Warning renewed for Baby Acetaminophen

The FDA has renewed a warning about the potential for dosing errors with liquid acetaminophen products for infants. FDA advisory committees made recommendations in 2009 that all liquid acetaminophen be produced in a single concentration: 160mg/5mL. The recommendation was voluntary and not all manufacturers have followed it so there are still products with strengths of…

Multaq Use Limited by FDA

A recent study showed Multaq doubled the risk of heart-related complications in patients with permanent atrial fibrillation. The study, conducted bythe drugmaker,  Sanofi, showed higher rates of heart attack, stroke and death in certain patients. While the FDA did not remove Multaq from the market, they recommended restricting the use of the drug to patients…

FDA warns HCG diet products are illegal

The Food and Drug Administration last week posted a warning on its website against homeopathic products containing the hormone human chorionic gonadotropin (hCG) that are used for weight loss with severe 500-calories-per-day dieting. The agency also notes that a 500-calorie-a-day diet poses a variety of health risks, including malnutrition, gallstones, electrolyte imbalance and irregular heartbeat.…

FDA Panel: Newer birth control medications should carry stronger safety warnings.

NBC Nightly News (12/8, story 7, 2:20, Williams) reported, “Medical experts have been taking…[a] look at Drospirenone/Ethinyl Estradiol [Yaz], because of studies that show they may be more likely to cause dangerous blood clots than older versions of the” medication. Chief Medical Editor Dr. Nancy Snyderman said, “Two of the most popular birth control” medications…

HCG weight loss agents pulled by FDA

Over the counter weight loss products containing human chorionic gonadotropin (HCG) have been declared fraudulent and illegal by the FDA and the Federal Trade Commission. The agencies have told seven manufacturers to stop selling them. The warning letters sent t manufacturers note that HCG has not received FDA approval for any weight-loss indication. It has…

Fosamax Duration of Use Questioned by FDA

In September, The FDA’s Reproductive Health Drugs Advisory Committee and the Drug safety and Risk Management Advisory Committee held a joint meeting to discuss the appropriate duration of use for Fosamax and other bisphosphonates. Earlier this year the FDA required manufacturers to include language in their labels stating that the optimal duration for patient use…