Warning on Medications, Drugs, Etc.

[New-disc]

Thanks for the info!!

[maz]

Hi Rich what an very interesting article! I am experiencing bladder pain at the moment and this is under investigation I am sure its related to medication. Do you know if any research about bladder pain andmedications for pain? I have just had an ultrasound (clear) and bloods are clear waiting for cytoscopy in the next day or two hope thats clear will keep you posted and many thanks for remembering me Maz

[Harrison]

Maz, I've not heard or looked into this bladder issue. Good luck with your diagnostic procedures (ouch?!) and if you can, update your related threads(even if you don't, I can merge topics...).

[Harrison]

This may have been posted elsewhere, but I will continue tracking FDA warnings on meds that are commonly used by spine patients.
_________________________________________________

Esophageal cancer linked to osteoporosis drug use
January 5, 2009

The popular osteoporosis drug Fosamax (alendronate sodium, Merck) and other similar drugs may carry a risk for esophageal cancer, a Food and Drug Administration official said last week.

Diane Wysowski of the FDA’s division of drug risk assessment said researchers should check into potential links between so called bisphosphonate drugs and cancer, according to a press release.

In a letter in the New England Journal of Medicine, Wysowski said that since the initial marketing of Fosamax in 1995, the FDA has received 23 reports of patients who developed esophageal tumors after taking the drug. Typically, 2 years lapsed between the time patients started taking the drug and the onset of esophageal cancer. Eight patients died, according to her report.

In Europe and Japan, physicians logged 21 cases involving esophageal cancer and Fosamax use, with another six instances where Procter & Gamble’s Actonel (risedronate) and Didronel (etidronate) and Roche’s Boniva (ibandronate) may have been involved. Six of those patients died, according to the release.

Esophagitis — an inflammation of the lining of the esophagus — is one side effect of the drugs, which is why patients are instructed to remain upright for at least 30 minutes after taking them, she said.

In her letter, Wysowski also recommended that doctors should avoid prescribing the drugs to people with Barrett’s esophagus, which is a change in the lining that leads to the stomach. It is often found in people with acid reflux disease and itself increases the risk of cancer, according to the press release.

Also last week, researchers at the University of Southern California School of Dentistry released clinical data linking alendronate sodium to an increased incidence of jaw necrosis. The study is among the first to acknowledge that even short-term use of common oral osteoporosis drugs may leave the jaw vulnerable to devastating necrosis, according to the report in the Jan. 1 issue of the Journal of the American Dental Association.

Reference: www.ORTHOSuperSite.com.

[Harrison]

July 1, 2009

Ban Is Advised on 2 Top Pills for Pain Relief

By GARDINER HARRIS

ADELPHI, Md. — A federal advisory panel voted narrowly on Tuesday to recommend a ban on Percocet and Vicodin, two of the most popular prescription painkillers in the world, because of their effects on the liver.

The two drugs combine a narcotic with acetaminophen, the ingredient found in popular over-the-counter products like Tylenol and Excedrin. High doses of acetaminophen are a leading cause of liver damage, and the panel noted that patients who take Percocet and Vicodin for long periods often need higher and higher doses to achieve the same effect.

Acetaminophen is combined with different narcotics in at least seven other prescription drugs, and all of these combination pills will be banned if the Food and Drug Administration heeds the advice of its experts. Vicodin and its generic equivalents alone are prescribed more than 100 million times a year in the United States.

Laureen Cassidy, a spokeswoman for Abbott Laboratories, which makes Vicodin, said, “The F.D.A. will make a final determination and Abbott will follow the agency’s guidance.” The agency is not required to follow the recommendations of its advisory panels, but it usually does.

Full article here:
http://www.nytimes.com/2009/07/01/health/01fda.html?em

[Harrison]

Unfortunately, more bad news today, from the Wall Street Journal.
__________________________________________________ _________

Risks Seen on Bone Drug

By JENNIFER CORBETT DOOREN

The Food and Drug Administration said a proposed new type of osteoporosis drug from Amgen Inc. was effective at increasing bone mineral density and reducing the risk of fractures but could increase the risk of serious infections.

The FDA said it was concerned denosumab "has the potential to affect multiple layers of the immune system," which could result in the development of serious infections and cancer. In order to treat or prevent osteoporosis, denosumab is designed to inhibit a protein known as RANK Ligand that's involved with bone destruction. However, the same protein also plays a role in the body's immune system.

The agency said clinical trials involving denosumab showed a slightly higher rate of serious infections and the development of certain types of cancer. The agency also said there's a "potential for tumor progression in patients with cancer."

Denosumab, faces a review Thursday by an outside panel of medical experts, and the FDA posted a review of the product on its Web site Tuesday.

Amgen is seeking FDA approval for denosumab to treat or prevent osteoporosis in postmenopausal women and bone loss caused by hormone treatment in patients with breast or prostate cancer. The company said denosumab has a "favorable benefit-risk profile in the indications sought."

Write to Jennifer Corbett Dooren at jennifer.corbett-dooren(at) dowjones.com

[cathydownunder]

This is a bit off-topic but drug related so I'll add it here....

My neighbours husband died of an aggressisve type of leukemia just before last Christmas. He had been taking Lyrica for many months to relieve the pain of shingles. When his oncologist found out about the Lyrica, he stated he'd seen several patients with leukemia who'd also been on Lyrica , and there was a suspician amongst his colleagues that there was a definite connection between the two.
Scary...but food for thought???

[Harrison]

Some of you may have seen the FDA warning & recall on some pain relief products; here's the right web link to see the entire list -- you can also check the lost number corresponding to purchased products:

http://www.mcneilproductrecall.com/page.jhtml?id=/include/prd_all.inc

It applies to selected product names of Benadryl, Tylenol, Motrin and Rolaids.

[Harrison]

CORRECTED - UPDATE 2
FDA rules out bisphosphonate, thigh fracture link

Thu, Mar 11 2010

(Corrects to show Actonel is owned by Warner Chilcott, 4th paragraph)

* FDA says no thigh fracture risk with bisphosphonates
* Bisphosphonates such as Fosamax treat osteoporosis
* FDA statement follows case reports of thigh fractures (Adds Merck statement)
By Toni Clarke

BOSTON, March 10 (Reuters) - U.S. regulators said on Wednesday they have found no link between oral bisphosphonate osteoporosis medications such as Merck & Co Inc's <MRK.N> Fosamax and certain thigh bone fractures.

The U.S. Food and Drug Administration issued its statement following the publication of case reports of atypical subtrochanteric femur fractures -- or fractures in the bone just below the hip joint -- in women with osteoporosis using oral bisphosphonates.

Bisphosphonates are a class of drug aimed at preventing bone fractures and offseting bone loss associated with menopause.

They include Fosamax, Roche Holding AG's <ROG.VX> Boniva, Novartis AG's <NOVN.VX> Reclast and Warner Chilcott's <WCRX.O> Actonel.

In June 2008, the FDA requested information from all bisphosphonate drug makers related to these type of fractures. The agency said a review of the data did not show an increased risk for women using the medications.
The FDA said that, although its review of the data did not show a clear connection between bisphosphonates and atypical subtrochanteric femur fractures, the agency is working closely with outside experts to gain more insight into the issue.

Bisphosphonates, which have been on the market for roughly a decade, have raised safety concerns in the past, including heart risks.

But in 2008, the FDA said the drugs showed no overall risk of heart problems. The agency's review followed reports in the New England Journal of Medicine of serious atrial fibrillation, a type of abnormal heartbeat.

In January, a Manhattan federal judge refused to dismiss a lawsuit alleging that Fosamax caused jaw damage to a woman during the nearly eight years she took the pill.

Merck faces a slew of lawsuits involving almost 900 cases by patients who say Fosamax caused osteonecrosis of the jaw, or death of jaw bone tissue.
"In clinical studies, Fosamax has not been associated with increased fracture risk at any skeletal site," Merck spokesman Ron Rogers said in a statement.

"Low energy femoral shaft and subtrochanteric fractures have been reported in the medical literature as occurring in non-bisphosphonate users," Rogers noted, adding that Merck is currently conducting studies "to further investigate the issue of low energy femoral shaft and subtrochanteric fractures."

The FDA recommended patients keep taking their medication unless told not to by their doctor. It also recommended that healthcare professionals be aware of a "possible risk" of atypical subtrochanteric femur fractures in patients taking oral bisphosphonates.

(Reporting by Toni Clarke; additional reporting by Bill Berkrot in New York; editing by Andre Grenon)

Source: Reuters.com

[annapurna]

Don't bet on the headlines on the bi-phosphonates yet. It just happened to be that I was just discussing this issue with an MD that had bi-phosphonates mess up her life due to bone necrosis. She mentioned that that the recent data exonerating them for bone fractures was matched by equally recent data that still calls them into question.