Safety of generic Viagra and other drugs questioned after FDA finds false data – Longmont Times-Call

The U.S. Food and Drug Administration in June warned brand-name and generic drugmakers about a research company in India that had falsified data from key trials to gain approval for its drugs. Data from researcher Synapse Labs Pvt. Ltd. may have been used in hundreds of drugs that remain available in pharmacies and in American medicine cabinets. (Dreamstime/TNS)

Anna Edney | (TNS) Bloomberg News

According to a Bloomberg analysis, generic versions of the erectile dysfunction drugs Viagra and Cialis, as well as other drugs, were approved on the U.S. market despite potentially problematic data questioning their safety and effectiveness.

The U.S. Food and Drug Administration on June 18 notified brand-name and generic drug manufacturers about a research company in India that had falsified data from key studies to gain approval for its drugs. Data from the researcher, Synapse Labs Pvt. Ltd., may have been used in hundreds of drugs that remain available in pharmacies and in American medicine cabinets.

Last year, European regulators reported Synapse to the FDA, which later told U.S. companies that relied on Synapse for key trials to get their drugs approved that they would have to repeat the work elsewhere.

The FDA said companies that have used Synapse have one year to submit new data on the drugs. Without that information, it’s difficult to know the true results of the trials and their safety. And insurers may have reason to retroactively decide not to cover the drugs.

“I think it raises a lot of questions about the impact on drugs on the market,” says Massoud Motamed, who was an FDA inspector until January 2023 and has a doctorate in biochemistry.

Motamed said its biggest concern was that the drugs Synapse was involved in could contain too much or too little active ingredient. Too much can lead to dangerous toxicity problems. Drugs that don’t contain enough active ingredient risk not working.

‘Confidential information’

The FDA does not tell patients, doctors and pharmacists which of the thousands of drugs could be affected. The reason: The question of whether a drug manufacturer has commissioned a specific research company is “confidential information,” the FDA warning states.

“It kind of shocks me,” said Michael Santoro, a professor at Santa Clara University who specializes in business ethics and co-authored a book called “Ethics and the Pharmaceutical Industry,” about the FDA’s drug secrecy. “There’s no doubt in my mind that this data needs to be made available to the public.”

Cherie Duvall-Jones, a spokeswoman for the agency, said: “The FDA remains vigilant and will take action should we identify safety issues.”

She said the FDA has so far found no evidence in its side-effect data that the drugs pose serious safety concerns. The FDA has not suspended sales of the drugs, as European Union regulators have recommended to member states, and would not say how many drugs have been approved based on research conducted by Synapse.

U.S. regulators have provided little information to the public on the matter. Patients cannot learn which brand-name drugs Synapse’s research was used on. For generics, however, the FDA has directed consumers to an obscure database of codes that indicate whether a generic is considered equivalent to the brand-name drug. If a drug’s code has recently changed from equivalent to non-equivalent, that could indicate that Synapse was involved in its approval in the U.S.

“It’s like a puzzle,” said Erin Fox, director of the University of Utah’s Drug Information Service, which tracks drug shortages.

Fox said that in addition to safety concerns, there may be insurers who will not cover the cost of non-therapeutically equivalent drugs and may even demand reimbursement.

Generics database

Such switches are rare, and the FDA usually informs the public. For example, last year the FDA said it no longer considered a generic organ transplant drug made by Accord Healthcare Inc. to be the same as the copied brand-name version. Accord’s tacrolimus released too much of the drug into the body at once, which could cause kidney failure or seizures, the agency found after testing the drug after doctors raised concerns for years.

Bloomberg’s analysis identified a number of generic drugs that are no longer considered brand-name products, even though they were earlier this year. Among them are generic versions of Viagra and Cialis made by India’s Umedica Laboratories Pvt. Umedica is a contract manufacturer that sells these drugs to other pharmaceutical companies that package and market them, including Nivagen Pharmaceuticals Inc. in Sacramento, Calif., and pharmacies that supply various health care facilities, such as doctor’s offices and hospitals. Bloomberg used FDA and National Institutes of Health databases to identify the drugs and their sellers.

Other drugs on the list include generic versions of the cholesterol-lowering drug Lipitor from India’s Lupin Ltd and risendronate sodium from Aurobindo Pharma Ltd. Lupin sold 25 million prescriptions for generic Lipitor in the U.S. between 2020 and most of 2023, according to Symphony Health prescription data compiled by Bloomberg. Atorvastatin and carbamazepine, an epilepsy drug made by Umedica, are also on the list.

Umedica, Nivagen, Lupin and Aurobindo did not respond to requests for comment.

The FDA often shields company information, such as which factory makes a drug, for fear of violating trade secret laws. In 2011, during an inspection of a Cetero Research facility, the FDA found that lab technicians who were supposedly conducting certain tests were not in the office at the time. The agency did not disclose at the time which drugs were approved based on the Cetero data.


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