Frova Warnings and Precautions (Cont.)

• Frova has been reported to increase the risk of a heart attack or a life-threatening change in a person's heart rhythm (arrhythmia). You should not take Frova if you have heart disease or a history of a heart attack or chest pain (see Frova and Heart Problems for more information). 

If you have risk factors for heart disease (see Heart Disease Risk Factors), it is also strongly recommended that you take your first dose of Frova in your healthcare provider's office so he or she can monitor your heart. You should also have your heart checked periodically while taking Frova.

• In some cases, a stroke or transient ischemic attack ("mini-stroke") can be misdiagnosed as a migraine. Your healthcare provider should make sure you are not having a stroke, especially if you have never had migraines in the past (see Stroke Symptoms for more information on the symptoms of a stroke).
   
• If you have chest pain or tightness in the jaw or neck after taking Frova, contact your healthcare provider immediately. These side effects are fairly common with Frova and are not usually serious. However, your healthcare provider may need to make sure you are not having heart problems.
   
• Medications like Frova can cause blood vessels to spasm, including in the arms, legs, or colon (large intestine). This can cause a decrease in blood flow to these areas. The symptoms will vary based on the location. For example, a spasm in the colon can lead to severe abdominal pain or bloody diarrhea.
   
• Taking Frova with certain antidepressants, including selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), can increase your risk of a dangerous group of symptoms called serotonin syndrome. Do not use Frova with depression medications without first discussing it with your healthcare provider. Contact your healthcare provider immediately if you have any possible symptoms of serotonin syndrome, including:

o Confusion

o Seeing or hearing things that are not really there (hallucinations)

o A fast heartbeat (tachycardia)

o Feeling faint

o Fever

o Sweating

o Muscle spasms

o Difficulty walking

o Diarrhea.

• Frova can cause an increase in blood pressure. You should not take Frova if you have untreated high blood pressure (hypertension).
   
• Frova is considered a pregnancy Category C medication. This means that Frova may not be safe for use during pregnancy. Talk to your healthcare provider before using Frova if you are pregnant (see Frova and Pregnancy for more information).
   
• It is not known if Frova passes through breast milk. Therefore, if you are breastfeeding or plan to start breastfeeding, be sure to talk with your healthcare provider about this.
   
• Tell your healthcare provider if you have liver problems (including liver failure or cirrhosis) before taking Frova. This is because Frova is removed from the body through the liver. People with severe liver problems should not take Frova.
   
• Frova can interact with certain medications (see Frova Drug Interactions).