The FDA has told the makers of Ritalin, Adderall and other drugs for attention deficit hyperactivity disorder to produce brochures warning patients of risks of psychiatric harm and heart damage.
The medication guides, to be handed out by pharmacists, would alert patients to side effects, the FDA said today in a statement. People being treated for ADHD ``should read the information before taking the medication and talk to their doctors if they have any questions or concerns,'' the FDA said.
The decision was an effort to resolve debate among doctors, parents of children who use the drugs, and the FDA's own advisers about medicines regularly given to children with trouble concentrating in school. Opponents had said stronger warnings might discourage use of effective treatments.
``There's no excuse for this not happening six months ago or more,'' Sidney Wolfe, health research director of Public Citizen, a Washington-based consumer group, said in a telephone interview. ``No one is saying, `Stop taking these drugs.' But you should be aware that if these psychiatric or cardiovascular problems come up, they may be related to the drug.''
The pamphlets would be required for medicines including Shire's Adderall pills and Daytrana patch, Eli Lilly & Co.'s Strattera, Novartis AG's Ritalin and Focalin, and Ovation Pharmaceuticals Inc.'s Desoxyn.
More at Bloomberg
3 comments:
Perhaps we are moving in the right direction. The big pharma companies must be made to tell the truth and disclose everything about their drugs that is important to the safety of patients. Why? Fot one simple reason.
The big pharma's promotional philosophy is very simple: Tell them the good but not the bad and the ugly. If you have to tell them only that part of the bad and ugly that will not scare them away from buying your drug.
Also as far as good about your drug, expand it to any lenght including making claims still unproven and still not in their product monograph.
They would discose serious side effect only when confronted by someone who knows or forced to do so as in this case by FDA.
When their reps disclose side effects, which every drug has, they stick with the mildest ones and they always minimize their effects.
Here is an example: Elidel, a non-steroid cream for eczema. When introduced few years ago was hailed as miracle drug by the maker.Soon after few cases of skin cancer and lymphone were reported in USA and FDA was about to issue recommendation that the drug can be used only after all others have failed. At that time in Canada there were no cases reported but few doctors/specialists were aware of the US cases and started asking questions from Canadian operation drug reps.
The reps were issued strict orders by the management, not to discuss these cases, proactively. Only if the doctor asks about them they were to admit and refer the doctor to head office for info.
So because this potentially serious side effect did not appear in Canada yet, the company did not want to alarm local doctors or patients, for the sales would suffer.
At the same time, the reps were promoting it as first line therapy even in children by alarming the doctors that stroids as traditional therapy were dangerous etc. etc. even though this was not in their product monograph.
Currently the FDA has the recommendation that this drug is used "only if other drugs have failed" and this only for short term therapy. Perhaps it is same in Canada. However if anyone thinks that the company would promote it this way, well check it out. it would limit its use to few million instead to few hundred if not more.
How can they risist?
Please,
If you are in charge of a blog, report the facts. The story did not say that it caused heart problems, it said that it may cause injury or death to people with heart problems...
Also, it could effect those people that ALREADY HAVE PSYCH PROBLEMS........
SAME AS ANY OTHER DRUG!!!!!
Quote from story:
Draft versions of the guides posted on the FDA Web site include discussion of reports of increased blood pressure and heart rate in ADHD patients, as well as cases of sudden death in some who have heart problems and heart defects. In adult patients, the reported problems also include stroke and heart attack.
The alerts also cover psychiatric problems, such as hearing voices, unfounded suspicions and manic behavior, of which there is a slightly increased risk in patients who take the drugs, the FDA said. The guides also tell patients and their parents of precautions they can take to guard against the risks.
Finally someone from Novartis or thier apologist, broke the code of silence, they made a comment. Again it is a justification based on technicality. Ritalin, has been giving problems to patients from the very begining. They knew it as they knew about the most serious side effects that Elidel can cause if one is not using it absolutely right and even then can happen.
Would they promote their drugs in such a way that every aspect is covered. No, for then only those patients who REALY need it and have no alternative would use it, knowing the risk but also the possible benefits.
What's wrong with such promotion, everything according to big pharma for it leads only to level of sales that corresponds to level of real illnes to be treated with that given drug. Those sales levels would be not enough to justify all those multiple sales forces, promotional budgets, entertainment of customers, and so on. In other words, it would not be fun at all.
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