July 1th
2008
1:08 PM
I posted the following information belolw under Simvastatin, the generic equivalent of Zocor, which may apply to the brand name as well:
"In follow-up to my posting 3-days ago, regarding an adverse reaction to Simvastatin 80mg, I would encourage patients/consumers to directly send their complaint to the web sites listed at the very bottom, if you are either a U.S. (FDA Form 3500) or Canadian resident. Also, if your physician is unresponsive to your negative experience with generic Simvastatin, inform him/her that you refuse to continue with this drug, and that you have sent an adverse reaction complaint to the FDA/Canadian equivalent. Provide both your doctor and pharmacy with a copy of the FDA Form 3500 if your a U.S. resident, so they know you're serious. Lastly, I'm back to feeling normal, after I "demanded" my physician switch me to generic Pravastatin 40mg (2 tabs a day - 80mg), manufactured by Teva Pharmaceutical - corporate HQ Israel with manufacturing facility in Pennsylvania. By the way, a 90-day supply of this quality controlled drug is available at Walmart Pharmacy for $10. I hope this helps, especially seniors on a fixed income. -
U.S.A.
http://www.fda.gov/opacom/backgrounders/problem.html
CANADA (http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/compli-conform/gui-44_consumer_complaint-plainte_consommateur-eng.pdf). Contact Name: Drug Compliance Verification and Investigation Unit Tel: (613) 952-9906 Fax: (613) 954-0941 E-Mail: DCVIU_UVCEM@hc-sc.gc.ca "
In closing, I would encourage discontinuation of your statin, if it's made by a company based in India or China (call your pharmacist, they can tell you the country of origin).
-- By drmike4777 | Reply | Private Message me
June 29th
2008
12:08 PM
In follow-up to my posting 3-days ago, regarding an adverse reaction to Simvastatin 80mg, I would encourage patients/consumers to directly send their complaint to the web sites listed at the very bottom, if you are either a U.S. (FDA Form 3500) or Canadian resident.
Also, if your physician is unresponsive to your negative experience with generic Simvastatin, inform him/her that you refuse to continue with this drug, and that you have sent an adverse reaction complaint to the FDA/Canadian equivalent. Provide both your doctor and pharmacy with a copy of the FDA Form 3500 if your a U.S. resident, so they know you're serious.
Lastly, I'm back to feeling normal, after I "demanded" my physician switch me to generic Pravastatin 40mg (2 tabs a day - 80mg), manufactured by Teva Pharmaceutical - corporate HQ Israel with manufacturing facility in Pennsylvania. By the way, a 90-day supply of this quality controlled drug is available at Walmart Pharmacy for $10.
I hope this helps, especially seniors on a fixed income.
-------------------------------------------------------------------------------------
U.S.A.
http://www.fda.gov/opacom/backgrounders/problem.html
Contact Name: Drug Compliance Verification and Investigation Unit
Tel: (613) 952-9906
Fax: (613) 954-0941
E-Mail: DCVIU_UVCEM@hc-sc.gc.ca
June 27th
2008
2:59 AM
i was a healthy 35 year old male but had high cholesterol, so the doctor prescribed lovastatin (mevacor) and tried it for a month but developed muscle weakness. months later, i'm still experiencing severe muscle spasms and my neurologist is stumped -- mri's, spinal tap, emg -- all normal. I just want to feel normal again. can anyone help? please email me!
-- By folrsi30 | Reply | (6) replies | Private Message me
April 7th
2008
3:48 PM
From Canada:
Leukotriene receptor antagonists: suspected adverse reactions
The cysteinyl leukotrienes are inflammatory mediators that bind to cysteinyl leukotriene receptors found in the human airway and cause a number of airway actions including bronchoconstriction, mucous secretion, vascular permeability and eosinophil recruitment.1 Zafirlukast (Accolate®) and montelukast sodium (Singulair®), marketed in Canada since November 1997 and August 1998 respectively, are competitive cysteinyl leukotriene receptor antagonists. Zafirlukast is indicated for the prophylaxis and chronic treatment of asthma in patients 12 years of age and older.2 Montelukast is indicated for the prophylaxis and chronic treatment of asthma, the treatment of asthma in ASA-sensitive patients and the prevention of exercise-induced bronchoconstriction in pediatric patients 6-14 years of age and adults 15 years of age and older.1
As of June 1, 1999, the CADRMP has received 41 reports of suspected adverse drug reactions associated with the use of zafirlukast and 22 associated with the use of montelukast. This article will discuss a serious and rare adverse reaction associated with the use of these agents, drug-drug interactions and unexpected adverse reactions that have been reported to the CADRMP.
http://www.hc-sc.gc.ca/dhp-mps/medeff/bulletin/carn-bcei_v9n4_e.html
Conditions are discussed in the article.
-- By concernedcitizen | Reply | Private Message me
July 1th
2008
3:45 PM
Because of a “Global economy” - I suspect ingredients (even for Brand names) are coming from China or being manufactured in India with poor to non-existent quality control standards, and is the primary reason for the majority of Adverse Reactions to the Statins in general. Please take time to submit your complaint directly to the FDA, and hope they investigate and take action (see bottom of page for web sites to submit complaint).
My own recent experience with statins: After 3-weeks of being on generic Simvastatin 80mg for elevated LDL, I experienced significant fatigue, shortness of breath with tightness around my chest and a bout of Gout in my left foot. I would encourage patients/consumers to directly send their complaint to the web sites listed at the very bottom, if you are either a U.S. (FDA Form 3500) or Canadian resident. Also, if your physician is unresponsive to your negative experience with Statins (generic or Brand Name), inform him/her that you refuse to continue with this drug, and that you have sent an adverse reaction complaint to the FDA/Canadian equivalent. Provide both your doctor and pharmacy with a copy of the FDA Form 3500 if you’re a U.S. resident, so they know you're serious. Lastly, I'm back to feeling normal, after I "demanded" my physician switch me to generic Pravastatin 40mg (2 tabs a day - 80mg), manufactured by Teva Pharmaceutical - corporate HQ Israel with manufacturing facility in Pennsylvania. By the way, a 90-day supply of this quality-controlled drug is available at Walmart Pharmacy for $10. I hope this helps, especially seniors on a fixed income.
U.S.A.
http://www.fda.gov/opacom/backgrounders/problem.html
CANADA
-- By drmike4777 | Reply | (3) replies | Private Message mehttp://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/compli-conform/gui-44_consumer_complaint-plainte_consommateur-eng.pdf
Contact Name: Drug Compliance Verification and Investigation Unit Tel: (613) 952-9906 Fax: (613) 954-0941 E-Mail: DCVIU_UVCEM@hc-sc.gc.ca