FDA issues advisory on varenicline
The United States Food and Drug Administration (FDA) has issued a public-health advisory to alert health-care providers, patients, and caregivers to new safety warnings concerning varenicline (sold in the US as Chantix and in the Philippines as Champix), a prescription medication used to help patients stop smoking.
The alert follows the agency's review of postmarketing adverse-event reports on varenicline related to changes in behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior.
"As the agency's review of the adverse-event reports proceeded, it appears increasingly likely that there may be an association between varenicline and serious neuropsychiatric symptoms," the FDA said. This prompted the FDA to request Pfizer, the manufacturer of varenicline, to elevate the prominence of this safety information to the warnings and precautions section of the varenicline prescribing information or labeling.
Pfizer has complied with the FDA request, saying this will help ensure that health-care providers and patients will appropriately consider this information in their discussions about varenicline. "By heightening awareness of these postmarketing events and facilitating this discussion, patients and doctors can play an important role in mitigating potential risk and ensuring the full benefits of Chantix," the company said.
"There are few things that provide greater health benefits than quitting smoking. When considering the use of Chantix for their patients, health-care providers should discuss the risks of smoking, the health benefits of quitting smoking, and the product's efficacy and safety profile," said Dr. Joe Feczko, chief medical officer for Pfizer.
In its advisory, the FDA emphasized the following:
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Patients should tell their health-care provider about any history of psychiatric illness prior to starting varenicline. Varenicline may cause worsening of current psychiatric illness even if it is currently under control. It may also cause an old psychiatric illness to reoccur. Patients with these illnesses were not included in the studies conducted for the drug's approval.
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Health-care professionals, patients, patients' families, and caregivers should be alert to and monitor for changes in mood and behavior in patients treated with varenicline. Symptoms may include anxiety, nervousness, tension, depressed mood, unusual behaviors, and thinking about or attempting suicide. In most cases, neuropsychiatric symptoms developed during varenicline treatment, but in others, symptoms developed following withdrawal of varenicline therapy.
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Patients should immediately report changes in mood and behavior to their doctor.
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Vivid, unusual, or strange dreams may occur while taking varenicline.
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Patients taking varenicline may experience impairment of the ability to drive or operate heavy machinery.
Said Dr. Bob Rappaport, director of the FDA division of anesthesia, analgesia, and rheumatology products:
"While Chantix has demonstrated clear evidence of efficacy, it is important to consider these safety concerns and alert the public about these risks. Patients should talk with their doctors about this new information and whether Chantix is the right drug for them, and health-care professionals should closely monitor patients for behavior and mood changes if they are taking this drug."
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Heart stents safe for wide use
CHICAGO
A major study of the first two commercially available drug-releasing coronary stents has found that both appear to be safe for use in a variety of patients. This latest study of 2,098 men and women at five university hospitals in Denmark found that "the rates of serious adverse events such as cardiac death, acute myocardial infarction, and stent thrombosis were low, suggesting that, at least when considering 18 months of follow-up, the use of drug-eluting stents in the general population may be safe." The study also found no significant difference in the effectiveness of the two stents in releasing the medications-sirolimus and paclitaxel.
Stents are tubes used to keep previously blocked coronary arteries open. The advent of drug-releasing stents has cut the rate of reblockage in half to about 10 percent, according to the study published in the Journal of the American Medical Association. But the stents were approved based on results from relatively small trials and a number of follow-up studies were "challenging to interpret," according to an accompanying editorial.
A third drug-releasing stent will come onto the market in 2008, "which yielded similar or fewer major adverse cardiac events among patients," according to the editorial authored by Debabrata Mukherjee and David Moliterno of the University of Kentucky, Lexington. "The ongoing choice of a drug-eluting stent will likely depend on multiple factors that will include safety, effectiveness, deliverability, and-given recent cuts in reimbursement-cost of the device."
The new findings follow a study released in January that showed sirolimus to be better than paclitaxel at reducing the constriction of a blood vessel or heart valve in the cardiac treatment of diabetic patients.
M AFP
Avastin delays cancer progress
BASEL, Switzerland
Roche announced that a phase-III study in metastatic breast cancer investigating bevacizumab (Avastin) in combination with docetaxel chemotherapy compared to docetaxel alone, met its primary end point of improving the time patients live without their disease advancing.
The findings come from the first analysis of the Avastin and Docetaxel (AVADO, BO17708) study that investigated the addition of docetaxel to Avastin administered either at 7.5 or 15 mg/kg every three weeks. Both doses of Avastin in combination with chemotherapy showed statistically significant improvements in the time patients live without their disease advancing, as measured by progression-free survival, compared with chemotherapy alone. The study was not designed to compare the two Avastin-containing arms. No new safety signals related to Avastin were observed in the trial.
Medical oncologist David Miles of Mount Vernon Hospital, United Kingdom, principal investigator, welcomed the news: "Each year more than one million women are diagnosed with breast cancer leading to over 400,000 deaths globally. This study confirms Avastin's effect of prolonging the time in which patients live without their disease getting worse in combination with a widely used chemotherapy partner-this time gained is very precious."
This second positive phase-III trial follows the recently published landmark E2100 study, which formed the basis for European Commission approval of Avastin in combination with paclitaxel as first-line treatment for metastatic breast cancer in March 2007. Study E2100 showed that the addition of Avastin to paclitaxel resulted in a doubling of progression-free survival compared to paclitaxel alone.
BO17708 is an international phase-III trial that randomized 736 patients who did not receive previous chemotherapy for their metastatic breast cancer to one of three groups: Avastin 7.5 mg/kg every three weeks in combination with docetaxel; Avastin 15 mg/kg every three weeks in combination with docetaxel; and docetaxel plus placebo as control arm.
The study sought to demonstrate superiority in progression-free survival of combining Avastin with docetaxel vis-à-vis docetaxel alone. Secondary end points included overall survival, response rate, duration of response, quality of life, safety, and tolerability.
Avastin has been approved in the European Union, Japan, and the United States as first-line treatment for advanced or metastatic colorectal, breast, lung, and kidney cancer.
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FDA warns of Botox hazards
WASHINGTON
The US Food and Drug Administration (FDA) has warned that using botulinum toxins, such as the popular cosmetic treatment Botox, can have serious side effects including death, but stopped short of banning them.
"[W]e've become aware of a number of reports of serious adverse reactions from botulinum toxins," including breathing difficulties and death, said Dr. Russell Katz, head of the FDA division of neurology products. "These are reactions distant from where the product was injected."
In a statement, the FDA said the adverse reactions were "suggestive of botulism, which occurs when botulinum toxin spreads in the body beyond the site where it was injected. "The most serious cases had outcomes that included hospitalization and death," it added.
Botulinum toxins are approved by the FDA to treat a variety of symptoms including spasms of the eyelids or neck, the easing of facial lines or excessive sweating.
Most of the severe reactions and deaths seen in the review occurred in children who were given botulinum toxins in the legs to control spasticity related to cerebral palsy-one of many indications that physicians prescribe botulinum toxins for, even though it is "off-label" or not approved by the FDA, Katz said. "We believe the toxin spread from there to affect breathing," he said.
Katz stressed that no patients who had used Botox for cosmetic purposes were among the fatalities, but urged vigilance. "If someone uses Botox cosmetically and develops symptoms that might be related to this distant spread, physicians and patients should take it seriously," he said.
Katz said data studied by the FDA had shown "a relative handful" of cases of severe adverse reactions related to the distant spread of the toxin, but refused to give a precise figure, saying the review was in the early stages.
Botox, Botox Cosmetic, and Myobloc warn on their labeling of the possibility of adverse reactions near the site of the injection for each product's approved uses and of "the rare potential of distant side effects," including severe difficulty swallowing and difficulty breathing when the products are used on patients with neuromuscular disorders.
The FDA review appears to indicate that distant side effects can occur in a broader population, said Katz. But the agency stressed it has "not concluded there is a causal relationship between the drug products and the emerging safety issue" and did not "advise health-care professionals to discontinue prescribing these products."
M AFP
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