Label Changes for:
(lansoprazole delayed-release 15 mg capsules and naproxen 500 mg tablets kit)
Changes have been made to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- October 2008
|The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.|
Summary of Changes to Contraindications and Warnings
MEDICATION GUIDE for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs):
NSAID Medications that Need a Prescription:
Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS, Anaphylactoid Reactions, and PRECAUTIONS –Preexisting Asthma).
GI Effects - Risk of Ulceration, Bleeding, and Perforation:
NSAIDs, including Naprosyn, can cause serious GI adverse events including inflammation...
These serious adverse events can occur at any time, with or without warning symptoms in patients treated with NSAIDs...
...Only 1 in 5 patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic.
...For high risk patients, alternate therapies that do not involve NSAIDs should be considered.
Epidemiological studies, both of the case-control and cohort design, have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper GI bleeding. In two studies, concurrent use of an NSAID or aspirin potentiated the risk of bleeding (see PRECAUTIONS: Drug Interactions). Although these studies focused on upper GI bleeding, there is reason to believe that bleeding at other sites may be similarly potentiated.
NSAIDs should be given with care to patients with a history of inflammatory bowel disease (ulcerative colitis, Crohn’s disease) as their condition may be exacerbated.
As with other NSAIDs, anaphylactoid reactions may occur in patients without known prior exposure to Naprosyn and/or Prevacid. Naprosyn should not be given to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs (see CONTRAINDICATIONS and PRECAUTIONS, Preexisting Asthma).
...Anaphylactoid reactions, like anaphylaxis, may have a fatal outcome.
For current Medication Guide contact Takeda Pharmaceuticals at 1-877-226-4589.