Meridia belongs to generic sibutramine hydrochloride monohydrate, was granted approval in November 1997 by the US Food and Drug Administration for long-term treatment of obesity. It is produced by Abbott Laboratories, who also markets the same product in Europe under the brand names Reductil, Ectiva, and Reduxade.
Meridia controls appetite through the brain. It helps to reduce food intake by increasing satiety or the feeling of fullness, hence, Meridia does not suppress appetite. It blocks the re-absorption in the brain of two chemicals that make the individual feel full. It works by not allowing these chemicals to penetrate the nerve cells brain, then, the individual will soon feel full which will lead to eating less and consequently, lose weight.
While Abbott Laboratories states that obesity can be a chronic condition, Meridia helps the dieter to lose weight between 5% and 9% within 6 months. If the dieter decides to stop using Meridia, weight is regained. Because of this, most of the dieters take Meridia permanently, either regularly or in cycles to sustain weight loss.
Individuals Who Should Avoid Taking Meridia
Presently, Meridia is one of the two pharmacologic options for long-term weight management, particularly for about 2 years, which was granted approval from the European Regulatory agency and the US Food and Drug Administration. A dieter cannot take Meridia if he/she is taking a prescription medicine that belongs to a group of medicines called monoamine oxidase inhibitors or MAOIs, which can also be used treat depression or Parkinson’s disease. Dieters or patients cannot take Meridia if they have anorexia nervosa if they are taking other weight loss medications that act on the brain, and those that are sensitive to the ingredients of Meridia.
Meridia should not be taken by patients who have a history of coronary artery disease, arrhythmias, congestive heart failure, or stroke. Meridia increases levels of blood pressure in some patients, and regular monitoring of blood pressure is needed while taking the medicine. Meridia should be prescribed with caution to patients with a history of hypertension, should not be given to patients with uncontrolled or poorly controlled hypertension.
Side Effects of Meridia
Some common side effects of Meridia are dry mouth, headache, constipation, anorexia, and insomnia. However, Meridia is controlled substance and abuse of this drug may result in dependency. If you or any of your family members are taking Meridia, and are experiencing any of the side effects, you should seek medical attention immediately. Patients who are using Meridia should see their doctors for their regular follow-up visits to monitor their general health condition, including blood pressure and pulse rate.
Health Concerns On Meridia
Public Citizen, a national nonprofit consumer advocacy group which was founded by Ralph Nader, presented a petition to the Department of Health and Human Services or HHS in March 2002, requesting that Meridia should be removed from the market because of some doubts about its safety and benefits. Public Citizen claimed that Meridia was involved in 29 deaths, where 19 deaths due to heart-related causes, and hundreds of other negative reactions from February 1998 and September 2001.
Public Citizen stated that from397 severe adverse reactions that were reported to FDA since Meridia was approved, there were 152 were hospitalized; 143 of those who were hospitalized had irregular heartbeats. The advocacy group also stated that Ministry of Health in Italy had already suspended the sales of Meridia due to reported two deaths, and its safety was now being reviewed by other nations. Public Citizen said that Meridia had no proof of long-term benefits and major proofs of short-term risks and death.
Medical experts stated that it was hard to know if individuals died because they were using Meridia or they were already experiencing from obesity-associated illnesses. When Meridia was approved, there were results of the studies that showed that the drug increased the blood pressure level of some patients, and medical professionals gave warnings that individuals with heart problems should not take Meridia.
FDA recognized that it was also concerned about the events stipulated in the petition of the Public Citizen, but it also felt that the cautions on the label of the medicine were adequate to inform everybody of the risks of using Meridia, particularly the risks for cardiac complications.
Public Citizen also announced that it evaluated the inspection report of the US FDA on one of the Abbott Laboratories. The report stated that one death was related with Meridia was not reported to FDA and the other cases of death that were reported to FDA were incorrect or incomplete. The Public Citizen, then, filed for criminal charges against the Abbott for unlawfully concealing the information from the FDA about these deaths and harmful side effects in Meridia patients.
Abbott answered the allegations of Public Citizen on June 4, 2002, where they asserted that the unreported death was unverified and Abbott had “completely responded” to all of the other findings in the reports of FDA.
Nevertheless, the US FDA issued an official warning letter to Abbott on July 19, 2002, about the delays in reporting the adverse medicine events.
Public Citizen gave an updated petition to US FDA on September 3, 2003, reinforcing its position that Meridia should be prohibited from the market, and correcting to 49 cardiovascular death cases among those who used Meridia.
Obtaining Legal Assistance
Since all medications have side effects, it is the obligation of the manufacturer to make their products safe and inform medical community, healthcare providers, and the general public about its risks related to the product or medicine. If it fails to do this, the manufacturer can be held liable to patients who were injured as a consequence of insufficient warnings, under a legal principle called product liability.
If you or one of your family members has taken Meridia and suffered side effects or injury, you should seek medical attention right away. Then, you can find for an experienced lawyer who can explain and discuss your options and safeguard your rights for legal remedy or recovery from the injury sustained due to the use of Meridia.