FDA notified healthcare professionals and patients that it is aware of four recently-published observational studies that looked at the use of insulin glargine (Lantus) and possible risk for cancer in patients with diabetes. Three of the four studies suggest an increased risk for cancer associated with use of insulin glargine. Based on the currently available data, the FDA recommends that patients should not stop taking their insulin therapy without consulting a physician, since uncontrolled blood sugar levels can have both immediate and long-term serious adverse effects.
FDA is currently reviewing many sources of safety data for insulin glargine, including these newly published observational studies, data from all completed controlled clinical trials, and information about ongoing controlled clinical trials, to better understand the risk, if any, for cancer associated with use of insulin glargine. Discussions are also ongoing between FDA and the manufacturer of insulin glargine as to whether any additional studies evaluating the safety and efficacy of this drug will need to be performed. FDA will communicate the results on its ongoing review to the public, as appropriate, as our review continues.
The FDA encourages both healthcare professionals and patients to report side effects from the use of insulin glargine to the FDA’s MedWatch Adverse Event Reporting Program. For more information visit the FDA website at: [Web] and [Web].
What is this medicine?
INSULIN GLARGINE (IN su lin GLAR geen) is a human-made form of insulin. This drug lowers the amount of sugar in your blood. It is a long-acting insulin that is usually given once a day.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
This medicine is for injection under the skin. Use exactly as directed. It is important to follow the directions given to you by your health care professional or doctor. You will be taught how to use this medicine and how to adjust doses for activities and illness. You may take this medicine at any time of the day but you must take it at the same time everyday. Do not use more insulin than prescribed. Do not use more or less often than prescribed.
Always check the appearance of your insulin before using it. This medicine should be clear and colorless like water. Do not use it if it is cloudy, thickened, colored, or has solid particles in it.
Do not mix this medicine with any other insulin or diluent.
It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
It is important not to miss a dose. Your health care professional or doctor should discuss a plan for missed doses with you. If you do miss a dose, follow their plan. Do not take double doses.
Some medications can hide the warning symptoms of low blood sugar. You may need to monitor your blood sugar more closely if you are taking one of these medications. These include:
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Visit your health care professional or doctor for regular checks on your progress. To control your diabetes you must use this medicine regularly and follow a diet and exercise schedule. Checking and recording your blood sugar and urine ketone levels regularly is important. Use a blood sugar measuring device before you treat high or low blood sugar.
Always carry a quick-source of sugar with you in case you have symptoms of low blood sugar. Examples include hard sugar candy or glucose tablets. Make sure family members know that you can choke if you eat or drink when you develop serious symptoms of low blood sugar, such as seizures or unconsciousness. They must get medical help at once.
Make sure that you have the right kind of syringe for the type of insulin you use. Try not to change the brand and type of insulin or syringe unless your health care professional or doctor tells you to. Switching insulin brand or type can cause dangerously high or low blood sugar. Always keep an extra supply of insulin, syringes, and needles on hand. Use a syringe one time only. Throw away syringe and needle in a closed container to prevent accidental needle sticks.
Insulin pens and cartridges should never be shared. Sharing may result in passing of viruses like hepatitis or HIV.
Wear a medical identification bracelet or chain to say you have diabetes, and carry a card that lists all your medications.
Many nonprescription cough and cold products contain sugar or alcohol. These can affect diabetes control or can alter the results of tests used to monitor blood sugar. Avoid alcohol. Avoid products that contain alcohol or sugar.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your health care professional or doctor as soon as possible:
Symptoms of low blood sugar:
You may feel nervous, confused, dizzy, hungry, weak, sweaty, shaky, cold, and irritable. You may also experience headache, blurred vision, rapid heartbeat and loss of consciousness.
Symptoms of high blood sugar:
You may experience dizziness, dry mouth, dry skin, fruity breath, loss of appetite, nausea, stomach ache, unusual thirst, frequent urination
Insulin also can cause rare but serious allergic reactions in some patients, including:
Side effects that usually do not require medical attention (report to your health care professional or doctor if they continue or are bothersome):
increase or decrease in fatty tissue under the skin, through overuse of a particular injection
itching, burning, swelling, or rash at the injection site
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store unopened vials in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze or use if the insulin has been frozen. Opened vials (vials currently in use) may be stored in the refrigerator or at room temperature, at approximately 25 degrees C (77 degrees F) or cooler. Keeping your insulin at room temperature decreases the amount of pain during injection. Once opened, your insulin can be used for 28 days. After 28 days, the vial should be thrown away.
Store unopened pen-injector cartridges in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F.) Do not freeze or use if the insulin has been frozen. Insulin cartridges inserted into the OptiClik system should be kept at room temperature, approximately 25 degrees C (77 degrees F) or cooler. Do not store in the refrigerator. Once inserted into the OptiClik system, the insulin can be used for 28 days. After 28 days, the cartridge should be thrown away.
Protect from light and excessive heat. Throw away any unused medicine after the expiration date or after the specified time for room temperature storage has passed.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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