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  • Over-The-Counter (OTC) Drug Overdose Raise FDA Concern

    Posted on July 15th, 2009 Editor More Than 14 Days

    The Food and Drug Administration (FDA) is currently trying to find out the possible ways to prevent the deaths that are caused by the over-the-counter drug overdose. They are mainly concerned with the overdosing deaths that are related to drugs which contain acetaminophen. Some of these drugs that use this ingredient include Tylenol, Nyquil and Excedrin. FDA told the media that acetaminophen is the main reason behind these increase in number of deaths and this chemical has resulted in more liver failures in the United Status.

    The agency also added that public are yet unaware of the potential risks of taking this chemical above the limit in spite of the efforts taken to educate them regarding this. The advisory committee of FDA had a meeting last week to decide whether prescriptions and medications containing this chemical, acetaminophen need special regulation to stop or prevent overdosing.

    When asked about the increase in deaths related to overdosing drugs, Federal regulators said that lot of people are dying just because they are taking in excess amount of these OTC drugs that contain acetaminophen. FDA also made a note that the maximum dosage level that is printed on the label of these drugs is shy of the actual levels that can cause severe liver damage. The chemical is present in hundreds of drugs and this causes the confusion among people and makes them take twice or thrice the dose of these says Sandra Kweeder, Office of new drugs, FDA.

    CDC also commented on overdose of acetaminophen when it said the chemical causes lots of deaths and sends almost 56000 people to the emergency ward every year. Kweeder also added to this point and said that there are many people who tend to get confused when they take more than one OTC drug that has this acetaminophen.

    The Food and Drug Administration is now considering a viable solution to this problem and is thinking of lowering the recommended dosage of acetaminophen, ways to eliminate acetaminophen – containing drugs and also adding additional warning box to all the products to make people aware of these risks. Drug manufacturers are also aware of these and they are also taking steps to prevent these death related to acetaminophen overdose. Linda Suydam, member of Consumer Healthcare Products Association feels that acetaminophen is a very safe ingredient and more than 99% of people who take this chemical appropriately do not suffer from any problem. When asked about this, the makers of popular OTC drug Tylenol said that they consider safety as their number one priority and they also feel that some of the recommendations of FDA are out of focus and would not serve to solve the root cause of acetaminophen-overdose.

    Some drug manufactures are also voluntarily involved in taking corrective steps to prevent this problem. Some of these steps include boosting the info in the warning labels, eliminate non-child bounded packaging and also modify the liquid medications to prevent overdose. Though these steps may prove useful, the most important advice to the public is to read the label thoroughly and follow all directions correctly and do not exceed the daily dosage specified. Not taking more than one drug containing acetaminophen is also a nice step if you wish to prevent overdosing.