Archive for May, 2010

Xenical-Liver Risks Reported

Thursday, May 27th, 2010

Orlistat (Xenical), used as a weight loss drug, is notorious for its gastrointestinal side effects- described as “treatment effects”, which can include steatorrhea  (oily, loose stools), since it inhibits the digestion of fat. The drug, which appeared to be safe for long-term use-don’t all drugs?-is available without prescription in the United States, the European Union, and Australia. Over-the-counter approval was controversial in the United States with consumer advocacy group, Public Citizen repeatedly opposing it on safety and efficacy grounds.

The AMA in its “Morning Rounds” reports the FDA is now requiring a liver-injury warning label, after receiving reports of liver damage by patients on this wildly popular diet drug.  (ABC World News 5/26, story 8, 0:20, Diane Sawyer.) The drug has been taken by nearly 40 million people.

The FDA has decided to put the new warning on Xenical (orlistat), developed by Roche’s Genentech, and its over-the-counter version,”Alli,” which is manufactured by GlaxoSmithKline (GSK).  To date, the agency has identified 32 cases of severe liver damage hepatocellular necrosis or acute hepatic failure, 2 of them outside the US.

Now, the revised label for orlistat (Xenical) will include new safety information about rare cases of severe liver injury. The agency stated, however, that “it has not yet established a causal relationship between orlistat use and severe liver injury.” For instance, some of the patients in question were taking other drugs while using the diet medications, others may have had conditions that exacerbated their liver disease.

Still, HealthDay (5/26, Gardner) reported, the agency is “‘telling consumers and healthcare providers to be vigilant should patients develop symptoms suggestive of liver impairment,” said FDA spokeswoman Elaine Gansz Bobo. She added, “We are not advising routine monitoring of liver enzymes as that will not help predict who may develop hepatic impairment on the drug.” People taking Orlistat — the active ingredient in both drugs — were warned to be on the lookout for itching, yellow eyes or skin, dark urine and loss of appetite, all of which are symptoms of liver problems.

If history is any guide, many more cases of serious liver problems will emerge in future.  The true extent of most drug reactions, serious, and not-so-serious-take years to come to the attention of the authorities and the public before proper warnings are issued or the offending drug is taken off the market.






Probable Dangers of Proton Pump Inhibitors (PPI’a)

Thursday, May 20th, 2010

Proton pump inhibitors (PPIs) are among the most popular drugs used to treat acid reflux and ulcers. They are sold under brand names like Nexium (the famous “purple pill”), Prilosec and Prevacid, and generate “$13.5 billion in sales. In 2009, approximately 119 million PPI prescriptions were written in the US, making the medicines part of the third-largest selling class of drugs. The six available PPI medicines are roughly equal in effectiveness and safety but differ markedly in cost. Two—omeprazole (Prilosec, Prilosec OTC) and lansoprazole (Prevacid,)—are available as both a prescription and a nonprescription drug. Taking effectiveness, safety, cost, and other factors into account, if you need a PPI,  consider following Consumer Reports Best Buy Drugs:live streaming film Straight Outta Compton online

■ Prilosec OTC
■ Generic omeprazole OTC

Both of these drugs are available without a prescription. You could save about $200 a month or more by choosing one of these drugs over a more expensive medication listed above. See this informative report.

Unfortunately, like all drugs, PPI’s have problems. The Wall Street Journal reviews several recent reports from the medical literature about complications, and CNN  reported on its website that medical experts claim the risks of taking PPIs may outweigh the benefits for people with less serious conditions. PPI’s can have rare but serious side effects, including an increased risk of GI bacterial infection and bone fracture, according to several new studies in the Archives of Internal Medicine.  Over prescribing these drugs for simple heartburn or dyspepsia has become almost reflexive.

The Boston Globe (5/10, Cooney) “WhiteCoat Notes” blog reported that patients on PPI’s had a 47 percent increased risk of spine fractures, a 26 percent increased risk of forearm or wrist fractures, and a 25 percent increased risk of other fractures.”

Doctors at the Beth Israel Deaconess Medical Center in Boston, analyzed data on more than 100,000 patients discharged from the hospital over a five-year period, HealthDay (5/10, Goodwin). They found that taking a proton pump inhibitor each day increased the chances of a serious diarrheal disease, C. difficile infection by 74 percent,” and “patients who took proton pump inhibitors longer than that had more than double the chance.”

Five years ago, I wrote that “the oldest and still the most widely used first line drugs for heartburn and dyspeptic symptoms are the antacids, such as Tums, Maalox, Mylanta, Rolaids, etc. These have the advantage of rapid relief in most patients, and low price. …With GERD and ulcer, the H2-receptor antagonists, Zantac (ranitidine), Pepcid (famotidine), and Tagamet (cimetidine), etc. are in most cases as effective as the PPI’s.

“Proton pump inhibitors are often over prescribed in long-term care, disregarding published guidelines for their use..”  It is interesting to note that PPI’s are not approved for treatment of simple dyspepsia or uncomplicated heartburn.



Treating Prostate Cancer: only $93,000 for 4 Months

Saturday, May 8th, 2010

 

NBC Nightly News (4/29, story 3, 2:00, Williams) reported that “the FDA has approved” Provenge (sipuleucel-T), “a vaccine for prostate cancer. It doesn’t prevent the disease, so vaccine is a bit of a misnomer, ..it could be a game-changer.”  The the media hype goes on: “It could help as many as 100,000 men with advanced prostate cancer,” the CBS Evening News (4/29, story 7, 2:00, Katie Couric) reported.  It offers “a new way to attack the disease which could be deployed against other kinds of cancer,” ABC World News (4/29, story 7, 1:55, Diane Sawyer) reported. But this is typical media hype, unsupported pure speculation.

 

The AP  reports that “three years ago…the FDA delayed a decision on the treatment, “despite an expert panel’s recommendation for approval.” According to the Los Angeles Times  “agency officials were concerned that, even though the vaccine extended lifespan in men with metastatic cancer who did not respond to hormone-deprivation therapy…it did not slow tumor growth.” The FDA also said that too few men given Provenge had been studied and asked Dendreon to perform a larger trial in more than 500 men.

 

Those results were presented last year, see TheWashington Post. During the trial, which involved “512 patients with advanced prostate cancer, Provenge increased overall survival by about four months, boosting median survival from 21.7 months to 25.8 months.”

 

The New York Times (4/30, A13, Pollack) reports that “a full treatment (with Provenge) will cost $93,000. Dendreon officials defended that price, saying it was in line with those of other cancer drugs in terms of cost per extra month of life provided by the drug.”

 

Bloomberg News said that the treatment “will initially be available at about 50 sites used for clinical trials, and more widely distributed after four plants are cleared for use by mid-2011, Seattle-based Dendreon said in a statement.”

 

But why did the FDA approve the drug without further testing?  It’s increasingly clear that  public pressure for life-extending new drugs for cancer is irresistible.  Would you like to take a chance on 4 miserable months for $23,000 a month, on the basis of this single study? Tough question. Is it time to load up on Dendreon stock?