In an op-ed in the Boston Globe (1/24) Paula J. Caplan, a clinical and research psychologist at Harvard University, wrote that an “overlooked” primary cause of “America’s obesity epidemic” is the increased use of psychiatric medicines, as many of them “cause weight gain — often of the rapid and massive sort.” Caplan suggests that this link is not well known possibly due to the power of the pharmaceutical industry or clinicians not knowing other treatments.
Caplan argues against listing obesity as a mental illness, as it can be caused by “physical problems that are often undiagnosed.” Caplan also says that doctors should “explore other non-drug ways to treat emotional problems.” What happens when the drug you are taking causes serious side-effects? Are there legal remedies for dangerous drugs?
The AP (1/22, Perrone) reports that the FDA “on Thursday added new warnings to weight loss pill Meridia [silbutramine] about the increased risk of heart attack and stroke in patients with a history of heart problems.” The new label “states only that the drug should not be used in patients with heart failure, hypertension, irregular heart beats and other problems.”
European regulators call for sibutramine ban. The Wall Street Journal (1/22, Favole) reports that the European Medicines Agency on Thursday said the sale of sibutramine should be suspended because of the risks of stroke and heart attack. The European Commission will now review the agency’s advice. The Journal also notes that both the FDA and EMA announcements come following a study of 10,000 patients that showed 11.4 percent of those who took sibutramine had a cardiovascular event, compared with 10 percent of patients who received a placebo.
The AP (1/13, Perrone) reports that the FDA “issued enforcement letters to Eli Lilly, Bayer, Amylin Pharmaceuticals, and Cephalon for making inaccurate or incomplete statements while promoting their drugs.” The agency’s “letter to Lilly cites a print advertisement for the antidepressant Cymbalta, which is approved to treat depression, generalized anxiety disorder, diabetic nerve pain, and the pain ailment fibromyalgia.” The FDA indicated that Lilly’s ad fails to “adequately display information about the drug’s side effects.” Dow Jones Newswire (1/13, Favole) reports that the FDA said Amylin and Lilly representatives overstated diabetes drug Byetta’s weight loss benefits, and that Bayer’s promotional material for the birth-control drug Mirena does not adequately warn women of the risk of losing their baby if they become pregnant while taking the drug.
Meanwhile, the FDA’s letter to Cephalon said the drugmaker did not include important risk information on a dosing card for its lymphoma treatment Treanda, Reuters (1/13, Heavey) reports. The FDA asked that the drugmakers halt use of the advertisements and promotional materials immediately.
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New York Times (1/7, B3, Pollack) reports, “The Food and Drug Administration said Wednesday that it would review the safety of…widely used anemia drugs sold by Amgen and Johnson & Johnson after another clinical trial suggested that high doses of one of the drugs,” Aranesp (darbepoetin alfa), “might cause strokes.”
Agency officials published an article in The New England Journal of Medicine that said “the results of the new trial, as well as of previous trials, ‘raise major concerns’ about the use of the drugs to treat the anemia caused by chronic kidney disease.” In a commentary published in The Journal of the American Society of Nephrology, Dr. Ajay K. Singh, of Brigham & Women’s Hospital and Harvard Medical School, said “that avoiding the use of the drugs in kidney patients not undergoing dialysis ‘is now the soundest approach given’” in the recent study.
Bloomberg News (1/7, Waters) reports that the agency “will convene an advisory committee to re-evaluate the use of” Amgen’s Aranesp and Epogen and J&J’s Procrit following studies that showed “high amounts boost the risk of heart attacks, blood clots, and stroke.” Robert Temple, deputy director for clinical science at the FDA’s Center for Drug Evaluation and Research, noted that the trials were intended “to show that using” the drugs “to raise hemoglobin concentration…improves clinical outcomes,” but “all results have suggested the opposite.”
Agency officials said lower doses of the drugs and monitoring blood hemoglobin more frequently may improve clinical outcomes, Dow Jones Newswire (1/7, Dooren) reports. According to a spokeswoman for the FDA, the advisory panel will address target levels for blood hemoglobin. Aranesp and Procrit are also currently approved for anemia in certain cancer patients who undergo chemotherapy. Reuters (1/7) also covered the story.
In a column at Portfolio.com (1/4), Ed Silverman writes that critics say sales of atypical antipsychotics have been spurred in part by “an epidemic of off-label marketing. And so drugmakers encouraged doctors to prescribe these meds for children before the FDA sanctioned their use for youngsters.” Another side effect “is even more disturbing-unnecessary deaths among elderly patients, who shouldn’t receive these medicines if they suffer from dementia.” Robert Rosenheck, a Yale University professor of psychiatry and epidemiology and director of the Division of Mental Health Services and Outcomes Research, said, “The general public and the patients may not be better off. There’s evidence the drugs aren’t always effective, may be harmful, and can cost a good deal of money, but there’s nothing we can do about it, because we’re committed to the principal that doctors should be able to choose whatever treatments are best for their patients.”