"March 11, 2014 - The U.S. Food and Drug Administration allowed marketing of the first device as a preventative treatment for migraine headaches. This is also the first transcutaneous electrical nerve stimulation (TENS) device specifically "...
The following adverse reactions are discussed in more detail in other sections of the labeling:
- Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina [see WARNINGS AND PRECAUTIONS].
- Arrhythmias [see WARNINGS AND PRECAUTIONS].
- Chest and or Throat, Neck and/or Jaw Pain/Tightness/Pressure [see WARNINGS and PRECAUTIONS].
- Cerebrovascular Events [see WARNINGS AND PRECAUTIONS].
- Other Vasospasm Reactions [see WARNINGS AND PRECAUTIONS].
- Medication Overuse Headache [see WARNINGS AND PRECAUTIONS].
- Serotonin Syndrome [see WARNINGS AND PRECAUTIONS].
- Increase in Blood Pressure [see WARNINGS AND PRECAUTIONS].
Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Incidence in Controlled Clinical Trials
Adverse reactions to MAXALT were assessed in controlled clinical trials that included over 3700 adult patients who received single or multiple doses of MAXALT Tablets. The most common adverse reactions during treatment with MAXALT ( ≥ 5% in either treatment group and greater than placebo) were asthenia/fatigue, somnolence, pain/pressure sensation and dizziness. These adverse reactions appeared to be dose related.
Table 1 lists the adverse reactions (incidence ≥ 2% and greater than placebo) after a single dose of MAXALT in adults.
Table 1: Incidence ( ≥ 2% and Greater than Placebo) of Adverse
Reactions After a Single Dose of MAXALT Tablets or Placebo in Adults
|Adverse Reactions||% of Patients|
|Pain and other Pressure Sensations||6||9||3|
|tightness/pressure and/or heaviness||< 2||3||1|
|tightness/pressure and/or heaviness||< 1||2||0|
|Pain, location unspecified||3||3||< 2|
|Headache||< 2||2||< 1|
The frequencies of adverse reactions in clinical trials did not increase when up to three doses were taken within 24 hours. Adverse reaction frequencies were also unchanged by concomitant use of drugs commonly taken for migraine prophylaxis (including propranolol), oral contraceptives, or analgesics. The incidences of adverse reactions were not affected by age or gender. There were insufficient data to assess the impact of race on the incidence of adverse reactions.
Other Events Observed in Association with the Administration of MAXAL T in Adults
In the following section, the frequencies of less commonly reported adverse events are presented that were not reported in other sections of the labeling. Because the reports include events observed in open studies, the role of MAXALT in their causation cannot be reliably determined. Furthermore, variability associated with adverse event reporting, the terminology used to describe adverse events, limit the value of the quantitative frequency estimates provided. Event frequencies are calculated as the number of patients who used MAXALT and reported an event divided by the total number of patients exposed to MAXALT (N=3716). All reported events occurred at an incidence ≥ 1%, or are believed to be reasonably associated with the use of the drug. Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are those defined as those occurring in at least ( > )1/100 patients; infrequent adverse experiences are those occurring in 1/100 to 1/1000 patients; and rare adverse experiences are those occurring in fewer than 1/1000 patients.
Atypical Sensations: Frequent were warm sensations.
The adverse reaction profile seen with MAXALT-MLT Orally Disintegrating Tablets was similar to that seen with MAXALT Tablets.
Pediatric Patients 6 to 17 Years of Age
Incidence in Controlled Clinical Trials in Pediatric Patients
Adverse reactions to MAXALT-MLT were assessed in a controlled clinical trial in the acute treatment of migraines (Study 7) that included a total of 1382 pediatric patients 6-17 years of age, of which 977 (72%) administered at least one dose of study treatment (MAXALT-MLT and/or placebo) [see Clinical Studies]. The incidence of adverse reactions reported for pediatric patients in the acute clinical trial was similar in patients who received MAXALT to those who received placebo. The adverse reaction pattern in pediatric patients is expected to be similar to that in adults.
Other Events Observed in Association with the Administration of MAXALT-MLT in Pediatric Patients
In the following section, the frequencies of less commonly reported adverse events are presented. Because the reports include events observed in open studies, the role of MAXALT-MLT in their causation cannot be reliably determined. Furthermore, variability associated with adverse event reporting, the terminology used to describe adverse events, limit the value of the quantitative frequency estimates provided.
Event frequencies are calculated as the number of pediatric patients 6 to 17 years of age who used MAXALT-MLT and reported an event divided by the total number of patients exposed to MAXALT-MLT (N=1068). All reported events occurred at an incidence ^1%, or are believed to be reasonably associated with the use of the drug. Events are further classified within system organ class and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are those occurring in ( > )1/100 pediatric patients; infrequent adverse experiences are those occurring in 1/100 to 1/1000 pediatric patients; and rare adverse experiences are those occurring in fewer than 1/1000 patients.
General: Frequent was fatigue.
Gastrointestinal disorders: Frequent was abdominal discomfort.
Nervous system disorders: Infrequent were coordination abnormal, disturbance in attention, and presyncope.
The following section enumerates potentially important adverse events that have occurred in clinical practice and which have been reported spontaneously to various surveillance systems. The events enumerated include all except those already listed in other sections of the labeling or those too general to be informative. Because the reports cite events reported spontaneously from worldwide postmarketing experience, frequency of events and the role of MAXALT in their causation cannot be reliably determined.
Special Senses: Dysgeusia.
Read the Maxalt (rizatriptan benzoate) Side Effects Center for a complete guide to possible side effects
The dose of MAXALT should be adjusted in propranolol-treated patients, as propranolol has been shown to increase the plasma AUC of rizatriptan by 70% [see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY].
Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. Because these effects may be additive, use of ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) and MAXALT within 24 hours is contraindicated [see CONTRAINDICATIONS].
Other 5-HT1 Agonists
Because their vasospastic effects may be additive, co-administration of MAXALT and other 5-HT-i agonists within 24 hours of each other is contraindicated [see CONTRAINDICATIONS].
SSRIs/SNRIs and Serotonin Syndrome
Cases of serotonin syndrome have been reported during co-administration of triptans and selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) [see WARNINGS AND PRECAUTIONS].
Monoamine Oxidase Inhibitors
MAXALT is contraindicated in patients taking MAO-A inhibitors and non-selective MAO inhibitors. A specific MAO-A inhibitor increased the systemic exposure of rizatriptan and its metabolite [see CONTRAINDICATIONS and CLINICAL PHARMACOLOGY].
Read the Maxalt Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 1/5/2012
This monograph has been modified to include the generic and brand name in many instances.
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