • Pharmacy Refill Details
  • Details of Pharmacy Dispensing Details are taken as Confirmatory

4. Did the patient have any pre-existing conditions, allergies or contraindications for Onglyza?

5. What was the injury due to Onglyza?

6. When and where was the injury diagnosed? Whether hospitalized? Dates of hospitalization?

  • Treatment/management. Any complications
  • Follow-up visits for treatment/management of injury.
  • Outcome/prognosis. Resolution of injury?

Specific Focus:

Identify and report cases with the following scenarios:-

  1. No Injuries: Patient took Onglyza but did not develop any injuries
  2. No Onglyza intake: Patient was given a different drug and not Onglyza. Hold case and communicate to client
  3. Onglyza contraindicated in patient but still prescribed
  4. Any medical/surgical history, social history that could have had an effect on the injury

Missing record communication:

Identify and report on missing medical records

Apart from identifying critical missing records that are important for the case, provide a detailed outline on what records are needed, why we need them, how did we get a clue that these records are missing and whether the records missing are confirmatory/probable. This will also help in following up and retrieving the records.

Missing Records are presented in the following format

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