viernes, 2 de noviembre de 2012

Drug Shortages > Impact of Ameridose shutdown and recall on drug supply

FDA is aware that the voluntary shutdown of Ameridose and the recall of Ameridose products may affect supplies of certain life-saving drugs for some health care systems. FDA has identified six Ameridose products on the FDA critical shortage list, which already were in shortage prior to the recall. The recall has the potential to exacerbate one or more of these shortages:

Sodium Bicarbonate Injection
Succinylcholine Injection
Atropine Sulfate Injection
Bupivacaine Hydrochloride Injection
Lidocaine Hydrochloride Injection
Furosemide Injection

For these 6 drugs in shortage, these are the actions FDA will continue to take the following actions:

FDA is working with manufacturers for these 6 drugs, requesting that they ramp up production if they are willing and able to do so.
For any manufacturers for these 6 drugs that may be experiencing manufacturing/quality problems, FDA is offering assistance, where appropriate, to help address these problems to enable those manufacturers to manufacture shortage drug products that are safe and high quality.
If the manufacturers of critical drugs intended for the U.S. are not able to meet U.S. patient needs, FDA explores companies that are willing and able to import foreign drugs to address the shortage in the U.S. In these instances, FDA evaluates the foreign drug to ensure that it is of adequate quality and that the drug does not pose undue risks for U.S. patients.
As with shortages of any critical products, FDA will expedite the reviews of any pending applications that could help with addressing the shortages.
FDA is identifying any additional manufacturers willing to initiate or increase production.

FDA encourages health care providers and facilities to use only FDA-approved drugs if possible. If you believe there is a drug entering shortage, please notify our Drug Shortage Staff at drugshortages@fda.hhs.gov.
FDA is committed to do everything we can to address any drug shortage, using all available tools. For updated information on supply availability for these 6 drugs as well as other shortage drugs, please refer to FDA's drug shortage website http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm.
For more information please visit the Questions & Answers on Ameridose Recall document posted today at: Ameridose Q&A
and the Ameridose Recall Impact web page at: Impact

Impact of Ameridose shutdown and recall on drug supply

[11-01-2012] FDA is aware that the voluntary shutdown of Ameridose and the recall of Ameridose products may affect supplies of certain life-saving drugs for some health care systems. FDA has identified six Ameridose products on the FDA critical shortage list, which already were in shortage prior to the recall. The recall has the potential to exacerbate one or more of these shortages:

Sodium Bicarbonate Injection
Succinylcholine Injection
Atropine Sulfate Injection
Bupivacaine Hydrochloride Injection
Lidocaine Hydrochloride Injection
Furosemide Injection

For these 6 drugs in shortage, these are the actions FDA will continue to take the following actions:

FDA is working with manufacturers for these 6 drugs, requesting that they ramp up production if they are willing and able to do so.
For any manufacturers for these 6 drugs that may be experiencing manufacturing/quality problems, FDA is offering assistance, where appropriate, to help address these problems to enable those manufacturers to manufacture shortage drug products that are safe and high quality.
If the manufacturers of critical drugs intended for the U.S. are not able to meet U.S. patient needs, FDA explores companies that are willing and able to import foreign drugs to address the shortage in the U.S. In these instances, FDA evaluates the foreign drug to ensure that it is of adequate quality and that the drug does not pose undue risks for U.S. patients.
As with shortages of any critical products, FDA will expedite the reviews of any pending applications that could help with addressing the shortages.
FDA is identifying any additional manufacturers willing to initiate or increase production.

[10-20-2012] FDA is aware many hospitals and clinics across the country are customers of Ameridose and that the current production shutdown of Ameridose may impact supplies of certain drugs for some health care systems. FDA's top priority is to ensure that drugs are safe for the American public and we are working with Ameridose to ensure that this is the case. Please refer to the drug shortage website for information on availability of drugs currently in shortage. FDA will share additional information as soon as it is available.