Schizophrenia maker Janssen Pharmaceutica admits making misleading claims regarding Risperdal's risks
25 Jul 2004
Source: Medical News Today
Janseen Pharmaceutica Products LP has admitted that it had made misleading claims regarding its schizophrenia drug Risperdal. Risperdal does have potentially fatal safety risks.
The company has sent a letter to doctors stating that it had, in fact, minimized the risks and had made misleading claims about Risperdal in its promotional material.
Last year the FDA had told anti-psychotic drug makers to bring their product labels up-to-date. Janssen Pharmaceutica did so, but the FDA said the company’s promotional material was still misleading with regard to the risk of strokes, diabetes and other side-effects (some of which are fatal).
The FDA also stated that the company was wrong to say that its product was better and safer than drugs produced by competitors.
According to a news source in Florida (Miami Herald), a number of boys developed lactating breasts after they were put on Risperdal.
10 million people have been on Risperdal globally.
A doctor recently filed a federal lawsuit stating that many children have been damaged, some even killed, as a result of aggressive marketing of anti-psychotic drugs by pharmaceutical companies.
Carol Goodrich, a spokesperson for Johnson and Johnson (Janssen is part of J&J) said in a statement "The FDA did not think we had provided enough information, so that is why further notification was done.”
Risperdal has been on the market for eight years. The drug brings in revenues of $2.1 billion annually for Johnson and Johnson.