-Recall Involves 1 mg Physician Sample Blister Packs and 1 mg Hospital Blister Packs Only-
Bristol-Myers Squibb initiates a voluntary recall of 3 lots of physician sample blister packs of Coumadin® 1 mg tablets and 5 lots, of Coumadin 1 mg tablet hospital unit dose (HUD) blister packs. The following lot numbers are included in this recall: Physician Sample Blister Packs: Lot# 9A48931A, 9A48931B, 9A48931C, expiration January 2012; HUD Blister Pack: Lot# 8F34006B, 8K44272A, 8K46168A, 9F44437A and 9K58012B with expiry dates between June 2011 and November 2012. The recall is a precautionary measure based upon the company’s determination that some of the tablets, over time, may not meet specification for isopropanol. Isopropanol is used to maintain the active ingredient, Coumadin, in the crystalline state, and could affect the therapeutic levels of the active ingredient.
Coumadin is prescribed to treat or prevent blood clots. A decrease of active ingredient may increase the risk of clots which could lead to heart attack or stroke and if there is too much active ingredient, there is an increased risk of bleeding.
The recall only involves Coumadin 1 mg tablet blister-packs distributed in the U.S. This recall does not involve Coumadin 1 mg supplied in bottles or any other strengths and dosage forms of the product. Patients who may have product from the subject lots should contact their physicians to ensure that their anticoagulation therapy is not interrupted.
To date, the company has not received any reports of adverse events related to this issue. Bristol-Myers Squibb is committed to ensuring patient safety and is working to resolve this issue quickly and appropriately. The company has notified the U.S. Food and Drug Administration (FDA), and has issued recall communications to all physicians9 and other customers10 involved.
Any adverse reactions may also be reported to the FDA's MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov11.
Healthcare professionals and customers may call the following for assistance if they have further questions about the recall:
1-877-546-0128 begin_of_the_skype_highlighting 1-877-546-0128 end_of_the_skype_highlighting
|General Inquiries||Bristol-Myers Squibb Customer Relations
1-800-332-2056 begin_of_the_skype_highlighting 1-800-332-2056 end_of_the_skype_highlighting (option 1, then option 4)
|Medical Inquiries||Bristol-Myers Squibb Medical Information
1-800-321-1335 begin_of_the_skype_highlighting 1-800-321-1335 end_of_the_skype_highlighting (option 5)
|Recall Reimbursement Process||Bristol-Myers Squibb Customer Service Operations
1-800-631-5244 begin_of_the_skype_highlighting 1-800-631-5244 end_of_the_skype_highlighting (option 1, then option 5)
People with the” King disease” need to get a second, 3rd or 4th opinion until they find a doctor who will prescribe a medicine that will not kill. Gout pain is terrible, but the side effects of FDA approved medicine Colcrys (colchicines) are worse and in some cases even fatal.
Apparently Colcrys can induce severe drug interaction with common drugs like antibiotics and statins, (cyclosporine, erythromycin, digoxin, lipitor, simvastatin…), increasing the risk of potentially fatal colchine toxicity. Fatal drug interactions have been reported in patients treated with colchicine when clarithromycin were also being used. There are non-fatal, but terrible side effects too, like neuromuscular toxicity, thrombocytopenia, aplastic anemia…just to name a few. Toxicity has also been reported in a patient who consumed grapefruit juice or grapefruit daily while being treated chronically with colchicines!
Knowing that this drug can cause fatal toxic reactions (especially when used at the same time as many common medications) – even in approved dosages!-how doctors could prescribe such a dangerous drug is unbelievable.
While I was reading the recent FDA news release about the approval of a new blood-thinning drug Effient, I couldn’t believe my eyes. When will this stop? Who do they work for? Effient, Eli Lilly’s new blood thinner is so dangerous that the FDA approved it only for people getting angioplasty. Why? Because in the study, the approval was based on, patients taking Effient vs. Plavix (top selling blood thinner) faced “a grater risk of significant, sometimes fatal bleeding”. Not only that, but patients who already had strokes were more likely to have another stroke. And while Effient slightly reduced the risk of non-fatal heart attacks, the numbers of deaths and strokes were similar with both groups. So, Effient doesn’t work better, but increases the risk of repeated stroke and fatal bleeding. Why did FDA approved it? We all know why!
The drug labeling will include a boxed warning that the drug can cause significant, sometimes fatal bleeding. They are “washing” their hands. What about us? If you want to live and are scheduled for angioplasty better be sure the doctor doesn’t use Effient!
If you are taking the artificial insulin Lantus (insulin glargin) better run to your doctor to switch you off immediately. FDA announced that it is aware of four studies, three of which demonstrated a link between Lantus and cancer. A German study found possible 31% increased cancer risk for diabetics using Lantus. And a Swedish study showed that patients taking Lantus faced double the risk for breast cancer. While scientists are calling for further investigations and the FDA is reviewing different sources to better understand the risk of cancer associated with the use of Lantus, patients should stay away of the drug!
The reason I started this rubric is that I am sick and tired of Big Pharma poisoning and killing us with drugs that should never been released to the market. There are countless examples of intentional wrong doing and greed that one can ask yourself how we came to this point? It’s time to take care of ourselves!
From now on I will post an alert for every drug that is dangerous.
I will start with my personal experience .During my resent “vacation” in the hospital I developed severe bladder infection. They gave me antibiotic, but the infection wasn’t cleared. I was prescribed sulfamethoxazole-Tmp DS, which I was told was one of the best for my problem. On the third day in the morning I started to have pain in all of my joints and during the night I was already screaming. I couldn’t walk, lie, band, stand, nothing. Only excruciating, debilitating pain. I gave natural birth to my son, so I know what pain is. And the pain from this medicine was unbelievable!
My advice? No matter what the doctors tell you about the benefits of this drug, please, go on internet, read for yourself, gather more information, check what other” victims” are saying, ask another doctor, but most importantly-DON’T TAKE IT!