Generic versions drug for erectile dysfunction drugs Viagra and Cialis were allowed on the US market using potentially problematic data and calling into question their efficacy.
On June 18, the US Food and Drug Administration alerted brand name and generic companies about a research company in India that has fake data used in key studies to gain approval for their medication.
Last year, European regulators flagged Synapse to the FDA, later FDA told US companies that relied on Synapse for studies to gain approval for their medication. The FDA said companies that used Synapse data will get a year to submit new data on the drugs. Without studies, it will be difficult to know the actual results of the drug and to know if it is safe to use or not.
Massoud Motamed, who was an FDA inspector until January 2023 and has a doctorate in biochemistry said, “ I think it raises a lot of questions about the implications for the drugs in the market and my biggest concern is that the drug Synapse was involved with may have too much or too little active ingredient. Too much can lead an dangerous toxicity issues and drugs with low active ingredients can be dangerous because of not working”
FDA is keeping information to itself they are not revealing to patients, doctors or pharmacists which drugs among thousands might be impacted because the agency said drugmakers using particular research companies is confidential information according to the FDA alert.
Last year FDA said it to no longer a generic organ transplant drug from Accord Healthcare Inc. same as the brand name version it copied. Tacrolimus releases too much of medicine once in the body, which could cause kidney failure and seizures. But now information these companies have kept private.
