Lawsuits filed over drug side effects

A Philadelphia law firm today said it filed 10 lawsuits on behalf of boys and young men who developed serious side effects - including the growth of breasts - while taking the antipsychotic medications Risperdal and Invega.

The suits were filed in Philadelphia Court of Common Pleas. Lawyer Stephen Sheller said he expected to file an additional 20 to 30 similar cases in Philadelphia in the next two months. His firm also has 10 cases involving boys who took Risperdal and another medication pending in New Jersey.

The drugs in the Philadelphia cases are made by Janssen, a division of Ortho-McNeil-Janssen Pharmaceuticals Inc., which is part of Johnson & Johnson. All of the companies, which are named in the suits, are based in New Jersey, but Ortho-McNeil-Janssen is incorporated in Pennsylvania, Sheller said.

Only one of the plaintiffs, a young man who took Risperdal in his teens, is from Philadelphia. He could not be reached for comment. The suit says he experienced rapid weight gain and developed breasts that will require surgical removal. The side effects caused him to suffer "mental anguish" and "embarrassment," the suit said.

Sheller said some of his already-troubled clients grew significant bosoms, a fact their doctors may not have taken seriously enough because of the weight gain. "I would say 38D, some of them," Sheller said. "No boy wants to have a B cup, certainly not a D."

Janssen declined to comment. "We have not received details of the cases and are therefore unable to comment at this time," spokeswoman Kara Russell said.

The suits also named Excerpta Medica Inc., of Bridgewater, N.J., and its parent, Elsevier Science Publishing Co. Inc., of New York. Sheller said the companies were involved in publishing ghostwritten studies they should have known were misleading or exaggerated. An Elsevier spokesman said the company had not had time to evaluate the suits.

READ MORE @ PHILADELPHIA INQUIRER

FDA Okays First Monthly Antipsychotic Drug

The FDA has approved the injectable maintenance drug paliperidone palmitate (Invega Sustenna), making it the first once-monthly, atypical antipsychotic for schizophrenia.

The long-acting drug is approved for both acute and maintenance treatment.

The parent drug -- paliperidone in a once-daily tablet -- is an active metabolite of an old pharmaceutical, the atypical antipsychotic risperidone (Risperdal). (See Invega (paliperidone), Son of Risperdal (risperidone), Wins FDA Okay for Schizophrenia)

Researchers see once-monthly dosing as a potential solution for the medication adherence problems common in schizophrenia, noted Henry A. Nasrallah, MD, of the University of Cincinnati, an investigator in the paliperidone palmitate clinical trials.

"Inconsistent compliance with medications is arguably one of the single greatest impediments to managing the symptoms of schizophrenia and delaying the time to relapse," he said in a prepared statement.

READ MORE @ MEDPAGE TODAY

JNJ's Janssen closer to new Invega OK

Diversified health-care products maker Johnson & Johnson on Friday said its Janssen-Cilag unit's schizophrenia drug candidate Invega received a positive recommendation from European regulators.

The Committee for Human Medicinal Products in the European Union gave the drug a positive recommendation for approval. The drug will likely be approved in the European Union based on the positive recommendation. Also Friday, the U.S. Food and Drug Administration approved the drug as a long-term treatment for schizophrenia. It had already been approved as a short-term treatment.

READ MORE @ Hemscott.com

Johnson n Johnson schizophrenia drug gets wider US approval

Johnson & Johnson said on Friday that U.S. health regulators have broadened the approval for its Invega antipsychotic drug as a long-term maintenance treatment for schizophrenia.

The drug, a longer-acting version of J&J’s Risperdal, was approved in December to treat acute, or short-term, schizophrenia.

READ MORE @ at Reuters