Atorvastatin: Are Generic Drugs Worth the Risk?
Atorvastatin is the generic formulation of Pfizer’s Lipitor, mega-blockbuster of unknown proportions. The cholesterol-lowering statin, the top selling drug in pharmaceutical history, is a familiar brand name that went the way of generics in 2011. Over its branded history, Lipitor brought in over $125 billion in sales for Pfizer. But now the consumer is reaping the rewards; the generic version can save a patient literally hundreds in health care dollars per month. Now that Lipitor is available generically as atorvastatin, what are some important issues a consumer should know about with this cost-saving -- and potentially life-saving -- generic?
Concerns About Generic Quality of Atorvastatin
In March 2014, India-based Ranbaxy, the original generic pharmaceutical manufacturer of atorvastatin, recalled over 64,000 thousands of bottles of the drug due to a possible tablet mix-up in their atorvastatin shipments. A pharmacist found a stray 20-milligram (mg) tablet in a sealed 10-mg bottle, according to the U.S. Food and Drug Administration (FDA). In addition, Ranbaxy also issued a recall in November 2012 due to glass particles found in atorvastatin bottles.
In May 2013, Ranbaxy agreed to pay a $500 million fine to the US government to settle criminal and civil charges for manufacturing quality issues that included using raw chemicals from unapproved sources, supplying fictitious in-house test results to meet FDA standards, and further hiding these activities by supplying fraudulent records, according to the Department of Justice. Due to these and other serious quality control issues, the FDA banned Ranbaxy from shipping any pharmaceuticals from certain plants in India to the U.S. market, including from their Ohm Laboratories located in New Jersey.
In April 2014, Ranbaxy was sold to Sun Pharma, and Ranbaxy will no longer exist after the $3.2 billion merger with Sun, a deal expected to close by the end of 2014. In March 2014, the FDA also banned an antibiotic plant owned by Sun Pharma due to serious quality issues.
Can Generic Manufacturers Be Trusted?
Although substandard quality control issues can be alarming for the public, most generic manufacturers can be trusted to produce equivalent generic substitutions due to regulatory oversight from FDA. In fact, it is the FDA inspections and regulatory action that halted the Ranbaxy shipments. In addition, many other manufacturers also make high-quality versions generic atorvastatin.
Nonetheless, consumers should be proactive in assessing the conditions of their medications if they have a concern. Consumers can find the manufacturer listed on their prescription label or they can ask their pharmacist, and question if there has been recent recalls. In addition, consumers can check other manufacturers to see if their generic products are AB rated, meaning they meet therapeutic and bioequivalency standards as set by the FDA. Return the product to your pharmacy if you detect an unusual odor or crumbling of the pills. Patients should never discontinue any medication until discussing concerns with their prescribing physician.
New Cholesterol Guidelines: Should I Take a Statin Like Atorvastatin?
Generic substitution is not the only controversial issue surrounding atorvastatin. After almost a decade, new guidelines addressing heart health, obesity and other risk factors were released at the end of 2013 by the American College of Cardiology and the American Heart Association. Initially, there was an uproar because statin therapy was recommended for a larger proportion of the population, but the guidelines also recommended that some younger patients be removed from statin drugs. The guidelines no longer recommend using speciﬁc cholesterol targets in the treatment of high lipids.
Every patient and their healthcare provider should individualize treatment regimens, and according to the guidelines, patients should be using a statin drug as a first-choice medicine:
- to lower cholesterol if they have cardiovascular disease
- if they are 21 years of age or over with bad (LDL) cholesterol 190 mg/dL or higher
- if they are 40 to 75 years of age with type 2 diabetes
- if they are 40 to 75 years of age with an estimated 10-year risk of cardiovascular disease of 7.5% or more
Statins are useful in the treatment of high cholesterol because they can decrease the incidence of major coronary events and death in patients. When statins are used in conjunction with diet, exercise, and smoking cessation, they can reduce the risk of a ﬁrst cardiac event and death in patients with risk factors such as high low-density lipoprotein cholesterol (LDL or “bad cholesterol), low high-density lipoprotein (HDL or “good cholesterol), high blood pressure or diabetes. In patients who have not had a first cardiac event, such as a heart attack, Overall, the health benefit of statins outweigh any risks due to adverse effects.
In addition, heart healthy, not necessarily low-calorie, diets are recommended. As always, exercise is important to help reduce the risk for heart disease by keeping blood pressure and cholesterol levels under check. Finally, a calculated BMI and waist measurement can help uncover obesity risk factors, too. At the very least, patients 40 to 75 years of age should know their 10-year risk of heart attack and stroke and discuss this number with their doctor. Discussions with a healthcare provider can help define individual needs for statin treatment. Many affordable generic statins are available, too, and patients should discuss medication cost with their doctors.
Atorvastatin Side Effects: What Should I Know?
Statins such as atorvastatin are usually well-tolerated. If side effects do occur, your doctor might lower your dose to see if the side effect will subside. Side effects that may occur with atorvastatin include:
- Common side effects like diarrhea, upset stomach, tiredness, memory loss, confusion, and muscle or joint pain.
- Muscle problems may range from soreness, pain, cramping and tenderness to rare muscle effects like rhabdomyolysis, a severe muscle breakdown that can lead to kidney failure. Certain drug interactions may increase the risk for muscle effects.
- Liver problems: Your doctor will do blood tests to monitor your liver function before you start and while you take statin drugs like atorvastatin. Symptoms of liver problems might include weakness, loss of appetite, stomach pain, brown urine, skin or eyes turning yellow.
- A rare but increased risk of developing diabetes.
- Allergic reactions.
These are not all the side effects that may occur with the use of atorvastatin. Ask your doctor or
pharmacist for a complete list or view more atorvastatin side effects here.
How is Atorvastatin Dosage Determined?
The starting dose of atorvastatin for high lipid levels or for prevention of heart events may range between 10 milligrams (mg) to 80 mg by mouth once a day. Atorvastatin may be taken at any time of the day without regard for meals. Your doctor may adjust doses every 2 to 4 weeks. Additional information on atorvastatin dosing can be seen here.
Should I Be Concerned About Atorvastatin Drug Interactions?
Combining certain drugs can lead to interactions and may cause serious side effects. Especially tell your doctor if you take medicines for:
- your immune system
- birth control
- heart failure
- HIV or AIDS
There are over 280 drug interactions that may occur with this drug. Check for additional drug interactions here.
Be sure to tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the names of all of the medicines you take. Keep a list of them with you to show your doctor and pharmacist.
Learn more about Atorvastatin:
- Atorvastatin Consumer Information
- Atorvastatin for Health Professionals
- Side Effects in Detail
- Recommended Dosage
- Use during Pregnancy or Breastfeeding
- Drug Images
- Drug Interactions
- Support Group
- User Reviews
Last updated: 2014-04-29 by Leigh Anderson, PharmD.