Good, balanced comment, TML
There is positive and negative in everything. Heart disease is a killer and some people have genetically high cholesterol that they can’t get down via diet and lifestyle. Still, don’t take one too easily and don’t trust the drug reps.
— Posted by rini
Drugs have trade-offs. Anything that crosses the blood-bair barrier has the potential to affect memory or cognition. If you need a statin to save your life then it’s worth the risks. If you really don’t need it and can manage your cholesterol with diet and exercise, don’t take it.
However, all this isn’t as clear-cut as it may seem. There have been some studies on using statins to promote neurogenesis and improve cognitive function in patients with traumatic brain injury. There have also been studies showing that statins reduce memory impairment caused by other drugs. And finally, there is evidence that high cholesterol is a major risk factor for dementia. Looks like it goes both ways.
— Posted by TML
Special to The Washington Post
Tuesday, August 28, 2007; Page HE04
On many online message boards and Internet chat rooms, anxious patients share details about the muscle pain and memory loss they have noticed since they started taking statins to lower their cholesterol. A new study suggests these people may be seeking validation for good reason: Some of their complaints might otherwise be going unheard.
According to a survey of 650 patients published last week in Drug Safety, a peer-reviewed journal, doctors frequently ignored or dismissed patients’ concerns about such side effects. The study suggests this pattern of reaction goes beyond statins to other drugs.
When doctors fail to recognize a patient’s symptoms as drug side effects, more than that patient’s care is put at risk. Because the doctor makes no “adverse event report” to the Food and Drug Administration, the regulatory agency may underestimate the problem, and other doctors and patients may assume the drug is safer than it is.
Researchers from the University of California at San Diego had been investigating the side effects of statins when they noticed the problem.
“Person after person spontaneously [told] us that their doctors told them that symptoms like muscle pain couldn’t have come from the drug. We were surprised at how prevalent that experience was,” said Beatrice Golomb, associate professor of medicine and the study’s lead researcher.
Tens of millions of people worldwide take statins such as Lipitor and Zocor. Many experts view them as something of a panacea for everything from stroke and cancer to arthritis, although they do pose a risk of side effects in some patients, ranging from muscle injury to liver and kidney dysfunction.
Survey respondents, recruited via Web solicitations and other advertisements, were in their early 60s on average and mostly from the United States. Some of the solicitations were placed on Web sites where patients had posted complaints, raising the possibility that respondents were more apt to have had side effects than the average patient. Most said they’d complained to their doctors about such possible side effects as problems with memory or attention, or tingling or numbness in their hands and feet.
According to experts, muscle pain and other side effects occur in up to 30 percent of statin patients, by some estimates, and often lead doctors to stop or change a prescription. But patients surveyed said their doctors rarely linked their symptoms to statins — even when the symptoms were well-documented as side effects.
“Overwhelmingly, it was the patient that initiated that conversation” making the connection between the statin and their symptoms, Golomb said.
Many doctors instead attributed the symptoms to the normal aging process, denied their connection to statins or dismissed the symptoms altogether — missing opportunities to switch their patients’ prescriptions or otherwise mitigate the side effects, Golomb said.
Golomb speculated that doctors’ actions might reflect the relative dearth of information on the downsides of statins. “Ad campaigns that preserve statins’ miracle drug image are more powerful than education about side effects,” she said.
The findings raise important concerns about American drug safety monitoring, said Harvard Medical School professor Jerry Avorn, author of “Powerful Medicines: The Benefits, Risks and Costs of Prescription Drugs.”
“We already know that there is horrendous underreporting of side effects. Ninety to 99 percent of serious side effects are not reported by doctors,” he said.
Yet the FDA relies heavily on their reports. Tracking a drug’s safety once it hits pharmacies — so-called post-market surveillance — is a critical part of keeping patients safe, particularly since clinical trials with limited enrollees and a limited study period cannot catch every side effect.
Managed care deserves some of the blame, Avorn said. “Part of [the problem] is that doctors are granted so few minutes to deal with patient visits. It’s not as if doctors don’t care.”
Golomb and others worry that if even well-documented side effects aren’t being recognized by doctors, others will take much longer to surface. “A fifth of all drugs that fully pass FDA approval will ultimately have black box warnings or be withdrawn from market because of adverse effects,” Golomb said.
Some say that the FDA and drug companies should work harder to get feedback directly from patients. Getting drug surveillance reports from patients is common practice in New Zealand and other countries.
U.S. patients can report side effects to the FDA themselves — by logging onto the MedWatch Web site ( http://www.fda.gov/medwatch). But few know about this option, Avorn said.
The new study “points out that doctor reports on side effects is a very unreliable means of learning about the true extent of problems,” he said. “We ought to have a [better] mechanism for gathering information from patients. A lot of it will be noise, but there may be important signals there as well.”
Atorvastatin Calcium; Lipitor; Statin. As the health care system fights hypercholesterolemia in America, statin drugs have become one of the most commonly prescribed drugs in medicine - sixteen million Americans take Lipitor to fight their diagnosed high cholesterol. Is the health care system doing the right thing with their patients?
Among countless suspicions against the negative side effects of Lipitor, we have something called TGA, temporary global amnesia. The connection between memory loss and statins is proven with biochemistry. Let me explain…
Cholesterol is one of the building blocks of the body. It aids in the rebuilding component of scar tissue; it is important in the digestion of fats; it is a leading antioxidant, protecting us against cancer and aging. Cholesterol is the precursor to ALL hormones produced in the adrenal cortex – meaning that if there is a low level of cholesterol, we are more apt to experience blood sugar problems, edema, mineral deficiencies, chronic inflammation, difficulty in healing, allergies, asthma, reduced libido, infertility and various reproductive problems. I say these things to draw importance to a balance of cholesterol in the body.
What does cholesterol have to do with memory? A lot. Glial cells, located in the brain between adjacent neurons, function mainly to provide support to the neurons (nerve cell bodies) and insulation for the transmission of messages through the nervous system. The brain cannot tap into the blood’s cholesterol supply – the molecules involved are too large to pass through the blood-brain barrier. So, the brain must depend upon its own cholesterol synthesis–which the glial cells provide. Statin drugs are able to cross the blood-brain barrier because they are fat soluble, so when these drugs are taken, they enter the brain environment and interact with the glial cell synthesis of cholesterol. Here we find a potential for memory loss to be caused by statin drugs. When cholesterol is limited, due to he consumption of statin drugs, the functions of the glial cells and therefore the transmission of messages throughout the nervous system is limited as well.
One person’s account states: “I have spent a lot of time with Doctors to determine what was wrong with me including an MRI that showed my brain has shrunk since starting Lipitor. I have had every battery of blood work to rule out other diseases. I just had a DNA test for the Apo gene, a test for early onset Alzheimer’s, if paired, and it was not positive. In four weeks I am having a memory evaluation test at a rehabilitation facility to measure the amount of damage to my short-term memory. I am only 54 years old and used to write software specifications and hold a patent in artificial intelligence.”
What I’m concerned with is why the pharmaceutical companies are choosing to keep this drug on the market with such a severe set of side effects including malfunction of neurotransmission. With a list of natural products like Policosanol, Guggulipid Extract, Green Tea Extract, and Tumeric Extract that do the same job with less of the problematic effects, why not look into these products a bit more before continuing to prescribe potentially harmful products to our citizens?
Have you had a bad experience with taking a statin drug? If so, please share. What we need is more people speaking up and being honest about the way these medications are affecting them.
RateADrug.com definitely has potential. It seems like it’s in beta version, but it’s a great idea to provide surveys that patients can forward to doctors, caregivers or family member about their medications so that everyone can stay informed about changes in patients health. A very nice tool for self-evaluation. More people should take these surveys!
User Comment from Rate A Drug http://rateadrug.com/Lipitor.aspx:
I experienced increased anxiety. It was difficult to separate my life events as a source of anxiety from the Lipitor as a source of anxiety. However, I did some “experiments” of starting and stopping the drug (and a similar cholesteral lowering drug) and decided it was the drub.
That is the site I use! Rate A Drug is really useful. Check it out:
Involving 8,888 subjects treated with LIPITOR 80 mg/day (n=4439) or simvastatin 20-40 mg daily (n=4449), there was no difference in the overall frequency of adverse events or serious adverse events between the treatment groups during a median follow-up of 4.8 years.
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 <2% of patients.
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, hematuria, albuminuria, urinary frequency, cystitis, impotence, dysuria, kidney calculus, nocturia, epididymitis, fibrocystic breast, vaginal hemorrhage, 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.
Adverse events associated with LIPITOR therapy reported since market introduction, that are not listed above, regardless of causality assessment, include the following: anaphylaxis, angioneurotic edema, bullous rashes (including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis), rhabdomyolysis, fatigue, and tendon rupture.
Lipitor can cause serious side effects. These side effects have happened only to a small number of people. Your doctor can monitor you for them. These side effects usually go away if your dose is lowered or Lipitor is stopped. These serious side effects include:
Call your doctor right away if you have:
Common side effects of Lipitor include headache, constipation, diarrhea, gas, upset stomach and stomach pain, rash, and muscle and joint pain. These side effects are usually mild and may go away.
How long after taking lipitor do these side effects occur?
admin wrote:
Sharon diptee wrote:
1. July 2008 at 5:12 pm :
Cool idea. User’s guide is a good thing with all the fuss over recent FDA problems and Pharma ghost writing issues in The Lancet and JAMA et al
11. July 2008 at 3:58 pm :
I agree with Dr Fenstine. I look forward to seeing more submissions here.