Prandin Side Effects

Generic Name: repaglinide

Please note - some side effects for Prandin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Prandin - for the Consumer

Prandin

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Prandin:

Diarrhea; headache; joint or back pain; nasal or chest congestion; sinus inflammation.

Seek medical attention right away if any of these SEVERE side effects occur when using Prandin:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fever, chills, or persistent sore throat; low blood sugar symptoms (eg, anxiety, fast heartbeat; lightheadedness; severe or persistent dizziness, drowsiness or headache; tremors; unusual sweating; weakness); severe or persistent blurred vision or other vision problems.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Prandin Side Effects - for the Professional

Prandin

Hypoglycemia: See PRECAUTIONS and OVERDOSAGE sections.

Prandin has been administered to 2931 individuals during clinical trials. Approximately 1500 of these individuals with type 2 diabetes have been treated for at least 3 months, 1000 for at least 6 months, and 800 for at least 1 year. The majority of these individuals (1228) received Prandin in one of five 1-year, active-controlled trials. The comparator drugs in these 1-year trials were oral sulfonylurea drugs (SU) including glyburide and glipizide. Over one year, 13% of Prandin patients were discontinued due to adverse events, as were 14% of SU patients. The most common adverse events leading to withdrawal were hyperglycemia, hypoglycemia, and related symptoms. Mild or moderate hypoglycemia occurred in 16% of Prandin patients, 20% of glyburide patients, and 19% of glipizide patients.

The table below lists common adverse events for Prandin patients compared to both placebo (in trials 12 to 24 weeks duration) and to glyburide and glipizide in one year trials. The adverse event profile of Prandin was generally comparable to that for sulfonylurea drugs (SU).

Commonly Reported Adverse Events (% of Patients)*

* Events ≥ 2% for the Prandin group in the placebo-controlled studies and ≥ events in the placebo group † See trial description in CLINICAL PHARMACOLOGY,Clinical Trials
EVENT	Prandin	PLACEBO	Prandin	SU
	N = 352	N = 108	N = 1228	N = 498
	Placebo controlled studies		Active controlled studies
Metabolic
Hypoglycemia	31†	7	16	20
Respiratory
URI	16	8	10	10
Sinusitis	6	2	3	4
Rhinitis	3	3	7	8
Bronchitis	2	1	6	7
Gastrointestinal
Nausea	5	5	3	2
Diarrhea	5	2	4	6
Constipation	3	2	2	3
Vomiting	3	3	2	1
Dyspepsia	2	2	4	2
Musculoskeletal
Arthralgia	6	3	3	4
Back Pain	5	4	6	7
Other
Headache	11	10	9	8
Paresthesia	3	3	2	1
Chest pain	3	1	2	1
Urinary tract infection	2	1	3	3
Tooth disorder	2	0	<1	<1
Allergy	2	0	1	<1

Cardiovascular Events

In one-year trials comparing Prandin to sulfonylurea drugs, the incidence of angina was comparable (1.8%) for both treatments, with an incidence of chest pain of 1.8% for Prandin and 1.0% for sulfonylureas. The incidence of other selected cardiovascular events (hypertension, abnormal EKG, myocardial infarction, arrhythmias, and palpitations) was ≤ 1% and not different between Prandin and the comparator drugs.

The incidence of total serious cardiovascular adverse events, including ischemia, was higher for repaglinide (4%) than for sulfonylurea drugs (3%) in controlled comparator clinical trials. In 1-year controlled trials, Prandin treatment was not associated with excess mortality when compared to the rates observed with other oral hypoglycemic agent therapies.

Summary of Serious Cardiovascular Events (% of total patients with events) in Trials Comparing Prandin to Sulfonylureas

* glyburide and glipizide
	Prandin	SU*
Total Exposed	1228	498
Serious CV Events	4%	3%
Cardiac Ischemic Events	2%	2%
Deaths due to CV Events	0.5%	0.4%

 Seven controlled clinical trials included Prandin combination therapy with NPH-insulin (n=431), insulin formulations alone (n=388) or other combinations (sulfonylurea plus NPH-insulin or Prandin plus metformin) (n=120). There were six serious adverse events of myocardial ischemia in patients treated with Prandin plus NPH-insulin from two studies, and one event in patients using insulin formulations alone from another study.

Infrequent Adverse Events (<1% of Patients)

Less common adverse clinical or laboratory events observed in clinical trials included elevated liver enzymes, thrombocytopenia, leukopenia, and anaphylactoid reactions.

Although no causal relationship with repaglinide has been established, postmarketing experience includes reports of the following rare adverse events: alopecia, hemolytic anemia, pancreatitis, Stevens-Johnson Syndrome, and severe hepatic dysfunction including jaundice and hepatitis.

Combination Therapy with Thiazolidinediones

During 24-week treatment clinical trials of Prandin-rosiglitazone or Prandin-pioglitazone combination therapy (a total of 250 patients in combination therapy), hypoglycemia (blood glucose < 50 mg/dL) occurred in 7% of combination therapy patients in comparison to 7% for Prandin monotherapy, and 2% for thiazolidinedione monotherapy.

Peripheral edema was reported in 12 out of 250 Prandin-thiazolidinedione combination therapy patients and 3 out of 124 thiazolidinedione monotherapy patients, with no cases reported in these trials for Prandin monotherapy. When corrected for dropout rates of the treatment groups, the percentage of patients having events of peripheral edema per 24 weeks of treatment were 5% for Prandin-thiazolidinedione combination therapy, and 4% for thiazolidinedione monotherapy. There were reports in 2 of 250 patients (0.8%) treated with Prandin-thiazolidinedione therapy of episodes of edema with congestive heart failure. Both patients had a prior history of coronary artery disease and recovered after treatment with diuretic agents. No comparable cases in the monotherapy treatment groups were reported.

Mean change in weight from baseline was +4.9 kg for Prandin-thiazolidinedione therapy. There were no patients on Prandin-thiazolidinedione combination therapy who had elevations of liver transaminases (defined as 3 times the upper limit of normal levels).

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Side Effects by Body System - for Healthcare Professionals

General

Repaglinide has been usually well tolerated. Over one year, 13% of patients treated with repaglinide in clinical trials discontinued due to adverse events.

Metabolic

Metabolic side effects have included hypoglycemia, an extension of repaglinide's pharmacologic effects. Hypoglycemia occurred in 16% of patients treated with repaglinide. Patients with liver disease may be at an increased risk of hypoglycemia due to diminished gluconeogenic capacity.

Cardiovascular

Cardiovascular side effects have included angina and chest pain which were reported in 1.8% of patients treated over one year. The overall incidence of other cardiovascular events including hypertension, abnormal EKG, myocardial infarction, arrhythmias, and palpitations was less than 1%.

The incidence of serious cardiovascular adverse events, including ischemia, was higher for repaglinide (4%) than for sulfonylurea drugs (3%) in controlled comparator clinical trials. In one year controlled trials, repaglinide was not associated with increased mortality rates compared to rates observed with other oral hypoglycemic agents.

Hypersensitivity

Hypersensitivity side effects during clinical trials involving 2,931 patients include one patient who experienced an anaphylactoid reaction.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, diarrhea, constipation, and dyspepsia which occurred in up to 5% of patients in clinical trials.

Nervous system

Nervous system side effects have included headache which was reported with an incidence of 9% to 11% in patients taking repaglinide compared to 10% in placebo treated patients. Paresthesia was also reported with an incidence of 2% to 3%.

Musculoskeletal

Musculoskeletal side effects have included back pain and arthralgia which were reported in 5% and 6% of patients, respectively.

Respiratory

Respiratory side effects have included upper respiratory infection, sinusitis, rhinitis, and bronchitis which were reported in 2% to 16% of patients. These frequencies were similar to those reported for placebo-treated and sulfonylurea-treated patients.

Hepatic

Hepatic side effects have included elevated liver enzymes which were reported in less than 1% of patients in clinical trials. Additionally, there have been case reports of acute hepatotoxicity and cholestatic hepatitis.

Postmarketing experience has included reports of severe hepatic dysfunction including jaundice and hepatitis.

Hematologic

Hematologic side effects have included thrombocytopenia and leukopenia which were reported in less than 1% of patients.

Ocular

Ocular side effects have included blurred vision and visual disturbances, especially at the initiation of treatment.

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