FDA Updates Warning for Reclast

The FDA has issued a new safety update for the bisphosphonate Reclast, warning that patients have experienced kidney failure requiring dialysis or resulting in death after having an injection of the drug. Patients should be screened for kidney problems before being given the injection.

(Image: m_bartosch / FreeDigitalPhotos.net)

The Food and Drug Administration (FDA) has issued an update to the drug label for Reclast, an injection used to prevent or treat osteoporosis.  The new warning is in regards to the risk of renal failure.

Reclast, generic name zoledronic acid, is a bisphosphonate that is used to treat or prevent osteoporosis in women who are in menopause and to increase bone mass in men with osteoporosis.  The injection is given in a single dose every one to two years.

The FDA has recently received reports of patients experiencing kidney failure while taking Reclast.  These patients reporting kidney failure either required dialysis or died from the complication.

While kidney failure is a rare condition in patients using Reclast, it is more likely to occur in those patients who have a history of or risk factors for kidney problems.  Risk factors include an underlying moderate to severe renal impairment, use of kidney-damaging or diuretic medicines, and severe dehydration before or after receiving Reclast.

The risk of developing renal failure increases with age.  Your doctor should screen you for any kidney problems prior to giving you Reclast.  You should tell your doctor about any medications you are taking so that he or she can better identify whether these medications will adversely react with Reclast.

Earlier this year, Reclast was identified as a drug that is likely to cause a femur fracture in patients.  The FDA has sent out a safety announcement warning patients about the risks bisphosphonates pose and is continuing to review data regarding the risk of femur fractures in patients.


Tylenol Lowers Daily Recommended Dose

Johnson & Johnson has recently lowered the daily recommended dose for its popular OTC drug, Extra Strength Tylenol. The drug, which contains acetaminophen, has been shown to cause liver failure when patients overdose on it.

Tylenol! Pictures, Images and Photos

Do you take over-the-counter (OTC) pain medications daily at the maximum recommended dosage?  If so, you may be over-medicating yourself.  

Johnson & Johnson, the manufacturer of the popular OTC pain pill Tylenol recently announced that it would be reducing the recommended dose of its Extra Strength Tylenol from 4,000 mg or eight pills a day to 3,000 mg or six pills a day.  Tylenol contains acetaminophen, which is found in more than 600 medicines, including Alka-Seltzer, Nyquil, and Sudafed.   People mixing these medicines often unknowingly overdose on acetaminophen.
So why is Johnson & Johnson changing its dosing instructions now?  More than 56,000 Americans are hospitalized each year after overdosing on acetaminophen, which can cause liver failure.  In fact, acetaminophen overdoses are the leading cause of liver failure in the United States and lead to nearly 458 deaths each year.
Because acetaminophen is found in so many other OTC products, Johnson & Johnson thought it would be best for consumers if the company lowered the daily recommended dose.  New labels on Extra Strength Tylenol with the reduced dosage will start rolling out this fall.  Next year, Johnson & Johnson will also change the dosing instructions on its regular Tylenol.
While health experts are praising Johnson & Johnson for voluntarily changing the labels to reflect the lower recommended dosage, they are also worried that companies that produce similar OTC products are not informing consumers sufficiently about these medicines and how they may interact with other medicines.
Beginning as early as 2009, some medical experts called on Johnson & Johnson and the Food & Drug Administration (FDA) to lower the recommended dose to as little as 2,600 mg per day.  They also urged the major pharmaceutical company to require a prescription be written for Extra Strength Tylenol 500 mg.  Neither of these changes were made at the time, and Extra Strength Tylenol is still available as an OTC medication.
In recent years, Johnson & Johnson has suffered major setbacks in manufacturing several of its popular OTC drugs.  Just this year, the company recalled 43 million packages of Tylenol, Benadryl, Sudafed, and Sinutab products because the equipment used to produce the drugs was not sufficiently cleaned.
Even with “safe” OTC drugs on the market, pharmaceutical companies need to help consumers understand what ingredients are in the medicines they are taking, how those interact together, and the maximum dosage of each drug they should be taking per day.