The FDA is taking action against unapproved ear drop products and is therefore urging patients and doctors alike to opt for approved medication only.
It seems that there are quite a few products available on the market that treat affections of the ear that have not been approved by the United States Food and Drug Administration (FDA). Therefore, the organization has decided to implement a series of swift measures in order to help patients steer clear of these products.
The FDA has sent notifications to numerous companies, urging them to stop marketing a total of 16 unauthorized products at once. These products are all used to treat the inflammation of the ear and to reduce local pain associated with these issues.
Their main ingredients are hydrocortisone and benzocaine. While the FDA does not take issue with this particular aspect, it does however find it absolutely unacceptable that the efficacy and safety of these drugs have not been tested according to criteria that they impose.
It seems that these drugs have been sold in pharmacies and prescribed by medical professionals for quite some time now. Taking into account that the labels of the products did not include information regarding FDA approval, putting them in use constitutes gravely improper conduct, because the drugs might put the lives of patients in danger.
“If we don’t know whether these drugs have any benefits, we should not accept any possible risk of side effects,” says FDA representative, Dr. Charles E. Lee.
Moreover, special precautions should be taken regarding the drugs from this category, as they are most frequently used in children, since they constitute the main risk group associated with ear infections.
When a certain drug receives FDA approval, this means that its effects the members of the high risk groups in particular have been tested, thus conveying the certainty that the risks associated with the administration of the drug are situated inside the limits described in the official description of the drug.
This description includes information regarding the active substance in the drug, but also regarding the excipients. These are the substances that need to be added to the composition of a drug, along with the active substances, in order to obtain the final pharmaceutical form, the pill itself. It also includes extensive information about the specific action of the drug, the risk groups and the side effects that have been observed during the drug’s testing.
The FDA advises people to always use medical products that have been approved by the organization and to always check this matter themselves before taking any kind of medication. The notice regarding a drug’s FDA approval is always present on the label of the product.
Therefore, a drug that does not include this information has most likely not been approved. In this situation, people are advised to ask a medical professional for an alternative product with the same action and even the same active substance that has been granted FDA approval.
Image Source: medscape.com