AdverseEvents, Inc. a company that analyzes the FDA’s adverse drug event database says that 10 of the most popular epilepsy drugs in the United States have been found to have a large numbers of birth defect-related adverse events.

Carbatrol/Tegretol, Depacon/Kene/Kote, Dilantin, Keppra (and IR, Klonopin, Lamictal, Neurontin, Topomax, Trileptal, and Zonegran were found to have more than 25 individual birth defect case reports.

AdverseEvents is recommending that the drugs be re-classified to D class from C class, associating them with “positive evidence of human fetal risk”. Class D drugs are generally not prescribed to pregnant women unless there is no less risky alternative.

It is especially significant that the FDA re-classify these drugs because most epileptic women do not have the option of not taking their medication while pregnant. Are you on epilepsy and considering getting pregnant? What do you think of these findings? Please let us know by commenting below.

If you think your child’s birth injury was due to medical negligence and would like to speak to an experienced birth trauma attorney, please fill out our form on the contact page or just give us a call at the number provided.

The numbers in the database only present women in the United States who may have died as a result of taking Yaz or Yasmin birth control pill. Many of the victims are young women with no reported medical or health problems, who suddenly developed dangerous blood cloths, pulmonary embolisms, suffered strokes or gallbladder diseases after taking the pill.

Bayer faces about 7,000 Yaz and Yasmin wrongful death lawsuits, which have been consolidated as a part of a multidistrict litigation in the U.S. District Court of the Southern District of Illinois. Several cases are pending against Bayer at the state level in New Jersey and Pennsylvania.

The Bayer birth control lawsuits were brought on by women injured by the drug, or the families of women who died as a result of taking Yaz or Yasmin, alleging that the company failed to adequately research the medications or warn about the possible side effects.

Joan Cummins of New Jersey filed a wrongful death lawsuit against Bayer Corporation alleging that its birth control Yaz caused the sudden death of her eighteen-year old daughter, Michelle Pfleger. Pfleger suddenly collapsed on her way to a college class. The autopsy report showed that the victim died from cardiac arrest triggered by a pulmonary emboli, a blood clot in the lungs that can lead to low blood pressure and sudden death. Cummins alleges that Yaz caused her daughter’s blood clot which lead to her death.

In a pooled result, the study found that any prenatal exposure to acetaminophen was associated with increased chances of asthma and wheezing in the children ages 1 ½ to 7. These findings are consistent with a 2009 meta-analysis that found an association between use of acetaminophen during pregnancy and both asthma and wheeze, as reported in the issue of Clinical and Experimental Allergy. Overall, the study found that using the painkiller during pregnancy was associated with a 21% increased risk of asthma in young children. No information was available on dosage or frequency of use.

The researchers felt that the message of the study should be that more urgent analysis is needed and to reinforce the general principle to avoid unnecessary medication during pregnancy. The scientists urge pregnant women to abstain from unnecessary use of acetaminophen but should consider it as a preferred analgesic to bring down fever.
Another Spanish study found a link between the use of acetaminophen by mothers at least once a month during the gestational period and the chance a child had wheezing by preschool age.

A pregnant woman taking Topamax during the first trimester is 20 times likely to risk their child developing an oral birth defect than a woman not taking the medication, says Reuters. The FDA warns pregnant women that they are at risk of having a baby develop the facial anomalies when exposed to dangerous drugs such as Topamax.

While Topamax has an FDA-approved seal to treat seizures and migraine headaches, it is being used off-label by doctors and health care providers for treatment of psychiatric conditions. Topamax made Johnson and Johnson $2 billion last year, thanks in part to its successful drug sales rep marketing campaign.

The FDA fined Johnson and Johnson for illegally marketing Topamax for psychiatric conditions. Despite the action, it has become a catch-all drug for a variety of pain conditions and other unapproved uses. It is used in the military and is known to cause brain-fogging, says Army Times.

In 2004, the FDA issued another warning to the drug maker, alleging its sales material downplayed the serious side effects associated with Topamax. The FDA raised concern over dangerous side effects such as acute myopia, secondary angle closure glaucoma, hyperthermia, metabolic acidosis and serious public health concerns in pediatric patients.

The settlement of the investigation includes an admission of guilt by Allergan, Inc. a criminal fine of $375 million and a $225 million civil settlement to the federal government. The civil settlement resolves the allegations that Botox has induced doctors to trick the government into paying for the use of Botox for non-sanctioned uses. The company has also agree to a 5 year corporate integrity agreement with the government to ensure through independent audits and monitoring that the company is following the federal drug marketing regulations and rules.

At this time the guilty plea by Allergan is a misdemeanor, if there are similar infractions in the future it would be considered a felony and the U.S. Department of Health and Human Services would remove all of the company’s products from the market and from all government health plans. While everyone would love to see a product that could significantly reduce the problems caused by birth injuries such as cerebral palsy the safety of the patients should be of the utmost importance. This means that all drugs should be approved by the FDA and used in the method intended.

An autopsy has determined that a blood clot in Michelle’s lung caused her death, and it has been noted that the report did not link the untimely death to her prescription medication. Because the young woman was taking Yaz to treat acne, which it has not been FDA approved for, several close friends suggested that Michelle’s mother look into other cases where women have died from taking Yaz and Yasmin. The concerned mother collected evidence that links Yaz with an increased risk of blood clots.

A woman in Switzerland recently died from the same type of lung blood clot as Michelle and her death was attributed to the birth control pills. While the pharmaceutical company that makes Yaz has issued several warnings about the possibility of side effects and death, many women are continuing to use the product, often for the treatment of acne.

At this time the number of lawsuits against the Bayer Company over Yaz and Yasmin are threatening to top more than 30,000. The first is set to begin in September of 2011. The loss of a vital young woman before she really had a chance to live, simply because she wanted to clear her acne blemishes is a shame. The distraught mother will not rest until some sort of justice has been served.

Is it the fault of the drugs, the doctors prescribing the drugs or the patients for not paying attention to the risks that the drugs present before taking them?

André Sommer from Pfronten, Bavaria, is suing Bayer for the defects he suffered after his mother took the drug while pregnant with him in 1975. He was born with severe problems with his bladder and sexual organs.

His case will be heard soon by the Berlin District Court, and will include the documents which have recently come to light in which doctors wrote to each other about problems they had observed.

“The seeming relation between the increase in birth defects and the sale of the pregnancy test is pretty alarming,” one scientist wrote on November 1967.

“We have to be extremely careful,” when using the drug with pregnant women, another wrote.

Sommer, a teacher, says he is determined to force Bayer to open its files on the matter.

“Why were these gentlemen talking with each other about this internally, but were silent in public?” he asked.

A Bayer lawyer wrote to the court saying that all claims for information and compensation had run out of time – and that there was never any proof of a link between the use of Duogynon and birth defects.

Sources: Der Spiegel, The Local

Cappolino Dodd Krebs is currently investigating cases of fraternal twins diagnosed with autism who’s mother was treated with terbutaline during pregnancy. If you or someone you love has autistic fraternal twins, please contact us for professional insight.

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The study found that women who take Prozac during pregnancy are more than four times as likely to give birth to a child with heart defects; for Paxil, the incidence of birth defects was more than three times as likely.

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The risk of fetal heart defects is raised again if the mother also smoked while taking the antidepressants. The highest risk group was women taking Prozac while smoking more than ten cigarettes a day, yielding 5.4 times as many children with heart problems.

Researchers recommend that pregnant smokers who are on one of these two drugs stop smoking. They also urge that patients talk to their doctor before deciding to cease medication.

The  birth trauma attorneys at Cappolino Dodd Krebs LLP care about public health. If you or someone you know has experienced birth trauma at the hands of negligent doctors or hospital staff, call today.

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