(MintPress) – One in ten Americans assumes the risk of antidepressants in order to curb emotion, mood and anxiety. A new study, however, is saying that the physical risks and side effects could outweigh the benefits of antidepressant medication. At the high rate of which antidepressants are prescribed, those in the mental health field have come under scrutiny for over-prescribing a medication that has been claimed to have caused premature death in the elderly and questionable results in other people.
At McMaster University in Hamilton, Ontario, Canada, researchers concluded that many antidepressant medications are ineffective for their audience and long-term use can result in a full-blown relapse of depression symptoms if a patient is taken off the medication. The study also detailed high-risk side effects seen without long-term use. The findings showed instances of developmental problems in infants whose mother was on antidepressants, digestive problems, sexual function in adults and abnormal bleeding and stroke in elderly patients.
With an estimated 34.3 million Americans on antidepressants, the study models as a cautious tale for those willing to accept antidepressants as treatment without doing research first. Lead author of the study and evolutionary biologist Paul Andrews noted that prescriptions are handed out on a “widespread” level and that people simply aren’t talking about the potential side effects as much as they ought to be.
“We need to be much more cautious about the widespread use of these drugs,” Andrews said in an interview with MedicalXpress. “The thing that’s been missing in the debates about anti-depressants is an overall assessment of all these negative effects relative to their potential beneficial effects. Most of this evidence has been out there for years and nobody has been looking at this basic issue.”
Other noted side effects of antidepressants include an increased risk of suicidal thoughts, emotional numbness and apathy, weight gain and suppressed REM sleep.
Risk vs. reward
Andrews’ study looked at the influence and impact of serotonin on the body; a chemical that is generally related to providing the body with an overall sense of happiness and well-being. Many antidepressants work by manipulating the amount or absorption rate of serotonin in the brain to provide a feeling of happiness for those exhibiting depression-like symptoms. The medication has to be prescribed precisely and effectively as only 5 percent of serotonin in the body is in the brain. Ninety percent of serotonin is stored in the digestive tract, which is why digestive problems such as diarrhea, indigestion, constipation and bloating are deemed common side effects.
At the conclusion of the study, the authors criticized the use of antidepressants as being prescribed without adequate scientific research and ineffective. It noted that the prescriptions most commonly used are not safe and cause unnecessary physical harm. In the United States, the three most commonly prescribed antidepressants, by retail name, are Zoloft, Celexa and Prozac.
“Indeed, it is widely believed that antidepressant medications are both safe and effective; however, this belief was formed in the absence of adequate scientific verification,” the authors wrote. “The weight of current evidence suggests that, in general, antidepressants are neither safe nor effective; they appear to do more harm than good.”
Furthering the debate of antidepressants is the practice of combining more than one antidepressant or mood-altering medications for a patient with another. This results in patients taking multiple medications for the same symptoms, and potentially increasing their likelihood for side effects. The American Journal of Psychiatry has said positive treatment of depression has been seen by combining multiple medications, but warns against weight gain and sedation as not only possible side effects, but expected side effects.
Pharmaceutical Manufacturing Magazine believes that while positive results have been expressed through combining medications, it says the combinations are a way of selling more pills for patients that may not need them.
“There is no question that antidepressants have helped and do help many people, but research suggests that they may still be incorrectly and overprescribed,” the publication said.
Regulations of the industry
New drugs being pushed by companies with the hopes of it hitting retail markets must first put their drug through the Food and Drug Administration’s (FDA) New Drug Application (NDA). After applying a new drug with the FDA, the medication is then introduced to clinical trials, where it is tested on volunteers in three phases: The first face is a test on healthy humans to determine whether the drug is toxic. The second phase provides different dosages to the volunteers to determine what an appropriate dose is. Finally, in the last phase, a placebo test is done to ensure that they drug performs as advertised.
While many drugs are not deemed safe by the idea that all drugs have a level of toxicity by nature, legal requirements set by the FDA in regards to safety must show scientific evidence suggests that benefits of the drug outweigh the risks and side effects.
But the FDA has come under scrutiny in the past for lax studies of drugs and knowingly approving drugs that can have serious side effects. FDA Office of Drug Safety scientist David Graham was outspoken against the FDA in 2009 for its approval of painkiller Vioxx. Graham said the FDA left Vioxx on the market for over five years, despite evidence that it was doing for more harm than good.
“I know that FDA is responsible for 100,000 people being injured. And FDA wants to keep that swept under the rug nice and quiet,” Graham told CBS news.
Graham said it was a commonplace in the drug industry to ignore red flags with the drug after it passes initial inspection because companies have already started marketing the drug. Another high-profile case was the diabetes treatment Rezulin. The drug cleared the NDA, but it was discovered after marketing that it was linked to liver failure. The FDA kept Rezulin on the market for three years after the discovery, from 1997-2000.
“Most of the time a safety issue that comes up after marketing is something that wasn’t identified before marketing,” Graham said. “It’s something that wasn’t anticipated. And it’s not like you’re pointing a finger of blame at them. But it gets interpreted that way, I think. There’s no equal power. We have no power and they have all the power.”