Zyprexa

“I guess my up-front message, front and center,” she continued, “is that you know that ADHD drugs can cause serious side effects and death, including sudden death, hypertension, myocardial infarction, stroke, and possibly bipolar disorder.

“This being the case,” she said, “I urge you to recommend that these drugs have an appropriate black box warning placed on the label starting immediately.”Sandra Lucas, appeared at the hearing to speak on behalf of the Citizens Commission on Human Rights, a psychiatric watchdog group, and told the panel, “we do know that the side effects of the stimulants are not only present, they are extremely serious and sometimes lethal.” “So,“ she asked the committee, “while the FDA ponders the problem of studying the issue and conducting the studies that may have inherent flaws, what real, immediate protections are to be put in place for parents and children?

”During the hearing, Drug Safety panel member, Dr Art Levin, told the committee, “I think we have to recognize that when a drug is approved and marketed the public assumes a level of comfort in the safety of that drug unless they are told otherwise.”“And, for us to sit around and talk about this,” he...

That was up from 90, or 29 percent, the year before, and 86, or 31 percent, in 2002.

The rejection rate now may be even higher.

The FDA recently toughened its procedure by requiring that possible names be checked against overseas brands because of concerns about U.S.

drugs that have names identical to some used abroad, but very different uses.To find out whether a drug works, a manufacturer runs studies, with the guidance of the FDA.

The agency then decides whether the product merits approval.

With a proposed name, the agency does its own internal tests to see whether the name is likely to be confused with that of an existing drug.

The tests involve writing the names on mock prescriptions to check how they would look in real-world conditions, conducting Web searches and using a proprietary software program that the agency has never released.The pharmaceutical companies, adept at getting their way on big Washington policy matters, admit to being stumped sometimes by the process.

The proof: a graveyard of expensive but never-used drug names.Eli Lilly & Co.

reaped a bonanza of positive brand publicity from a successful clinical trial of its experimental sepsis drug, dubbed Zovant.

But the FDA rejected the name, saying that it was too close to others used in critical care.

The other drugs were Zofran, an antinausea drug, and Zosyn, an antibioti...

Anti-psychotics are intended for use against schizophrenia and other psychotic illnesses.

Psychosis is a severe mental disorder characterized by derangement of personality, loss of contact with reality and deteriorating social function.

Attention deficit disorder is sometimes accompanied by temper outbursts and other disruptive behavior.

As a result, some doctors prescribe anti-psychotics to these children to calm them down - a strategy some doctors and parents say works.

The drugs, which typically cost several dollars per pill, are considered safer than older anti-psychotics - at least in adults - but they still can have serious side effects, including weight gain, elevated cholesterol and diabetes.

Anecdotal evidence suggests similar side effects occur in children, but large-scale studies of youngsters are needed, Cooper said.

The researchers analyzed data on youngsters age 13 on average who were involved in annual national health surveys.

The surveys involved prescriptions given during 119,752 doctor visits.

The researchers used that data to come up with national estimates.

Cooper said some of the increases might reflect repeat prescriptions given to the same child, but he said that is unlikely and noted that his findings echo results from smaller studies.

The study appears in the March-April edition of the journal Ambulatory Pediatri...