Recall of metformin extended release
In May 2020, the
Food and Drug Administration (FDA)recommended that some makers of metformin extended release remove some of their tablets from the U.S. market. This is because an unacceptable level of a probable carcinogen (cancer-causing agent) was found in some extended-release metformin tablets. If you currently take this drug, call your healthcare provider. They will advise whether you should continue to take your medication or if you need a new prescription.
Metformin is a prescription drug used to treat type 2 diabetes. It belongs to a class of medications called biguanides. People with type 2 diabetes have blood sugar (glucose) levels that rise higher than normal. Metformin doesn’t cure diabetes. Instead, it helps lower your blood sugar levels to a safe range.
Metformin needs to be taken long-term. This may make you wonder what side effects it can cause. Metformin can cause mild and serious side effects, which are the same in men and women. Here’s what you need to know about these side effects and when you should call your doctor.
Metformin causes some common side effects. These can occur when you first start taking metformin, but usually go away over time. Tell your doctor if any of these symptoms are severe or cause a problem for you.
The more common side effects of metformin include:
- stomach pain
- nausea or vomiting
- weight loss
- unpleasant metallic taste in mouth
Nausea, vomiting, and diarrhea are some of the most common side effects people have when they first start taking metformin. These problems usually go away over time. You can reduce these effects by taking metformin with a meal. Also, to help lessen your risk of severe diarrhea, your doctor will likely start you on a low dosage of metformin and then increase it slowly.
Metformin is sometimes used to prevent diabetes in women with polycystic ovarian disease (PCOS). It’s used off-label for this purpose. The side effects for this use are the same as for other uses.
The most serious, but uncommon, side effect metformin can cause is lactic acidosis. In fact, metformin has a “boxed” — also referred to as a “black box” — warning about this risk. A boxed warning is the most severe warning the Food and Drug Administration (FDA) issues.
Lactic acidosis is a rare but serious problem that can occur due to a buildup of metformin in your body. It’s a medical emergency that must be treated right away in the hospital.
See the precautions section for more information about factors that raise your risk of lactic acidosis.
Call your doctor right away if you have any of the following symptoms of lactic acidosis. If you have trouble breathing, call 911 right away or go to the nearest emergency room.
- extreme tiredness
- decreased appetite
- trouble breathing
- a fast or slow heart rate
- feeling cold
- muscle pain
- flushing or sudden reddening and warmth in your skin
- stomach pain with any of these other symptoms
Metformin can decrease the levels of vitamin B-12 in your body. In rare cases, this can cause anemia or low levels of red blood cells. If you don’t get much vitamin B-12 or calcium through your diet, you may be at higher risk of very low vitamin B-12 levels.
Your vitamin B-12 levels can improve if you stop taking metformin or take vitamin B-12 supplements. Do not stop taking metformin without talking to your doctor.
The more common symptoms of anemia include:
If you think you may have anemia, make an appointment with your doctor to have your red blood cell levels checked.
Alone, metformin does not cause hypoglycemia or low blood sugar. However, in rare cases, you may develop hypoglycemia if you combine metformin with:
- a poor diet
- strenuous exercise
- excessive alcohol intake
- other diabetes medications
Call your doctor if you have any symptoms of hypoglycemia, which can include:
- stomach pain
- abnormally fast or slow heartbeat
Several factors raise your risk of lactic acidosis while you take metformin. If any of these factors affect you, be sure to discuss them with your doctor before taking this drug.
Your kidneys remove metformin from your body. If your kidneys don’t work well, you’ll have higher levels of metformin in your system. This raises your risk of lactic acidosis.
If you have mild or moderate kidney problems, your doctor may start you at a lower dosage of metformin.
If you have severe kidney problems or are 80 years old or older, metformin may not be right for you. Your doctor will likely test your kidney function before you start taking metformin and then again each year.
Your heart may not send enough blood to your kidneys. This would prevent your kidneys from removing metformin from your body as well as they normally would, raising your risk of lactic acidosis.
You should not take metformin if you have severe liver problems. Your liver clears lactic acid from your body.
Severe liver problems could lead to a buildup of lactic acid. Lactic acid buildup raises your risk of lactic acidosis. Metformin also raises your risk, so taking it if you have liver problems is dangerous.
Drinking alcohol while taking metformin raises your risk of hypoglycemia. It also raises your risk of lactic acidosis. This is because it increases lactic acid levels in your body.
You should not drink large amounts of alcohol while taking metformin. This includes long-term alcohol use and binge drinking. If you drink alcohol, talk with your doctor about how much alcohol is safe for you while you take metformin.
Surgical or radiologic procedures
If you plan to have surgery or a radiology procedure that uses iodine contrast, you should stop taking metformin 48 hours before the procedure.
These procedures can slow the removal of metformin from your body, raising your risk of lactic acidosis. You should resume taking metformin after the procedure only when your kidney function tests are normal.
If your doctor has prescribed metformin and you’re concerned about its side effects, talk with them. You may want to review this article with them. Be sure to ask any questions you have, such as:
- What side effects should I watch out for?
- Am I at high risk of lactic acidosis?
- Is there another medication I could take that might cause fewer side effects?
Your doctor can answer your questions and work with you to manage any side effects you may have.