Tagged Articles

suicidal thoughts 42 articles

FDA questions accuracy of Pfizer’s collection of Chantix side effects

Mere days before a Food and Drug Administration (FDA) advisory committee reviews new clinical data to decide whether to recommend removing the black box warning on Pfizer’s smoking cessation drug Chantix regarding psychological side effects such as agitation, depression and suicidal thinking, the FDA is questioning whether Pfizer adequately captured the number of adverse events, biasing the research in favor of the drug. The clinical trial data was requested by the FDA after a high rate of suicidal thoughts and suicides were linked to Chantix. The trials also included GlaxoSmithKline’s anti-smoking drug Zyban, and pitted both against a placebo. In ... Read More

Parents call for stronger psychiatric side effects warnings for asthma drug Singulair

The asthma medication Singulair has been linked to depression and suicidal thoughts in children as young as 4, prompting parents to call for new warning labels. Singulair contains the active ingredient montelukast, and is indicated for children ages 2 to 14 with frequent intermittent, mild persistent, or exercise-induced asthma. Parents who have treated their children with the drugs say youngsters have burst into fits of rage, upending furniture and screaming hysterically. Others say that their children who have used the medication have expressed severe self-loathing said things like, “I want to go to heaven and I don’t want to be here anymore,” ... Read More

Many antidepressants ineffective, unsafe for children, teens

Most antidepressants prescribed to children and teenagers with major depressive disroder are ineffective and in some cases unsafe, according to a new study published in the journal The Lancet. The study is touted as the most comprehensive analysis to date of commonly prescribed antidepressants used in children and teens. The research, conducted by scientists with the University of Oxford in the UK, involved a systematic review and analysis of all published and unpublished randomized clinical trials comparing the effects of 14 antidepressants in young people with major depressive disorder. In total, 34 trials involving 5,260 patients were analyzed. The drugs were assessed on efficacy, ... Read More

Reanalysis raises efficacy, safety concerns for Paxil use in children, teens

A study published in 2001 paved the way for doctors to write millions of prescriptions of the antidepressant Paxil for children and adolescents, but a reanalysis of that study published in the British Medical Journal shows that the medication is ineffective and potentially dangerous. The original paper, which was published by the Journal of the American Academy of Child and Adolescent Psychiatry, allegedly claimed that the drug was both safe and effective for treating depression in children and teenagers. Two years later, the Food and Drug Administration (FDA) ordered GlaxoSmithKline (GSK), the manufacturer of Paxil, to put a black box warning on ... Read More

Experimental psoriasis drug linked to suicidal thoughts

AstraZeneca is reviewing data on its experimental psoriasis treatment to determine whether it will move forward after reports that the medication caused patients to have suicidal thoughts. If the drug company continues development of the drug, if approved by the Food and Drug Administration (FDA), the agency may require the medication to carry a warning label. The drug, called brodalumab, is designed to treat psoriasis and related arthritic conditions. AstraZeneca was in partnership with Amgen Inc., but Amgen opted to pull out of the deal after reports of suicidality as a possible side effect. Analysts had initially projected that the ... Read More

FDA approves new diet pill Contrave

A new prescription diet pill has been given clearance by the Food and Drug Administration (FDA) for marketing in the United States. Contrave, made by Orexigen Therapeutics, is a combination of bupropion, an antidepressant that is also used for smoking cessation, and naltrexone, a drug used to treat drug and alcohol dependence. Contrave is approved for overweight or obese patients with a body mass index (BMI) of 30 or higher, as well as people with a BMI of 27 or higher with at least one other health issue such as diabetes. Patients treated with Contrave lost an average of 4.2 ... Read More

Mental health groups ask FDA to remove black box warning for suicide risk from antidepressants

Mental health experts are petitioning the Food and Drug Administration (FDA) to remove its severest warning involving suicidal thoughts from the safety labels on all antidepressants because the warning has resulted in a 33 percent increase in suicide attempts, and has scared away some patients who may benefit from the medication. In 2004, the FDA placed a black box warning, its most serious kind, on all categories of antidepressants, indicating that there is an increased suicide risk in children and adolescents treated with the drugs. Two years later, the FDA extended the warning to young adults to age 25 and recommended ... Read More

Warnings of teen suicide risk with antidepressants may have led to increase in teen suicide attempts

Researchers are concerned that recent warnings about antidepressants increasing suicide risk in teens may have contributed to a rise in teen suicide attempts. The study, published in the British Medical Journal, set out to investigate this possible power of suggestion since 2003, when the Food and Drug Administration (FDA) began publicizing suicide risks (including suicide attempts and completed suicides) with antidepressant use in young adults. The study involved data from about 2.3 million adolescents and young adults. Researchers found that the warnings led to a significant drop in antidepressant use in young people, beginning in 2003. At the same time, ... Read More

North Carolina woman says prescription drug-induced psychosis led husband to kill daughters

The moment Kim Crespi of Charlotte, N.C., heard that her husband David had stabbed their 5-year-old twin daughters to death, she knew that the real culprit behind the horrific act wasn’t her spouse but a cocktail of prescription drugs, including Selective Serotonin Reuptake Inhibitors, or SSRIs – a form of antidepressants. According to Charlotte’s WBTV, David Crespi, a Charlotte-area banker, called 911 on the morning of Jan. 20, 2006 to report that he had just killed his own daughters. Mr. Crespi was arrested and ultimately took a plea bargain to avoid the death penalty. He is now serving two life ... Read More

Young people who start antidepressants at higher doses more prone to suicidal thoughts

Children and young adults who start taking antidepressants at higher than recommended doses are twice as likely to have suicidal thoughts or attempt suicide than those who begin treatment at lower doses, according to a new study published in JAMA Internal Medicine. For the study, researchers examined data from 1998 through 2010 on about 163,000 people ages 10 to 64 who were treated for depression. Some people in the study were given the recommended dosage, while others were started at higher doses. It was not made clear why some individuals started at higher-than-typical doses. About 18 percent of 10- to ... Read More