An attack on my liver: FDA's MedWatch adverse drug reports on Xenical

Dr. Sidney Wolfe of Public Citizen warned against the use of Xenical and Alli (weight-loss drugs in the orlistat class), after reviewing the reports of adverse reactions to them according to the U.S. government's FDA MedWatch reports. Here's the experience of one customer:

Monique Paulwell of Bowie, Maryland said she only took Alli four times before she began feeling fatigue, loss of appetite, a nagging headache and jaundice. "After a battery of tests, [doctors] said there had been an attack on my liver. By the time I was admitted to the hospital, I had 48 hours to live. It was that serious."

She said she thought taking Alli would help her lose a few pounds and maybe boost her acting career. Instead, she had a near-fatal experience her doctors told her was caused by the drug. She said she needed a liver transplant to save her life.

Public Citizen found that severe side effects affected dozens of patients who'd taken the drug, and that the drug's benefits, in any event, were minor, amounting to 4 - 5 pounds of weight loss. That has to be weighed against the 20% chance of side effects, some of which are severe, e.g., liver disease, pancreatitis, and kidney stones. The FDA received 47 reports of acute pancreatitis and 73 cases of kidney stones attributed to orlistats.

As with any drug, one should weigh the likely benefits in light of the possible harm. The advice of a pharmacist can be helpful in this context. A drug like Xenical works by blocking absorption of about a third of the fat enzymes that enter the body. Instead, the fat passes through the body to the gastrointestinal tract until it is excreted. These medications also block fat-soluble vitamins including vitamins A, B, and K.

Advice: For me, it's much easier to give advice like "maintain a healthy weight" than it is to follow my own advice. Yet it is important, especially because the surgical alternative for weight loss has some serious trade-offs, as discussed in my book, Getting Your Best Health Care: Real-World Stories for Patient Empowerment.

Thanks to Lara Salahi of ABC News for some of the background information here from their story on April 14.

I CAN'T TASTE ANYTHING: Zicam Cold Remedy Nasal Gel

Charlene's friend’s story:
I want my friends and loved ones to know what has happened to me in hopes that it will never happen to you or anybody you care about.

About 10 days ago, I felt a cold coming on; so before I went to bed I used Zicam Cold Remedy Nasal Gel. It's supposed to help you "get over your cold faster." Immediately after I sprayed it into each nostril I felt the most horrific burning sensation imaginable. It literally felt like I had sprayed pepper spray directly into my brain. It burned all the way to the top of my skull. Mynasal passages swelled, my eyes watered – the burning lasted all night long into the next day. 
 


After about a day, I realized I couldn't taste anything and I thought, "Wow - I must really have a bad cold." Then I noticed that I couldn't smell coffee brewing, couldn't smell my perfume when I put it on, couldn't smell the popcorn I burned, couldn't smell my favorite candle. Ipanicked and starting smelling everything that I could find that had really strong odors – ammonia, finger nail polish remover, bleach, etc. I couldn't smell ANYTHING!

I started tasting everything that had really strong tastes such as HOT salsa, raw red onions, Doritos, coffee. I couldn't taste ANYTHING! 
 
I told my mother about this and she said, "Oh, I've heard Zicam can affect your Olfactory nerve."

I went online, typed in "Zicam side effects" and bam - up popped all sorts of web sites with people reporting the same thing I experienced. It seems that this past June, Zicam pulled the swabs for adults and children off the shelf but not the nasal gel. 
 


I went to my ENT and he said the Zicam had basically "FRIED" my Olfactory nerve and the results are most likely permanent. He put me on a strong dose of a steroid called Prednisone in hopes of recovering ANY bit of the nerve damage but he told me to "take this and pray." He said he had read about the side effects of Zicam and couldn't believe it is still on the shelf. It isn't FDA approved.

I am taking the Prednisone and praying but nothing is happening. I LITERALLY CANNOT SMELL OR TASTE ANYTHING! I can tell if foods are hot or cold, I can tell the consistency and I can faintly detect if it is salty but that is it. 
 


PLEASE, PLEASE, PLEASE pass this on to everyone you care about. I don't want this to happen to ANYONE else!!!!!!!!!! And if you have Zicam in your medicine cabinet—THROW IT AWAY!

Read the FDA Advisory.

Read a story about a very different kind of treatment for a nasal condition. Thanks to Charlene Casucci for sharing this story.

For more than two years: Genetic tests and personalized medicine

For more than two years, Jody Uslan had been taking the drug tamoxifen in hopes of preventing a recurrence of breast cancer. Then a new genetic test suggested that because of her genetic makeup, the drug wasn't doing her any good.

"I was devastated," she said. She stopped taking tamoxifen, and is now evaluating alternative treatments.

Experts say most drugs, whatever the disease, work for only about half the people who take them. For the others, their genetic makeup makes the drug ineffective, e.g., because the person may lack an enzyme to process the drug appropriately. The hope of "personalized medicine" is that doctors will be able to consider the likely effectiveness of a drug for a particular patient in light of that person’s relevant genes, in deciding which drug to prescribe.

Scientists are learning about a growing number of genetic markers that determine the likely effectiveness of particular drugs. Some genetic tests are available, many at a cost of several hundred dollars. The Food and Drug Administration has formally recommended genetic tests to guide the selection or use of some drugs, but has not yet made formal recommendations on many others.

Advice: To avoid the side effects, cost, and nuisance of using certain drugs unnecessarily, talk to a genetic counselor if you use Herceptin (trastuzumah), Erbitux (cetuximab), Vectibix (panitumumah), chemotherapy for breast cancer, Tamoxifen, Ziagen (abacavir), Camptosar (irinotecan), Tegretol (carbamazepine), Coumadin (warfarin), or Celebrex (celecoxib). Ask the counselor whether you should have a genetic test to determine the drug’s likely effectiveness for you.

Read another story about the value of genetic counseling.

Thanks to Andrew Pollack for the source article in today's New York Times.

The FDA had violated its own policy: Adverse drug reactions from defective heparin

Baxter International announced recently that it is recalling virtually all its heparin products. Baxter makes and sells more than 500,000 multi-dose vials of heparin in the U.S. each month. Heparin is used to prevent blood from clotting during dialysis and some common forms of heart surgery.

More than 400 adverse reactions have already been reported in the US from the use of heparin, including up to 21 deaths. Investigators are trying to identify the root cause, which seems related to the practices of small Chinese suppliers of crude heparin.

To make heparin, workers collect and cook the mucous membrane from the intestines of slaughtered pigs, producing crude heparin. Major producers refine that and sell it to Baxter and others, which make the finished product for use in hospitals.

Blue ear pig disease has swept through China, depleting stocks, and leading some farmers to sell sick pigs. This led companies to switch to using small, often unsanitary and unregulated village workshops as less expensive suppliers. As much as 70% of China’s crude heparin now comes from such small factories in poor villages.

The FDA had admitted this month that it had violated its own policy by failing to inspect Changzhou SPL, located west of Shanghai, before the factory began shipping crude heparin, an ingredient of the medicine heparin, in 2004. The Chinese government does not inspect such factories.

Advice to heart surgery and dialysis patients: Ascertain, or ask your patient advocate to ascertain, the source of the heparin you will receive. A sufficient supply is available from safer suppliers.

Browse for related stories in the index at the very bottom of this page.

Thanks to Walt Bogdanich and David Barboza for the two source articles in last week's NY Times.

She can't help but wonder: Adverse effects of Procrit and Aranesp

Belinda G.'s mother was a chemotherapy patient who was also given anemia drugs. Although Belinda acknowledges that her mother was dying of small cell cancer, Belinda can't help but wonder if the use of anemia drugs resulted in her mother passing away sooner than she would have otherwise.

My mom had been sick since 2000 with lung cancer and it was small cell carcinoma at that time. She beat it and went into remission in 2001. She had never had Procrit or Epogen prior to her remission. Her cancer came back and the cancer spread to her adrenal glands and her organs. They did radiation every day for 10 days and chemo at the same time. The Procrit was given to her in injections that started around February or March 2002.

She was a fighter—at the beginning she even continued working and running apartments. Once she started getting shots more frequently, her cancer got progressively worse. She died rather suddenly on January 15, 2003. She was on the shots until she passed away.

They [medical staff] were telling her that she needed to have the shot because her cell count was low. One time, she asked for it as though she believed it was something she needed to help the situation. I asked why she was taking it, when she did better without it. Back then, there was not a lot known about that.

Every time my mom had chemotherapy, they gave her the anemia shots. She had been doing well until they started the shots. Did they accelerate the process? I don't know. Small cell is inoperable and there was nothing we can do about it. But I think the anemia drugs might have progressed the situation.

Belinda is not the only one left wondering if anemia drugs either caused a loved one's death or accelerated the rate at which a loved one has died. In November, the FDA strengthened the safety warning on Aranesp, Epogen and Procrit to alert patients to the risk of death, heart attack and the progression of certain cancers. Additionally, a new study has been released linking anemia drugs to an increased risk of leukemia in patients with myelofibrosis.

Doctors have also been warned to use the lowest possible doses of the anemia drugs required to avoid a blood transfusion. Patients who receive higher doses of Aranesp, Epogen or Procrit are at an increased risk of accelerated tumor development.

Today Andrew Pollack of the NY Times described a meta-analysis (carefully pooling the results of multiple studies) in the Journal of the American Medical Association (JAMA). Dr. Charles Bennett and the other authors of the study found that widely used anemia drugs raise the risk of death among cancer patients by 10%.

The U.S. Food and Drug Administration (FDA) will convene a meeting on March 13 to discuss restrictions on the use of the drugs.

Advice to cancer patients taking Aranesp or Procrit: Alert your doctor to the study in this highly esteemed medical journal, and ask your doctor whether and how it should affect your treatment.

Browse for similar stories in our index at the very bottom of this page, or read an FDA drug review story.

Thanks to Heidi Turner for the source story in the Jan. 1 issue of LawyersandSettlements.com.

This nonsensical situation: Prohibition on personal injury lawsuits about medical devices

In 1994, the U.S. Food and Drug Administration issued its pre-market approval for the use of a balloon catheter made by Medtronic for widening coronary arteries. Two years later, Charles Riegel underwent angioplasty – a form of heart surgery that uses a special balloon device to mash plaque against the walls of the artery to allow blood to flow more freely. The balloon catheter burst while being inserted, injuring him. He filed a lawsuit against Medtronic, the device maker, but the case was dismissed. He died after the lawsuit was filed, and his widow, Donna, carried on the case, appealing the dismissal of the case to the U.S. Supreme Court.

The Supreme Court decided on Wednesday that makers of medical devices like implantable defibrillators or breast implants are immune from liability for personal injuries as long as the FDA approved the device before it was marketed and the device meets the FDA's specifications.
The case turned on what Congress had meant by a clause in the 1976 Medical Device Amendments statute that bars states from imposing different requirements from federal requirements. The justices apparently decided on the Congress' intent without asking either of two current congressmen who had key roles in moving the bill forward back in 1976. Both the Senate’s sole sponsor of that legislation – Sen. Teddy Kennedy – and Rep. Henry Waxman, a member of the House panel that approved the bill, were sharply critical of the decision.

Sen. Kennedy commented, "In enacting legislation on medical devices, Congress never intended that FDA approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices." Rep. Waxman said, "The Supreme Court's decision strips consumers of the rights they've had for decades. This isn't what Congress intended, and we'll fix this nonsensical situation."

Advice to people who may need surgery to implant a medical device: Do your homework carefully to understand the safety of various devices.

Browse for related stories in the index at the very bottom of this page, or read a medical device malfunction story.

Thanks to Linda Greenhouse for the source article in today's NY Times.

He was found dead at his computer: A Fentanyl overdose

Adam Hendelson had been in a car accident as a teenager. For years, on his right arm he had worn a Duragesic patch, containing Fentanyl gel, to manage his chronic hip pain. In December 2003, at age 28, he was found dead at his computer. The cause was traced to a leak in the patch that had given him a fatal overdose. In June 2007, a Florida jury awarded his family $5.5 million.

Last week, noticing that hundreds of people had died from similar accidents, the Food and Drug Administration issued a warning about the use of Fentanyl. The FDA warned doctors against prescribing Fentanyl patches to anyone new to opioids, the family of painkillers that includes morphine. The drug is only to be used for chronic pain in people who are used to using narcotics, such as cancer patients. Fentanyl can cause other people to have trouble breathing.

Advice to those with family members using Fentanyl patches: Read the FDA warning.

Browse for related stories in the index at the very bottom of this page, or read a less harmful story about conscious sedation.

Thanks to Lauran Neergaard of the Associated Press and Kenneth Reid for the source stories in the Dec. 22 issue of the Boston Globe and the June 18 issue of Adverse Event Reporting News, respectively.

Rats and mice get better protection: FDA and informed consent for human subjects

The case of Audine Graybill demonstrates the flaws in the system. According to the U.S. Food and Drug Administration, in the spring of 2005, she decided to try an experimental drug to treat mania associated with bipolar disorder. The consent form that she signed on May 29 said she could change her mind at any point in the study.

She checked into High Pointe healthcare in Oklahoma City, a psychiatric center owned by a psychiatrist, Dr. David Linden. On June 3, she changed her mind and asked to leave.

Dr. Linden refused to let her go.

On June 6, she was given the experimental medicine. Her lawyer, Anthony Sykes, presented a writ of habeas corpus to High Pointe to obtain her release. But the hospital staff neither obeyed it nor gave it as requested to Dr. Linden.

More than nine months later the FDA discovered many other problems there, but only this summer finally wrote a warning letter. Meanwhile, the Oklahoma Board of Medical Licensure and Supervision suspended the doctor's license.

Dr. Linden has conducted clinical trials for most major pharmaceutical companies and continues to do research, according to his website.

According to today's front-pagestory in the New York Times, Audine's experience is quite common because of lax management by the FDA.

"Rats and mice get greater protection as research subjects in the United States than do humans," said Dr. Arthur Caplan, Chairman of the Department of Medical Ethics at the University of Pennsylvania.


Advice to human subjects in clinical trials: Talk through your rights with a patient advocate or lawyer.

Read another of our informed consent stories, or read Gardiner Harris’ source story in today’s New York Times.

What chemo dose should my 150-pound Golden Retriever take?: An adverse drug reaction story

Dr. Lawrence Burgh has a sober outlook on life. A 48-year-old physician whose career has centered on treating seriously ill patients, he himself was diagnosed with cancer in December 2006. He has begun dosing himself with DCA, a simple laboratory chemical that has never before been used to treat cancer in people.

Last month, he learned the cancer in his thigh had spread to his lungs. "My prognosis is very poor," he says. "Standard chemotherapy would give me only a slim chance of survival at five years." So he turned to DCA, after reading about the promising lab experiments in New Scientist (20 January, p 13).

But Lawrence (a pseudonym) has yet to see DCA make any impact on his cancer. Medical scans on 19 March showed that the primary tumour in his thigh has shrunk, and is less active, but this may be due to the delayed effects of radiotherapy and chemotherapy Burgh had in January. The number of metastatic tumors in his lungs has not changed since last month, and they are larger and more active. "These results are very preliminary," he stresses, "but I was really hoping for better results." On 21 March, he stopped taking the drug after noticing symptoms which by 24 March included a numbness in his hands, which he believes to be a sign of a disease of the nervous system (neuropathy), and a hypoglycemic attack. He advises other people with cancer not to self-medicate with DCA except under medical supervision. "I am concerned others may try this drug on their own in desperation," he says. "DCA is chemotherapy, a serious drug with potentially serious side effects."

DCA is not patentable as a medication, so there is no incentive for pharmaceutical companies to run the clinical trials necessary to make DCA legal as a cancer treatment. So two Web sites sprang up: one with research papers and chat rooms to discuss DCA, and another site selling DCA supposedly for use in pets with terminal cancer. Both sites are run by a California man who operates a pest-control company. The FDA is investigating both web sites because DCA hasn't gone through clinical trials or been approved for human use. Even marketing DCA for pets is illegal. Even so, researchers have been getting emails from people asking for dosage information for, say, a 150-pound "Golden Retriever."

Advice to patients with advanced cancer: Read Linda Geddes’ article in the New Scientist, the research, and the web site of the Abigail Alliance, which advocates faster drug development for critically ill patients, then discuss it with your oncologist.

Read another chemo story.

Thanks to April Rabkin of Mother Jones for summarizing the New Scientist article.