Ибупрофен и подобные ему опасны не только для желудка
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17.07.2015
На этикетках лекарств из этой категории указано, что НПВП-препараты «могут стать причиной» повышенного риска развития инсульта и сердечного приступа, однако, Управление настаивает, что недавно проведенные исследования показали, что этот риск является более существенным.
Впервые информация о том, что прием медикаментов группы НПВП связан с повышением вероятности возникновения инсульта и инфаркта, появилась еще в 2005 году. Управление напомнило, что в группу риска чаще всего попадают пациенты, страдающие от проблем с сердечно-сосудистой системой, однако даже у здоровых людей прием препаратов повышает риск развития инсульта и сердечного приступа.
В ближайшее время FDA попросит производителей НПВП изменить этикетки лекарств, указав на них более точную информацию, а именно, что такие препараты не «могут вызывать», а «вызывают» повышение риска инсульта и сердечного приступа. Кроме того, Управление считает, что на этикетках нужно указывать, что риск может наблюдаться уже в самом начале лечения.
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Источник: Нью-Йорк Таймз | http://www.nytimes.com/2015/07/10/us/fda-is-set-to-toughen-nonaspirin-warnings.html?ref=health&_r=1 |
WASHINGTON — The Food and Drug Administration is strengthening warnings on painkillers like ibuprofen to say that they cause an increased risk of heart attack and stroke. The over-the-counter forms include Advil, Motrin IB and Aleve.
The distinction was subtle: The labels already say such drugs “may cause” increased risk of heart attack and stroke. But the agency said that new data from a recent analysis provided stronger evidence of the increased risk of heart failure from such drugs, called nonaspirin nonsteroidal anti-inflammatory drugs (Nsaids), which are taken by millions of Americans.
In the coming months, the agency said it would ask manufacturers to change the labels to say that the drugs “cause an increased risk” of serious heart failure. It also will ask them to add that the risk may occur early in treatment and may increase the longer the patient uses the medicine.
The changes will apply to over-the-counter and prescription forms of the medicine, an F.D.A. spokesman said. The agency said people with heart problems should consult a doctor before taking the medication. The F.D.A. said it reviewed a large number of studies that supported the conclusion that the medicines caused increased risk. The studies estimated that the relative risk increased by 10 percent to 50 percent, depending on the drugs and the doses considered.
The agency first warned of the risk of heart attack and stroke in the prescription medicines in 2005. People who have heart disease, particularly those who recently had a heart attack or stroke, are most at risk, the agency said. But it added that even those who had never had heart disease were at risk.
“Everyone may be at risk, even people without an underlying risk for cardiovascular disease,” Dr. Judy Racoosin, the deputy director of the F.D.A.’s Division of Anesthesia, Analgesia and Addiction Products, said in a written explanation of the change.
Last year, the F.D.A. convened a panel of experts to review the studies and evidence that informed its decision on Thursday.
The over-the-counter form of the drugs is used to treat pain or fever. The prescription forms tend to be stronger and are used to treat arthritis and other painful conditions, the agency said.
In a statement, the Consumer Healthcare Products Association, a trade association for makers of over-the-counter medicines, said such drugs “have a long history of safety and efficacy when used as directed,” and that the current label already addresses heart risks “and directs consumers to take the smallest effective dose.” It said it would work with the F.D.A. to make the changes it is requesting “to ensure continued safe consumer use.”
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