U.S. Food and Drug Administration regulators said Monday that Sanofi-Aventis' weight-loss drug rimonabant may raise users' risk of suicidal thoughts.
The assessment was posted on the agency's Web site one step ahead of an advisory panel meeting Wednesday to weigh U.S. approval for the drug, which is also known as Acomplia or Zimulti.
The FDA has already postponed a decision on rimonabant three times, the Bloomberg news service reported.
The drug, already approved in Europe, is among a new class of medicines called CB1 antagonists, which block brain receptors that regulate hunger.
But the FDA documents posted Monday noted two suicides among clinical trial participants who tested the medicine, Bloomberg said. Other reported side effects included mood swings, anxiety and depression.
The advisory panel will help the agency decide whether there is a causal link between the drug and suicidal thoughts, and if the drug's benefits outweigh its potential risks.
Sanofi seeks the drug's approval to treat obesity and as a treatment for diabetes, Bloomberg said. The FDA's final word is due by July 27.
Overall UV Exposure May Influence Skin Cancer Risk
Overall exposure to the sun's ultraviolet (UV) rays in childhood, not just sunburns, may be a major factor influencing a person's risk for skin cancer later in life, suggest initial results of research looking at the interaction of genes and UV exposure in 214 people with melanoma, the most deadly form of skin cancer.
Dr. Nancy Thomas, a dermatologist at the University of North Carolina, used satellite data to track average UV radiation in the towns and states where the patients lived at different times of their lives, the Associated Press reported.
She and her colleagues found that the patients who'd experienced the highest UV exposure by age 20 had the highest number of melanoma-related BRAF gene mutations. The same patients also had the most moles, another important risk factor for melanoma.
More research is needed, but Thomas suggested that rapidly growing skin on young people may be especially vulnerable to damage from UV rays, the AP reported.
In related news, the U.S. Food and Drug Administration is putting the finishing touches to new rules for sunscreen ratings. Currently, sun protection factor (SPF) ratings tell consumers only how well a sunscreen protects against UV-B rays that cause sunburn.
The agency wants the SPF ratings to also include how well sunscreens protect against UV-A rays that cause cancer and wrinkles, the AP reported. The proposed changes should be introduced within the next few weeks, but are subject to a public comment period before they take effect.
Chinese Patients Given Drips With Fake Plasma Protein
Chinese officials say 18 hospitals and more than 30 pharmacies in the northeastern state of Jilin were sold or were selling fake plasma protein (albumin) used in drips for patients suffering from shock and burns or those having open-heart surgery, BBC News reported.
"There was no element of protein, so it could not perform its intended function," said Xu Fei, the deputy director of the food and drug administration in Jilin. "These were out-and-out fakes."
The fake plasma protein could prove fatal for patients who are already in serious condition, experts said. Chinese officials did not reveal whether any patients had died or become ill after receiving the fake plasma protein. However, one Chinese newspaper said a patient had died, BBC News reported.
This is the latest in a series of cases involving counterfeit food and medicine products made in China. Both the United States and European Union have expressed concern over food and drug imports from China.
Researchers Call for Studies on Anti-Epilepsy Drugs for Children
There's an urgent need to conduct safety studies on newer anti-epilepsy drugs that are being prescribed in rapidly increasing numbers to children, says a study in the British Journal of Clinical Pharmacology.
U.K. researchers analyzed data on anti-epilepsy drugs given to nearly 8,000 children over a 13-year period, and found that the use of such drugs increased five-fold over that time, BBC News reported. In particular, there was a "massive" increase in prescriptions for three drugs -- lamotrigine, topiramate, and levetiracetam.
"The uptake of these drugs has been rapid, yet their long-term safety has not been established and further research must now be seen as a priority," said lead author Professor Ian Wong, of the Center for Pediatric Pharmacy Research in London.
He and his colleagues noted that many of the drugs have not been fully tested in children. This means that doctors have no official guidance on doses and have to estimate a safe and effective dose based on a child's age and size, BBC News reported.
Wong noted that there have been reports of multi-organ failure, renal failure, blood disorders and skin reactions in some patients taking lamotrigine.
Report Compares U.S. States' Health Care Quality
States have made promising gains in certain areas of health care quality but need to improve in other areas, according to the annual State Snapshots report released Monday by the U.S. Agency for Healthcare Research and Quality.
The analysis of 2006 data focused on 129 health care quality measures -- ranging from preventing bed sores to screening for diabetes-related foot problems to providing antibiotics -- and included the 50 states and Washington, D.C.
The report found that, across the states, an average of about 59 percent of adult surgery patients insured by Medicare received appropriate timing of antibiotics.
It also found that only about 54 percent of men over 50 reported that they'd ever had a flexible sigmoidoscopy or colonoscopy and that only 54 percent of Medicare managed care patients said their health care providers always listened carefully, explained things clearly, and spend enough time with them.
Certain states were better in specific areas. For example, New York had the lowest suicide rate, Montana was ranked first for pneumonia vaccinations for seniors, and Utah had the lowest colorectal cancer death rate.
"It is clear that the nation must continue pursuing important opportunities to improve the quality of health care," AHRQ Director Dr. Carolyn M. Clancy said in a prepared statement. "The State Snapshots help policymakers understand the breadth of those problems and how their states compare with others. With that knowledge, they are better equipped to take vital steps that will improve the health of people in their states."
Court Hearing Looks at Link Between Vaccines, Autism
A court hearing scheduled to begin Monday is the first of a number test cases dealing with claims by U.S. parents that their children's autism was caused by routine vaccinations.
The hearing in the U.S. Court of Federal Claims will be presided over three special master appointed by the court, the Associated Press reported. The hearing, expected to last until June 29, will explore the theory that autism is caused by the measles, mumps and rubella vaccine in combination with other vaccines containing a preservative called thimerosal, which is about 50 percent mercury by weight.
Since 1999, more than 4,800 families have filed claims with the U.S. government alleging that their children's autism was caused by vaccines that contained thimerosal. If the link is proven, the families would be entitled to compensation from a multibillion dollar trust fund, the AP reported.
Large studies have concluded there is no association between autism and vaccines that contain thimerosal, which is no longer found in routine childhood vaccines. However, it is still used in some flu vaccines.