Consumer Alert: Zofran Linked to Congenital Birth Defects

Consumer Alert: Zofran Linked to Congenital Birth Defects

Posted By Maher Law Firm || 22-Jul-2016

More than 200 lawsuits have been filed across the U.S. against the maker of the pharmaceutical Zofran, the generic version of which is widely prescribed off-label for the purpose of alleviating morning sickness in pregnant women. The generic “ondansetron” has been linked with serious birth defects, including heart and kidney malformation, cleft palate, and neural tube defects.

With the number of lawsuits against GlaxoSmithKline LLC continuing to grow, the U.S. Judicial Panel on Multidistrict Litigation is consolidating all cases in a product liability litigation MDL number 2657 in the District of Massachusetts. GlaxoSmithKline LLC urged the court to require all plaintiffs to designate whether they used the branded or generic form of the drug. There are currently 30 generic ondansetron medications available on the market.

Zofran originally received FDA approval in 1991 to treat post-operative nausea and to alleviate severe nausea in patients undergoing chemotherapy. It has never been tested for safety in pregnant women, and thus has never been approved for treating morning sickness. Nevertheless, many doctors continue to prescribe the medication for this off-label purpose.

The Maher Law Firm advises you to always initiate a conversation with your doctor about prescription drugs before agreeing to take them. According to Peter J. Hughes, Pharm. D., as many as one in five prescriptions are for off-label use, which means that many people are taking medicines for reasons not associated with the original intended use of the product and exposing themselves to potential dangers.

You should ask your doctor the following questions during your visit:

  • Why am I receiving this prescription?
  • Is this medication being prescribed for an off-label purpose?
  • If this is an off-label prescription, what kind of evidence exists in support of your decision to prescribe it to me?

GlaxoSmithKline LLC, the maker of Zofran, has faced allegations in the past of paying kickbacks to doctors who prescribed the drug. They are now being accused of illegally and aggressively marketing the drug for purposes other than its original intended use, and withholding vital safety information from consumers in connection with use in pregnant women. The drug is still marketed with inadequate warning labels, and sadly, legal recourse is becoming less available to injured consumers.

If your child was born with a birth defect after you took Zofran or any of its generic versions, you should immediately contact a national Zofran lawyer at The Maher Law Firm. We are prepared to review your potential case and advise you on your best course of action. Recommended by satisfied clients for more than 40 years, we have recovered billions of dollars on behalf of the injured, including those who have been harmed by dangerous drugs.

To schedule your complimentary case evaluation with a member of our team, please call (855) 338-0720.

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