Breast Growth in Boys Taking J&J's Risperdal Was Known Since at Least 2004

(MoneyWatch)  The risk that boys taking the atypical antipsychotic Risperdal might grow breasts was known as far back as 2004. The Wall Street Journal reports that the FDA heard about this worrying side effect in a meeting on Risperdal last week:

The FDA's Tom Laughren, who runs the psychiatric medicines division, didn't see a need to strengthen warnings on the drug, despite calls to do so from some doctors at the meeting.

Johnson & Johnson's Janssen Pharmaceuticals unit is being sued by a lawyer who represents six boys who developed breasts. The news comes on the heels of revelations that J&J showered money on a conflicted Harvard doctor, Joseph Biederman to produce studies showing a need for antipsychotics in kids. Two of the six boys in the suit required mastectomies to get rid of their bosoms.

But this effect, which includes lactating breasts in some boys, was first reported in the Miami Herald and then again in the Washington Post as far back as the summer of 2004. You can see the Post item here.

The Herald item is no longer hosted in its original place on the paper's web site, but copies of the story can be seen here and here. An excerpt:

Antoinette R. Appel, a Plantation neuropsychologist, studied the records of about 50 South Florida foster children who had been prescribed Risperdal.

She said many of the children developed severe side-effects, including obesity, lethargy, lack of concentration, hormonal disorders and the inappropriate development of secondary sexual characteristics, such as lactating breasts in boys or young girls.

One boy had to got to court in order to win the right to stop taking Risperdal:

One of the clinic's most high-profile clients, identified in court papers as M.W., won a Florida Supreme Court ruling that child welfare authorities cannot lock up foster kids in psychiatric hospitals without a hearing. M.W. had developed lactating breasts after doctors forced him to take Risperdal, court records show.