FDA refuses to withdraw Meridia despite 50 deaths, health dangers

The FDA banned ephedra last year, on trumped-up charges that it killed an overweight, out of shape pro baseball player wannabe, something never proven and never confirmed by autopsy. Ephedra was popular as a weight loss herb. It worked by suppressing the appetite and increasing metabolism.

Yet, after twice being asked (in 2002 and again in 2003) to withdraw the appetite-suppressing prescription drug Meridia, the US FDA today again rejected Consumer advocacy group Public Citizen's request.

Side effects of the drug range from headaches and constipation to higher blood pressure and a faster heart rate, according the Public Citizen.

Public Citizen's Health Research Group Director Sidney Wolfe said the 50 heart-related deaths reported since the drug's approval still warrant its removal. While Meridia use has dropped, "many people are still getting this dangerous but not very effective drug," said Wolfe.

The manufacturer of Meridia, Abbott Laboratories, Inc., criticized Public Citizen's analysis and said Meridia had repeatedly been proven safe and effective.

The FDA concluded that "sibutramine's overall risk-benefit profile supports it remaining available as a prescription drug for the treatment of appropriately selected obese patients," wrote Steven Galson, head of the agency's drug division.

Apparently Galson was paying no attention to FDA veteran scientist David Graham when he said Meridia should be one of the top five prescription drugs scrutinized when he spoke at a congressional hearing in 2004.

RxList.com lists side effects of Meridia including headache, back pain, vomiting, nausea, chest pain, abdomninal pain, palpitations, tachycardia, increased blood pressure, migraines, neck pain, vasodilation, allergic reactions, constipation, increased appetite, dyspepsia, anorexia, dry mouth, insomnia, dizziness, rhinitis, pharyngitis, dysmenorrhea, sweating, rashes and a host of other symptoms and maladies, at much higher rates than chance or placebo. Clearly, a drug capable of making you feel bad. Very bad.

So -- it's okay to ask your doctor for Meridia, but you still can't buy ephedra, even though a judge in Utah said the FDA overstepped its bounds in banning it in 2004.