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The Class Actions team at Siskinds LLP recently commenced a new case against the pharmaceutical manufacturers of Zofran. The class action claim alleges that the drug manufacturers failed to warn that off-label use of Zofran is unsafe for pregnant women.

Zofran is a powerful anti-nausea medication approved by Health Canada to treat nausea and vomiting in postoperative and chemotherapy patients. Zofran is available orally or by injection. A generic equivalent is also available called Ondansetron. Zofran was never approved for treating pregnant women, yet Canadian women with severe morning sickness continue to be prescribed Zofran or Ondansetron.

Off-label drug use is inherently risky since the pharmaceutical product has not been proven safe or effective through Health Canada’s regulatory process. When a prescription drug is approved by Health Canada, it is approved for a particular purpose(s).[1] For example, Zofran was approved for treating patients with nausea and vomiting after surgery or during cancer treatment. Health Canada’s approval also stipulates the population for whom the drug can be prescribed.[2] Sub-groups of the population that are often omitted from the approval process are children, the elderly, and pregnant or nursing women, because these populations are frequently excluded from clinical trials. Zofran is not approved for use in pregnant women; medications that are approved for treating pregnant and nursing women are subject to further clinical investigation to demonstrate the product’s safety and effectiveness. When a drug is prescribed for an unapproved purpose or to a member of an excluded population, this is referred to as an “off-label” use.

For a drug manufacturer to obtain approval for an additional indication or population, the manufacturer must file a supplemental new drug submission (SNDS).[3] The SNDS will be assessed for safety and effectiveness similar to a new drug submission. “As a result, completion and approval of an SNDS for a new indication may be a long and expensive process for drug manufacturers, and they have little or no incentive to incur these costs if there will be no increase in sales.”[4]

Despite the risks, off-label drug use is a common practice. It is estimated that one in nine prescriptions in Canada are for off-label uses, most of which are not supported by strong scientific evidence.[5] Health Canada and the Standing Senate Committee on Social Affairs, Science and Technology, have identified this practice as an area of concern.[6] There appears to be a regulatory gap as Health Canada has the authority to approve drugs for specific uses and ensure continued compliance with the regulatory regime, it does not have jurisdiction over physicians’ prescribing practices.[7]

Physicians may lawfully prescribe a drug for other than its authorized use as set out on the label.[8] Medical practitioners are free to endorse or recommend off-label uses for medications and often do.[9] However, prescribing a drug for purpose that is contraindicated on the label, without a patient’s informed consent, constitutes medical malpractice.[10] It is clear that physicians are reliant on the warnings published on drug labels when prescribing for off-label uses.

Physicians learn about off-label drug uses through various means, such as their own experience, medical-research in peer-reviewed journals, presentations, and newsletters.[11] However, drug manufacturers are prohibited under the Food and Drug Regulations from promoting off-label drug uses, and may be found civilly liable for wrongfully and falsely promoting a drug for an off-label use in Canada.[12]

The Zofran class action is an example of the dangers and consequences of off-label drug use. Siskinds has learned that off-label use of Zofran carries a risk of birth defects when the medication is used during the first trimester of pregnancy. Studies have demonstrated an association between Zofran use in the first trimester of pregnancy and birth defects, including: heart defects, septal defects, cleft lip, cleft palate, kidney defects, and musculoskeletal defects.[13]

The claim alleges that the Defendant drug manufactures misrepresented to physicians and pregnant women that Zofran is a safe and effective treatment for nausea and vomiting during pregnancy and specifically marketed and promoted Zofran as a morning sickness drug. When in fact, the drug was never approved for this off-label use, and Zofran has never been studied in pregnant women, much less shown to be safe and effective to ingest during pregnancy.

In the United States, the Defendant drug manufactures’ promotion of Zofran for use during pregnancy eventually led to a federal investigation. In 2012, the Defendants entered into a civil settlement with the US Department of Justice regarding its off-label promotion of Zofran.[14]

Through the Zofran class Action, Siskinds seeks to squarely address the dangers of off-label drug promotion. Siskinds seeks to recover compensation for persons in Canada who experienced birth defects as a result of their mothers being prescribed Zofran.

If you were prescribed Zofran during the first trimester of pregnancy to treat morning sickness, and your child suffered birth defects, we encourage you to join Siskinds LLP’s Zofran class action. Visit www.classaction.ca/zofran, email [email protected] or call 1-800-461-6166.

[1] Off-Label Use, Prescription Pharmaceuticals in Canada, Standing Senate Committee on Social Affairs, Science and Technology, (Ottawa: 2013) at 3 [Off-Label Use].

[2] Ibid.

[3] Food and Drug Regulations, CRC, c 870, s C.08.003, made under Food and Drugs Act, RSC 1985, c F-27.

[4] Natalie de Paulsen, “The Regulatory Gap: Off-Label Drug Use in Canada” (2005) 63 UT Fac L Rev 183-211 at para 14 [Off-Label Drug Use in Canada].

[5] Supra, Off-Label Use at 6.

[6] Ibid.

[7] Ibid at 3.

[8] Goodridge v Pfizer, 2010 ONSC 1095, [2010] OJ No 655 at para 14 [Goodridge].

[9] Ibid.

[10] Fowlow v Southlake Regional Health Centre, 2012 ONSC 6531, [2012] OJ No 5436.

[11] Supra, Off-Label Drug Use in Canadaat para 5.

[12]Supra, Goodridge paras 11, 15.

[13] Anderson et al, “Ondansetron Use in Early Pregnancy and the Risk of Congenital Malformations— A Register Based Nationwide Control Study” (2014); Danielsson, Wikner, & Kallen, “Ondansetron During Pregnancy and Congenital Malformations in the Infant” (2014) Reproductive Toxicology 50 134-137; Anderka et al, “Medications Used to Treat Nausea and Vomiting of Pregnancy and the Risk of Selected Birth Defects” (2012) Birth Defects Res A Clin Mol Teratol, 2012 January 94(1).

[14] U.S. Department of Justice, “Settlement Agreement” available online

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