The FDA announced a nationwide recall of over 140,000 bottles of a prescription cholesterol medication due to “failed dissolution specifications,” announced earlier this month.
Ascend Laboratories of New Jersey recalled certain bottles of atorvastatin calcium tablets, a generic version of Lipitor, sold nationwide. The recall was announced on Sept. 19 and given a Class II risk level on Oct. 10.
The Class II classification indicates that the recalled medication “may cause temporary or medically reversible adverse health consequences,” but the risk of serious health consequences is low.
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The recall currently affects bottles of 10mg, 20mg, 40mg and 80mg atorvastatin calcium tablets manufactured by Alkem Laboratories, Ltd., of India, and distributed by Ascend. The recalled bottles contained different quantities of the tablets, ranging from 90-count to 1000-count bottles. Just under 142,000 bottles of the 10mg medication were involved in the recall; the quantity of recalled bottles containing 20mg, 40mg and 80mg tablets was listed in the FDA’s enforcement report.
More specific information on the recalled medication, including lot codes and expiration dates, is available in the report here.
What Is the Drug Supposed to Do?
Atorvastatin calcium is a drug used to control cholesterol levels and help prevent heart attacks or strokes, per the National Institutes of Health. The most common brand name of atorvastatin calcium tablets is Lipitor, a drug manufactured by Pfizer. In 2023, Harvard Health estimated that more than 40 million Americans are prescribed statins, making them “the most prescribed” drug in the country.
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According to Yale Medicine, 47 million Americans take cholesterol medication each day.
What Cholesterol Medication Does
Cholesterol medications, also known as statins, work by lowering cholesterol levels in the blood. They do this by:
- Inhibiting cholesterol production: Statins block an enzyme in the liver that is responsible for producing cholesterol.
- Removing cholesterol from the bloodstream: They help the liver remove existing cholesterol from the blood and into the bile, where it is excreted from the body.
By reducing cholesterol levels, statins can help:
- Prevent heart disease: High cholesterol levels increase the risk of heart disease by forming plaque in the arteries.
- Lower triglycerides: Statins can also help lower triglycerides, another type of fat in the blood that can contribute to heart disease.
- Improve blood flow: By reducing plaque buildup, statins can improve blood flow throughout the body.
It’s important to note that statins are prescription medications and should only be taken under the guidance of a healthcare professional.
Side Effects of Statins in Cholesterol Medication
Muscle Pain and Damage
According to the National Institutes of Health, one of the most common complaints of people taking statins is muscle pain. You may feel this pain as a soreness, tiredness, or weakness in your muscles. The pain can be a mild discomfort, or it can be serious enough to make it hard to do your daily activities.
However, researchers have found a “nocebo effect” when it comes to people thinking they have muscle pain from statins. A nocebo effect means people who expect a negative side effect from a medicine report experiencing the potential side effect at higher rates than the medicine should cause.
The real risk of developing muscle pain from taking statins is about 5% or less compared with taking a placebo. A placebo is a pill that doesn’t contain medicine. Studies have found that people stopped taking the pills because of muscle aches even when they were taking a placebo. A strong predictor of if you’ll experience muscle aches when taking statins could be whether you read about the potential side effect.
Very rarely, statins can cause life-threatening muscle damage called rhabdomyolysis (rab-doe-my-OL-ih-sis). Rhabdomyolysis can cause extreme muscle pain, liver damage, kidney failure, and death. The risk of very serious side effects is extremely low. Only a few cases of rhabdomyolysis occur per million people taking statins. Rhabdomyolysis can occur when you take statins in combination with certain medicines or if you take a high dose of statins.
Liver Damage
Sometimes, statin use could cause an increase in the level of enzymes in the liver. These enzymes signal inflammation. If the increase is only mild, you can continue to take the statin. Rarely, if the increase is severe, you may need to try a different statin.
Although liver problems are rare, your healthcare team may order a liver enzyme test before or shortly after you begin to take a statin. You won’t need any further liver enzyme tests unless you begin to have signs of trouble with your liver.
Contact your healthcare professional right away if you have unusual fatigue or weakness, loss of appetite, pain in your upper stomach, dark-colored urine, or yellowing of your skin or eyes.
Increased Blood Sugar or Type 2 Diabetes
It’s possible that your blood sugar, known as blood glucose, may increase when you take a statin. This may lead to type 2 diabetes. The risk is small but important enough that the U.S. Food and Drug Administration (FDA) has issued a warning on statin labels about blood glucose levels and diabetes.
The increase in blood sugar is small. And it does not cause concern unless it occurs when blood sugar levels are already high. People with prediabetes or diabetes may be more aware that their blood sugar levels rise when they start taking a statin.
But statins also prevent heart attacks in people with diabetes. The benefit of taking statins likely outweighs the small risk to have the blood sugar level go up. Talk to your healthcare team if you have concerns.
Neurological Side Effects
The FDA warns on statin labels that some people have developed memory loss or confusion while taking statins. These side effects reverse once you stop taking the medicines. There is limited evidence to prove a cause-effect relationship, and several studies have found that statins have no effect on memory. Talk to your care team if you experience memory loss or confusion while taking statins.
There also has been evidence that statins may help with brain function — in people with dementia, for example. This is still being studied. Don’t stop taking your statin medicine before talking to your healthcare professional.
Who’s at risk of developing statin side effects?
Not everyone who takes a statin will have side effects, but some people may be at a greater risk. Risk factors include:
- Taking multiple medicines to lower your cholesterol.
- Taking medicines that interact with statins.
- Taking the highest dose of any given statin.
- Being female.
- Having a smaller body frame.
- Being age 80 or older.
- Having kidney or liver disease.
- Drinking too much alcohol.
- For some statins, drinking too much grapefruit juice.
- Having hypothyroidism or neuromuscular conditions, including amyotrophic lateral sclerosis (ALS).
For any of these side effects or any side effect you may experience, consult your physician.
