FDA Refuses to Ban Meridia Despite Reports of Serious Side-Effects and Deaths Linked to the Diet DrugAug 18, 2005 | www.Newsinferno.com The Food and Drug Administration (FDA) has refused to ban Abbott Laboratories’ prescription diet drug Meridia, despite numerous reports of elevated blood pressure, heart complications, and deaths associated with the medication.
Complaints about Meridia were brought to the FDA by the consumer watchdog group, Public Citizen (http://www.citizen.org/).
Public Citizen first petitioned for the removal of Meridia from the market in 2002 when Italian health authorities suspended the drug after reports of two patient deaths. The country later re-approved the drug and the European Union's Committee for Proprietary Medicinal Products ruled that the drug should continue to be sold in Europe.
Recently, Public Citizen claimed Meridia in only their 20s and 30s had died of heart problems and that even before Meridia was approved for sale, the FDA was aware it could increase blood pressure in some cases.
The group’s petition to pull the drug from the market was denied on August 9.
Although the FDA had directed Abbot Labs to ensure that dieters with heart disease aren't prescribed the drug and to stress the importance of monitoring patient’s blood pressure, the agency defended its decision to keep Meridia on the market saying that the drugs benefits still outweighed the side effects.
Whether this claim is true, however, is open to question. Public Citizen was not the first to raise questions about Meridia’s safety. David Graham, an FDA drug safety officer and well-known whistleblower, testified before Congress last fall that the FDA was allowing five medicines including Meridia to remain on the market despite serious concerns about their safety.
Furthermore, between 1997 and 2003, the FDA received reports of 30 Meridia users who died of cardiovascular problems and 224 with of nonfatal strokes, heart attacks and other cardiovascular ailments.
In response to these charges, and with somewhat circular logic, the FDA argues that cardiovascular disease is frequent among the group of obese people the drug is designed to help (those trying to lose at least 30 pounds) and it is difficult to decipher whether Meridia itself increased any of these risk factors.
Simultaneously, the agency ordered a stricter warning that the drug should not be given to those who suffer from poorly controlled hypertension, heart disease, stroke, or severe liver or kidney disease as well as breast feeding or pregnant women.
An upcoming study should help settle the question of Meridia’s effect on heart problems. The new study considers 9,000 obese Europeans at particularly high risk for cardiovascular disease because of a previous heart attack or other problem. Half will take Meridia and half will not. The groups will then be evaluated monthly by an independent monitor.
As expected, Abbott Laboratories was pleased with the FDA decision claiming that Meridia is helping 15 million patients in 75 countries lose 5% to 10% of their body weight in combination with a healthy diet and exercise program. The drug has also contributed significantly to the company’s profits with global sales of $300 million in 2004.
Public Citizen's Dr. Sidney Wolfe condemned the FDA's ruling as "dangerously flawed," and cited it as yet another instance of the government continually siding with the pharmaceutical industry in cases where drugs with highly questionable track records, clinical trials, and adverse event reports have been allowed to remain on the market far too long before being recalled or having their warnings made significantly stronger.