Assessment of Risk Involved in the Combination Medicine of Paracetamol and Caffeine

Abstract

Paracetamol (acetaminophen) with caffeine is a combination medicine indicated for the temporary relief of pain and discomfort associated with a number of conditions such as headache or muscle pain. There is a controversy going on this combination concerning their safety in patients, since 1 year later of their introduction in 1950. Paracetamol is a first-line therapy of choice in adults and children with fever and pain. Caffeine is used in this product to increase the pain relieving effects of paracetamol. Paracetamol has a narrow safety margin and there are number of risks associated with paracetamol. It is only safe and effective when used according to directions on OTC (Over-The-Counter) and Rx labeling. FDA (Food and Drug Administration) drug safety communication state that prescription paracetamol products to be limited to 325 mg per tablet, capsule, or other dosage unit, making these products safer for patients. Chronic or excessive administration of caffeine has been implicated in a range of dysfunctions involving the liver, renal system, gastrointestinal system, and musculature. It is difficult to arrive at standard dose, since caffeine is present in various consumer goods. The extent to which caffeine improves the analgesic effect of paracetamol is in doubt. Compared with paracetamol alone, a patient taking the combination of paracetamol with caffeine may be more likely to adverse effects than to get improved analgesia. The purpose of this study is to show the risk of liver damage, renal medullary necrosis and rebound headache associated with combination medicine of paracetamol and caffeine.