Pregabalin

Pregabalin was originally FDA-approved in 2004 as an anti-epileptic drug, also called an anticonvulsant. It works by slowing down impulses in the brain that cause seizures. Pregabalin also affects chemicals in the brain that send pain signals across the nervous system and belongs to the drug class called gabapentinoids. It is a Schedule V controlled substance, the lowest schedule for abuse potential.

Pregabalin is used to treat pain caused by fibromyalgia, or nerve pain in people with diabetes (diabetic neuropathy), herpes zoster (post-herpetic neuralgia), or spinal cord injury.

Pregabalin is also used with other medications to treat partial-onset seizures in adults and children aged at least 1 month.

Pregabalin comes as immediate-release capsules, an oral solution, and extended-release tablets. The extended-release tablets are approved for a narrower set of uses than the capsules and oral solution: they are indicated only for nerve pain from diabetic peripheral neuropathy and for post-herpetic neuralgia. Their efficacy has not been established for fibromyalgia or for partial-onset seizures.

Pregabalin may cause serious side effects, including:

• serious, even life-threatening, allergic reactions
• swelling of your hands, legs, and feet
• suicidal thoughts or actions
• dizziness and sleepiness
• serious breathing problems.

Do not stop using pregabalin suddenly, even if you feel fine. Stopping suddenly may cause withdrawal symptoms.

These serious side effects are described below.

Serious, even life-threatening, allergic reactions

Pregabalin can cause a severe allergic reaction. Stop taking pregabalin and seek emergency medical help if you have:

• swelling of your face, mouth, lips, gums, tongue, throat, or neck
• trouble breathing
• rash, hives (raised bumps), or blisters

Suicidal thoughts or actions

Like other antiepileptic drugs, pregabalin may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. This can happen while you take pregabalin capsules or after stopping. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

• thoughts about suicide or dying
• attempts to commit suicide
• new or worse depression
• new or worse anxiety
• feeling agitated or restless
• panic attacks
• trouble sleeping (insomnia)
• new or worse irritability
• acting aggressively, being angry, or violent
• acting on dangerous impulses
• an extreme increase in activity and talking (mania)
• other unusual changes in behavior or mood.

If you have suicidal thoughts or actions, do not stop pregabalin without first talking to a healthcare provider.

• Stopping pregabalin suddenly can cause serious problems.
• Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

How can I watch for early symptoms of suicidal thoughts and actions?

• Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
• Keep all follow-up visits with your healthcare provider as scheduled.
• Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Serious breathing problems

There have been reports of life-threatening breathing problems (respiratory depression) with gabapentinoids, such as pregabalin. The risk is higher in those with preexisting breathing disorders (such as COPD), the elderly, or those taking other medicines that can cause drowsiness or slow your breathing, such as opioids or CNS depressants. Seek emergency medical attention if you have very slow breathing.

Swelling of your hands, legs, and feet

Call your doctor if you have weight gain or swelling in your hands or feet while taking pregabalin. This swelling can be a serious problem for people with heart problems.

Dizziness and sleepiness

Do not drive a car, work with machines, or do other dangerous activities until you know how pregabalin affect you. Ask your healthcare provider about when they will be okay to do these activities.

Take pregabalin exactly as prescribed by your doctor and read all medication guides or instruction sheets about pregabalin. Your doctor may occasionally change your dose.

Take pregabalin at the same time each day. Regular pregabalin can be taken with or without food, but extended-release tablets must be taken after your evening meal.

Extended-release pregabalin tablets are taken once a day after an evening meal. Swallow them whole and do not split, crush, or chew them.

Measure pregabalin liquid medicine carefully. Use the dosing syringe provided or a medicine dose-measuring device (not a kitchen spoon).

Call your doctor if your symptoms do not improve or if they get worse.

Do not stop using pregabalin suddenly, even if you feel fine. Stopping suddenly may cause increased seizures or unpleasant withdrawal symptoms. Follow your doctor's instructions about tapering your dose over a minimum of 1 week before stopping completely.

In case of emergency, wear or carry medical identification to let others know you take seizure medication.

Store at room temperature away from moisture, heat, and light.

You should not use pregabalin if you are allergic to it.

Tell your doctor if you have ever had:

• lung disease, such as chronic obstructive pulmonary disease (COPD), or other breathing problems
• a mood disorder, depression, or suicidal thoughts;
• heart problems (especially congestive heart failure);
• a bleeding disorder, or low levels of platelets in your blood;
• kidney disease (or if you are on dialysis);
• diabetes (unless you are taking pregabalin to treat diabetic neuropathy);
• drug or alcohol addiction; or
• a severe allergic reaction (angioedema).

Do not give this medicine to a child without medical advice.

• Pregabalin is not approved for use by anyone younger than 18 years old to treat nerve pain caused by fibromyalgia, diabetes, herpes zoster, or spinal cord injury.
• Pregabalin is not approved for seizures in anyone younger than 1 month old.

Some people have thoughts about suicide while taking pregabalin. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Pregnancy and breastfeeding

Seizure control is very important during pregnancy, and having a seizure could harm both mother and baby. Do not start or stop taking pregabalin without your doctor's advice, and tell your doctor right away if you become pregnant.

If you take pregabalin during pregnancy, you are encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry, which collects information on the safety of anti-epileptic drugs in pregnancy. You can enroll by calling 1-888-233-2334 or visiting aedpregnancyregistry.org.

Tell your doctor if you take opioid medicines during pregnancy. Taking pregabalin with opioids for a long time near your delivery date can cause withdrawal symptoms in your newborn baby.

Pregabalin passes into breast milk. It is not known if it can harm your baby. Breastfeeding is not recommended while you are taking pregabalin. Talk to your doctor about the best option for you and your baby.

Animal studies have shown that pregabalin made male animals less fertile and caused sperm to change. Also, in animal studies, birth defects were seen in the offspring of male animals treated with pregabalin. It is not known if these problems can happen in people. If you are a man planning to father a child, ask your doctor about your risk.

Pregabalin can cause a severe allergic reaction. Stop taking this medicine and get emergency medical help if you have: hives or blisters on your skin; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Pregabalin may cause serious side effects. Call your doctor at once if you have:

• weak or shallow breathing;
• blue-colored skin, lips, fingers, and toes;
• confusion, extreme drowsiness, or weakness;
• vision problems;
• skin sores (if you have diabetes);
• easy bruising, unusual bleeding;
• swelling in your hands or feet, rapid weight gain (especially if you have diabetes or heart problems); or
• unexplained muscle pain, tenderness, or weakness (especially if you also have fever or don't feel well).
• feeling "high".

Pregabalin can cause life-threatening breathing problems. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up. Breathing problems may be more likely in older adults or in people with COPD.

If you have diabetes, tell your doctor right away if you have any new sores or other skin problems.

Common side effects of pregabalin may include:

• dizziness, drowsiness;
• swelling in your hands and feet;
• trouble concentrating;
• increased appetite;
• weight gain;
• dry mouth; or
• blurred vision.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

If you miss a dose of pregabalin capsules or oral solution, take that dose as soon as you remember. If it is almost time for your next dose, then skip the missed dose. Do not take two doses at one time.

If you are taking extended-release tablets and you miss your dose after an evening meal, take your usual dose before bedtime, following a snack. If you miss that, take your usual dose after a morning meal. If you miss the morning dose too, take your usual dose at the usual time that evening after an evening meal.

Symptoms reported with pregabalin overdose include reduced consciousness, confusion, agitation, restlessness, depression, and anxiety. Seizures and heart block have also been reported. Deaths have been reported with pregabalin overdose, most often when it was taken together with other medicines.

Thoughts about suicide or self-harm have been reported both during pregabalin treatment and after stopping it. Do not stop pregabalin on your own if you have these thoughts; call your healthcare provider.

Taking pregabalin with alcohol, lorazepam, or oxycodone can have an additive effect on thinking and coordination, even though these medicines do not change how much pregabalin is in your body.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid drinking alcohol. It may increase certain side effects of pregabalin.

Avoid driving or hazardous activities until you know how pregabalin will affect you. Your reactions could be impaired.

Using pregabalin with other drugs that slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, cold or allergy medicine, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your other medicines, especially:

• oral diabetes medicine--pioglitazone, rosiglitazone; or
• an ACE inhibitor--benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril, or trandolapril.

This list is not complete. Other drugs may affect pregabalin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.