GlaxoSmithKline, a British multinational pharmaceutical company, markets and distributes more than one-hundred and eighty-three medications throughout the United States. Located in Brentford, London, GlaxoSmithKline is considered one of the top pharmaceutical companies after Johnson & Johnson, Novartis, Hoffmann-La Roche, Pfizer, and Sanofi.
GlaxoSmithKline, which was created in 2000 after a merger of Glaxo Wellcome and SmithKline Beecham, has established itself as a top pharmaceutical company. They have created dozens of medications to fight a wide variety of conditions and diseases including cancer, infections, diabetes, digestive disorders, mental health conditions, and asthma. Some of their most popular drugs include Advodart, Augmentin, Lovaza, Lamictal, and Flovent.
Recently GlaxoSmithKline has fought several legal battles, including a 2012 case where they agreed to pay an estimated $3 billion dollars in fines and penalties to resolve criminal and civil charges. The criminal charges alleged that they promoted two of their most popular products, Wellbutrin and Paxil, for uses that were not approved by the FDA. Additionally, they paid billions of dollars to settle civil claims that they promoted Avandia without detailing specific safety concerns to consumers, they paid kickbacks to distributors for the unauthorized promotion and distribution for certain products, and they falsely reported pricing information to Medicaid.
GlaxoSmithKline, one of the world’s largest drug manufacturers, introduced Zofran to the United States market in 1991. Although Zofran had been approved for the elimination of nausea symptoms for cancer patients receiving chemotherapy treatment, it had not been approved as an anti-nausea drug for women during pregnancy. Unfortunately, the marketing of Zofran for pregnant women did occur without adequate notification to patients about the potential risks to the unborn. Although warnings were not issued by the company, earlier testing had suggested that there could be a link between the use of Zofran and birth-defects. For instance, there had been some evidence that several women had children who had birth defects after their mothers took Zofran for severe morning sickness during the first trimester of their pregnancy.
In recent lawsuits against GlaxoSmithKline claimants have alleged that GlaxoSmithKline should have known about the potential risks of marketing their medication for the off-label use by pregnant women. Instead of issuing adequate warnings about their products, however, they actively promoted Zofran to pregnant women. In 1999, the FDA was notified about the GlaxoSmithKline’s promotion of the product for pregnant women and issued a communication which ordered the company to “cease distribution of this and other similar promotional materials for Zofran that contain the same or similar claims without balancing risk information.”
GlaxoSmithKline was formed in 2000 with the merger of Glaxo Wellcome and SmithKline Beecham. The genesis of Wellcome can be traced to 1880, however, when Burroughs Wellcome & Company was created by two pharmacists, Henry Wellcome and Silas Burroughs. Prior to the merger of Glaxo Wellcome, Glaxo was founded in New Zealand in the early 1900s and produced baby food. The two companies merged in 1995 forming Glaxo Wellcome, and by 1999 the company had become the world’s third largest pharmaceutical company marketing and manufacturing some of the world’s most popular medications including Zovirax for coldsores, Retrovir for the treatment of AIDS, and Imigran for the treatment of migraine headaches. Prior to the merger with SmithKline Beecham, Glaxo Wellcome employed close to 60,000 employees throughout the world and had close to 80 operating companies. By 2000 the company had completed their merger with SmithKline Beecham to become GlaxoSmithKline.
In 2012 GlaxoSmithKline settled the largest pharmaceutical settlement with the United States to date. GlaxoSmithKline paid an estimated $3 billion in civil and criminal penalties for promoting the sale of Zofran for conditions which had not been approved by the FDA, for making false representations about the “safety and efficacy of Zofran concerning the use of Zofran to combat hyperemesis and pregnancy-related nausea,” and for offering kickbacks to healthcare professionals to promote Zofran for this use. Given that over 70% of pregnant women experience minor to severe nausea during pregnancy it was very profitable for GlaxoSmithKline to promote Zofran for this use. In fact, reports indicate that the off marketing and selling of Zofran to pregnant women, along with its other uses, made Zofran the fifth most prescribed medication throughout the United States in the early to mid 2000s. In fact, it is estimated that over 1,000,000 women may have taken this medication for severe morning sickness with little to no information about the potential risks to their unborn child.
Although Zofran can be effective at treating a wide variety of health conditions, the FDA has warned that it also can have negative side-effects. In November of 2013 the FDA issued an updated warning about Ondansetran, better known by its brand name, Zofran. The FDA reports that recent studies indicate Zofran may not be safely used by pregnant women and may cause congenital cardiac malformations and oral clefts in the unborn, especially in early pregnancy. The FDA also warns that women who are severely dehydrated or who suffer from an electrolyte imbalance may experience a condition called Serotonin Syndrome, which can include confusion, instability, and other cognitive issues. Pregnant women should not take Zofran for nausea but should instead talk to their doctors about other options such as Diclegis which is currently the only Pregnancy Category A medication with FDA approval.