Safety of Acetaminophen?

Adr Bulletein

Concept- Shinu.C, Asst prof.

Safety of Acetaminophen?

                                    

                When you or a member of your family experiences pain, you naturally wish to stop it so the day’s normal activities can continue. However, non prescription pain tablets are powerful medications that must be fully respected if they are to be used safely. Just because these products are available without a prescription does not mean they can be taken without thought.

               The Food and Drug Administration (FDA) has warned that the popular painkiller acetaminophen (also known as paracetamol) may cause rare but serious skin reactions.

Acetaminophen is a pain reliever and a fever reducer. It is used to treat many conditions such as headache, muscle aches, arthritis, backache, toothaches, colds, and fevers. It relieves pain in mild arthritis but has no effect on the underlying inflammation and swelling of the joint.

Reported Side effects of Acetaminophen :

·         Bloody or black, tarry stools

·         bloody or cloudy urine

·         fever with or without chills (not present before treatment and not caused by the condition being treated)

·         pain in the lower back and/or side (severe and/or sharp)

·         pinpoint red spots on the skin

·         skin rash, hives, or itching

·         sore throat (not present before treatment and not caused by the condition being treated)

·         sores, ulcers, or white spots on the lips or in the mouth

·         sudden decrease in the amount of urine

·         unusual bleeding or bruising

·         unusual tiredness or weakness

·         yellow eyes or skin

Any one taking acetaminophen who develops a rash or other skin reaction should "stop taking the product immediately and seek medical attention right away."

Recently reported adverse effects:                                                                                           Why now, after decades of widespread acetaminophen use?

                            The result of reviews of the medical literature as well as the number of "adverse event" reports received by the FDA since 2012 have made them to take a decision to warn the use of Acetaminophen. It was observed that bad skin reactions resulting in hospitalizations and death occurred due to the use of single-ingredient acetaminophen products. The reported adverse effects were classed as either "probable" or "possible”. Such small numbers of serious skin reactions from such widespread use of the drug give perspective to the newly identified risk.

                                                                                              
                                                                                           More about the rare skin reactions:

There are three known skin reactions to acetaminophen for which consumers need to seek medical attention.

The two most serious are Stevens-Johnson syndrome and toxic epidermal necrolysis.   

                            These reactions are very rare but people who get them will usually need to be hospitalized, and in some cases the conditions can lead to death.

Acute generalized exanthematous pustulosis is the third recognized skin reaction. Immediately stopping taking the medication and seeing a doctor will usually mean this condition clears up within two weeks.

Stevens-Johnson Syndrome and toxic epidermal necrolysis are usually signaled by:

·         Flu-like symptoms

·         Followed by rash, blistering and extensive damage to the surfaces of the skin.

Seeking immediate medical help is important and "recovery can take weeks or months, and possible complications include scarring, changes in skin pigmentation, blindness and damage to internal organs," the FDA warns.

PATIENT INFORMATION

·         Use paracetamol exactly as prescribed by your doctor.

·         Do not use more of this medication than is recommended. An overdose of paracetamol can cause serious harm. The maximum amount for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Using more paracetamol could cause damage to your liver. If you drink more than three alcoholic beverages per day, talk to your doctor before taking paracetamol and never use more than 2 grams (2000 mg) per day. If you are treating a child, use a pediatric form of paracetamol. Carefully follow the dosing directions on the medicine label. Do not give the medication to a child younger than 2 years old without the advice of a doctor.

·         Measure the liquid form of paracetamol with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. You may need to shake the liquid before each use. Follow the directions on the medicine label.

·         The paracetamol chewable tablet must be chewed thoroughly before you swallow it.

·         Make sure your hands are dry when handling the paracetamol disintegrating tablet. Place the tablet on your tongue. It will begin to dissolve right away. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

·         To use the paracetamol effervescent granules, dissolve one packet of the granules in at least 4 ounces of water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

·         Do not take a paracetamol rectal suppository by mouth. It is for use only in your rectum. Wash your hands before and after inserting the suppository.

·         Try to empty your bowel and bladder just before using the paracetamol suppository. Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

·         For best results from the suppository, lie down and insert the suppository pointed tip first into the rectum. Hold in the suppository for a few minutes. It will melt quickly once inserted and you should feel little or no discomfort while holding it in. Avoid using the bathroom just after inserting the suppository.

·         Stop using paracetamol and call your doctor if:

 you still have a fever after 3 days of use;

 you still have pain after 7 days of use (or 5 days if treating a child);

 you have a skin rash, ongoing headache, or any redness or swelling; or

 if your symptoms get worse, or if you have any new symptoms.

·         Urine glucose tests may produce false results while you are taking paracetamol. Talk to your doctor if you are diabetic and you notice changes in your glucose levels during treatment.

·         Store paracetamol at room temperature away from heat and moisture. The rectal suppositories can be stored at room temperature or in the refrigerator.

·         Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day.

·         Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

·         Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose

·         An overdose of acetaminophen can damage your liver or cause death.

·         The first signs of paracetamol overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes. Seek emergency medical attention if you think you have used too much of this medicine.

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.1. www.drugs.com

2. www.medicalnewstoday.com

3. www.rxlist.com