The U.S. Food and Drug Administration (FDA) has approved Topamax (generic topiramate) for use in preventing migraine headaches in adolescents ages 12 to 17.
This is the first FDA approval of a migraine prevention drug for this age group. The medication is taken daily to reduce the frequency of migraine headaches.
Topamax was first approved by the FDA in 1996 to prevent seizures, and it was approved in 2004 for migraine prevention in adults, according to a press release by the FDA.
A Philadelphia jury ordered Johnson & Johnson (J&J)’s Janssen Pharmeceuticals unit to pay $11 million in a lawsuit alleging the company failed to warn doctors and patients that its drug Topamax can cause birth defects when taken during pregnancy.
The Topamax lawsuit, brought on behalf of a woman who gave birth to a son with a cleft lip, is the second loss for Janssen in less than a month. The company lost a $4.02 million verdict in October in a lawsuit on behalf of a Virginia woman whose son suffered similar injuries. Janssen said it will appeal both verdicts.
This case was selected by the drug manufacturer to go to trial.
A Virginia woman wouldn’t have taken Topamax for more than six months to treat migraines had she known the risks to her unborn child, her lawyer told the jury in a trial that began on October 15 in the Philadelphia Court of Common Pleas.
The woman filed a Topamax lawsuit blaming drug manufacturer Janssen for her son’s cleft palate and lip. She also claimed the company was negligent in its failure to inform patients about the alleged risks life-altering risks to unborn babies until the U.S. Food and Drug Administration (FDA) ordered stronger label warnings in 2011.
Janssen will face the first two of 63 lawsuits regarding Topamax this month in Philadelphia.
According to researchers in Ireland, the reason for cleft palate or cleft lip birth defects is caused by lack of folic acid during the first three months of pregnancy.
The Growing Up in Ireland Study performed by the department of public health and primary care at Trinity College School of Medicine wished to assess the effectiveness of folic acid supplements in preventing cleft palate and cleft lip.
A cleft lip is a separation in the upper lip while a cleft palate is an opening in the roof of the mouth. Clefts result from incomplete development of the lip and/or palate in the early weeks of pregnancy.
Pregnancy Category X means the risks involved in using Qsymia in pregnant women clearly outweigh the potential benefits. Studies in animals or humans have demonstrated fetal abnormalities. What are the fetal abnormalities? To be more specific – oral cleft birth defects such has cleft palate and/or cleft lip.
The FDA just approved a new diet drug called Qsymia. For obese post-menopausal women and for men of all ages, Qsymia has some concerns and contraindications such as increased heart rate, hyperthryroidism and glaucoma but the real danger lies with women of child bearing age who could and/o are trying to get pregnant.
Qsymia is comprised of two active ingredients – topiramate and phentermine. Topiramate (Topamax) is prescribed as an anticonvulsant and/or to prevent migraine headaches. Many women who took this drug also lost weight. Topamax previously was a Pregnancy Category C upgraded to a Pregnancy Category D in 2011. Phentermine is used for a limited period of time to speed weight loss in overweight people who are exercising and eating a low-calorie diet.
There is something terribly wrong about a diet drug like Qsymia when doctors and pharmacists are mandated to counsel women about birth control before prescribing and dispensing Qsymia.
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If you are pregnant or of childbearing age and plan to get pregnant, talk to your doctors about any over-the-counter, herbal, dietary supplements, and prescription drugs that you are now taking or recommended to take in the future.
Many prescription drugs cause serious birth defects.
Clinical drugs trials on pregnant women are unethical and not practiced. The safety of most medications taken by pregnant women is unknown and dependent on many factors.
However, it’s important to note that if you are now pregnant, you should not stop taking any type of medication without first talking with a doctor. Sometimes women don’t even realize they are pregnant while taking a potentially harmful drug.
What medications can cause birth defects?
Harmful drugs are thalidomide (also known as Thalamid®) and isotretinoin (also known as Accutane®). Such medications should be avoided by all women who are or might become pregnant. While some medications are known to be harmful when taken during pregnancy, the safety of most medications taken by pregnant women has been difficult to determine. Women who are pregnant or trying to get pregnant should not discount dietary and herbal products as they could be harmful to your unborn baby or have other serious side effects when taken during pregnancy.
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Topamax (generic topiramate) is an anti-seizure medication that is also used to prevent migraine headaches. Off-label, Topamax is prescribed to treat mood instability, weight loss, Parkinson’s, stroke, and psychiatric disorders. Off-label means when a prescription medicine is used to treat a disease or condition for which the drug has not been approved by the FDA. While the FDA regulates how a medication can be advertised or promoted by the manufacturer, these regulations do not restrict a doctor’s ability to prescribe the medication for different conditions, in different doses, or for different lengths of time.
Topamax when taken during the first trimester of pregnancy may cause birth defects such as oral clefts.
Some women taking Topamax for seizures and preventing migraine headaches also tout that they have lost weight while on the drug. Weight loss is a side effect of Topamax. Some people are thrilled and others concerned. What is concerning is that taking Topamax while pregnant (when women don’t even know they’re pregnant yet) has devastating side effects on the unborn fetus.
Why would any doctor prescribe Topamax for weight loss?
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Topamax (generic topiramate) is an anti-seizure medication that is also used to prevent migraine headaches. Off-label, Topamax is prescribed to treat mood instability, weight loss, Parkinson’s, stroke, and psychiatric disorders. Off-label means when a prescription medicine is used to treat a disease or condition for which the drug has not been approved by the FDA. While the FDA regulates how a medication can be advertised or promoted by the manufacturer, these regulations do not restrict a doctor’s ability to prescribe the medication for different conditions, in different doses, or for different lengths of time.
Topamax when taken during the first trimester of pregnancy may cause birth defects such as oral clefts.
Some women taking Topamax for seizures and preventing migraine headaches also tout that they have lost weight while on the drug. Weight loss is a side effect of Topamax. Some people are thrilled and others concerned. What is concerning is that taking Topamax while pregnant (when women don’t even know they’re pregnant yet) has devastating side effects on the unborn fetus.
Why would any doctor prescribe Topamax for weight loss?
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There’s nothing quite like a migraine headache. The sufferer just wants to lie down in a dark place and hope the pulsing throbbing pain on one side of his or her head subsides soon. Sometimes migraines come with vomiting, nausea and sensitivity to light and sound. Sometimes auras or distracting dots and numbness alert the sufferer to the imminent headache.
Migraine headaches are debilitating to the point of not doing chores or driving a car or going to work. Migraine headaches typically last from 4 to 72 hours.
Medications used to quell migraines fall into two categories:
• Pain-relieving medications – Drugs are taken during migraine attacks and are designed to stop symptoms that have already begun.
• Preventive medications – Drugs taken regularly, often on a daily basis, to reduce the severity or frequency of migraines.
Pain relieving medications include over the counter medications like Motrin, Advil, and Tylenol. Some prescription drugs are Axert, Zomig, Relpax, Migergot, and Cafergot.
Preventive medications don’t eliminate headaches entirely, and some cause serious side effects like the anti-seizure drug Topamax. FDA approved the use of Topamax to prevent migraine headaches, but not to relieve the pain of migraines. Anti-seizure drugs may cause side effects like nausea and vomiting, diarrhea, cramps, hair loss, and dizziness.
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Put it on your calendars, Anapol Weiss attorney James Ronca will be speaking on “Topamax: What You Need to Know, The Science and the Litigation” from 10:45 am to 11:15 am at the semi-annual Mass Torts Made Perfect Seminar in Las Vegas, Nevada on October 13, 2011. The acclaimed national event for Pharmaceutical and Medical Device Mass Torts will celebrate its 10th anniversary at The Bellagio Hotel and Casino in Las Vegas.
Mr. Ronca is a vital part of Anapol Weiss Dangerous Drug and Medical Device team and is intimately involved with Topamax litigation along with partner Sol Weiss, who is co-liaison counsel to the coordinated litigation. You can register for the event online here or by calling (800) 320-2227. The cost of registration is $1,395 for lawyers and $995 for paralegals or administrators for firms; a $300 discount is obtainable for all affiliates of The National Trial Lawyers.
Mass torts can be separated from other kinds of personal injury cases by numerous key attributes. For one, they employ large amounts of claims that correspond to one product. Secondly, regardless of the large number of individuals involved, there is a similar nature to the facts and legal implications of the cases. Thirdly, there is interconnectedness between all the separate cases. Such is the case with Topamax, a drug used to treat epileptic seizures and other disorders that has also been linked to causing birth defects. If you’ve been injured by Topamax or another dangerous drug, call 1-866-735-2792 to contact the Pennsylvania dangerous drug attorneys at Anapol Weiss today.
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