off-label

J & J faces thousands of Risperdal lawsuits

More than 5,000 lawsuits have been filed against Johnson & Johnson for failure to warn doctors and consumers that Risperdal can cause boys to grow large breasts, a condition known as gynecomastia. Risperdal Litigation At least 1,500 Risperdal cases have been consolidated in Pennsylvania on behalf of individuals who allege the drug caused excessive male breast...

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Dangers of Off-Label Drug Use

We recently reported on the possible dangers of the anti-nausea drug Zofran® and equivalent generics when they are used off-label. But what does “off label” really mean? What is Off-Label Use of Medications? As we explained in an earlier post, “When a drug is used in a way that is different from that described...

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Zofran Lawsuits

Zofran® and its generic equivalents have been linked to birth defects and other problems when the medication is taken during pregnancy.  The manufacturer, GlaxoSmithKline, promoted the off-label use of the drug as a remedy for morning sickness in addition to its approved use as a drug for controlling nausea and vomiting after chemotherapy and...

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Zofran Linked to Birth Defects

The anti-nausea drug Zofran® has often been prescribed off-label to pregnant women suffering from serious morning sickness.  However, the evidence is growing that taking this drug may cause women to give birth to babies with a variety of birth defects. Zofran was approved in 1991 by the Food and Drug Administration (FDA) for treating...

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Side Effects of Anti-Nausea Drug Zofran

The drug Zofran® , also known as Ondansetron, is approved by the Food and Drug Administration to treat nausea and vomiting resulting from chemotherapy treatment for cancer and after being administered anesthetic during surgery. The medication works by blocking serotonin, a natural substance in the human body, which can cause vomiting, It is manufactured by...

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Whistleblowers Receive $168 Million

In one of the largest payouts in history, people from three states will be taking home a share of the $167.7 million awarded to whistleblowers for exposing Johnson & Johnson’s use of improper marketing and kickbacks. $2 Billion Settlement In a press conference yesterday, Attorney General Eric Holder told reporters that Johnson & Johnson...

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What is off-label drug use?

In the United States before a drug is approved by the Food and Drug Administration (FDA), it must undergo extensive testing. These tests, known as clinical trials, are used to determine if a drug safely works the way it is expected, to treat a specific medical condition. Once the FDA is satisfied that the...

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