In 2002, the american consumer advocacy group Public Citizen has waged a battle alledging that Sibutramine is unsafe, and that Abbott Laboratories knew of serious side effects of Sibutramine but didn't tell anyone. On March 19th 2002, they ³⁸formally requested that the FDA remove Meridia from the US market. On March 21st, they announced that they had obtained FDA documents alledging that at a recent investigation of Abbott Park, Illinois, the FDA uncovered evidence that Abbott Laboratories deliberately failed to report one death caused by Meridia, and that information on seven other deaths was missing, inaccurate, or that conclusions were reached without adequate data.

39In March, 2002 the first lawsuit was filed in the US against Abbott Laboratories, who make and market Meridia; BASF Corporation, and Knoll Pharmaceuticals, a unit of BASF and the company that jointly makets Meridia with Abbott Laboratories. The lawsuit alleges that Abbott Laboratories was aware of serious side effects of Sibutramine but did not inform either patients or doctors, and as such is guilty of negligence, strict liability for failure to warn, strict liability for a defective product, breach of express warranty, breach of implied warranty and unjust enrichment. In June 2002 more lawsuits were filed, including some class action lawsuits

⁴⁰According to the BBC, 2 patients died and 200 suffered adverse side effects as of March 15^th. Continued use of Sibutramine (Marketed as Reductil®) in the UK was justified on the grounds that it was believed that the major causes of death were not due to Sibutramine but due more to the patient's underlying medical condition.

On the other hand, on March 7th 2002, Italy removed Meridia from shelves pending the results of a reassessment of Sibutramine's safety. This was prompted by 50 reports of health related problems, and also reacting to the UK's own Drug and Therapeutics Bulletin, which stated that Sibutramine had limited benefits and unwanted side effects.

³⁹ These concerns were by no means isolated - prior to the 1997 approval of Meridia by the FDA, the approval committee voted 5 to 4 that the clinical benefits of Meridia did not outweigh the risks, and the doctor in charge of the committee wrote that Meridia "has an unsatisfactory risk-benefit ratio and therefore this Reviewer recommends non-approval of the original submission." All these objections were based on the evidence that Sibutramine increases the blood pressure and heart rate in some patients.

This lead to Abbott Laboratories, on March 20th to issue a 41statement asserting that the use of Meridia was safe when used within its recommended guidelines, and that the Public Citizen request was misleading and unfair. It also pointed out that the allegations that Meridia was unsafe were based on very few isolated incidents, and that the risk of death if patients remained obese was significantly higher.

Overall, the view of the international medical establishment seems to be in favour of Sibutramine - The ⁴¹Abbott press release states that health authorities in Germany, Sweden, Denmark, the Netherlands and Finland saw no reason to take any action against Meridia, and that health authorities in Portugal and Spain have stated that the risk/benefit ratio still remains favourable. Abbott Laboratories also took pains to point out that Meridia was not banned from Italy, rather sales were temporarily suspended pending a reassessment of the safety of the drug. The legal challenges and safety assessments, in the US especially, are still ongoing.