Download Medical Opinion – Penny D Hardy

Lipitor - Case Review – Focus Blocks
LIPITOR - Drug information:
Lipitor is the brand name for the drug atorvastatin. Lipitor (atorvastatin) was introduced in 1996 by
Warner-Lambert Company, which was subsequently acquired by Pfizer. This prescription medication
is a popular drug to treat high cholesterol. It is a member of the Statin class of hypolipidemics.
The FDA approved Lipitor in December of 1996. It is prescribed in 10 mg to 80 mg tablets that are
taken daily.
Like other Statin medications, Lipitor prevents an enzyme in the liver from creating low density lipids
(LDLs). LDLs are a type of cholesterol that blocks arteries. Lipitor works to prevent the production of
LDL and reduces the user’s risk of developing heart disease.
FDA WARNING ABOUT LIPITOR:
In 2012, the FDA forced label changes for Lipitor and other stations to add information to the
“Warnings and Precautions” section about the potential link to an increased risk of diabetes.
However, the Lipitor warnings added by Pfizer remain incomplete and inadequate, failing to properly
warn users or the medical community about the risk of diabetes or the importance of monitoring
blood glucose levels.
LAWSUIT FOCUS:
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Development of Diabetes
Skeletal Muscle Side Effects caused due to Lipitor
Risk of kidney or liver damage
Areas to be focused in Medical Records Review
1. Whether the patient was prescribed Lipitor
2. Did the patient have any preexisting conditions, allergies or contraindications for the Lipitor
drug?
3. Dosage and Intake details
Critical Review of
Physician Drug Prescription Details
Pharmacy Dispensing Details
Pharmacy Refill Details
Details of Pharmacy Dispensing Details are taken as Confirmatory
4. Did the patient develop diabetes or skeletal muscle problem after Lipitor intake?
5. When and where was it diagnosed?
6. Treatment/management
7. Follow-up visits for management
8. Outcome/prognosis
9. Any medical/surgical history, social history (smoking) that could have had an effect on the
injury
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Resultant Injuries:
DIABETES
Postmenopausal women taking Lipitor may have an increased risk of developing Lipitor Type 2
diabetes side effect.
LIPITOR MIGHT CAUSE SKELETAL MUSCLE SIDE EFFECTS:
According to its FDA-mandated drug label, Lipitor, like other Statin drugs, can cause skeletal muscle
side effects such as myopathy and rhabdomyolysis, a condition characterized by atrophying skeletal
muscle tissue. The lost muscle mass (myoglobin) collects in patients’ blood and can cause severe
kidney problems and even death. Most of the time, this disease is caused by severe injury such as a
muscle being crushed by a heavy object, and in other cases it arises due to extreme alcohol abuse.
Primary symptoms include:
1. Pain
2. Tenderness
3. Weakness
4. Swelling
The broken-down muscle mass can cause other problems throughout the body such as:
1. Electrolytic disturbances
2. Nausea
3. Vomiting
4. Confusion
5. Coma
6. Cardiac arrhythmia
7. Dark urine
8. Oligura or Anuria (decreased or non-existent urine production, respectively)
9. Internal blood clotting
Lipitor Might Cause Memory Loss
Also in the February 2012 update, the FDA informed the public that it was investigating reports of
Lipitor memory loss that occurred to users who had been on the drug for several years. Symptoms
arose in every age group, though more often in patients over the age of 50. Examples are:
Memory loss
Forgetfulness
Confusion
4. “Fuzzy” or unfocused thinking
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Treatment and Complications
Treatment includes rapid rehydration, as most cases of rhabdomyolysis are caused by severe
accidents. Doctors may also prescribe various drugs to cause myoglobin to disintegrate. In extreme
cases, they’ll put patients on dialysis.
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Drug interactions:
Later, in March 2012, the FDA warned the public that Lipitor use combined with certain other drugs,
namely “protease inhibitors” meant to treat HIV and hepatitis C, can raise the amount of Lipitor in
users’ blood, which can cause muscle damage. The FDA contraindicates using Crestor with these
drugs.
Risk for developing complication is higher if the patients are

Are obese or have excess weight

Are inactive

Have high blood sugar

Have high blood pressure

Have high triglycerides

Have a family history of Type 2 Diabetes
Other manufacturer of generic Lipitor and its recall:
Ranbaxy in November recalled its Atorvastatin from the U.S. market and stopped manufacturing the
widely used cholesterol lowering medicine after the company discovered contamination with tiny
glass particles in certain lots of 10 milligram, 20 mg and 40 mg doses of the drug. Atorvastatin is the
generic name for Lipitor.
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