Recently in Safety and Risks Category
The retrospective case-control study, published in the December 12, 2007 issue of the Journal of the American Medical Association, was conducted in older patients with diabetes and showed that thiazolidinedione (TZD) treatment, primarily with rosiglitazone, was associated with an increased risk of congestive heart failure (CHF), myocardial infarction (MI), and mortality when compared with other combination oral hypoglycemic agent treatments.
The study has reignited the arguments surrounding the safety of rosiglitazone, with Dr Steven Nissen (Cleveland Clinic) issuing new calls for more forceful action on the drug from the Food and Drug Administration (FDA), while GlaxoSmithKline highlights limitations of the new study and continues to defend the cardiovascular profile of its product.
These formulations are currently marketed as DDAVP (sanofi-aventis US, LLC), Minirin (Ferring Pharmaceuticals, Inc), and Stimate (CSL Behring, LLC).
(NewsTarget) A diabetes expert has claimed that pharmaceutical company GlaxoSmithKline threatened him with legal action after he raised concerns about the safety of the company's anti-diabetes drug rosiglitazone, marketed as Avandia.
In a written testimony to a congressional subcommittee, John Buse of the University of North Carolina said that he received phone calls from company executives in 1999, just after Avandia's release, warning him that his comments about the drug "were scurrilous enough to attempt to hold me liable for a loss in market capitalization." Buse later signed a statement, drafted by GlaxoSmithKline, attempting to alleviate the concerns that his comments had raised with stockholders.
by Mike Adams, NewsTarget.com
The U.S. Senate Health, Education, Labor and Pensions Committee voted 15-5 to approve a bill that aims to strengthen FDA oversight of drug company advertising and post-approval follow-up studies. The bill was sponsored by Wyoming Republican Sen. Mike Enzi and Massachusetts Democrat Sen. Edward Kennedy. The primary motive for the bill is to give the FDA more power to stop a future Vioxx disaster from being repeated.
The Bush Administration is against the bill and offered sharp objections to the bill's provisions, saying it would slow down drug approvals. Republicans also argued that the banning of drug advertisements on television was "unconstitutional."
A new analysis by researchers at the Harvard School of Public Health and Brigham and Women's Hospital of laws and regulations governing public disclosure of clinical trial data submitted to the FDA suggests changes should be made to the way the FDA implements its policy regarding the confidentiality of those data. Allowing greater access to safety data would enable researchers to independently evaluate risks, resulting in more timely risk detection. The review and commentary appears in the current issue of Health Affairs.
The move comes hot on the heels of a consultation conducted by the Commission last year which found that that the current system is "contradictory, confusing, unclear and complex."
The feedback from the consultation suggested that there are complex reporting rules implemented differently by different EU member States, a lack of robust safety studies and complex decision-making at EU-level.
Abuse of prescription drugs is about to exceed the use of illicit street narcotics worldwide, and the shift has spawned a lethal new trade in counterfeit painkillers, sedatives and other medicines potent enough to kill, a global watchdog warned Wednesday.
Prescription drug abuse already has outstripped traditional illegal drugs such as heroin, cocaine and Ecstasy in parts of Europe, Africa and South Asia, the U.N.-affiliated International Narcotics Control Board said in its annual report for 2006.
In the United States alone, the abuse of painkillers, stimulants, tranquilizers and other prescription medications has gone beyond "practically all illicit drugs with the exception of cannabis," with users increasingly turning to them first, the Vienna-based group said.
Recent problems at FDA can be attributed to the lack of consistent, long-term leadership; insufficient resources; and not enough authority to address safety issues, according to four former FDA commissioners who participated Wednesday in a panel discussion at the George Washington University School of Public Health and Health Services, the Newark Star-Ledger reports.
David Kessler, who served as commissioner from 1990 to 1997, criticized the pharmaceutical industry's use of mass-marketing techniques and direct-to-consumer advertising. "The notion that you can come up with a new drug and millions and millions of people take it safely -- the blockbuster -- that is what got us in trouble," Kessler said.
China will tighten the inspection of pharmaceutical products to prevent drug safety accidents, the country's drug watchdog said Tuesday, disclosing that the licenses of 353 medicines have been revoked since August 2006.
Wu Zhen, deputy director of the State Food and Drug Administration (SFDA), said about 3,049 applications for producing new drugs were turned down since last August to fend off shoddy manufacture of medicines.
Attending an online interview hosted by the central government's website, Wu said the administration has required its officials to leave offices to check whether the production conditions meet the description of the applications filed to the SFDA.