Subutex and Pregnancy

Unfortunately addiction doesn't take a break and that includes when you become pregnant. Either planned or unplanned, you now have another life to consider in your decisions and this is often the main motivation behind why many patients finally decide to seek treatment and get help. And study after study has shown that babies born to mothers in treatment for their opioid use disorder fare much better than those not treated at all. This is particularly important in today's environment given the current opioid epidemic ravaging our nation and the increasing prevalence of opiate use in the pregnant population.

Background

Before Buprenorphine came along, Methadone was the only form of treatment available to pregnant women and still plays a major role even in today's society. However, with the advent of Buprenorphine in 2002 pregnant women now had another option to treat their opiate addiction that was potentially a better alternative. Similar to Methadone, Subutex is classified as pregnancy category C by the FDA which means that in general these drugs are usually alright to take during pregnancy but not enough research has been done to determine if they are completely safe. Regarding their efficacy, several studies have been performed to try to determine which drug is superior and most have concluded that in general they are both good options and one drug may work better than the other for certain people. One such study known as the Maternal Opioid Treatment: Human Experimental Research (MOTHER) study showed that babies experiencing neonatal abstinence syndrome (NAS) born to mothers taking Buprenorphine had a slightly decreased length of hospital stay (4.1 days vs. 9.9 days) and also required much less morphine (mean total doses of 1.1 mg and 10.4 mg) compared to Methadone. However, other outcomes such as birth weight and length and which babies developed NAS were similar so further research is needed.

Is Suboxone Safe In Pregnancy?

As you recall from a prior article, the main difference between Subutex and Suboxone is that Subutex doesn't contain any Naloxone which is only used to deter abuse. It has generally been recommended to switch someone from Suboxone to Subutex when they become pregnant to limit the amount of drugs that a fetus is exposed to. However, when Suboxone is taken properly under the tongue the amount of Naloxone absorbed into your body is minimal and therefore the amount that the fetus is exposed to is also minimal. In addition, Naloxone is also pregnancy category C so has not been shown to be teratogenic but is still best avoided if possible. I currently treat several pregnant patients and have noticed that the ability to find a pharmacy that carries Subutex is becoming harder and harder to find. Patients have even been told by the pharmacy that the manufacturers have discontinued making Subutex so they are no longer going to have it on stock. To my knowledge this is not true and there seems to be some confusion regarding this matter. Reckitt Benckiser Pharmaceuticals, the makers of the Suboxone film, at one point made a Suboxone tablet but this was discontinued in 2012 due to increased accidental pediatric exposures. Since Subutex only comes in tablet form, the company also quit marketing Subutex around that time so the FDA moved the drug to the “Discontinued Drug Product List” in their "Orange Book" which is their list of all “Approved Drug Products with Therapeutic Equivalence Evaluations.” This obviously caused confusion so an inquiry was made to the FDA to clarify whether Subutex was in fact discontinued and their response was that Subutex was NOT withdrawn for reasons of safety or effectiveness. However, due to supply issues and sometimes cost issues Subutex may not always be the best choice for pregnant patients. Other patients may simply wish to remain on Suboxone (film or generic tablet) out of fear of changing their normal routine. Despite the reason, concern remains about any possible increased risk that comes with Naloxone exposure. Luckily, a recent retrospective study showed that Buprenorphine-naloxone appears to be safe for use in pregnancy and suggests that switching from Suboxone to Subutex may not be necessary. Of course you should always consult your provider and weight the pros and cons of all of your options before reaching a final decision.