My friend who happens to be a nurse said to me last week (when I was probably giving her a lecture) “All drugs have side-effects”.
Absolutely… but not all drugs have deadly side effects which are denied by the drug regulators who licence these drugs and psychiatry Ireland who should know better and are supposedly there to help people and firstly “DO NO HARM”.
I heard on the radio last week “the pharmaceutical industry is the biggest money maker in Ireland at the present time”. So am I surprised that some pharmaceutical companies’ are getting away with murder? NO!
Wikipedia…In a trial of 2000 patients on taking sertindole, 27 patients died unexpectedly, including 13 sudden deaths.
So how can another of lundbecks drugs get a licence when the side-effects just might include…
• Thoughts or talk of death or suicide
• Thoughts or talk of self-harm or harm to others
• Any recent attempts of self-harm
• Increase in aggressive behaviour, irritability or agitation.
2009-04-03 15:56:29 GMT (Reuters)
FDA concerned with Lundbeck drug death risk.
WASHINGTON, April 3 (Reuters) – U.S. regulators remain concerned about a possible risk of sudden death with H Lundbeck A/S’s proposed schizophrenia drug Serdolect, documents released on Friday said.
Food and Drug Administration reviewers, in a memo prepared for an advisory panel, said the drug appeared effective for treating schizophrenia but also noted data suggesting Serdolect patients had a higher chance of sudden cardiac death.
Lundbeck said the drug offered a distinct advantage, reducing suicidal behaviour that outweighed any risks. The FDA will ask an advisory panel that meets Tuesday if there is enough evidence to back a claim of reduced suicidal behaviour, and whether the drug is safe and effective for schizophrenia.
“There remains … a concern about a possible risk of sudden cardiac death with this drug,” Dr. Thomas Laughren, director of the FDA’s division of psychiatry products, wrote in a March 10 memo.
Lundbeck said Serdolect, which has been sold in Europe for years, reduced the risk of suicide attempts by up to 50 percent and potential side effects could be managed.
“With this positive benefit-risk profile, (Serdolect) offers an effective treatment modality,” the company said in a summary prepared for the FDA panel.
Lundbeck shares fell 3 percent in trading in Copenhagen.
(Reporting by Lisa Richwine; Editing by Gerald E. McCormick and John Wallace)
On the internet…
My ex who worked on a psych ward said they used to call it “Certain death” because 2 patients dropped dead on it of cardiac abnormalities within 2 years in the hospital he was working in. (This was in England)
Tell your doctor or mental health professional immediately, or go to the nearest hospital, if you have any of the following suicidal thoughts or other mental/mood changes:
• thoughts or talk of death or suicide
• thoughts or talk of self-harm or harm to others
• any recent attempts of self-harm
• increase in aggressive behaviour, irritability or agitation
All mentions of suicide or violence must be taken seriously.
Serdolect is made by H. Lundbeck