Federal health regulators have strengthened the safety warnings for a common class of pain relievers, which include the likes of Advil, Aleve, Celebrex and Motrin IB due to risks for stroke and heart attack.
The U.S. Food and Drug Administration (FDA) said that new data have prompted it to conclude that these medicines also known as nonsteroidal anti- inflammatory drugs, or NSAIDs, which include generic ibuprofen, meloxicam, naproxen and diclofenac, can definitely lead to increased risks for stroke and heart attack albeit the agency has long required that this class of drugs show a warning that this may cause an increased risk.
The FDA will require producers of the prescription versions of these drugs to change their label to include the statement that the increased risks may be present for the entire course of drug use and even within the first weeks of treatment.
The agency likewise said that it would ask makers of over-the-counter versions of these drugs to come up with similar changes in the coming months. Such change in over-the-counter labels is different from the regulatory process involving prescription drugs.
The FDA pointed out that the increased risk often occurs with higher doses and that patients who have taken NSAIDs after their first heart attack have increased odds of drying within the first year compared with their counterparts who were not treated with this class of drugs.
The Consumer Healthcare Products Association, which represents the producers of over-the-counter NSAIDs said that people often take lower doses of the drug for shorter terms instead of for chronic conditions.
The change in labeling is FDA's latest step in its safety review of the drugs that goes back a decade earlier. In 2004, Merck & Co Inc. pulled out Vioxx off of the market because it has been tied to heart attack and stroke.
The drug was promoted as a new kind of NSAID that was easier on the stomach but the company's withdrawal of the drug from the market shook the medical industry and paved way to a new era of drug safety.
The following year, FDA required drug makers to add boxed warning to all prescription NSAIDs, which are often used for long term chronic pain conditions such as arthritis.
A similar warning was also added to lower dose and over-the-counter NSAIDs with those drugs warning patients to take only the lowest dose possible for a short period of time.
Photo: Mike Mozart | Flickr
