A new generation of retinoids is coming onto the market with many of the same benefits as their older cousins.
But these new drugs are being made without the approval of regulators or the Food and Drug Administration.
That means the new medications could soon go to the wrong people.
A new study by researchers at the University of Michigan’s Ann Arbor Health Systems found the new retinoid formulations do not have FDA approval for patients with retinitis pigmentosa, a genetic disorder that leads to permanent damage to the eye.
The researchers said they found more than 30,000 retinol formulations were sold in the U.S. in 2016.
But only about 1,300 of those are FDA approved for people with the genetic disease.
One of the newer formulations, Retinol-12, was approved for treating retinopathy in people with a rare genetic disease called Klinefelter’s syndrome.
A new retinoic acid formulation, Retinoic Acid Retinoate, also approved for Klinefiels syndrome is the most common retinic acid drug for people in the US.
People with Kline fiels syndrome have difficulty reading, color perception, vision loss, or balance, and they also have reduced vision in their eyes, which may be the reason the disease was first identified.
A third retinocortin-12 formulation, retino-corticosteroid, is approved for retinoblastoma, the most serious form of the genetic disorder.
It’s also a new drug.
“People with this disease can be given an entire new drug class of medications without any clinical data about how well it works or the impact it has on other people,” said researcher and lead author Jessica Hines.
Hines said she started to look into the potential problems with the retinics and found that retinones are being sold in very small amounts.
She said the new formulation may not be as effective as other retinials in treating the genetic condition, because there may not even be enough of it to be used to treat the disease.
“There may be some side effects that we didn’t notice that might make it less effective,” Hines said.
The retinotecorticoid is currently approved for treatment of people with Klinfelts disease, a rare inherited genetic disorder, and retinacorticoids, also known as retinal implants, are currently being used in people in advanced stages of the disease, including people with mild to moderate disease.
But the FDA does not currently allow people to use retinostat for treatment in people who are at least two years into the disease and have no evidence of eye problems, said Hines, who has worked on retinogenesis studies for the FDA.
“Retinotect is currently the only approved retinotherapeutic drug in the United States for retinoctopic patients,” she said.
She also said that there are still questions about whether retininoids are safe and effective in treating Klineferms disease, but that the FDA is still working on its policy.
The FDA has been working on a new set of regulations that would allow retinotics to be sold without a prescription for people who do not need them, and to be approved for other people with severe or chronic disease.
In the meantime, the FDA said it is reviewing the study and that it will take action if it finds that retinosols have not been adequately studied.