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synthroid
- Thread starter bigdog9
- Start date
Delinquent
Well-known member
Hey I just watched a thing on world news tonight about them. The gov't is ordering the company to either make it less harmful or they're pulling it.
T
The_Eviscerator
Guest
Synthroid is T-4 not T-3. I am not sure T-4 will convert to T-3 at a greater level just by adding more T-4. Usually people that take T-4 produce none, thus they have no T-3. I would do more research before using that stuff. I think you want to find some Cytomel and get rid of the Synthroid.
Article from USAToday
FDA questions Synthroid's dosages
By Andrew Clark, Reuters
WASHINGTON — The Food and Drug Administration has ruled Abbott Laboratories must seek approval to keep selling the thyroid drug Synthroid, the No.3 most-prescribed medicine in the U.S., saying it has a "history of potency failures."
The ruling raises the prospect that the drug, which millions of Americans take daily, could be pulled from the market, although FDA officials said Friday they would act cautiously and analysts said such drastic action was unlikely.
"We have not made any final decisions," said FDA spokeswoman Susan Cruzan. "A lot of patients are on this drug, and we do want to keep in mind patient needs."
Synthroid, known generically as levothyroxine sodium, has been used for more than 40 years by people with low natural levels of thyroid hormones.
Abbott says the safety and efficacy of the the drug has been "extensively studied and validated" over that time and it is working with the FDA to resolve the issue.
The agency, citing manufacturing and potency problems, decided in 1997 to regulate levothyroxine drugs and require them to go through its drug approval process. Thyroid replacement therapy requires precise dosages and sub- or super-potent tablets can pose safety risks, the agency says.
Two other manufacturers have since received approvals from the FDA, but Synthroid maker Knoll Pharmaceuticals, which Abbott bought, instead petitioned the agency to rule its drug "safe and effective" and exempt it from testing.
The FDA's denial of that petition in late April was first reported by the Wall Street Journal Friday. In a letter, the agency said: "The history of potency failures ... indicates that Synthroid has not been reliably potent and stable."
Abbott shares fell 36 cents, or 0.7 %, to $51.62 in New York Stock Exchange trading on Friday.
The decision apparently leaves Abbott facing a mid-August deadline to obtain an approval that usually takes 10 to 12 months.
"If these products are not the subject of an approved application by Aug. 14, they are subject to regulatory action," Cruzan said, adding the agency is "examining what our course of action will be."
Abbott said it had already notified the FDA of its intent to submit an application and was "working cooperatively with the agency to meet the filing timeframes."
Analysts say they seriously doubt the FDA would go as far as to bar the drug while it considers the application.
"What in the world would you be doing to take a product off the market that people need daily while you do it. That's not sensible," said Salomon Smith Barney analyst Anne Malone. "I don't think it will get pulled."
"I am confident that this is not a big issue," said Morgan Stanley analyst Glenn Reicin. "(The application) will obviously be filed in the next couple of months and they'll do the review and it will stay on the market."
But consumer groups urged the agency to take a tough stand. "If the company cannot meet the FDA's safety standards, then Synthroid should be removed from the marketplace," said Tim Fuller, executive director of the Gray Panthers, a senior citizens' advocacy group.
The other companies that have FDA approval for their levothyroxine drugs are King Pharmaceuticals and Jerome Stevens Pharmaceuticals, which has a marketing agreement on the drug with Watson Pharmaceuticals.
FDA questions Synthroid's dosages
By Andrew Clark, Reuters
WASHINGTON — The Food and Drug Administration has ruled Abbott Laboratories must seek approval to keep selling the thyroid drug Synthroid, the No.3 most-prescribed medicine in the U.S., saying it has a "history of potency failures."
The ruling raises the prospect that the drug, which millions of Americans take daily, could be pulled from the market, although FDA officials said Friday they would act cautiously and analysts said such drastic action was unlikely.
"We have not made any final decisions," said FDA spokeswoman Susan Cruzan. "A lot of patients are on this drug, and we do want to keep in mind patient needs."
Synthroid, known generically as levothyroxine sodium, has been used for more than 40 years by people with low natural levels of thyroid hormones.
Abbott says the safety and efficacy of the the drug has been "extensively studied and validated" over that time and it is working with the FDA to resolve the issue.
The agency, citing manufacturing and potency problems, decided in 1997 to regulate levothyroxine drugs and require them to go through its drug approval process. Thyroid replacement therapy requires precise dosages and sub- or super-potent tablets can pose safety risks, the agency says.
Two other manufacturers have since received approvals from the FDA, but Synthroid maker Knoll Pharmaceuticals, which Abbott bought, instead petitioned the agency to rule its drug "safe and effective" and exempt it from testing.
The FDA's denial of that petition in late April was first reported by the Wall Street Journal Friday. In a letter, the agency said: "The history of potency failures ... indicates that Synthroid has not been reliably potent and stable."
Abbott shares fell 36 cents, or 0.7 %, to $51.62 in New York Stock Exchange trading on Friday.
The decision apparently leaves Abbott facing a mid-August deadline to obtain an approval that usually takes 10 to 12 months.
"If these products are not the subject of an approved application by Aug. 14, they are subject to regulatory action," Cruzan said, adding the agency is "examining what our course of action will be."
Abbott said it had already notified the FDA of its intent to submit an application and was "working cooperatively with the agency to meet the filing timeframes."
Analysts say they seriously doubt the FDA would go as far as to bar the drug while it considers the application.
"What in the world would you be doing to take a product off the market that people need daily while you do it. That's not sensible," said Salomon Smith Barney analyst Anne Malone. "I don't think it will get pulled."
"I am confident that this is not a big issue," said Morgan Stanley analyst Glenn Reicin. "(The application) will obviously be filed in the next couple of months and they'll do the review and it will stay on the market."
But consumer groups urged the agency to take a tough stand. "If the company cannot meet the FDA's safety standards, then Synthroid should be removed from the marketplace," said Tim Fuller, executive director of the Gray Panthers, a senior citizens' advocacy group.
The other companies that have FDA approval for their levothyroxine drugs are King Pharmaceuticals and Jerome Stevens Pharmaceuticals, which has a marketing agreement on the drug with Watson Pharmaceuticals.
