20 May 2016

Seizure Drug Linked To Birth Defects, Highlighting Challenge Of Drugs During Pregnancy

Every pharmaceutical presents risks and benefits. In many cases, both positive and negative effects remain largely unknown until a drug has been released onto the market, entering the medicine cabinets and bodies of thousands, if not millions, of patients. In prescribing drugs, doctors don’t look for products that have never been linked to a side effect or adverse reaction. Drugs like that don’t really exist. Prescription is a matter, not of preventing all harm, but of determining whether or not a drug’s specific benefits outweigh its potential risks for a particular patient.

Prescriptions & Pregnancy

These decisions are no more difficult than when pregnant patients are involved. Developing fetuses aren’t surrounded by an impermeable shield in the womb. In fact, the placental barrier is highly permeable, and many chemicals can be absorbed directly by fetal tissue after being ingested by the mother.

That’s a scary thought, especially since growing bodies are particularly vulnerable to the effects of these chemicals. But since few drugs are ever tested on pregnant women prior to their release, and fewer still are actually approved for use during pregnancy, we rarely have any understanding of how the chemicals marketed by pharmaceutical companies can alter fetal development. In short, prescribing any drug to a pregnant woman is a risk.

When Disease & Treatment Are Both Risky

But pre-existing health conditions pose their own risks to fetal development. Take epilepsy, a range of neurological conditions that predispose patients to have recurrent, unpredictable seizures. Every year, 150,000 Americans are diagnosed with epilepsy, and while slightly more of these people are male, population studies have shown that around 6 out of every 1,000 women will be diagnosed with the condition. Invariably, some of these women will decide that they want to become pregnant. In doing so, they’ll be faced with a difficult decision.

Pregnant Woman With Doctor

Epilepsy is a hard condition to treat. In fact, it’s one of the only disorders for which mainstream Western health publications, like WebMD, suggest alternative treatments and dietary modifications with few reservations. While the first-line treatment for epilepsy remains a pharmaceutical drug, there are over 20 drugs on the market approved to treat seizures.

Most of these drugs aren’t particularly effective on their own. One of the primary goals in treating epilepsy, beyond reducing the amount of seizures, is getting patients down to a single antiseizure medication. Before that goal is achieved, the majority of epilepsy patients receive multiple prescriptions. Finding the right ones, and putting them in the correct combination, is a complex medical task. If a patient decides to become pregnant, that complexity is only multiplied.

Once a patient’s condition is well-controlled with pharmaceutical drugs, stopping the medication will increase the risk of experiencing a seizure, in turn creating the possibility of harm to the fetus. Having a seizure during pregnancy has been linked to a number of significant risks, from declining fetal heart rates to miscarriage. It would seem then that preventing seizures in pregnant women should be our primary medical goal, and we usually do that with drugs.

Valproate: Effective But Dangerous

But some epilepsy drugs themselves present significant risks to a developing baby. Valproate, more commonly known by its brand name Depakote, is an effective anticonvulsant used in patients who experience a range of seizure disorders. It can also drastically increase the risk of birth defects. As many as 9% of children exposed to the drug prenatally will be diagnosed with autism spectrum disorders. The incidence of autism in the general population is lower than one percent. Rates of spina bifida, atrial septal defect, cleft palate, hypospadias, polydactyly and craniosynostosis all rise among babies exposed to valproate.

It’s clear that valproate probably isn’t the right anticonvulsant for most women who choose to become pregnant. But again, valproate can be an effective antiseizure drug, and switching anticonvulsants right before a woman becomes pregnant is difficult. Making a sudden change in medication can adversely affect neurological functioning. Switching anticonvulsants during pregnancy is even more dangerous. That’s why health officials now say that doctors should include the simple fact that a patient is capable of becoming pregnant in their risk-benefit analysis before prescribing valproate.

Finding The Best Option In A Sea Of Choices

Of course, doctors treating epileptic patients aren’t forced to choose valproate. There are at least 19 other options, many of which have been shown to be just as effective. But again, we’re always learning new things about these drugs, especially where pregnancy is concerned.

Pregabalin, an antiseizure drug marketed as Lyrica in the US, was just linked to an increased risk for birth defects itself. In Sweden, researchers at the Swiss Teratogen Information Service discovered that women who took pregabalin during the first trimester of pregnancy were three times more likely to deliver children with major birth defects. These are very early results, and the study only looked at a small sample of women. Further research is certainly required, but it’s small steps, like the one taken in Sweden, that eventually lead to a mature understanding of a drug’s risks and benefits. Over time, this crucial information can help doctors and patients make better prescribing decisions, reducing the risk of negative consequences and increasing positive outcomes.

Transparency Is Critical

These are important decisions. For pregnant women, they may be the most important decisions a person will ever make. With respect to some drugs, like valproate, it may be a matter of life and death. It’s certainly a matter of quality of life. But none of these choices occur in a vacuum. Every prescribing decision is unique. After all, every patient is unique, with a personal medical history and individual genetic profile.

At bottom, accurate information is the key to making the safest decisions possible. Pharmaceutical companies, though, aren’t always as transparent as we would like them to be. In a recent victory for mothers and children, a Missouri jury found that the manufacturer of Depakote, the branded version of valproate, had concealed safety information about the drug from patients and their doctors. For the men and women on that jury, the problem wasn’t so much what researchers knew, or didn’t know, about the drug, but what a pharmaceutical company allowed patients and health care professionals to know about the drug.

Every pharmaceutical presents benefits and risks. We think it’s better when that information, all of it, is passed along to patients and physicians.

The Depakote case is Schmidt v. Abbott, CA No. 1222-CC-0247901, Missouri Circuit Court (St. Louis). The jury awarded a mother and her child, now living with spina bifida, $15 million in compensatory damages and $23 million in punitive damages. In Missouri, juries are only allowed to award punitive damages if they believe a company’s actions demonstrate a “conscious disregard” of public safety.

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