Re: Newsday on statins: cardiologist says muscle pain can be extreme

From: tcomeau (tunderbar_at_hotmail.com)
Date: 08/10/04 

Date: 10 Aug 2004 13:53:34 -0700

Time for a few massive class-action lawsuits. Lawyers need to get onto
this gravy train.

TC

fresh~horses@despammed.com (fresh~horses) wrote in message news:<abf8de5b.0408091947.140d7c1c@posting.google.com>...
> When statins cause problems
> http://www.newsday.com/news/health/ny-dscovn3924010aug10,0,5063441.story?coll=ny-health-big-pix
>
> Side effects of cholesterol-fighting drugs get attention in wake of
> concern about Crestor
>
> "I think the muscle part of the statins is underappreciated," said Dr.
> Paul Thompson, director of preventive cardiology at Hartford Hospital.
>
> BY RONI RABIN
> STAFF WRITER
>
> August 10, 2004
>
> Eileen Mulvey is a spry 70-year-old who's usually up and down the
> steps to her second floor co-op a dozen times a day. But in February,
> two weeks after she started taking Crestor to lower her cholesterol,
> she couldn't make it up the stairs.
>
> "My legs were throbbing and I would have to stop midway, and I'd have
> to sit down," said Mulvey, of Oakdale, who stopped taking the
> medication even before her doctor ran a blood test showing she had
> suffered muscle damage from the statin. "This wasn't normal for me. I
> wasn't short of breath - my muscles were screaming.
>
> "And I'm a very vigorous person," Mulvey added. "For me to be
> complaining about something is unusual."
>
> Harvey Gardner, a 73-year- old from Huntington, started taking a
> different statin, Zocor, March 10. After just a few doses, he said, he
> started feeling "lousy."
>
> "The symptoms were dramatic," Gardner said. "I had pain in my arms and
> my legs. ... I felt like I had arthritis all over my body."
>
> The pain subsided when he quit taking the drug, but now he wonders
> whether the numbness he's had in his toes for several years might be a
> side effect of another statin, Mevacor, that he took several years
> ago. Doctors have diagnosed the numbness as peripheral neuropathy,
> which is listed as one of the potential side effects of statins.
>
> Millions of Americans now take statins, a class of medications whose
> remarkable ability to lower blood cholesterol levels has endowed them
> with virtual miracle drug status. But many who take the drugs worry
> about the effects they may have on their kidneys, liver and muscles,
> and a consumer advocacy group's call in June to ban Crestor, the
> newest statin, has reawakened concerns about the potential side
> effects. Officials for AstraZeneca, which makes Crestor, have
> dismissed the consumer group's allegations as inaccurate and
> misleading. "Statins overall are remarkably safe," said Gary Bruell, a
> spokesman for AstraZeneca. "Every drug ever invented has adverse
> effects."
>
> A rare side effect
>
> Rhabdomyolysis, a breakdown of muscle fibers that can cause kidney
> damage and may be fatal, is an extremely rare side effect, occurring
> in one in 10,000 patients, drug manufacturers say. But up to 5 percent
> of statin patients suffer non-life-threatening muscle pain disorders
> that can nevertheless be debilitating, according to doctors who have
> studied statin-related muscle syndromes. And, they say, certain
> patients - smaller people, women, the elderly, and athletes and people
> who exercise a lot - may be more vulnerable. People of Japanese
> descent also are at higher risk, as are patients with some other
> medical complications.
>
> "I think the muscle part of the statins is underappreciated," said Dr.
> Paul Thompson, director of preventive cardiology at Hartford Hospital
> and author of a paper on statin-associated muscle disease published in
> the Journal of the American Medical Association in April 2003. "Some
> people - not everybody, but a fair number of people - get a mild
> myalgia [muscle pain] on the drug. With some of these patients, it can
> be extreme."
>
> Public Citizen Health Research Group, a consumer organization, called
> on the Food and Drug Administration in 2001 to add a new warning,
> known as a black box warning, to the labels on statins, emphasizing
> that patients must notify their doctors if they experience muscle
> pain, tenderness and weakness, the symptoms that may precede
> rhabdomyolysis. The FDA has not taken any action, and an FDA official,
> Dr. Mary Parks, would not comment on the issue last week. At the time
> Public Citizen made its request, 72 deaths during a three-year period
> had been linked to statin use; 20 of those were linked to Baycol,
> which the FDA withdrew from the market the same year.
>
> Dr. Robert Rosenson, director of preventative cardiology at
> Northwestern's Feinberg School of Medicine in Chicago, whose review of
> statin-induced myopathy was published in the American Journal of
> Medicine in March, said 3 percent to 5 percent of statin patients
> experience muscle problems. He often tries switching drugs or lowering
> the dose, he said, but "some people can't tolerate any dose of a
> statin."
>
> Still, not all physicians recognize the link between the drugs and the
> muscle syndromes, Thompson said, and some of his colleagues dismiss it
> as insignificant. "A lot of lipid experts say: 'The myalgia stuff you
> talk about doesn't exist,'" he said. "I say, 'You're not taking care
> of enough patients.'"
>
> Jeanne Bruderman is one patient whose physicians did not recognize a
> link: After going through surgery to treat back problems, she
> experienced pain, weakness and cramps in her arms and legs and
> tingling in her fingers. She sought help from a rheumatologist, a
> neurosurgeon and a pain-management doctor. Finally, a physician's
> assistant mentioned the symptoms could be related to statins and
> ordered a blood test to measure levels of the enzyme creatine kinase,
> an indication of muscle damage. "I nearly fell off my chair," said
> Bruderman, who lives in Bellport, is only 39 and had been put on
> Lipitor 19 months earlier. She quit the drugs and says the tingling in
> her fingers has subsided.
>
> Wonder drugs?
>
> Many cardiologists consider statins to be wonder drugs - especially
> for people who are at high risk for cardiovascular disease. "You can't
> go to a cardiology meeting and ask who's on the drug without
> everyone's hand going up," Thompson said. He takes a statin himself,
> and acknowledged that he serves as a consultant to several
> pharmaceutical companies that make them. But, he said, "they do have
> nagging side effects in some people."
>
> That description doesn't quite capture the experience of Rena Sweeney,
> a physical education teacher in upstate Kinderhook who was raised in
> Yonkers and now lives in what she calls "a whirlwind of pain."
> Sweeney, who is 53, started taking a low dose of Lipitor around the
> end of October, after blood tests showed her total cholesterol was
> 239. By the time her family came to visit around Thanksgiving, she
> said she couldn't even enjoy their company.
>
> "I was feeling old and shriveled up, fatigued," she said. Until then,
> Sweeney said, she had been the kind of person who rarely even suffered
> a cold. "I'm a P.E. teacher, and I am in very, very good shape; I work
> out all the time."
>
> Her leg muscles had started twitching, and her legs had started
> feeling weak, "like rubber." A blood test showed she had elevated
> creatine kinase levels, an indication of muscle damage, but the level
> was not high enough to convince her doctor that it was related to the
> medication. Her doctor thought she was having panic attacks.
>
> Once an avid skier, Sweeney was barely able to complete two runs down
> the mountain last winter. The pain in her legs was so intense at
> times, she said, "I was crying, the fronts of my calves, my shins,
> were killing me. I felt poisoned." She feared she may have developed
> lupus or a neurological illness, and saw several specialists to rule
> out connective-tissue diseases.
>
> An acquaintance who is an orthopedic surgeon was the first to ask
> whether she had started taking any new medications - and advised her
> to quit the drug immediately.
>
> Sweeney stopped taking Lipitor on New Year's Eve and said her weakness
> and the "shriveled-up feeling" are gone, though she still has muscle
> pain after exertion, even gardening.
>
> A spokeswoman for Pfizer, maker of Lipitor, declined to comment on the
> product's safety. In clinical trials, 5.6 percent of patients taking a
> 20-milligram dose of Lipitor reported myalgia or muscle pain, compared
> to 1.1 percent of subjects taking a placebo, according to the
> prescribing information. At a 40-milligram dose, 5.1 percent of
> patients taking Lipitor reported arthralgia or joint pain, compared to
> 1.5 percent on placebo.
>
> Sweeney said doctors have been unable to give her a definitive answer
> about what triggered her symptoms. Such myalgia can occur without the
> elevated enzyme levels that mean muscle damage has resulted in protein
> leaking out of the muscle cells into the blood. Doctors who followed
> four patients at Scripps Mercy Hospital Clinical Research Center in
> San Diego found the patients were able to guess correctly whether they
> were given statins or placebos, based on their muscle pain and
> performance on strength tests, even though they had normal creatine
> kinase levels in their blood.
>
> A number of other small studies have shown statins may exacerbate
> muscle injury during exercise. A study of 58 healthy men at the
> University of Pittsburgh in 1997, for example, found that those taking
> Mevacor (lovastatin) had much higher creatine kinase levels after 45
> minutes of downhill walking on a treadmill than a group taking a
> placebo.
>
> Jim Baggett, a housing inspector in Wilmington, N.C., said he started
> taking Zocor in July 2002 and became unable to do yardwork, couldn't
> get through his usual 2 1/2-hour weekend workouts and developed a
> cough, numbness in his feet, joint aches, weakness and tremors.
>
> Baggett, who is 58, underwent thousands of dollars' worth of tests to
> rule out Lyme disease, chronic fatigue syndrome, tuberculosis and
> amyotrophic lateral sclerosis, among other diseases. All of the test
> results were negative. Since quitting the drug, Baggett said, his
> health has improved, but he is not yet symptom-free.
>
> "I'm not one to say, 'Don't take it' - I'm not a doctor," Baggett
> said. "But at least be aware of what the problems are."
>
> Tony Plohoros, a spokesman for Merck, which makes Zocor and Mevacor,
> said side effects from both drugs are rare. "Both Mevacor and Zocor
> have excellent safety profiles," he said, adding that Merck is seeking
> FDA permission to sell Mevacor without a prescription. "The 20
> milligram dose has shown in clinical trials to have roughly the same
> side effects as a placebo."
>
> Risks and benefits
>
> The risk-to-benefit ratio of taking a statin must be evaluated for
> each patient individually, said Dr. Sidney Wolfe, director of Public
> Citizen.
>
> "There are millions of people getting statins who shouldn't be getting
> statins," Wolfe said. "These drugs have been especially useful for
> people when they are used for secondary prevention," in patients with
> established heart disease who are at risk for another heart attack, he
> said - and for them, "the benefits outweigh the risks."
>
> For people who don't have heart disease and who have no other risk
> factors, he said, "the risks outweigh the benefits."
>
> Dr. Mary Parks, deputy director of the FDA's division of metabolic and
> endocrine drug products, said she could not comment on the consumer
> group's 2001 petition to the agency to strengthen warnings on statins.
> She said the labels contain warnings already, and doctors need to
> convey the information to their patients.
>
> "People need to be aware that with any drug, there are going to be
> side effects," Parks said. "If you're taking this product and having
> aches and pains and it is in some way affecting daily activity, you
> need to contact your physician and talk about it. You may need to do a
> trial and go off the medicine. It may go away. It may also not be the
> medication.
>
> "Even in milder cases, it's worth people paying attention to it and
> not ignoring it," she said. In some cases of rhabdomyolysis, "if you
> can stop it early on, it may be of benefit to the patient."
>
> 1) This wasn't normal for me...My muscles were screaming.' - Eileen
> Mulvey, right, who was unable to climb stairs for two weeks after she
> started taking Crestor 2) 'The symptoms were dramatic. I had pain in
> my arms and my legs I felt like I had arthritis all over my body.' -
> Harvey Gardner, who began having symptoms after taking a few does of
> Zocar 3) 'A lot of lipid experts say: "The myalgia (pain) stuff you
> talk about doesn't exist." I say: "You're not taking care of enough
> patients.'' - Dr. Paul Thompson, director of preventive cardiology at
> Hartford Hospital 4) 'With any drug, there are going to be side
> effects. If you're taking this product and having aches and pains and
> it is in some way affecting daily activity, you need to contact your
> physician and talk about it It may also not be the medication.' - Dr.
> Mary Parks of the FDA's division of metabolic and endocrine drug
> products.
> Copyright © 2004, Newsday, Inc.

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