Posted on 11/18/2004 5:34:45 PM PST by neverdem
Group Calls Drug Unsafe
Since it came on the market last year, the drug Crestor has quickly helped millions of people with high cholesterol get their blood lipids down to healthier levels. It is the most powerful statin drug on the market, and many doctors and patients have warmly embraced it.
Not so the consumer advocacy group Public Citizen, which has waged a campaign to have Crestor taken off the market. In a citizen's petition to the Food and Drug Administration, the group said 29 cases of kidney failure or insufficiency that may have been related to Crestor have been reported.
Sidney Wolfe, director of Public Citizen's Health Research Group, argues that Crestor has a safety record uncomfortably similar to that of Baycol, Bayer Corp.'s powerful statin that was taken off the market in 2001 because of related serious side effects. "This is a drug with unique dangers but no real unique benefits," he said.
AstraZeneca Inc., which makes Crestor, disputes Wolfe's conclusions and says the drug is as safe as any other statin. The company's reviews of the 29 reports of "adverse events" showed they had no discernible connection to Crestor, said James Blasetto, AstraZeneca's executive director for strategic development. "The clinical evidence here does not suggest a causal relationship between Crestor and these events," he said.
The distance between the two positions illustrates how difficult -- and important -- the monitoring of approved drugs has become.
A number of researchers, as well as Public Citizen, strongly argued that the arthritis drug Vioxx should have been taken off the market years before its maker, Merck & Co., acted. But with 10,000 prescription drugs available now, the FDA does not have the resources to aggressively investigate all adverse drug reactions. In addition, the agency is always weighing the benefits to...
(Excerpt) Read more at washingtonpost.com ...
I hope not. I've been taking this for a few months now and it has worked very well.
When I see kidney failure, I wonder if there is any documentation as to how much water those taking it drank?
I know too many older types who probably don't dring a glass of water a day.
Then, compound problems and have to get other pills to alleviate the symptoms etc.
I'v got to ask how much of what's being called failure by evil drug companies is failure of those taking the drug to do any self-care at all.
You ought to be having blood drawn for routine liver function tests when someone is started on a statin. Tests for kidney function can be checked at the same time.
Ping
It must get along with you.
Side effects for Accupril: (Quinapril)
SIDE EFFECTS
Hypertension
Quinapril HCl has been evaluated for safety in 4960 subjects and patients. Of these, 3203 patients, including 655 elderly patients, participated in controlled clinical trials. Quinapril HCl has been evaluated for long-term safety in over 1400 patients treated for 1 year or more.
Adverse experiences were usually mild and transient.
In placebo-controlled trials, discontinuation of therapy because of adverse events was required in 4.7% of patients with hypertension.
Adverse experiences probably or possibly related to therapy or of unknown relationship to therapy occurring in 1% or more of the 1563 patients in placebo-controlled hypertension trials who were treated with quinapril HCl are shown in TABLE 1.
TABLE 1 Adverse Events in Placebo-Controlled Trials
Quinapril HCl Placebo
(N=1563) (N=579)
Incidence Incidence
(Discontinuance) (Discontinuance)
Headache 5.6 (0.7) 10.9 (0.7)
Dizziness 3.9 (0.8) 2.6 (0.2)
Fatigue 2.6 (0.3) 1.0
Coughing 2.0 (0.5) 0.0
Nausea and/or Vomiting 1.4 (0.3) 1.9 (0.2)
Abdominal Pain 1.0 (0.2) 0.7
Heart Failure
Quinapril HCl has been evaluated for safety in 1222 quinapril HCl treated patients. Of these, 632 patients participated in controlled clinical trials. In placebo-controlled trials, discontinuation of therapy because of adverse events was required in 6.8% of patients with congestive heart failure.
Adverse experiences probably or possibly related or of unknown relationship to therapy occurring in 1% or more of the 585 patients in placebo-controlled congestive heart failure trials who were treated with quinapril HCl are shown below (TABLE 2).
TABLE 2
Quinapril HCl Placebo
(N=585) (N=295)
Incidence Incidence
(Discontinuance) (Discontinuance)
Dizziness 7.7 (0.7) 5.1 (1.0)
Coughing 4.3 (0.3) 1.4
Fatigue 2.6 (0.2) 1.4
Nausea and/or vomiting 2.4 (0.2) 0.7
Chest Pain 2.4 1.0
Hypotension 2.9 (0.5) 1.0
Dyspnea 1.9 (0.2) 2.0
Diarrhea 1.7 1.0
Headache 1.7 1.0 (0.3)
Myalgia 1.5 2.0
Rash 1.4 (0.2) 1.0
Back Pain 1.2 0.3
See PRECAUTIONS, Cough.
Hypertension and/or Heart Failure
Clinical adverse experiences probably, possibly, or definitely related, or of uncertain relationship to therapy occurring in 0.5% to 1.0% (except as noted) of the patients with CHF or hypertension treated with quinapril HCl (with or without concomitant diuretic) in controlled or uncontrolled trials (N=4847) and less frequent, clinically significant events seen in clinical trials or post-marketing experience (the rarer events are in italics) include (listed by body system):
General: back pain, malaise, viral infections
Cardiovascular: palpitation, vasodilation, tachycardia, heart failure, hyperkalemia, myocardial infarction, cerebrovascular accident, hypertensive crisis, angina pectoris, orthostatic hypotension, cardiac rhythm disturbances, cardiogenic shock
Hematology: hemolytic anemia
Gastrointestinal: dry mouth or throat, constipation, gastrointestinal hemorrhage, pancreatitis, abnormal liver function tests
Nervous/Psychiatric: somnolence, vertigo, syncope, nervousness, depression, insomnia, paresthesia
Integumentary: alopecia, increased sweating, pemphigus, pruritus, exfoliative dermatitis, photosensitivity reaction, dermatopolymiositis
Urogenital: imotenceacute renal failure, worsening renal failure
Respiratory: eosinophilic pneumonitis
Other: amblyopia, pharyngitisagranulocytosis, hepatitis, thrombocytopenia
Fetal/Neonatal Morbidity and Mortality
See WARNINGS, Fetal/Neonatal Morbidity and Mortality.
Angioedema
Angioedema has been reported in patients receiving quinapril HCl (0.1%). Angioedema associated with laryngeal edema may be fatal. If angioedema of the face, extremities, lips, tongue, glottis, and/or larynx occurs, treatment with quinapril HCl should be discontinued and appropriate therapy instituted immediately. (See WARNINGS.)
Clinical Laboratory Test Findings
Hematology: (See WARNINGS)
Hyperkalemia: (See PRECAUTIONS)
Creatinine and Blood Urea Nitrogen: Increases (>1.25 times the upper limit of normal) in serum creatinine and blood urea nitrogen were observed in 2% and 2%, respectively, of all patients treated with quinapril HCl alone. Increases are more likely to occur in patients receiving concomitant diuretic therapy than in those on quinapril HCl alone. These increases often remit on continued therapy. In controlled studies of heart failure, increases in blood urea nitrogen and serum creatinine were observed in 11% and 8%, respectively, of patients treated with quinapril HCl; most often these patients were receiving diuretics with or without digitalis.
DRUG INTERACTIONS
Concomitant Diuretic Therapy: As with other ACE inhibitors, patients on diuretics, especially those on recently instituted diuretic therapy, may occasionally experience an excessive reduction of blood pressure after initiation of therapy with quinapril HCl. The possibility of hypotensive effects with quinapril HCl may be minimized by either discontinuing the diuretic or cautiously increasing salt intake prior to initiation of treatment with quinapril HCl. If it is not possible to discontinue the diuretic, the starting dose of quinapril should be reduced (see DOSAGE AND ADMINISTRATION.)
Agents Increasing Serum Potassium: Quinapril can attenuate potassium loss caused by thiazide diuretics and increase serum potassium when used alone. If concomitant therapy of quinapril HCl with potassium-sparing diuretics (e.g., spironolactone, triamterene, or amiloride), potassium supplements, or potassium-containing salt substitutes is indicated, they should be used with caution along with appropriate monitoring of serum potassium (see PRECAUTIONS.)
Tetracycline and Other Drugs that Interact with Magnesium: Simultaneous administration of tetracycline with quinapril HCl reduced the absorption of tetracycline by approximately 28% to 37%, possibly due to the high magnesium content in quinapril HCl tablets. This interaction should be considered if coprescribing quinapril HCl and tetracycline or other drugs that interact with magnesium.
Lithium: Increased serum lithium levels and symptoms of lithium toxicity have been reported in patients receiving concomitant lithium and ACE inhibitor therapy. These drugs should be coadministered with caution and frequent monitoring of serum lithium levels is recommended. If a diuretic is also used, it may increase the risk of lithium toxicity.
Other Agents: Drug interaction studies of quinapril HCl with other agents showed:
Multiple dose therapy with propranolol or cimetidine has no effect on the pharmacokinetics of single doses of quinapril HCl.
The anticoagulant effect of a single dose of warfarin (measured by prothrombin time) was not significantly changed by quinapril coadministration twice-daily.
Quinapril HCl treatment did not affect the pharmacokinetics of digoxin.
No pharmacokinetic interaction was observed when single doses of quinapril HCl and hydrochlorothiazide were administered concomitantly.
Good luck on Crestor but please watch out for side effects. I have permanent damage from taking Lipitor and then zocor....statins don't always agree with everyone. I was on statin drugs for 4-5 yrs and have ended up with lasting muscle damage and kidney problems.
For a very long time I didn't associate my feeling horrible to the lipitor etc. but once I did I had to work very hard to get my dr. to finally agree it was indeed the statin meds...he now watches his patients a little closer for possible side effects.....
What side effects did you have on Crestor?
I've been on it a few months and it brought my cholesterol right down. No side effects that I can tell. I have to have a liver test every month.
>>>I had to work very hard to get my dr. to finally agree it was indeed the statin meds...he now watches his patients a little closer for possible side effects.....
Statins are evil. I had a dr. that said 'oh side effects are rare...' so I quit taking Lipitor, and changed doctors. Tried two other statins with the new doc, who was willing to listen, and agreed with my decision not to do statins.
The beginnings of myopathy, three times.
Interesting website: http://www.impostertrial.com
And the "physician" side of that website has most of the information on myopathies.
Thanks for the link!
Were your side effects related to muscle weakness and pain?
I was started on Lipitor and had to quit after about two ot three weeks because of muscle pain. Same happened when I tried Zocor, so I foind I cannot take an statins as they all have the same side effect on me.
Personally I think these statins may have a lot of effects, short and long, that are not known. I for one find them all dangerous.
By the way my Father was given Crestor and same side effects that I had, I told him to forget all the statins as I felt he would have the same problems with all.
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