October, 2010The Hive Announces Recall to Repair Revl Carbon Road Bicycle Brakes Due to Fall Hazard

The cable clamping area of the bicycle brakes can crack over time, causing the brakes to fail. This could pose a fall or crash hazard to the cyclist.

Chelation Products: Unapproved Over-the-Counter Drugs – Consumer Warning

Audience: Consumer ISSUE: FDA advised consumers to avoid “chelation” products that are marketed over-the-counter (OTC) to prevent or treat diseases. There are serious safety issues associated with chelation products. Depending on the condition, when…

LexisNexis® Legal News Podcast for October 13, 2010

The U.S. Supreme Court will not take up egregious fraudulent misjoinder in hormone replacement therapy actions, and a California appeals panel reverses a $12 million jury award to men who were injured in a gas line explosion. Hear these and other stories from LexisNexis® Mealey’s™ Publications. Copyright© 2010 LexisNexis, a division of Reed Elsevier Inc. For the latest litigation news headlines, visit www.lexisnexis.com/mealeys or www.lexisnexis.com/community.

Bisphosphonates (Osteoporosis Drugs): Label Change – Atypical Fractures Update

Audience: Patient, Family Practice, Geriatric including Fosamax, Fosamax Plus D, Actonel, Actonel with Calcium, Boniva, Atelvia, and Reclast
ISSUE: FDA is updating the public regarding information previously communicated describing the risk of…

Lipitor (atorvastatin) 40 mg: Recall specific bottles

Audience: Family Practice, Patient, Pharmacy ISSUE: Pfizer recalled specific bottles of Lipitor (40 mg only) due to a small number of reports of an uncharacteristic odor related to the bottles in which Lipitor is packaged.
BACKGROUND: A medical…

LexisNexis® Legal News Podcast for October 8, 2010

A New Jersey jury finds a pharmaceutical company did not fail to warn about a jaw risk from its bone drugs, and, a Chinese drug company and its CEO plead guilty to illegally distributing unapproved human growth hormone and will pay $7.5 million. Hear these and other stories from LexisNexis® Mealey’s™ Publications. Copyright© 2010 LexisNexis, a division of Reed Elsevier Inc. For the latest litigation news headlines, visit www.lexisnexis.com/mealeys or www.lexisnexis.com/community.

Slimming Beauty Bitter Orange Slimming Capsules: Undeclared Drug Ingredient

Audience: Consumers ISSUE: FDA notified consumers that Slimming Beauty Bitter Orange Slimming Capsules contain the active pharmaceutical ingredient sibutramine, a prescription-only drug which is a stimulant. Sibutramine is not listed on the product…

Meridia (sibutramine): Market Withdrawal Due to Risk of Serious Cardiovascular Events

Audience: Primary Care, Consumers ISSUE: Abbott Laboratories and FDA notified healthcare professionals and patients about the voluntary withdrawal of Meridia (sibutramine), an obesity drug, from the U.S. market because of clinical trial data…

Aromatase Inhibitors in Products Marketed as Dietary Supplements: Recall

Audience: Consumer, Family Practice, Pharmacy including Advanced Muscle Science (Arom-X, Arom-X UTT, Arom-XL, 4-AD, and Decavol), ArimaDex, Clomed, Off Cycle II Hardcore, iForce – Reversitol, Novedex XT

[Posted 09/20/2010; UPDATED…

“Alexander Designs” Brand Drop-Side Cribs Sold Exclusively at JCPenney Recalled for Repair Due to Entrapment, Suffocation and Fall Hazards

The drop-side rail hardware on the cribs can break or fail, allowing the drop side to detach from the crib. When the drop side detaches, a hazardous gap is created between the drop-side rail and the crib mattress in which infants and toddlers can become wedged or entrapped, posing risks of suffocation and strangulation. In addition, children can fall out of the crib when the drop-side rail falls unexpectedly or detaches from the crib. Drop-side rail failures also can occur due to incorrect assembly or with age-related wear and tear.