The US FDA has issued a guidance to the pharma industry on organ-specific warnings for internal analgesics, antipyretics, and anti-rheumatic drugs which are OTC and meant for human use. The regulatory authority has also called for labelling for products that contain Acetaminophen.
The guidance has been prepared by the Centre for Drug Evaluation and Research (CDER) at the Food and Drug Administration which once finalized will represent the US FDA’s recommendations on this issue. It is now distributed to the industry which will need to revert by September end.
The draft informs manufacturers of OTC internal analgesic, antipyretic, and anti-rheumatic (IAAA) drug products that contain acetaminophen of the circumstances in which FDA intends to exercise enforcement discretion with regard to the liver warning required under 201.326(a)(1)(iii)(A) (21 CFR 201.326(a)(1)(iii)(A)).
In the Federal Register of December 26, 2006 (71 FR 77314), FDA published a proposed rule on organ-specific warnings and related labelling for OTC IAAA drug products. In April 29, 2009 (74 FR 19385), the Federal Register published the final rule to clarify several provisions in response to industry feedback codified at 21 CFR 201.326. There is a serious risk of liver injury when using acetaminophen and the risk of stomach bleeding when using non-steroidal anti-inflammatory drugs.
Section 201.326(a)(1)(iii)(A) requires that the labelling for OTC IAAA products that contain acetaminophen and are labelled for adults only include the liver warning stating that the product contains acetaminophen. Severe liver damage may occur when one consumes more maximum number of daily dosage units in 24 hours, which is the maximum daily amount for the product, stated the guidance.
Directions for use can result in a maximum daily dose of acetaminophen that is less than 4,000 mg for a variety of reasons, including additional active ingredients in the drug product The dosage limitations is based upon specific product indications. The limit on the daily dose of acetaminophen can be the result of a voluntary restriction by the manufacturer. For instance, the maximum number of daily dosage units for an OTC acetaminophen-diphenhydramine combination drug intended as nighttime sleep aid and internal analgesic product is significantly less than 4,000 mg.
OTC IAAA products containing acetaminophen that are labelled only for children under 12 years of age, or for both adults, must include in their labelling the liver warnings required under 201.326(a)(1)(iv) and (v), respectively. For acetaminophen products labelled only for use by children under 12 years of age, the required liver warning explicitly states that severe liver damage may occur if a child takes more than five doses in 24 hours, rather than more than the maximum number of daily dosage units for the particular product.
For acetaminophen products labelled for use by both adults and children under 12 years of age, the required liver warning allows for different maximum daily doses based on age. For these products, FDA believes that the language described in section III.A. could add to consumer confusion about appropriate dosing. Therefore, FDA is not describing any general circumstances in which it intends to exercise enforcement discretion with respect to the liver warnings required for OTC IAAA acetaminophen products that are not labelled for adults only.
According to a section of medical experts, the warning guidance issued by US FDA for IAAA OTC drugs is crucial as patients need to be forewarned.
Source:Pharmabiz
The guidance has been prepared by the Centre for Drug Evaluation and Research (CDER) at the Food and Drug Administration which once finalized will represent the US FDA’s recommendations on this issue. It is now distributed to the industry which will need to revert by September end.
The draft informs manufacturers of OTC internal analgesic, antipyretic, and anti-rheumatic (IAAA) drug products that contain acetaminophen of the circumstances in which FDA intends to exercise enforcement discretion with regard to the liver warning required under 201.326(a)(1)(iii)(A) (21 CFR 201.326(a)(1)(iii)(A)).
In the Federal Register of December 26, 2006 (71 FR 77314), FDA published a proposed rule on organ-specific warnings and related labelling for OTC IAAA drug products. In April 29, 2009 (74 FR 19385), the Federal Register published the final rule to clarify several provisions in response to industry feedback codified at 21 CFR 201.326. There is a serious risk of liver injury when using acetaminophen and the risk of stomach bleeding when using non-steroidal anti-inflammatory drugs.
Section 201.326(a)(1)(iii)(A) requires that the labelling for OTC IAAA products that contain acetaminophen and are labelled for adults only include the liver warning stating that the product contains acetaminophen. Severe liver damage may occur when one consumes more maximum number of daily dosage units in 24 hours, which is the maximum daily amount for the product, stated the guidance.
Directions for use can result in a maximum daily dose of acetaminophen that is less than 4,000 mg for a variety of reasons, including additional active ingredients in the drug product The dosage limitations is based upon specific product indications. The limit on the daily dose of acetaminophen can be the result of a voluntary restriction by the manufacturer. For instance, the maximum number of daily dosage units for an OTC acetaminophen-diphenhydramine combination drug intended as nighttime sleep aid and internal analgesic product is significantly less than 4,000 mg.
OTC IAAA products containing acetaminophen that are labelled only for children under 12 years of age, or for both adults, must include in their labelling the liver warnings required under 201.326(a)(1)(iv) and (v), respectively. For acetaminophen products labelled only for use by children under 12 years of age, the required liver warning explicitly states that severe liver damage may occur if a child takes more than five doses in 24 hours, rather than more than the maximum number of daily dosage units for the particular product.
For acetaminophen products labelled for use by both adults and children under 12 years of age, the required liver warning allows for different maximum daily doses based on age. For these products, FDA believes that the language described in section III.A. could add to consumer confusion about appropriate dosing. Therefore, FDA is not describing any general circumstances in which it intends to exercise enforcement discretion with respect to the liver warnings required for OTC IAAA acetaminophen products that are not labelled for adults only.
According to a section of medical experts, the warning guidance issued by US FDA for IAAA OTC drugs is crucial as patients need to be forewarned.
Source:Pharmabiz
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