Drugs’ heart risk is FDA’s biggest worry: official

NEW YORK (Reuters) - The rise of serious heart risks in drugs that treat chronic conditions has become one of the U.S. Food and Drug Administration’s top worries and is changing how the agency weighs new medicines, a top FDA official said on Tuesday.

The agency is thinking about how to weigh such possible side effects as more drugs that treat diabetes, pain and other conditions also appear linked to heart attacks and other complications, Dr. John Jenkins, director of the FDA’s Office of New Drugs, told the Reuters Health Summit in New York.

“That has been the biggest safety shift in the last few years, and it’s also, I think, a driver for a lot of the public concern about drug safety,” he said.

“We are thinking about what the implications of these new data and these new findings are for all chronically-used drugs,” he said.

The agency has already said that it plans to give specific advice to drug makers about what kinds of data they will need to sell diabetes drugs in the United States.

The FDA’s recommendation, or guidelines, will be released “very soon,” Jenkins said.

In July, an FDA panel of outside advisers said companies should have to conduct long-term studies of cardiovascular effects or provide equivalent evidence to rule out an “unacceptable” risk of heart problems.


Related Posts:

NEW YORK (Reuters) - New data do not signal any heart risks with Takeda Pharmaceutical Co Ltd’s experimental drug to treat acid build-up in patients with gout, a top U.S. Food and Drug Administration official said in a document released on Thursday. Takeda is seeking U.S. approval to sell its drug febuxostat for chronic gout patients

Full Post: No heart risk seen with Takeda gout drug: FDA

By Susan Heavey WASHINGTON (Reuters) - Data show Novartis AG’s combination malaria drug Coartem appears to work and causes few serious side effects, U.S. Food and Drug Administration regulatory staff said in documents released on Monday. “The majority of AEs (adverse events) were of mild or moderate intensity. Deaths … and SAEs (serious adverse events) … were

Full Post: Novartis malaria drug safe, effective: FDA

WASHINGTON (Reuters) - A review of clinical trial data from four drugmakers shows no overall risk of heart problems in patients taking drugs to treat osteoporosis, the U.S. Food and Drug Administration said on Wednesday. The agency reviewed studies on Merck & Co’s Fosamax, Roche’s Boniva, Novartis AG’s Reclast and Procter and Gamble Co’s Actonel and

Full Post: Studies do not link heart risk to bone drugs: FDA

WASHINGTON (Reuters) - The U.S. Food and Drug Administration, hampered by increasing globalization and a rise in complex products, may not be able to adequately protect the public’s health, the watchdog arm of Congress said in new findings released on Thursday. “As a result, the American consumer may not be adequately protected from unsafe and ineffective

Full Post: Report cites FDA’s weaknesses over drugs, devices

By Maggie Fox, Health and Science Editor WASHINGTON (Reuters) - Quicker drug approvals and sophisticated marketing campaigns may be putting more patients at risk of dangerous side-effects but the same techniques might be put to use to protect them, a researcher argued on Tuesday. New U.S. Food and Drug Administration procedures have clearly sped up some drug

Full Post: Aggressive drug marketing may endanger people: study

Site Navigation

Most Read


Most Read


  • kinwrite.com@gmail.com