Agency pulls Cardec, Rondec, Organidin and Pediahist
BY Kathleen Lucadamo
NY DAILY NEWS STAFF WRITER - Wednesday, March 2nd 2011
The feds are pulling hundreds of cough, cold and allergy medicines that have been prescribed for years without government approval.
The Food and Drug Administration on Wednesday warned manufacturers of 500 drugs to stop distributing them in the U.S., saying they could be a danger to people.
"We have serious concerns about them because we just simply don't know what is in them, whether they work properly or how they are made," said Michael Levy, director of the FDA's Division of New Drugs and Labeling Compliance.
Many doctors may be not realize the drugs don't have FDA approval, he said.
The drugs are commonly sold at mom-and-pop and chain drug stores and some are even covered by insurance because they were on the market before the FDA's approval system, officials said.
They include Cardec, Rondec, Organidin and Pediahist, which is for children as young as one. Manufacturers worldwide were given 90 days to stop making them - or the FDA may seize them.
FDA bosses said they are doing outreach to doctors and pharmacists to alert them about unapproved drugs, many which are marketed in academic journals.
They advised consumers to ask health care practitioners if any prescription drug is FDA-approved.
"I think every doctor has prescribed some of the drugs on this list," said Michael Marcus, an allergist at Maimonides Medical Center in Brooklyn.
"I was surprised some of them never went through the approval process; I thought they did."
List of unapproved drugs: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm245048.htm
WASHINGTON — The Food and Drug Administration (FDA) on Wednesday ordered the makers of about 500 unapproved prescription cough-and-cold medicines to get them off the market because they have not been proved safe and effective.
The drugs have been linked to a few relatively minor problems, such as drowsiness and irritability, but the FDA is concerned that medical problems with them may be significantly underreported.
"We have some specific safety concerns with some of them," said Deborah Autor, head of compliance in FDA's drug office.
Some of the targeted drugs are labeled as suitable for infants and children but contain ingredients covered by a 2008 FDA advisory that warned against use in over-the-counter medications in children younger than 2.
Others the FDA ordered removed from the market are billed as time-release products. Such medications are difficult to manufacture and, if quality controls are inadequate, some may release drugs too slowly, too quickly or not at all, Autor said.
The FDA also moved against unapproved products with possibly dangerous combinations of drugs, such as two antihistamines, which can cause oversedation.
None of the drugs is a household name, though Autor listed Cardec, Lodrane 24D, Organidin and PediaHist as brands consumers may have encountered.
In addition, none of the drugs fills a unique niche. "There are multiple other (approved) products available," Autor said.
Wednesday's announcement does not affect over-the-counter preparations, widely used to treat cough-and-cold symptoms.
A pharmacist who reviewed the FDA's list of unapproved cough and cold drugs said many of them are already off the market. "A lot of these medications have been discontinued," said Sophia DeMonte, speaking on behalf of the American Pharmacists Association.
Together, the drugs contain 27 ingredients and are made by about 100 companies. The companies were served notice of FDA's intent to remove the drugs by an announcement Wednesday in the Federal Register.
Many of the drugs came on the market before a 1962 law that required makers to prove their effectiveness. Doctors may be prescribing the drugs without knowing they've never been approved, officials said.
Companies have 90 days to stop making the drugs and 180 days to halt shipments of them or face seizure or other enforcement action.
The agency has seized millions of dollars' worth of drugs, but federal law does not call for fines for selling unapproved drugs, and criminal prosecutions are rare.
Makers of unapproved drugs can also apply for FDA approval.
BY Kathleen Lucadamo
NY DAILY NEWS STAFF WRITER - Wednesday, March 2nd 2011
The feds are pulling hundreds of cough, cold and allergy medicines that have been prescribed for years without government approval.
The Food and Drug Administration on Wednesday warned manufacturers of 500 drugs to stop distributing them in the U.S., saying they could be a danger to people.
"We have serious concerns about them because we just simply don't know what is in them, whether they work properly or how they are made," said Michael Levy, director of the FDA's Division of New Drugs and Labeling Compliance.
Many doctors may be not realize the drugs don't have FDA approval, he said.
The drugs are commonly sold at mom-and-pop and chain drug stores and some are even covered by insurance because they were on the market before the FDA's approval system, officials said.
They include Cardec, Rondec, Organidin and Pediahist, which is for children as young as one. Manufacturers worldwide were given 90 days to stop making them - or the FDA may seize them.
FDA bosses said they are doing outreach to doctors and pharmacists to alert them about unapproved drugs, many which are marketed in academic journals.
They advised consumers to ask health care practitioners if any prescription drug is FDA-approved.
"I think every doctor has prescribed some of the drugs on this list," said Michael Marcus, an allergist at Maimonides Medical Center in Brooklyn.
"I was surprised some of them never went through the approval process; I thought they did."
+++++
List of unapproved drugs: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm245048.htm
+++++
The Food and Drug Administration on Wednesday ordered the makers of about 500 unapproved prescription cough-and-cold medicines to get them off the market because they have not been proved safe and effective.
Tribune Washington bureau
The drugs have been linked to a few relatively minor problems, such as drowsiness and irritability, but the FDA is concerned that medical problems with them may be significantly underreported.
"We have some specific safety concerns with some of them," said Deborah Autor, head of compliance in FDA's drug office.
Some of the targeted drugs are labeled as suitable for infants and children but contain ingredients covered by a 2008 FDA advisory that warned against use in over-the-counter medications in children younger than 2.
Others the FDA ordered removed from the market are billed as time-release products. Such medications are difficult to manufacture and, if quality controls are inadequate, some may release drugs too slowly, too quickly or not at all, Autor said.
The FDA also moved against unapproved products with possibly dangerous combinations of drugs, such as two antihistamines, which can cause oversedation.
None of the drugs is a household name, though Autor listed Cardec, Lodrane 24D, Organidin and PediaHist as brands consumers may have encountered.
In addition, none of the drugs fills a unique niche. "There are multiple other (approved) products available," Autor said.
Wednesday's announcement does not affect over-the-counter preparations, widely used to treat cough-and-cold symptoms.
A pharmacist who reviewed the FDA's list of unapproved cough and cold drugs said many of them are already off the market. "A lot of these medications have been discontinued," said Sophia DeMonte, speaking on behalf of the American Pharmacists Association.
Together, the drugs contain 27 ingredients and are made by about 100 companies. The companies were served notice of FDA's intent to remove the drugs by an announcement Wednesday in the Federal Register.
Many of the drugs came on the market before a 1962 law that required makers to prove their effectiveness. Doctors may be prescribing the drugs without knowing they've never been approved, officials said.
Companies have 90 days to stop making the drugs and 180 days to halt shipments of them or face seizure or other enforcement action.
The agency has seized millions of dollars' worth of drugs, but federal law does not call for fines for selling unapproved drugs, and criminal prosecutions are rare.
Makers of unapproved drugs can also apply for FDA approval.
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