Synopsis of Prescription Drug Litigation
The FDA initially approved Onglyza on July 31st 2009, a new oral hypoglycemic (anti-diabetic drug) closely related to the drug Januvia. There is a cancer risk of these types of drugs because it is known to suppress certain types of cancers (malignancies). Other possible adverse effects include pancreatitis, liver toxicity and extreme allergic reactions.
Onglyza® (saxagliptin): Manufactured by Bristol Myers, Squibb and approved by the FDA in 2009. Onglyza belongs to a class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors. The medication is used to reduce blood sugar in Type-1 diabetic patients.
Why is this medication prescribed?:
Saxagliptin is used along with diet and exercise to lower blood sugar levels in patients with type 2 diabetes (condition in which blood sugar is too high because the body does not produce or use insulin normally). Saxagliptin is in a class of medications called dipeptidyl peptidase-4 (DPP-4) inhibitors. It works by increasing the amount of insulin produced by the body after meals when blood sugar is high. Saxagliptin is not used to treat type 1 diabetes (condition in which the body does not produce insulin and, therefore, cannot control the amount of sugar in the blood) or diabetic ketoacidosis (a serious condition that may develop if high blood sugar is not treated).
FDA indications: ONGLYZA is a dipeptidyl peptidase-4 inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus in multiple
clinical settings. It should not be used for the treatment of type-1 diabetes mellitus or diabetic ketoacidosis.
What special precautions should I follow?:
Before taking saxagliptin,
- tell your doctor and pharmacist if you are allergic to saxagliptin, any other medications, or any of the ingredients in saxagliptin tablets. Ask your pharmacist or check the manufacturer's patient information for a list of the ingredients.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: certain antifungal medications such as itraconazole (Sporanox) and ketoconazole (Nizoral); clarithromycin (Biaxin); certain medications for HIV (human immunodeficiency virus) or AIDS (acquired immunodeficiency syndrome) such as atazanavir (Reyataz), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), and saquinavir (Invirase); insulin or oral medications for diabetes such as acetohexamide, chlorpropamide (Diabinese), glimepiride (Amaryl, in Avandaryl), glipizide (Glucotrol, in Metaglip), glyburide (Diabeta, Glynase, in Glucovance), nateglinide (Starlix), pioglitazone (Actos, in Actoplus Met, in Duetact), repaglinide (Prandin), rosiglitazone (Avandia, in Avandamet, in Avandaryl), tolazamide, and tolbutamide; nefazodone; and telithromycin (Ketek). You doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have ever had diabetic ketoacidosis and if you have or have ever had HIV or kidney disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking saxagliptin, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking saxagliptin.
- talk to your doctor about what you should do if you get hurt or if you develop a fever or infection. These conditions may affect your blood sugar and the amount of saxagliptin you may need.
Lawsuits: There are currently no pending lawsuits for Ongyza in the U.S. since it was just released for marketing in 2011.
When to call the Venardi Law Firm: Even though it was only released in 2009, Onglyza side effects have already drawn the FDA’s interest. The agency has asked the manufacturer, Bristol-Myers Squibb, to conduct post-marketing studies and is concerned about the drug’s heart risks, liver toxicity, and potentially severe skin reactions.
If you or a loved one has experienced serious adverse side effects from Onglyza or know of an individual that has died due to cancer, pancreatitis, liver toxicity, heart disease and Stevens Johnson syndrome (serious and possible fatal allergic skin reaction), you should call the Venardi Law Firm for a free consultation. We will be able to evaluate the strength of your case and take it on contingency.
