FDA To Acknowledge Low Risk For Cardiovascular Problems From Aleve/Naproxen
By Cyndi Root
The Food and Drug Administration (FDA) has released a briefing document in preparation for an upcoming advisory committee meeting. The document discusses Aleve/naproxen sodium and indicates that the medication has a low risk for cardiovascular (CV) events. It states that recent evidence continues to suggest that naproxen is a safe nonsteroidal anti-inflammatory drug (NSAID). Officials may change publications and labels after the committee meets to update the public on the low CV risk for naproxen.
Naproxen was approved by the FDA in 1976. It is available over-the-counter (OTC) and by prescription. Consumers can buy brands like Aleve or purchase generic versions. The drug is available globally in more than 50 countries. In 2005, the FDA changed the label of all prescription non-aspirin NSAIDs, alerting users that CV risks were possible. Additionally, allergic skin reactions and gastrointestinal (GI) bleeding were added to the warnings listed on the labels.
In 2005, Bayer and Roche supported its product by submitting evidence to the FDA that naproxen was safe and had a low risk for CV events. The evidence included studies of 80,000 people that showed no increased cardiovascular events, post-marketing studies that showed no cerebrovascular events in over a million people, and the clinical studies for naproxen New Drug Applications (NDAs). Supporting evidence was pharmacology data that showed cardio-protective abilities of naproxen in inhibiting platelet aggregation through its effects on COX-1.
Naproxen manufacturers believed in 2005 that the drug was safe and now, in 2014, the FDA is prepared to reopen the debate. The newly published briefing document is a comprehensive evaluation of the studies, data, and evidence accumulated since 2005:
- Two clinical studies, ADAPT (Alzheimer’s Disease Anti-inflammatory Prevention Trial) and TARGET (Therapeutic Arthritis Research and Gastrointestinal Event) demonstrated no CV risks.
- An analysis of 35 studies showed no increased risks.
- Six meta-analyses showed no evidence of risks from OTC or prescription naproxen.
- Pharmacovigilence studies by Bayer and Roche did not indicate risks for cerebrovascular accidents.
The FDA concludes that the evidence since 2005 shows little to no thromboembolic risk from naproxen. Some evidence suggests that the drug may protect the cardiovascular system in some measure. Finally, the agency states that “naproxen
has a lower overall CV risk than other selective and non-selective non-aspirin NSAIDs.”
Source: