Federal Regulators Concerned Over Influx of Dangerous Dietary Supplements

shady drugs

The U.S. Food and Drug Administration is having a difficult time managing the massive influx of illegal raw ingredients and finished products that reach the U.S. market. Black-market products, mostly coming from Asia, pose significant health risks to those who take them. Dietary supplements are not fully regulated by the FDA, although a vast majority [...]

FDA Warns of Strangulation Risk with Massage Device

FDA warning

This week, the FDA issued a new safety communication about the ShoulderFlex Massager, after receiving reports of adverse events linked to the device, including a fatality and other serious injuries. According to the agency’s warning, The Consumer Safety Products Commission has already received one report of death and another of near strangulation associated with use [...]

Complaints Against All-Metal Hip Implants on the Rise

depuy hip

Following a review of federal data, the New York Times discovered that the U.S. Food and Drug Administration has received more than 5,000 reports about metal-on-metal hip implants since January of this year, a number that exceeds what the agency previously received regarding these devices from the past for years combined. The recent surge in [...]

Consumer Group Warns of Dependency Issues with Acid Reflux Medications

Prevacid Lawyer

The consumer watchdog group, Public Citizen, this week asked the U.S. Food and Drug Administration to warn Americans that use of acid reflux medications, otherwise known as proton-pump inhibitors (PPIs) can be incredibly habit forming and also lead to the onset of several other serious side effects. Given the widespread use and popularity of these [...]

FDA Warns High Doses of Celexa Can Lead to Heart Problems


According to a recent warning issued by the U.S. Food and Drug Administration, Forest Laboratories’ popular antidepressant, Celexa, can interfere with the heart’s pumping action when used in high doses. Federal health regulators are urging doctors not to prescribe the drug in doses over 40 milligrams. Previously, the label for Celexa indicated that some patients [...]

Prescription Drug Ads Often Skirt FDA Regs

drug companies

New research recently reported in MedPage Today suggests that only a limited number of advertisements for prescription drugs are actually in compliance with FDA regulations on marketing to doctors. The research, which was conducted by Dr. Deborah Korenstein of Mount Sinai School of Medicine in New York, revealed that during a one month period, almost [...]

Teva Faces Second Trial Over Anesthetic Drug

teva pharma co

The legal team for Teva Pharmaceuticals returned to court this week, battling the company’s second lawsuit over its anesthetic product, propofol. Three Las Vegas patients are alleging that they were diagnosed with hepatitis C after receiving propofol by way of tainted vials during routine colonoscopies. The lawsuit claims that Teva, along with its distributors (Baxter [...]

Generic Drug Companies Fund FDA User-Fee Program


A tentative deal between the generic drug industry and the federal government will require generic drugmakers to pay annual fees in order to increase FDA inspection of foreign-based manufacturing plants. The proposed deal, which totals approximately $299 million, is similar to the ones that currently exist for companies who produce brand-name drugs and medical devices. [...]

Tylenol Cold Gelcaps Added to J&J’s Long List of Recalls


McNeil Consumer Healthcare, a division of pharmaceutical company, Johnson & Johnson, announced on Monday that it is recalling from retailers and wholesalers approximately 2.5 million packages of Tylenol Cold Multi-Symptom Nighttime Rapid Release Gelcaps. The company said that it issued the recall as a precaution, stemming from the discovery of higher-than-expected levels of a compound [...]

FDA Approves Final Warning Language for Actos

Actos Lawyer

According to a Drug Safety Communication issued last week, the U.S. Food and Drug Administration announced it has approved the final language for the new Actos label. The drug’s label now includes warning language regarding the increased risk for bladder cancer in patients taking the medication for more than a year. The updated label also [...]