September 13, 2010
by Jonathan Benson
Patients who undergo magnetic resonance imaging (MRI) scans are often given drug injections to enhance the quality of scan images. But the U.S. Food and Drug Administration (FDA) recently announced that these drugs will now require a black box warning label–the strongest in the industry–because they can cause a rare, and sometimes fatal, condition known as nephrogenic fibrosing dermopathy (NFD).
The drugs contain a magnetic, metallic chemical called gadolinium that travels throughout the heart and other organs to help clarify image quality during scans. Gadolinium is a known liver toxin that is also harmful to the unhealthy kidneys, but the FDA has permitted its use in medical imaging drugs since 1988.
Symptoms of NFD include skin hardening as well as tissue growth in the eyes, internal organs and joints.
Seven MRI drugs containing gadolinium have been approved by the FDA, and all can cause NFD in patients with kidney disease. But three in particular are “chemically more unstable” than the others, according to the FDA, meaning they are more likely to release the toxic chemical into the liver. These three are Bayer Healthcare’s Magnevist, General Electric Healthcare’s Omniscan and Covidien’s Optimark.
Rather than pull the drug, the FDA is requiring stronger labeling that instructs physicians to use the drug only on patients who have healthy kidneys. It also instructs physicians to screen all patients for kidney disease prior to administering any gadolinium-containing drugs.
Back in 2006, the FDA announced that it was aware of gadolinium’s dangers, but for whatever reason did not issue a black box warning at that time. The FDA continues to suggest that gadolinium is safe to use in patients with healthy kidneys, even though there is no evidence that the drug does not harm healthy kidneys.
According to reports, there are two imaging drugs on the market that do no contain gadolinium, but the FDA has only approved them for use during liver scans.
Click here to read the full report
June 18, 2010
By David Gutierrez
(NaturalNews) The FDA has ordered makers of drugs for a variety of inflammatory diseases to add a “black box warning” about an increased risk of cancer in children and adolescents.
A black box warning is the most severe warning that the FDA can place on a product without withdrawing it from the market.
The FDA began analyzing the drugs, known as tumor necrosis factor (TNF) blockers, when reports emerged that dozens of children had developed cancer while taking the drugs. TNF blockers are used to treat inflammatory and autoimmune diseases such as Crohn’s disease and rheumatoid arthritis. They include adalimumab (marketed as Humira), certolizumab pegol (marketed as Cimzia), etanercept (marketed as Enbrel), golimumab (marketed as Simponi) and infliximab (marketed as Remicade.
“FDA announced that it has completed its analysis of TNF blockers and has concluded that there is an increased risk of lymphoma and other cancers associated with the use of these drugs in children and adolescents,” spokesperson Crystal Rice said . “This new safety information is now being added to the boxed warning for these products.”
Click Here for the Full Report
August 11, 2009
By Julie Steenhuysen
People under age 25 who take antidepressants have a higher risk of suicide, but adults older than that do not, an analysis by U.S. Food and Drug Administration researchers released on Tuesday showed.
The report by the FDA scientists confirms earlier studies and supports the agency’s age-related warnings on the drugs’ labeling.
U.S. and European regulators have been sounding alarms on the use of antidepressant drugs since 2003 after clinical trials showed they increased the risk of suicidal thoughts and behaviors in those under age 18.
In February 2005, the FDA added a so-called black box warning — the agency’s strongest warning — on the use of all antidepressants in young children and teens to draw attention to the possible risks of these medications. In May 2007, it extended the warnings to young adults aged 18 to 24.
Many psychiatrists have criticized the warnings, saying they scare people away from effective treatment for depression, the leading cause of suicide. In fact, recent studies have suggested the warnings triggered an 8 percent rise in suicide among youth and teens in 2004, the biggest one-year gain in 15 years.
A LASTING DECLINE
A study published in June in the journal Archives of General Psychiatry said the FDA’s decision to impose black box warnings for children and young adults had a spillover effect on depression care in older adults, resulting in a lasting decline in depression diagnosis and treatment.
Those researchers urged the FDA to revise its policy.
The FDA analysis by Dr. Marc Stone, Dr. Thomas Laughren and colleagues involved a review of data from eight drug makers on 372 clinical trials involving nearly 100,000 adults.
Overall, they found the risk of suicide was “strongly age-dependent,” with higher risks in people under 25, no difference among those 25 to 64, and lower risks in people 65 and older.
The researchers said the findings, published on the British Medical Journal website, support the agency’s warnings on antidepressant drug labeling for people under 25, and they also support the notion that antidepressant drugs can have two distinct effects.
In some patients, they can promote suicidal thoughts or behavior — but this risk appears to diminish with age. In others, the drugs provide relief from depression, reducing the risk of suicide. They said more research is needed to understand these differences.
John Geddes from the University of Oxford and colleagues said in a commentary the findings were not new and noted that the trials studied by the FDA excluded sicker patients. The study did, however, make clear differences in risks among specific antidepressants, they said.
They noted specific differences in commonly used drugs called selective serotonin reuptake inhibitors, or SSRIs.
For example, the odds of suicidal behavior by people taking Pfizer Inc’s Zoloft, or sertraline, were around half of those who took placebo. By comparison, Forest Laboratories Inc’s Celexa, or citalopram, and Lexapro, or escitalopram, “seem to increase the risk of suicidal events,” Geddes and colleagues wrote.
“Increased risk is probably restricted to younger people and varies greatly between individual medicines.”
Click here for the full report from Reuters
July 2, 2009
New York Times
by Gardiner Harris & Duff Wilson
WASHINGTON — Federal drug regulators warned Wednesday that patients taking two popular drugs to stop smoking should be watched closely for signs of serious mental illness, as reports mount of suicides among the drugs’ users.
But officials emphasized that fear should not stop patients from taking the smoking-cessation medicines, Chantix, made by Pfizer, and Zyban, made by GlaxoSmithKline, which also sells it under the brand name Wellbutrin, for depression.
“Stopping smoking is a goal we should all be working towards,” said Dr. Curtis J. Rosebraugh, director of a drug evaluation office at the Food and Drug Administration. “We don’t want to scare people off from trying a medication that could help them achieve this goal. You should just be careful.”
Pfizer will add a so-called black box warning — the F.D.A.’s most serious caution — to the packaging information for Chantix.
The Pfizer drug, introduced in 2006, has about 90 percent of the market for prescription smoking-cessation drugs, according to IMS Health, a health care information company. Even so, Chantix sales — $846 million in 2008 — had been less than Pfizer had hoped because of previous warnings of its side effects.
Glaxo will expand its existing black box warning on Wellbutrin, citing suicidal thoughts by patients who use it for depression, to include Zyban, which has had only modest sales in the smoking cessation market.
Both companies will also be required to conduct clinical trials to assess the mental health risks associated with the drugs’ uses. Pfizer is already enrolling schizophrenia patients in a trial.
Because smokers and people trying to quit are statistically more likely to be depressed and suicidal, officials for both companies said it was difficult to identify the specific impact of the drugs on those risks. “Nicotine withdrawal itself can be very difficult for people to endure,” Dr. Steve Romano, a Pfizer vice president, said Wednesday.
Analysts said the F.D.A. action would have little effect on sales because of previous indications of the drugs’ psychiatric risks.
“I think the market and physicians have already been sensitized to this,” said Catherine J. Arnold, an analyst for Credit Suisse.
“I’m not panicking,” said Jami Rubin, an analyst for Goldman Sachs, “Sales are already down a lot. It is and will remain a small niche product.”
Chantix had already experienced a slight sales decline last year from the $883 million achieved in 2007. And this year’s first-quarter sales of $177 million were 36 percent below the corresponding period last year.
Ms. Arnold predicted that sales would probably continue falling to around $740 million for all of 2009, but that demand for smoking-cessation treatments would enable it to grow modestly after that — to perhaps half of the $2 billion in annual sales Pfizer had originally hoped for the drug.
European officials first alerted the F.D.A. in 2007 to problems associated with Chantix. In September of that year, Jeffrey Carter Albrecht, a keyboard player from the pop-music group Edie Brickell and New Bohemians, was killed by a neighbor who had complained that Mr. Albrecht was banging on his door, ranting. Mr. Albrecht’s girlfriend blamed Chantix, which she said had made him hostile.
The widely publicized event led to a cascade of similar reports and scrutiny by F.D.A. safety officials, who have now received 98 reports of suicides and 188 reports of suicide attempts among those taking Chantix.
As officials looked more closely, they found to their surprise that Zyban has similar associated risks. The agency received 14 reports of suicides and 17 reports of suicide attempts among those taking Zyban.
No one knows why the drugs are associated with mental problems. In some cases, patients could be experiencing nicotine withdrawal, but some of the reports involved patients who had yet to stop smoking. And many of the events happened just as patients began or stopped therapy, officials said.
“If this is nicotine withdrawal, it really doesn’t matter,” said Dr. Robert Temple, an F.D.A. official. “You need to pay attention to them.”
The agency’s action requires the drugs’ makers to mention the risk of suicide in advertising, and it prevents the companies from using “reminder” ads, during which consumers are encouraged to talk to their doctors about a health issue but the product’s name is not mentioned.
Click here for the full report from the New York Times.