Posts Tagged ‘ Cleft Palate ’

Infographic: Depakote Birth Defects, Off-Label Marketing by the Numbers

March 1st, 2013. By AbiK

Recently, a small British study that was published in the Journal of Neurology, Neurosurgery & Psychiatry (1/30/13), suggested women who take valproate while pregnant have an increased risk of having children with autism and neurodevelopment problems. The study also suggested that damage to the fetus happens during the early stages of pregnancy.

Valproate-based anti-convulsants (drugs used to treat seizure disorders including epilepsy) include brand-name drugs Depakote, Depakene, Depacon and Stavzor–all of which are pregnancy risk Category D drugs. Category D drugs have shown positive evidence of fetal risk based on adverse reaction data from investigation or marketing experience or clinical studies in humans.

The Depakote infographic below highlights some of the potential adverse effects in newborns that have been associated with taking Depakote during the first trimester of pregnancy.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Tags: birth defects, Cleft Palate, Depacon, Depakene, depakote, Depakote lawsuit, depakote legal help, heart defects, spina bifida, Stavzor, valproate
Posted in Drugs/Medical, Emerging Issues | No Comments »

Topamax Weight Loss a Risky Diet

June 30th, 2011. By AbiK

It’s not news that Topamax is prescribed for a number of conditions—migraine is one. And, given that migraines typically affect women more frequently than men, a Topamax prescription should raise a questioning eyebrow in women of child-bearing age. After all, Topamax has been linked to birth defects—oral defects such as cleft lip and cleft palate. So much so that the FDA recently switched the Topamax pregnancy category from a Pregnancy Category C to a Pregnancy Category D drug.

The beauty of pregnancy migraines, however, is that for many women, they cease to exist or at least diminish in their frequency or severity. And, ideally, a woman who has been given a Topamax migraine prescription then stops taking the drug as there is no apparent need for it. Unfortunately, as any migraine sufferer will tell you, it’s not that simple. If you get migraines, you know that the pain and nausea is enough to make you wish for a fate not less than death at times—just for the anticipated peaceful relief. So would a woman who wants nothing less than to avoid a migraine willingly stop taking Topamax on the mere hope that her migraines have subsided due to temporary hormonal changes from pregnancy? It’s questionable.

And, keep in mind, unlike some migraine medications, Topamax is taken daily to prevent the headache—it’s not taken ad hoc once a migraine starts to relieve pain. Once you’re on it, you’re on it.

Migraines aside, one condition that most all women have a hard time with during pregnancy is weight gain. There is no way around it. And chances are, if you’ve been pregnant yourself, you Read the rest of this entry »

Tags: Cleft Lip, Cleft Palate, Topamax, Topamax Birth Defects, Topamax Diet, Topamax Migraine, Topamax Side Effects, Topamax Weight Loss, topamax-birth-defects-topiramate-lawsuit
Posted in Drugs/Medical, Emerging Issues, Personal Injury | 10 Comments »

Topamax and Cleft Palate: Now the Insurance Battle

March 21st, 2011. By AbiK

Hooding Eyelids? Cosmetic elective surgery. Frown lines and laugh lines? Cosmetic elective surgery. Cleft Palate? Cosmetic elective surgery.

Wait—what was that last one?

That’s the incredulous moment a number of parents experience after submitting insurance claims for their child’s cleft palate surgery. They find themselves hearing that their insurance company deems the surgery as either “cosmetic” or “dental”. Translation: You’re on your own. And it doesn’t help to see those ads all over of children with cleft palates in foreign lands for whom there are constant requests for charitable relief. Not that those children don’t deserve assistance—they do—but it leaves folks closer to home questioning whatever happened to that phrase, “charity begins at home”?

Well, insurance companies aren’t in the charity business.

For parents of a child who’s been born with a cleft palate or cleft lip due to Topamax side effects—ie, a birth defect directly related to the mother having taken Topamax during the first trimester, navigating the world of insurance claims and denials is an unexpected battle. But there are some things you can do. Here, some tips from Cleftline.org, the website of the Cleft Palate Foundation:

1. If your insurance company denies your child’s cleft palate surgery claim, make sure you review your insurance plan—some policies have a clause for genetic birth defects that requires coverage for any medical treatment that is necessary because of a birth defect.

2. Try to talk with a case manager—not the customer service person who’s just following the insurance company script. The case manager typically has a medical background and may be better informed and versed in understanding your situation.

3. If your insurance provider deems cleft palate surgery as cosmetic, you can submit an appeal but you should have your doctor write a letter on your behalf to state the medical reasons why the surgery is necessary. A reviewer with the insurance company may not understand that their are benefits to having cleft palate surgery beyond boosting self-esteem. The Cleft Palate Foundation also suggests submitting pictures as well.

4. If your insurance provider says the cleft palate surgery is dental, not medical, try to have a plastic surgeon review your claim. Additionally, have your surgeon and primary physician write letters of support to be submitted to the insurance company. In the letters, ensure that the medical reason for the cleft palate surgery is stated, and that it is necessary, not some elective procedure.

5. If your child also has speech difficulties associated with the cleft palate, ensure that you document with the insurance company—and your doctor can state this in his letter also—knows that the condition is a direct result of the initial birth defect—not the result of an interim surgery or other condition. Otherwise the insurer may consider the speech problem as a secondary condition.

6. If your insurance company considers the cleft palate as a pre-existing condition, understand that many times—and particularly in this economy when many are still going without health insurance to get by—that insurance companies often receive claims from individuals who only sign up for benefits right before they know they will need to file a claim. The Cleft Palate Foundation suggests that you do not let your benefits lapse because you then may become at risk for this type of claim denial.

For more information and for further cleft palate resources, visit the Cleft Palate Foundation at cleftline.org, or call at 800-24-CLEFT. For more information regarding Topamax birth defect legal help and news see our Topamax news page.

Tags: Cleft Palate, Insurance Claim Denial, Insurance Claims, Topamax, Topamax Birth Defects, topamax-birth-defects-topiramate-lawsuit
Posted in Drugs/Medical, Emerging Issues, Insurance | No Comments »