Dear Cedric,

I read in the newspaper that Lipitor was being sued for causing muscle and nerve problems. Is it safe to take?

Christopher W.

Dear Christopher,

Imagine this scenario: it’s the early 1970s and millions of people are dying from heart attacks. Doctors try to treat the obvious causes — high blood pressure, diabetes, smoking, alcoholism, obesity — but people continue to die. Then, someone draws a connection between cholesterol and heart disease. Researchers find a medicine that decreases cholesterol levels. People take the medicine and heart attack rates go down. Hundreds of thousands of lives are saved.

That scenario could be the premise of an Academy Award-winning movie with Tom Hanks playing the lifesaving researcher. You’d cry at the end of the movie when the grandpa, played by the adorable yet curmudgeonly Wilford Brimley, is saved by Hanks who goes back in time, gives his Grandpa the medicine, saves his life and simultaneously foils a serial killer. You’d thank God that science, once again, improves our lives.

But that movie will never be made. Nor will the movie about the discovery of insulin, or antihypertensives, or asthma medicines. Why? Well, I can’t speak for Hollywood, but I think it’s because we’ve become numbed to real miracles. We forget how bad the past was, and take medical progress for granted. In fact, we get angry that science hasn’t made greater breakthroughs: why do we still have AIDS? Cold sores? Halitosis? We protest and act as if it’s our right as Americans to be rid of these scourges.

Well, the introduction of “statins,” as the cholesterol-lower medicines like Lipitor are called, did make a difference. They are proven to reduce heart attacks and strokes. Since the 1980s, they have already saved tens of thousands of lives. And they may have other benefits. Some studies show they may reduce the risk of certain cancers. Other studies hint at a reduction in the risk of Alzheimer’s Disease.

It’s clear, therefore, that statins prevent tragic heart attacks and strokes. But the problem with prevention is that nothing seems to happen. The person isn’t cured of a visible problem. The only effect is that a patient taking the drug probably doesn’t get a heart attack or stroke (although statistically many still do). Therefore, it becomes easy to doubt if there’s any effect at all. No one can conclusively say, “Lipitor saved my life.” People have to trust science and statistics to know that they’re healthier taking the medicine. And it’s hard not to second guess your decision if you’re taking a drug daily for thirty years.

But despite their great benefits, all medicines (even herbal medicines!) have potential side effects. The question is: do the benefits outweigh the risks? Drug companies are required by the FDA to document and publish a medicine’s side effects. By knowing the information, a patient can make an educated decision whether to take the pill. Here’s a summary of the potential side effects from taking Lipitor, as collected in the Physician’s Desk Reference (PDR):

The following adverse events were reported, regardless of causality assessment in patients treated with atorvastatin in clinical trials. The events in italics occurred in >/=2% of patients and the events in plain type occurred in Body as a Whole: Chest pain, face edema, fever, neck rigidity, malaise, photosensitivity reaction, generalized edema. Digestive System: Nausea, gastroenteritis, liver function tests abnormal, colitis, vomiting, gastritis, dry mouth, rectal hemorrhage, esophagitis, eructation, glossitis, mouth ulceration, anorexia, increased appetite, stomatitis, biliary pain, cheilitis, duodenal ulcer, dysphagia, enteritis, melena, gum hemorrhage, stomach ulcer, tenesmus, ulcerative stomatitis, hepatitis, pancreatitis, cholestatic jaundice. Respiratory System: Bronchitis, rhinitis, pneumonia, dyspnea, asthma, epistaxis. Nervous System: Insomnia, dizziness, paresthesia, somnolence, amnesia, abnormal dreams, libido decreased, emotional lability, incoordination, peripheral neuropathy, torticollis, facial paralysis, hyperkinesia, depression, hypesthesia, hypertonia. Musculoskeletal System: Arthritis, leg cramps, bursitis, tenosynovitis, myasthenia, tendinous contracture, myositis. Skin and Appendages: Pruritus, contact dermatitis, alopecia, dry skin, sweating, acne, urticaria, eczema, seborrhea, skin ulcer. Urogenital System: Urinary tract infection, urinary frequency, cystitis, hematuria, impotence, dysuria, kidney calculus, nocturia, epididymitis, fibrocystic breast, vaginal hemorrhage, albuminuria, breast enlargement, metrorrhagia, nephritis, urinary incontinence, urinary retention, urinary urgency, abnormal ejaculation, uterine hemorrhage. Special Senses: Amblyopia, tinnitus, dry eyes, refraction disorder, eye hemorrhage, deafness, glaucoma, parosmia, taste loss, taste perversion. Cardiovascular System: Palpitation, vasodilatation, syncope, migraine, postural hypotension, phlebitis, arrhythmia, angina pectoris, hypertension. Metabolic and Nutritional Disorders: Peripheral edema, hyperglycemia, creatine phosphokinase increased, gout, weight gain, hypoglycemia. Hemic and Lymphatic System: Ecchymosis, anemia, lymphadenopathy, thrombocytopenia, petechia.

Note that these side effects aren’t necessarily caused by the medicine. They’re simply any abnormal feelings reported by patients taking the medicine. Another chart, which I will spare you, shows that most of these same symptoms were reported by patients concurrently taking a placebo pill. That said, medicines do cause life-threatening side effects. Those cases are unpredictable and tragic. And very rare. Abnormal liver effects from Lipitor occur in about 1 of 100,000 patients. Not bad odds.

As you pointed out in your question, Lipitor was recently sued by patients claiming that it caused them debilitating muscle and nerve problems. Although I feel for the plaintiff’s pain, I have issues with their case. First, it’s unclear that the symptoms are from the Lipitor. Second, if the symptoms are from Lipitor, they are clearly documented as potential (yet rare) side effects. They are listed above in medical jargon as paresthesias, neuropathy, hypesthesia, hypertonia, myositis, and myasthenia. Even if the plaintiffs could prove the Lipitor caused their problem (highly specious), the patients knew the side effects could happen yet agreed to take the medicine because the benefits outweighed the risks.

The problem with these types of lawsuits, is that they actually hurt the public good. Many useful medicines (Tysabri for multiple sclerosis, Vioxx for muscle pain) have been discontinued over the years due to lawsuits. Others like Accutane are being threatened. These medicines could have reduced much pain and suffering, but due to people getting (or claiming to get) the potential documented side effects, the meds have been pulled. And that act precludes future generations from deciding for themselves if the medicine is right for them. People need to take responsibility for their decisions, and realize that their decisions have real positive and negative consequences.

The answer to your question, Christoper, as to whether Lipitor is safe, depends on your situation. It’s a terrific medicine. If the benefits outweight the risks then you should take it. Your job is to research the medicine so you can make an informed decision.