Tag Archives: food and drug administration

Obama Expected To Render Stricter FDA Imports Monitoring

With Barack Obama having been elected the next president of the United States on November 4, Americans are now expecting to see him keep his promise of bringing the change that the nation needs.

Currently, the Food and Drug Administration (FDA) is said to begin to both monitor more closely and to instate stricter regulations, as well, where imports are concerned, in order to prevent incidents similar to the recent salmonella outbreak from occurring in the future.

Moreover, since president-elect Obama, who is a former smoker trying to break the habit with the help of nicotine gum, is a sponsor of a legislation that aims to enable the FDA to only control (but not to ban) tobacco products, rumor has it that new institutions would be given the power to ban cigarettes and other products of the like.

Under former U.S. president George W. Bush’s administration, the FDA has come into much criticism, many claiming that it had become too lenient with regards to food and drugs safety measures, giving rise to consumer protection issues.

The first step that Obama is expected to take is appointing a new commissioner for the Administration. For the time being, there are about six people whose names have come up during talks about a new FDA leader, including Cleveland Clinic cardiologist Dr. Steven Nissen, former director of the FDA’s women’s health office Susan Wood and Baltimore’s health chief Dr. Joshua Sharfstein.

FDA Badge Furthermore, more inspections of imported food are to be performed by the FDA under Obama’s administration, along with ones concerning foreign drug manufacturing plants, which have been long neglected the time Bush was at the helm of the nation.

In addition, a tracing system for fresh produce is part of Obama’s plan for the FDA, in order to tighten the regulations regarding consumer protection.

As for the tobacco legislation the president-elect has sponsored, the proposal entails that the FDA would be able to request that nicotine products be rendered less addictive and toxic, but not to put a ban on tobacco or nicotine.

Source: By Jenny Huntington,- eFluxMedia

Anti-Smoking Drug Chantix Tied to Serious Mental Illness

Melinda and Kenny Peterson wanted to kick their two-pack-a-day smoking habit.

In early January, the Green Bay couple started taking three-month prescriptions of Chantix, a new anti-smoking pill. About six weeks later, they weren’t smoking at all.

But what the Petersons didn’t know was that as they were weaning themselves off cigarettes, the U.S. Food and Drug Administration issued an alert.

Chantix Causes Neuropsychiatric Symptoms

Some patients taking the powerful drug had experienced serious neuropsychiatric symptoms. And Pfizer, the maker of Chantix, had recently added a warning about these symptoms in a more prominent position in the drug’s information packet, at the FDA’s urging.

The alert was issued in early February. But the Petersons didn’t know about it until the end of March, when a friend who was a pharmacist filled them in.  By then, it was too late. About a week earlier, Kenny Peterson had spiraled into a deep depression. He told his wife he wanted to kill himself. His family checked him into a hospital psychiatric ward four days before Easter. Chantix’s safety is now under fire, as similar stories of patients with suicidal thoughts, depression and aggressive behavior surface. The FDA received reports of 37 suicides and 491 cases in which people had suicidal thoughts. The FDA also said it “appears increasingly likely that there is an association between Chantix and serious neuropsychiatric symptoms.” About 5 million people use the drug.

“I think the jury is still out on what’s going on here,” said Carlyle Chan, a professor in the psychiatric department at the Medical College of Wisconsin. “Be aware that there are some concerns about (Chantix). It needs to be watched closely.”

A Pfizer spokeswoman said the company was rolling out Chantix globally but halted advertising the drug to consumers in February. The FDA approved the drug in May 2006.

The company maintained that the serious neuropsychiatric symptoms are rare, but physicians and patients should be on the lookout for them. Pfizer said a causal relationship between the drug and these symptoms has not been determined.

“The real problem out there right now is smoking,” Senior Vice President and Chief Medical Officer Joe Feczko said at a health investor conference in March.

Chantix can help shrink the global population of 1.3 billion smokers, he said, thus addressing health problems such as cancer and cardiovascular disease. In 2007, Chantix brought in $883 million in revenue.

Chantix, known generically as varenicline, works by blocking nicotine receptors in the brain. When people smoke, nicotine attaches to receptors and the brain releases the chemical dopamine, which gives pleasure. Chantix activates the receptors and blocks nicotine from attaching to them.

Before You take Chantix Be WarnedThe drug now includes a mention of possible serious neuropsychiatric symptoms in a warning section of the printed information that accompanies each prescription and is folded inside the packaging. Previously, the information was in a less prominent place in a section of the drug’s literature in which “adverse events” were reported. But there is no requirement to put the warning on the actual package because the FDA hasn’t mandated it.

None of this is comforting to Melinda Peterson, who believes that Chantix cost her family too much.

In the psychiatric ward, Kenny Peterson was diagnosed with bipolar disorder. He’s out of the hospital now but can’t work, and his doctors said they wouldn’t know when he would be able to work.

“He is completely mentally ill right now,” Melinda Peterson said. “My belief is that the drug caused him to go into a manic episode. He has paranoia. He has delusions.”

Chan said it was unclear whether Chantix actually caused depression and suicidal thoughts or whether Chantix exacerbated the symptoms of people who already have some sort of depressive behavior.

The FDA reported that it has seen both types of situations – some in which patients had no history of depression, and cases in which depression previously was an issue.

Source: Ellen Gabler,  journalsentinel.com