Lyrica Associated with Birth Defects

Lyrica, the brand name for pregabalin (generic), is a popular drug prescribed for pain. It has recently been linked to birth defects. Pregabalin Birth Defects include heart defects, central nervous system (CNS) defects, and structural defects in organs. A recent study indicates that pregabalin during pregnancy has a tripled increased risk of birth defects when it is used in the first trimester. Lyrica birth defects also include spina bifida, anencephaly and more. Other than birth defects, there are many common and severe lyrica side effects, from tiredness to chest pain to suicidal thoughts.

Lyrica, which belongs to a class of medications called anticonvulsants, works by decreasing the number of pain signals set out by damaged nerves in the body. Often prescribed to diabetes patients, pregabalin helps relieve pain from damaged nerves that occurs in hands, arms, fingers, legs, toes or feet. It is also prescribed to help treat fibromyalgia symptoms (pain, muscle fatigue, tenderness and stiffness) and ease the pain of shingles. Combined with other medications it is used to treat some kinds of seizures in people with epilepsy. And the anti-epileptic medication has been prescribed for off-label uses, such as generalized anxiety disorder.

Data collected by the Swiss Teratogen Information Service, a facility that collects reports of potential harmful effects of drugs, found that women who took pregabalin (Lyrica), during pregnancy had a higher risk of having babies with birth defects, and three times as high if taken during the first trimester.

A study published in the journal Neurology (May 2016) found similar results. It links Lyrica to a tripled increased risk of major birth defects compared to women who did not use Lyrica. The study involved 164 pregnant women. Approximately 80 percent were on Lyrica before they got pregnant, and most women stopped taking it six weeks into their pregnancy. (The study' senior author, Dr. Thierry Buclin, noted that 77 percent of the women were taking pregabalin before they learned they were pregnant.)

Results were compared to 656 women who did not use Lyrica: 6 percent of babies exposed to Lyrica had a major birth defect compared to 2 percent of babies who were not exposed to pregabalin. The risk of central nervous system defects was 6 times higher in the Lyrica group compare to those not exposed.

The study showed an increased risk of major birth defects after first trimester exposure to pregabalin. While researchers noted that several factors, such as the small sample size, calls for more studies, they advise all women of childbearing age should take birth control while using Lyrica. They also recommend extra fetal monitoring in pregnant women who have already used Lyrica. Other experts say that pregnant women should avoid using Lyrica if possible. ""We checked and rechecked all of the outcomes","Dr Buclin told Time online (May 18, 2016). ""We were a bit surprised by the positive finding of higher birth defects. It''s definitely concerning.""

Before the above studies were published, evidence from animal studies showed a higher rate of skeletal and neural tube defects among those exposed to pregabalin, which raised concern about the risk for pregnant women.

To date, a lawsuit has not been filed linking Lyrica to birth defects, but attorneys are investigating complaints nationwide.

Pfizer, the Lyrica manufacturer, in 2009 agreed to pay $2.3 billion to the Department of Justice for illegally promoting sales of a Lyrica dosage, according to BBC News. Pfizer was allegedly urging doctors to prescribe Lyrica for "off-label" use. And the giant drug company "paid bribes and offered lavish hospitality to healthcare providers to encourage them to prescribe [Lyrica]".

That same year, Pfizer asked pregnant women on Lyrica to enroll in a study to investigate the risk of birth defects, but they didn't warn pregnant women about any Lyrica side effects. Lyrica is a "Pregnancy Category C"drug, which means it has shown evidence of causing birth defects in animal studies but the risk in humans is unknown.

Lyrica is one of Pfizer' top-selling drugs, generating $5.1 billion in sales in 2014.

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Last updated on Jun-15-16