New boxed warnings added to prescription NSAIDs

Naprosyn New boxed warnings added to prescription NSAIDsThe safety labels for prescription painkillers known as nonsteroidal anti-inflammatory drugs (NSAIDs) have been updated to include a new black box warning for risk of serious cardiovascular and gastrointestinal events. Boxed warnings are the most serious type of warning issued by the FDA and involve situations in which there is a significant risk of serious or even life-threatening adverse events.

The boxed warnings state the following:

Cardiovascular Thrombotic Events

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction (heart attack) and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
  • NSAIDs are contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Bleeding, Ulceration, and Perforation

  • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

Updates involving these warnings as well as heart failure and edema risks, were also made to the WARNINGS AND PRECAUTIONS sections of the medications. Regarding the heart failure and edema risk, the warning states that one study showed an approximately two-fold increase in hospitalizations for heart failure in patients treated with NSAIDs. Another study showed an increased risk of heart attack, hospitalization for heart failure, and death in NSAID-treated patients. Additionally, fluid retention and edema have been observed in patients treated with NSAIDs. The warning recommends NSAIDs not be used in patients with severe heart failure.

NSAIDs are available over-the-counter in generic forms or under brand names such as Advil. The warning only applies to prescription NSAIDs, which include the following brand names:

Anaprox (naproxen)
Ansaid (flurbiprofen)
Arthrotec (diclofenac sodium/misoprostil)
Caldolor (ibuprofen)
Cambia (diclofenac potassium)
Cataflam (diclofenac)
Celebrex (celecoxib)
Daypro (oxaprozin)
Daypro Alta (oxaprozin)
Duexis (ibuprofen and famotidine)
Dyloject (diclofenac)
Feldene (piroxicam)
Flector (diclofenac)
Indocin Capsules (indomethacin)
Indocin Capsules (indomethacin)
Indocin SR (indomethacin)
Indocin Suppositories (indomethacin)
Indocin Suspension (indomethacin)
Mobic Suspension (meloxicam)
Mobic Tablets (meloxicam)
Nalfon (fenoprofen)
Naprelan (naproxen)
Naprosyn (naproxen)
Naprosyn Suspension (naproxen)
Naprosyn-EC (naproxen)
Pennsaid 1.5% (diclofenac)
Pennsaid 2% (diclofenac)
Ponstel (mefenamic acid)
Solaraze (diclofenac sodium)
Sprix (ketorolac)
Tivorbex (indomethacin)
Treximet (naproxen and sumitriptan)
Vimovo (naproxen and esomeprazole)
Vioxx (rofecoxib)
Voltaren (diclofenac)
Voltaren Gel (diclofenac)
Voltaren-XR (diclofenac)
Zipsor (diclofenac)
Zorvolex (diclofenac)

Source: FDA