Commonly Used Gabapentin Helps Many But With Side Effects
Millions of papers are afflicted by seizures, hot flashes, neuropathic pain, and restless leg syndrome. These conditions lead to need for drug that can alleviate relief from symptoms that are hard to live with. In 1993, gabapentin, which is marketed as Neurontin, was approved by US Food and Drug Administration. The medication was formulated in 2004 to fight epilepsy and provide pain relief.
After the drug was approved in the US, Parke–David, a daughter company of Pfizer, prodded physicians to prescribe gabapentin to their clients for purposes that were not yet approved. As a result, the drug was easily accessed by a number of people, including healthcare providers, consumers, as well as insurer. It was not long before the drug was used to treat various illnesses, ranging from bipolar disorder to migraines.
Based on gathered data, around 10% to 20% of prescriptions account for off-label purposes. FDA regulations do not quite match results yet, that is why a number of doctors get way with prescribing off-label drugs. However, such practice may lead to undesirable circumstances.
A study including 46,000 patients’ health records showed that an estimated 80% of off-label prescribed drugs are not complemented with concrete scientific evidence. in fact, it was discovered that patients who were medicated with off-label medications had higher tendency of suffering from side effects compared with those treated in accordance with guidelines implemented by FDA.
As advised by Mayo Clinic, both treatment effectiveness and risks should be considered before prescribing a specific medication to a patient. Some of the notable side effects associated with off-label drug use include drowsiness, depression, aggressive behavior, distrust, drowsiness, rapid mood changes, tremors, false sense of well-being, sexual dysfunction, and suicide.
It was not until 25 years later that adverse effects of using off-label Neurontin have been discovered. One patient, Caryl Westwood, was prescribed with Neurontin to treat her lower back pain. She used the drug for several months until she started suffering from insomnia, fog, and anxiety. Westwood went back to her doctor and found out that the drug given to her was not really for pain but was instead, a strong epilepsy medication.
Thus, despite lack of scientific proof, Westwood’s doctor prescribed Neurontin to her. Statistics taken in 2004 showed that around 90% of $2.7 billion sales of Neurontin can be attributed to off-label prescriptions. This result show that doctors manage to fill patient prescription even if the drugs are not proven to be effective in treating their diseases.
Pfizer was implicated the scandal involving off-label use of Neurontin, and they paid $430 million in settlement. However, off-label use of drugs did not stop afterward.
Millions of papers are afflicted by seizures, hot flashes, neuropathic pain, and restless leg syndrome. These conditions lead to need for drug that can alleviate relief from symptoms that are hard to live with. In 1993, gabapentin, which is marketed as Neurontin, was approved by US Food and Drug Administration. The medication was formulated in 2004 to fight epilepsy and provide pain relief.
After the drug was approved in the US, Parke–David, a daughter company of Pfizer, prodded physicians to prescribe gabapentin to their clients for purposes that were not yet approved. As a result, the drug was easily accessed by a number of people, including healthcare providers, consumers, as well as insurer. It was not long before the drug was used to treat various illnesses, ranging from bipolar disorder to migraines.
Based on gathered data, around 10% to 20% of prescriptions account for off-label purposes. FDA regulations do not quite match results yet, that is why a number of doctors get way with prescribing off-label drugs. However, such practice may lead to undesirable circumstances.
A study including 46,000 patients’ health records showed that an estimated 80% of off-label prescribed drugs are not complemented with concrete scientific evidence. in fact, it was discovered that patients who were medicated with off-label medications had higher tendency of suffering from side effects compared with those treated in accordance with guidelines implemented by FDA.
As advised by Mayo Clinic, both treatment effectiveness and risks should be considered before prescribing a specific medication to a patient. Some of the notable side effects associated with off-label drug use include drowsiness, depression, aggressive behavior, distrust, drowsiness, rapid mood changes, tremors, false sense of well-being, sexual dysfunction, and suicide.
It was not until 25 years later that adverse effects of using off-label Neurontin have been discovered. One patient, Caryl Westwood, was prescribed with Neurontin to treat her lower back pain. She used the drug for several months until she started suffering from insomnia, fog, and anxiety. Westwood went back to her doctor and found out that the drug given to her was not really for pain but was instead, a strong epilepsy medication.
Thus, despite lack of scientific proof, Westwood’s doctor prescribed Neurontin to her. Statistics taken in 2004 showed that around 90% of $2.7 billion sales of Neurontin can be attributed to off-label prescriptions. This result show that doctors manage to fill patient prescription even if the drugs are not proven to be effective in treating their diseases.
Pfizer was implicated the scandal involving off-label use of Neurontin, and they paid $430 million in settlement. However, off-label use of drugs did not stop afterward.