Researchers here said today that the use of the investigational diabetes drug Pargluva (muraglitazar) doubles the risk of death, heart attack and stroke, and they asked the FDA to delay approval of the drug.
In an analysis that was released online by the Journal of the American Medical Association, Steven E. Nissen, M.D., and colleagues at the Cleveland Clinic said the FDA should not approve Pargluva until its cardiovascular safety can be proven in “a dedicated cardiovascular events trial.”
Drugs to treat erectile dysfunction need stronger warnings on their packaging about the risk of blindness, U.S. consumer group Public Citizen said on Thursday in a petition filed with health regulators.
The U.S. Food and Drug Administration should “immediately add a black box warning regarding the risks of drug-induced blindness for the three phosphodiesterase 5 (PDE5) inhibitors that are prescribed for the treatment of erectile dysfunction,” Public Citizen’s Health Research Group wrote.
Warnings that drugs such as Prozac, Paxil and Effexor can increase suicidal behavior in some children have resulted in a nearly 20 percent drop in U.S. pediatric prescriptions of the widely used antidepressants and have triggered deep concerns about the quality of current data on psychiatric drugs, doctors and regulators said.
The unprecedented fall of what were once considered wonder drugs comes as a series of taxpayer-funded analyses have systematically undermined the claims of industry-funded drug trials, raising thorny questions about the ways in which psychiatric drugs are being tested, marketed and used.
U.S. regulators on Friday rejected a last-ditch request from poultry veterinarians to delay its ban on a livestock antibiotic believed to reduce the effectiveness of similar drugs in humans.
Food and Drug Administration Commissioner Lester Crawford said the request failed to prove there would be “irreparable harm” if the drug, called Baytril, was banned.
Patients and doctors must register with manufacturers before using or prescribing Roche Holding AG’s acne drug Accutane or its generic versions, U.S. regulators said on Friday.
The requirement is part of a plan to strengthen safeguards meant to keep pregnant women from taking Accutane, the Food and Drug Administration said in a statement. The drug can cause birth defects.
Drug abuse in Russia has reached “catastrophic” proportions, posing a threat to national security, a top anti-narcotics police officer was quoted as saying on Friday.
Viktor Khvorostyan, head of the Moscow section of the Federal Narcotics Service, said some four percent of the population, or about six million people, are addicts. The average age of teenagers first trying drugs had fallen dramatically, he said.
A lawsuit against Merck & Co.‘s Vioxx goes to trial in a Texas state court on Monday in the first of thousands of cases claiming the pharmaceutical giant hid the risks of a popular painkiller.
The case in Angleton, near Houston, pits the family of deceased Texan Robert Ernst against the big drugmaker, which pulled Vioxx off the market in September after studies showed prolonged use could increase the risk of heart attack and stroke.
The lawsuit could help determine the direction litigation will take in the other state courts in New Jersey, California and Texas, and in the U.S. federal court in New Orleans, a legal expert said.
An Irish judge ruled on Friday that a man who believes the acne drug Accutane caused his son’s suicide can pursue his case against Swiss drugs maker Roche Holdings despite rejecting an out-of-court settlement.
Roche had hoped to get the case dismissed after Liam Grant turned down a settlement that offered maximum damages under Irish law, plus related costs, but did not include an admission of liability.
Justice Joseph Finnegan accepted that continuing the case would be both costly and expensive, involving millions of documents and months of court time, but ruled that Grant had a constitutional right to pursue his case to establish liability.
China has launched a people’s war on drug abuse, offering rewards for information on traffickers, a top official said on Thursday, tackling a problem that was wiped out after the Communist Party came to power in 1949.
China, which borders the “Golden Triangle” opium-producing region where the borders of Myanmar, Thailand and Laos meet, has about a million registered addicts and many more who are not registered.