Every now and then, the FDA releases new warnings about potential dangers with medications that have been on the market for years. They typically do this when they receive new reports that a certain drug is being overprescribed or when they learn people are getting harmed by the drug. This was the case with two drugs, commonly known as Gabapentin, Neurontin and Lyrica.
These drugs are used to treat things like seizure disorders, restless leg syndrome and nerve pain. What the FDA has found is that these drugs, when used alone or in combination with other drugs, can cause respiratory issues. Specifically, for people using opiate pain killers or medication for COPD, the drugs can cause respiratory depression.
The FDA is now requiring the manufacturers of these drugs to issue new warnings. These warnings will have to be added to the labels as well as the instructions issued at the pharmacy. The FDA is also requiring the drug manufacturers to conduct clinical trials to determine how dangerous the respiratory issues really are. They are also required to test to see what the likelihood of overuse and abuse is.
The FDA has found that these drugs are now being overused and abused, similar to the opiate medications. The companies who make these drugs are required to find out the abuse potential so they warn prescribers and patients. Once their clinical trials are completed, they’ll have to submit their findings to the FDA. The FDA will then decide what further action needs to be taken.
The drugs have been found to cause respiratory depression in healthy patients who don’t take other drugs as well. This is what has alarmed the FDA.
If you’re taking any medication that has harmed you in any way, contact our trusted lawyers right away.