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The rate of heart attack and strokes in patients who took Vioxx is nearly the same even after they stop using it, a new study released by Merck reveals — despite the company’s assertion to the contrary, according to a physician who served on both of the FDA advisory committees that reviewed the drug.
The FDA is planning a revised version of its controversial Drug Watch website which will provide a more balanced view of the drugs posted on the site to address industry concerns and avoid overreaction by physicians and the public to the information, a key agency official says.
The FDA has changed dramatically over the past year, becoming too cautious in its approval of new drugs due to a high-profile drug safety incident and a flood of congressional inquiries, a former agency official says.
A newly published study that suggests an increased adverse event risk with the short-term use of Merck’s arthritis drug Vioxx (rofecoxib) could cause a resurgence in lawsuits related to the medication, according to an attorney representing Vioxx users.
Clinical trial sponsors looking for a site with a strong edata compliance program should focus on how well the site documents its training and other standard operating procedures (SOPs), according to an industry expert.
Bristol-Myers Squibb will no longer make or sell the antibiotic Tequin (gatifloxacin) but is stopping short of pulling its current stock off the market as urged by a leading watchdog group.
As major pharmaceutical manufacturers introduce radiofrequency identification (RFID) tags into pharmaceutical packaging to prevent counterfeiting and diversion, some privacy advocates have begun to object that patient privacy and even safety could be compromised.
Only 20 percent of pharmaceutical companies are prepared for a July 1 deadline set by the American Medical Association (AMA) to change their IT systems so that doctors can "opt out" of having details of their prescribing behavior made available to sales representatives, according to a study conducted by the Gartner Group.
A new, more active adverse event reporting system involving insurance data mining, further analysis of electronic medical records and population-based databases is necessary to ensure drug safety, researchers say.
Researchers are proposing an alternative to Cox-2 inhibitors that lack the cardiovascular risks associated with those drugs and have discovered why those painkillers allegedly trigger heart problems in some patients, according to an article published April 13.