Guest guest Posted July 17, 2001 Report Share Posted July 17, 2001 I got this from my sister. Thought you all should like to see it. Synthroid Info > Manufacturer: Abbott Laboratories > Website: www.synthroid.com > Phone number: > Address: 200 Abbott Park Road, Abbott Park, IL 60064 > > Posted on synthroid.com: > 6/21/01 letter to pharmacists: > " Get the facts: Synthroid remains available " . The body of the letter is > relevant only to pharmacists. Anyone with questions can call the Abbott 800 > number. > > ----------------------------- > > The Endocrine Society (www.endo-society.org) press release: > > American Thyroid Association, The Endocrine Society, and ThyCa Call for > Continued Availability of Thyroid Hormone Products > > Washington, DC, June 4, 2001 - The American Thyroid Association, The > Endocrine Society, and ThyCa: Thyroid Cancer Survivors' Association are > urging that the Food and Drug Administration (FDA) maintain the > uninterrupted availability of Synthroid and other currently marketed thyroid > hormone (thyroxine) products to the 13 million U.S. patients who rely on > them every day for life to treat hypothyroidism, thyroid cancer, and other > thyroid conditions. > > The three professional and patient advocacy organizations are responding to > recent media reports claiming that the FDA may soon take actions to remove > Synthroid from the U.S. market. > > Two-thirds of patients who take thyroxine are prescribed Synthroid, the > first branded thyroxine preparation, which has been on the market for more > than 40 years. Synthroid is the third most commonly prescribed drug in the > U.S. > > The organizations are concerned that patients who take Synthroid or another > particular brand of thyroxine would suffer from the unnecessary > discontinuation, even temporarily, of their prescribed formulation. > > " Even the threat of an interruption could cause alarm, inconvenience, and > cost for patients who are doing well on their current thyroid medication, " > said W. Ladenson, M.D., Secretary of the American Thyroid Association. > " The American Thyroid Association, The Endocrine Society, and ThyCa are also > concerned that patients could be harmed medically if they were forced to > switch from one brand to another without appropriate monitoring and, when > needed, dose adjustment. " > > The three organizations express confidence in the FDA's well-established, > reliable procedures for assuring the safety and effectiveness of all > prescription drugs. Every brand-including Synthroid-and generic preparation > of thyroxine has met those standards as they have evolved. In 1997, the FDA > first determined that each thyroxine manufacturer would have to file a New > Drug Application (NDA). Abbott Laboratories, the maker of Synthroid, has > indicated its intent to file an NDA by the August 2001 deadline. King > Pharmaceuticals, the maker of Levoxyl, and Pharmaceuticals, the maker > of Unithroid, secured FDA approval earlier this year. > > The American Thyroid Association, The Endocrine Society, and ThyCa recognize > that the reason that Synthroid and some other thyroxine preparations have > not yet received FDA approval is logistical, not medical. > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 17, 2001 Report Share Posted July 17, 2001 I'm troubled by the many anecdotal and self-serving statements of support respecting Synthroid in view of the very specific findings of the FDA in their April 26, 2001 nine page letter refuting Knoll Pharmaceutical's (now Abbott Laboratories') position that Synthroid is safe and effective. I've attached a copy of the letter in PDF for all to read (if it comes through). How many of the physicians supporting Synthroid have actually read the nine page FDA denial? How many of the Thyca leadership have read it? Many Thyca survivors routinely go hypo for testing and ablation. Why is a single event of switching Brands any more traumatic than complete withdrawal for weeks? Earlier this year, I was troubled by the fact that I had read much literature indicating Synthroid should not be subject to excessive temperature in storage. I raised this question with my mail order provider (Merck-Medco) after receiving information over the phone from a Knoll Pharmaceutical pharmacist that I shouldn't order Synthroid through the mail. Subsequently, Merck-Medco contacted Abbott/Knoll and in a letter (I obtained a copy) dated March 15, 2001, Dr. Dolch (VP of Technical Operations for Abbott) advised Merck-Medco that it was all right to ship Synthroid through the U.S. Mails. Dr. Dolch is one of the named Petitioners on the application to the FDA which is attached. Godspeed, Bard Li wrote: > I got this from my sister. Thought you all should like to see it. > > Synthroid Info > > > > Manufacturer: Abbott Laboratories > > Website: www.synthroid.com > > Phone number: > > Address: 200 Abbott Park Road, Abbott Park, IL 60064 > > > > Posted on synthroid.com: > > 6/21/01 letter to pharmacists: > > " Get the facts: Synthroid remains available " . The body of the letter > is > > relevant only to pharmacists. Anyone with questions can call the > Abbott > 800 > > number. > > > > ----------------------------- > > > > The Endocrine Society (www.endo-society.org) press release: > > > > American Thyroid Association, The Endocrine Society, and ThyCa Call > for > > Continued Availability of Thyroid Hormone Products > > > > Washington, DC, June 4, 2001 - The American Thyroid Association, The > > > Endocrine Society, and ThyCa: Thyroid Cancer Survivors' Association > are > > urging that the Food and Drug Administration (FDA) maintain the > > uninterrupted availability of Synthroid and other currently marketed > > thyroid > > hormone (thyroxine) products to the 13 million U.S. patients who > rely on > > them every day for life to treat hypothyroidism, thyroid cancer, and > other > > thyroid conditions. > > > > The three professional and patient advocacy organizations are > responding > to > > recent media reports claiming that the FDA may soon take actions to > remove > > Synthroid from the U.S. market. > > > > Two-thirds of patients who take thyroxine are prescribed Synthroid, > the > > first branded thyroxine preparation, which has been on the market > for more > > than 40 years. Synthroid is the third most commonly prescribed drug > in the > > U.S. > > > > The organizations are concerned that patients who take Synthroid or > another > > particular brand of thyroxine would suffer from the unnecessary > > discontinuation, even temporarily, of their prescribed formulation. > > > > " Even the threat of an interruption could cause alarm, > inconvenience, and > > cost for patients who are doing well on their current thyroid > medication, " > > said W. Ladenson, M.D., Secretary of the American Thyroid > Association. > > " The American Thyroid Association, The Endocrine Society, and ThyCa > are > also > > concerned that patients could be harmed medically if they were > forced to > > switch from one brand to another without appropriate monitoring and, > when > > needed, dose adjustment. " > > > > The three organizations express confidence in the FDA's > well-established, > > reliable procedures for assuring the safety and effectiveness of all > > > prescription drugs. Every brand-including Synthroid-and generic > preparation > > of thyroxine has met those standards as they have evolved. In 1997, > the > FDA > > first determined that each thyroxine manufacturer would have to file > a New > > Drug Application (NDA). Abbott Laboratories, the maker of Synthroid, > has > > indicated its intent to file an NDA by the August 2001 deadline. > King > > Pharmaceuticals, the maker of Levoxyl, and Pharmaceuticals, > the > maker > > of Unithroid, secured FDA approval earlier this year. > > > > The American Thyroid Association, The Endocrine Society, and ThyCa > recognize > > that the reason that Synthroid and some other thyroxine preparations > have > > not yet received FDA approval is logistical, not medical. > > > > > > > For more information regarding thyroid cancer visit www.thyca.org. If > you do not wish to belong to this group, you may UNSUBSCRIBE by > sending a blank email to thyca-unsubscribe > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 17, 2001 Report Share Posted July 17, 2001 I'm troubled by the many anecdotal and self-serving statements of support respecting Synthroid in view of the very specific findings of the FDA in their April 26, 2001 nine page letter refuting Knoll Pharmaceutical's (now Abbott Laboratories') position that Synthroid is safe and effective. I've attached a copy of the letter in PDF for all to read (if it comes through). How many of the physicians supporting Synthroid have actually read the nine page FDA denial? How many of the Thyca leadership have read it? Many Thyca survivors routinely go hypo for testing and ablation. Why is a single event of switching Brands any more traumatic than complete withdrawal for weeks? Earlier this year, I was troubled by the fact that I had read much literature indicating Synthroid should not be subject to excessive temperature in storage. I raised this question with my mail order provider (Merck-Medco) after receiving information over the phone from a Knoll Pharmaceutical pharmacist that I shouldn't order Synthroid through the mail. Subsequently, Merck-Medco contacted Abbott/Knoll and in a letter (I obtained a copy) dated March 15, 2001, Dr. Dolch (VP of Technical Operations for Abbott) advised Merck-Medco that it was all right to ship Synthroid through the U.S. Mails. Dr. Dolch is one of the named Petitioners on the application to the FDA which is attached. Godspeed, Bard Li wrote: > I got this from my sister. Thought you all should like to see it. > > Synthroid Info > > > > Manufacturer: Abbott Laboratories > > Website: www.synthroid.com > > Phone number: > > Address: 200 Abbott Park Road, Abbott Park, IL 60064 > > > > Posted on synthroid.com: > > 6/21/01 letter to pharmacists: > > " Get the facts: Synthroid remains available " . The body of the letter > is > > relevant only to pharmacists. Anyone with questions can call the > Abbott > 800 > > number. > > > > ----------------------------- > > > > The Endocrine Society (www.endo-society.org) press release: > > > > American Thyroid Association, The Endocrine Society, and ThyCa Call > for > > Continued Availability of Thyroid Hormone Products > > > > Washington, DC, June 4, 2001 - The American Thyroid Association, The > > > Endocrine Society, and ThyCa: Thyroid Cancer Survivors' Association > are > > urging that the Food and Drug Administration (FDA) maintain the > > uninterrupted availability of Synthroid and other currently marketed > > thyroid > > hormone (thyroxine) products to the 13 million U.S. patients who > rely on > > them every day for life to treat hypothyroidism, thyroid cancer, and > other > > thyroid conditions. > > > > The three professional and patient advocacy organizations are > responding > to > > recent media reports claiming that the FDA may soon take actions to > remove > > Synthroid from the U.S. market. > > > > Two-thirds of patients who take thyroxine are prescribed Synthroid, > the > > first branded thyroxine preparation, which has been on the market > for more > > than 40 years. Synthroid is the third most commonly prescribed drug > in the > > U.S. > > > > The organizations are concerned that patients who take Synthroid or > another > > particular brand of thyroxine would suffer from the unnecessary > > discontinuation, even temporarily, of their prescribed formulation. > > > > " Even the threat of an interruption could cause alarm, > inconvenience, and > > cost for patients who are doing well on their current thyroid > medication, " > > said W. Ladenson, M.D., Secretary of the American Thyroid > Association. > > " The American Thyroid Association, The Endocrine Society, and ThyCa > are > also > > concerned that patients could be harmed medically if they were > forced to > > switch from one brand to another without appropriate monitoring and, > when > > needed, dose adjustment. " > > > > The three organizations express confidence in the FDA's > well-established, > > reliable procedures for assuring the safety and effectiveness of all > > > prescription drugs. Every brand-including Synthroid-and generic > preparation > > of thyroxine has met those standards as they have evolved. In 1997, > the > FDA > > first determined that each thyroxine manufacturer would have to file > a New > > Drug Application (NDA). Abbott Laboratories, the maker of Synthroid, > has > > indicated its intent to file an NDA by the August 2001 deadline. > King > > Pharmaceuticals, the maker of Levoxyl, and Pharmaceuticals, > the > maker > > of Unithroid, secured FDA approval earlier this year. > > > > The American Thyroid Association, The Endocrine Society, and ThyCa > recognize > > that the reason that Synthroid and some other thyroxine preparations > have > > not yet received FDA approval is logistical, not medical. > > > > > > > For more information regarding thyroid cancer visit www.thyca.org. If > you do not wish to belong to this group, you may UNSUBSCRIBE by > sending a blank email to thyca-unsubscribe > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 18, 2001 Report Share Posted July 18, 2001 I'm concerned about the Synthroid matter too although I think it is silly to obsess about it. Synthroid is an NTI (narrow therapeutic index) drug. This means that we (patients) need to be maintained on carefully adjusted doses. It's scary to think that the manufacturer may not be abiding by specific guidelines, however what can we do until the studies are completed and a decision has been made? If we all go nutso and switch medications, we may be doing ourselves more harm than good (considering how much cost and time is involved with the bloodwork needed for appropriate monitoring in such situations). I say, let the FDA do their job and soon enough we'll have an answer. This has gotten WAY out of control... My Opinion Only, Audra Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 18, 2001 Report Share Posted July 18, 2001 I don't intend to " go nutso and switch medications " nor will I obsess about it, but I have essentially put my health in the hands of a questionable medication...on a daily basis! Therefore, I think this subject matter deserves as much discussion as any other aspect of Thyca. Sandy TT/RAI Oct. 2000, multi-focal pap ..175 synthroid > I'm concerned about the Synthroid matter too although I think it is silly to > obsess about it. Synthroid is an NTI (narrow therapeutic index) drug. This > means that we (patients) need to be maintained on carefully adjusted doses. > It's scary to think that the manufacturer may not be abiding by specific > guidelines, however what can we do until the studies are completed and a > decision has been made? If we all go nutso and switch medications, we may be > doing ourselves more harm than good (considering how much cost and time is > involved with the bloodwork needed for appropriate monitoring in such > situations). I say, let the FDA do their job and soon enough we'll have an > answer. This has gotten WAY out of control... > > My Opinion Only, > Audra Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 18, 2001 Report Share Posted July 18, 2001 How much more expense and effort is required to switch to an FDA approved drug if it is done after going hypo or if it is done when testing dictates a level change in your Synthroid? I think that the physicians supporting Synthroid (and Thyca leadership as well) need to present more than anecdotal evidence and opinion to support their assertions. The problem would be far different if there were not already FDA approved alternatives available. The situation is further compounded when you consider that Abbott is approving shipment and delivery of Synthroid via the U.S. Mails while even physicians supporting Synthroid have cautioned against leaving it sit in a hot car. The FDA has done its job and has rejected Knoll's and Abbott's petitions. Abbott has now (as a result of extensive lobbying ) given Abbott an extended time period in which to qualify. The problem is that Synthroid is not now qualified and the present formula and manufacture are not approved. What happens to all those who continue to take the present Synthroid in a very long intervening period? Why should they? Times are achanging! It's ok to question physicians, honest! nysMommy1@... wrote: > I'm concerned about the Synthroid matter too although I think it is > silly to > obsess about it. Synthroid is an NTI (narrow therapeutic index) > drug. This > means that we (patients) need to be maintained on carefully adjusted > doses. > It's scary to think that the manufacturer may not be abiding by > specific > guidelines, however what can we do until the studies are completed and > a > decision has been made? If we all go nutso and switch medications, we > may be > doing ourselves more harm than good (considering how much cost and > time is > involved with the bloodwork needed for appropriate monitoring in such > situations). I say, let the FDA do their job and soon enough we'll > have an > answer. This has gotten WAY out of control... > > My Opinion Only, > Audra > > For more information regarding thyroid cancer visit www.thyca.org. If > you do not wish to belong to this group, you may UNSUBSCRIBE by > sending a blank email to thyca-unsubscribe > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 18, 2001 Report Share Posted July 18, 2001 , I understand your concerns, as they are my own. However, if we allow ourselves to become panicked about such a situation, it could have disastrous results. For example, the reason I take Synthroid is to suppress cancer growth. If I change medications midstream, I will have to visit the lab more frequently for blood work and the doctor will have to titrate my medication. I'm sure we all realize how long it can take to titrate Levothyroxine. Since 2/3 of all patients on Levothyroxine take Synthroid, can you imagine our physician offices if we ALL demanded a change (when I am really quite confident that Synthroid is as safe and efficacious as we believe it to be)? As if the demands placed on health care workers isn't enough these days with managed care stipulations.... Think of the chaos when millions of patients want their Synthroid changed to another " approved " product. I guess the most important question is, are we being managed appropriately on Synthroid? Is our TG where we want it to be? How about our TSH? And, does the Synthroid seem to be suppressing our cancer? If so, great! If not, ask your doctor. Why switch and worry about blood tests, titration, possible hypo or hyper thyroidism or even worse; elevations in our bloodwork, cancer recurrance, etc. There is no need for such alarm. SURE it is ok to question our physicians. I wouldn't expect anything less. However, if we all demand to be switched from Synthroid, who's doctor is going to have time to answer our important questions regarding our disease state? If you are not familiar with the US Pharmacopia, I urge you to look them up on the web. The following is a small description of what they are responsible for regarding our medications: 1. Standards for drugs, excipients, dietary supplements, vitamins and minerals. 2. Standards of strength, quality, purity, identity, packaging, labeling, and storage. 3. Tests, assays, and analytical methods—including identification, dissolution, content uniformity etc. These points are especially important when we discuss the quality, purity, identity and content of products. Understadably, manufacturers need to prove that their product has consitancy from tablet to tablet and dose to dose. It is especially important for those of us taking this narrow therapeutic index drug. If our tablets are NOT consistant dose to dose, then we suffer the consiquences. I might compare this to someone who takes Coumadin (anticoagulant) for example. If a person is not appropriately managed on Coumadin, and they fall out of therapeutic range....we are talking about bleeding if there is too much of the drug in the bloodstreem or stroke if there is too little of the drug in the bloodstream. Now start switching patients (at the pharmacy) who are very well managed on Coumadin (within INR range) to all sorts of different generic drugs within the same class. And what do we have? I've seen it up close and personal. There is wide variability allowed tablet to tablet and especially batch to batch and even more so product to product within the same class. Therefore, there is a difference in their INR....and whoola, we have people stroking and bleeding. This just goes to show that even though there are similar drugs in a " class " , the amount of active ingredient tablet to tablet may be variable. Do we really want to run that risk? If we are satisfied with our therapy on Synthroid, then should we take the risk of switching to another Levothyroxine in the same class? Will we be titrated immediately? Probably not. I know this from experience since my prescription was once changed at my local pharmacy to another product. In the mean time, my TSH shot up and I was hypothryoid and feeling miserable within 3 weeks. When I called my doctor, she asked my what my drug bottle said. She said, " If it doesn't say Synthroid, I'm calling in a script for you! " That day, I switched back to Synthroid and it took another 3 to 4 weeks to start feeling " normal " again. No, I don't work for the manufacturer (which is what you may be thinking!), but I am very familiar with the pharmaceutical industry.... As I mentioned in my previous e mail, this is my opinion only. I'm just trying to help people make the right decision. I don't think we should panic and I do believe the FDA knows what it is doing... Thanks, Audra Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 18, 2001 Report Share Posted July 18, 2001 , I understand your concerns, as they are my own. However, if we allow ourselves to become panicked about such a situation, it could have disastrous results. For example, the reason I take Synthroid is to suppress cancer growth. If I change medications midstream, I will have to visit the lab more frequently for blood work and the doctor will have to titrate my medication. I'm sure we all realize how long it can take to titrate Levothyroxine. Since 2/3 of all patients on Levothyroxine take Synthroid, can you imagine our physician offices if we ALL demanded a change (when I am really quite confident that Synthroid is as safe and efficacious as we believe it to be)? As if the demands placed on health care workers isn't enough these days with managed care stipulations.... Think of the chaos when millions of patients want their Synthroid changed to another " approved " product. I guess the most important question is, are we being managed appropriately on Synthroid? Is our TG where we want it to be? How about our TSH? And, does the Synthroid seem to be suppressing our cancer? If so, great! If not, ask your doctor. Why switch and worry about blood tests, titration, possible hypo or hyper thyroidism or even worse; elevations in our bloodwork, cancer recurrance, etc. There is no need for such alarm. SURE it is ok to question our physicians. I wouldn't expect anything less. However, if we all demand to be switched from Synthroid, who's doctor is going to have time to answer our important questions regarding our disease state? If you are not familiar with the US Pharmacopia, I urge you to look them up on the web. The following is a small description of what they are responsible for regarding our medications: 1. Standards for drugs, excipients, dietary supplements, vitamins and minerals. 2. Standards of strength, quality, purity, identity, packaging, labeling, and storage. 3. Tests, assays, and analytical methods—including identification, dissolution, content uniformity etc. These points are especially important when we discuss the quality, purity, identity and content of products. Understadably, manufacturers need to prove that their product has consitancy from tablet to tablet and dose to dose. It is especially important for those of us taking this narrow therapeutic index drug. If our tablets are NOT consistant dose to dose, then we suffer the consiquences. I might compare this to someone who takes Coumadin (anticoagulant) for example. If a person is not appropriately managed on Coumadin, and they fall out of therapeutic range....we are talking about bleeding if there is too much of the drug in the bloodstreem or stroke if there is too little of the drug in the bloodstream. Now start switching patients (at the pharmacy) who are very well managed on Coumadin (within INR range) to all sorts of different generic drugs within the same class. And what do we have? I've seen it up close and personal. There is wide variability allowed tablet to tablet and especially batch to batch and even more so product to product within the same class. Therefore, there is a difference in their INR....and whoola, we have people stroking and bleeding. This just goes to show that even though there are similar drugs in a " class " , the amount of active ingredient tablet to tablet may be variable. Do we really want to run that risk? If we are satisfied with our therapy on Synthroid, then should we take the risk of switching to another Levothyroxine in the same class? Will we be titrated immediately? Probably not. I know this from experience since my prescription was once changed at my local pharmacy to another product. In the mean time, my TSH shot up and I was hypothryoid and feeling miserable within 3 weeks. When I called my doctor, she asked my what my drug bottle said. She said, " If it doesn't say Synthroid, I'm calling in a script for you! " That day, I switched back to Synthroid and it took another 3 to 4 weeks to start feeling " normal " again. No, I don't work for the manufacturer (which is what you may be thinking!), but I am very familiar with the pharmaceutical industry.... As I mentioned in my previous e mail, this is my opinion only. I'm just trying to help people make the right decision. I don't think we should panic and I do believe the FDA knows what it is doing... Thanks, Audra Quote Link to comment Share on other sites More sharing options...
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