Topamax

Synopsis of Prescription Drug Litigation

Topamax, the epilepsy and migraine drug, has recently been linked to infant’s risk for oral birth defects. The Venardi Law Firm brings together an experienced team to help you understand the injuries caused by the drug and how to prove causation. The FDA warnings released earlier says new data suggests increased risk for the birth defects cleft lip and cleft palate in babies born to women who use the medication during pregnancy

Topamax® (topiramate): Topamax is manufactured by Ortho McNeil Neurologics and approved by the FDA in 1997. It is an anticonvulsant (anti-eplleptic drug) approved for use alone or with other medications to treat patients with epilepsy who have certain types of seizures. Topiramate is also approved for use to prevent migraine headaches.

Why is this medication prescribed?: Topiramate is used alone or with other medications to treat certain types of seizures in people who have epilepsy. Topiramate is also used with other medications to control seizures in people who have Lennox-Gastaut syndrome (a disorder that causes seizures and developmental delays). Topiramate is used to treat patients who continue to have seizures even when they take other anti-seizure medications. Topiramate is also used to prevent migraine headaches, but not to relieve the pain of migraine headaches when they occur. Topiramate is in a class of medications called anticonvulsants. It works by decreasing abnormal excitement in the brain.

FDA indications:
TOPAMAX is indicated for:

1. Treatment as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures.
2. Treatment as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome
3. Prevention of migraine headache in adults. The usefulness of Topamax® in the acute treatment of migraine headache has not been studied.

Off label uses:

1. Use to augment psychotropics (such as bipolar disease) or counteract weight gain with several antidepressants.
2. Investigational use in treating alcoholism and obesity especially to reduce binge eating.
3. The drug is used in clinical trials to treat post-traumatic stress disorder (PTSD)

What you should know before taking Topamax:

There is another medication with a name similar to the brand name for topiramate. You should be sure that you receive topiramate and not the similar medication each time you fill your prescription. Be sure that the prescription your doctor gives you is clear and easy to read. Talk to your pharmacist to be sure that you are given topiramate. After you receive your medication, compare the tablets to the pictures in the manufacturer's patient information sheet. If you think you were given the wrong medication, talk to your pharmacist. Do not take any medication unless you are certain it is the medication that your doctor prescribed.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with topiramate and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs) or the manufacturer's website to obtain the Medication Guide.

What special precautions should I follow?:
Before taking topiramate,

• tell your doctor and pharmacist if you are allergic to topiramate or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: acetazolamide (Diamox); amitriptyline; antidepressants; antihistamines; dichlorphenamide (Daranide); digoxin (Lanoxin, Digitek); hydrochlorothiazide (Microzide, Oretic); ipratropium (Atrovent); iron; isoniazid (INH, Nydrazid); lithium (Eskalith, Lithobid); medications for anxiety, irritable bowel disease, mental illness, motion sickness, Parkinson's disease, ulcers, or urinary problems; metformin (Glucophage); methazolamide; oral contraceptives (birth control pills); other medications for seizures such as carbamazepine (Tegretol) and phenytoin (Dilantin, Phenytek); pioglitazone (Actos); risperidone (Risperdal); salicylate pain relievers such as aspirin, choline magnesium trisalicylate (Trisalate), choline salicylate (Arthropan), diflunisal (Dolobid), magnesium salicylate (Doan's, others), and salsalate (Argesic, Disalcid, Salgesic); sedatives; sleeping pills; tranquilizers; valproic acid (Depakene, Depakote); and zonisamide (Zonegran). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you or any family members have or have ever had kidney stones, if you drink or have ever drunk large amounts of alcohol, and if you have ever thought about killing yourself or tried to do so. Also tell your doctor if you have or have ever had metabolic acidosis (a disturbance in the body's acid-base balance that results in excessive acidity of the blood); osteopenia, osteomalacia, or osteoporosis (conditions in which the bones are soft or brittle and may break easily); diabetes; glaucoma (a type of eye disease); any disease that affects your breathing such as asthma or chronic obstructive pulmonary disease (COPD); depression or abnormal moods; a growth problem; or liver or kidney disease. Also tell your doctor if you have diarrhea or if you develop diarrhea during your treatment.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking topiramate, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking topiramate.
• you should know that topiramate may make you drowsy, dizzy, confused, or unable to concentrate. Do not drive a car or operate machinery until you know how this medication affects you.
• if you are taking topiramate to control seizures, you should know that you may continue to have seizures during your treatment. You may need to avoid activities such as swimming, driving, and climbing so that you will not harm yourself or others if you lose consciousness during a seizure.
• ask your doctor about the safe use of alcoholic beverages while you are taking topiramate.
• if you are taking oral contraceptives (birth control pills), tell your doctor if unexpected bleeding or spotting occurs. Topiramate can decrease the effectiveness of oral contraceptives.
• you should know that topiramate can prevent you from sweating and make it harder for your body to cool down when it gets very hot. This happens most often in warm weather and to children who take topiramate. Avoid exposure to heat, drink plenty of fluids and tell your doctor if you have a fever, headache, muscle cramps, or an upset stomach, or if you are not sweating as usual.
• you should know that you may be more likely to develop a kidney stone while you are taking topiramate. Drink 6 to 8 glasses of water every day to prevent kidney stones from forming.
• you should know that your mental health may change in unexpected ways and you may become suicidal (thinking about harming or killing yourself or planning or trying to do so) while you are taking topiramate for the treatment of epilepsy, mental illness, or other conditions. A small number of adults and children 5 years of age and older (about 1 in 500 people) who took antiepileptics such as topiramate to treat various conditions during clinical studies became suicidal during their treatment. Some of these people developed suicidal thoughts and behavior as early as one week after they started taking the medication. There is a risk that you may experience changes in your mental health if you take an antiepileptic medication such as topiramate, but there may also be a risk that you will experience changes in your mental health if your condition is not treated. You and your doctor will decide whether the risks of taking an antiepileptic medication are greater than the risks of not taking the medication. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: panic attacks; agitation or restlessness; new or worsening irritability, anxiety, or depression; acting on dangerous impulses; difficulty falling or staying asleep; aggressive, angry, or violent behavior; mania (frenzied, abnormally excited mood); talking or thinking about wanting to hurt yourself or end your life; withdrawing from friends and family; preoccupation with death and dying; giving away prized possessions; or any other unusual changes in behavior or mood. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

Black Box  Warning:

Lawsuits:
Due to new evidence of birth defects, Topamax lawsuits are currently being filed throughout the country. It may soon come under Multi-District Litigation (MDL). That simply means that instead of all of the Topamax lawsuits being filed across the country, they're initially filed in one court, so the same judge can make sure everything proceeds in an orderly fashion. Many people confuse class action lawsuits with MDL proceedings.  By and large, if the lawsuit involves a large number of people hurt by a drug like Topamax, it will be an MDL.  However, there may also be a Topamax class action

When to call the Venardi Law Firm: If you feel you have been hurt or damaged while you were taking Topamax, call the Venardi Law Firm. Our experienced team will evaluate your case efficiently and determine if you have a potential lawsuit.

If you and your baby have experienced a birth defect such as cleft lip and cleft palate while taking Topamax, call the Venardi Law Firm for an immediate evaluation of your potential case.
While taking Topamax, if you have experienced serious eye problems that include:

any sudden decrease in vision with or without eye pain and redness, a blockage of fluid in the eye causing increased pressure in the eye (secondary angle closure glaucoma).
These eye problems can lead to permanent loss of vision if not treated. You should call your healthcare provider right away if you have any new eye symptoms and then seek legal advice with the Venardi Law Firm.