Booster Shots

Oddities, musings and news from the health world

Category: Food and Drug Administration

Take note, parents of children with autism: FDA says supplement is a drug

June 25, 2010 | 10:04 am

Osr The "dietary supplement" sold as OSR#1 is actually a toxic drug, with potentially serious side effects, the Food and Drug Administration has warned.

The product was the subject of a story published in the Times Health section a few months ago: Industrial chemical OSR#1 used as autism treatment

Here's the latest article, on the warning letter from the agency: FDA warns maker of product used as alternative autism treatment

The story quotes Ellen Silbergeld, an environmental health expert at Johns Hopkins University, as saying: "An industrial chemical known to be toxic — his own incomplete testing indicates it is toxic. It has no record of any therapeutic aspect of it, and it is being marketed for use in children."

-- Tami Dennis

Photo credit: Chicago Tribune

FDA approves Amgen's osteoporosis drug Prolia

June 1, 2010 |  3:52 pm

Walker In a long-awaited development, the first drug in a new class of osteoporosis medications was approved Tuesday by the Food and Drug Administration. The drug is Amgen's injectable treatment, Prolia. The medication, for postmenopausal women with osteoporosis, is expected to be popular as concerns have mounted about the safety of the class of osteoporosis drugs called bisphosphonates. Bisphosphonates, including the medication Fosamax, have been linked to cases of jaw necrosis.

Prolia works differently than other medications for bone health. It blocks production of cells called osteoclasts that break down bone. Prolia will require an injection every six months. The drug was shown in clinical trials to reduce vertebral, non-vertebral and hip fractures. Side effects include back pain, musculoskeletal pain, high cholesterol levels and bladder infections as well as some skin infections and low calcium levels in the blood. Prolia too may contribute to jaw necrosis, according to the FDA. As part of the approval agreement, Amgen will continue to gather data to monitor the safety of Prolia.

The drug's wholesale cost will be $825 per injection.

-- Shari Roan

Photo: National Institute of Arthritis and Musculoskeletal and Skin Diseases

The FDA approves new drug for Pompe disease

May 25, 2010 | 11:40 am

The Food and Drug Administration on Tuesday approved a new drug called Lumizyme for the treatment of Pompe disease, a disabling genetic disorder that is often fatal. A drug called Myozyme is available to treat the disease, but supplies have been severely restricted and it is reserved for use in children and infants with the most severe form of the disorder. Approval of Lumizyme, which is closely related to Myozyme, will make treatment available to much larger numbers of people.

Pompe disease, which affects about one in 40,000 Americans, is caused by mutations in the gene that is the blueprint for an enzyme called acid alpha-glucosidase, which is used by tissues to convert a form of sugar called glycogen into energy. If the enzyme is not working properly, glycogen builds up in tissues, especially in the heart and muscles, weakening them severely. Many different mutations have been discovered, and they vary in severity. Some mutations produce only a partial impairment in activity and the disease does not become a problem until adolescence or adulthood. In other cases, however, the enzyme does not work at all, and the disorder can be fatal at a very young age unless treated. In infants, symptoms include respiratory problems that often lead to infections, feeding problems, poor weight gain, muscle weakness, floppiness, head lag and an enlarged heart. More than half of victims also suffer enlarged tongues. In the late onset form, the primary symptom is muscle weakness leading to respiratory problems that can be fatal. The heart is usually involved, but it does not become grossly enlarged.

Myozyme, produced by Genzyme Corp. of Cambridge, Mass., is a synthetic form of alfa-glucosidase that breaks down the glycogen, easing Pompe symptoms. The company originally produced the drug in 160-liter batches, which limited the available supply so that its use had to be restricted to infants and children who were most severely affected. The company applied to the FDA to manufacture the drug in 2,000-liter batches, but the agency determined that the synthetic enzyme produced in the larger batches was slightly different from the original product. Apparently, more sugar molecules are attached to its surface. The company was thus forced to conduct clinical trials of the new form, which it chose to call Lumizyme. The safety and efficacy of the drug was demonstrated in a trial on 90 late-onset patients ages 10 to 70, and the FDA granted approval. An estimated 200 adult patients in this country are already receiving the drug on a compassionate basis, and it has already been approved in several other countries.

Because it is a protein, the drug has to be administered by infusion. The primary side effects are allergic reactions to the drug, which include hives, diarrhea, vomiting, itchy skin, skin rash and chest discomfort. The drug will carry a so-called black box warning cautioning about the possibility of severe allergic reactions. The company will undertake a post-marketing surveillance program to monitor for side effects, and the drug will be available only through a restricted distribution system to ensure that it reaches the proper patients, the FDA said.

-- Thomas H. Maugh II

How a fat cell comes to be

May 18, 2010 |  7:22 pm

Fatcell Look at that fat cell! Lovely, yes? Ever wonder how one forms?

Well, it just so happens that an article in the current issue of the journal Genes and Development describes how immature fat cells pass through a fleeting, previously unappreciated "intermediate-fat-cell" stage before emerging, like a butterfly from a chrysalis, into full, fatty maturity.

Well, maybe not quite like a butterfly emerging from a chrysalis. But the finding does have implications for drug development.

Scientists at the University of Pennsylvania School of Medicine found that early stage fat cells first enter an intermediate fat-cell stage. The intermediate stage is kick-started by hormones related to cortisol, the stress hormone. All kinds of changes in gene activity happen during this intermediate stage, ones that send the fat cell inexorably down the road to maturity even after the trigger has gone away.

Study author Dr. Mitchell Lazar of Penn suggests that these gene changes may offer clues to drugs that might stop the fat cells from maturing. Leads would seem to be needed, as quite a few anti-obesity candidates have not panned out. (One current hope is Qnexa, a combination of the drugs phentermine and topiramate, currently under review by the Food and Drug Administration.)

Photo credit: Dr. Mitchell A. Lazar, PhD / University of Pennsylvania School of Medicine

Foods should be subject to the same scrutiny as drugs, experts say

May 12, 2010 |  3:52 pm

They call it the Food and Drug Administration. So you might think the safety of food and drugs are tested to the same degree before they’re allowed to go on the market.

Fda In fact, that’s not the way it works. But perhaps it should, says Dr. John Ball, executive vice president or the American Society for Clinical Pathology in Chicago.

Ball chaired a committee organized by the Institute of Medicine that was asked to come up with a way to vet some of the biomarkers that are routinely used in safety studies. (For instance, do higher levels of “bad” cholesterol really translate into an increased risk of heart disease?)

But as the committee members contemplated a box of Cheerios, they started to consider a larger question: Was it okay for the box to tell consumers “You could lower your cholesterol 4% in 6 weeks”? And that led to an even bigger question: Is there any reason to hold health claims for foods and dietary supplements to a lesser standard than health claims made for drugs?

Their answer: No way. As Ball wrote in the preface to the committee’s report, which was released Wednesday:

There is neither rationale nor scientific basis for predicating regulatory decisions on different levels of scientific evidence for different substances: “science is science.” That is, the same level of scientific evidence of benefit and risk should be required of foods as of drugs.

As for the notion that drugs should be subjected to extra scrutiny because they are inherently riskier than foods, the committee didn’t buy it:

Foods are encountered by a greater population than the target group who encounter drugs, and though drugs are subject to professional mediation (e.g., prescription and counseling), foods are not. As for risk, no one who is allergic to peanuts, eggs, or shellfish would argue that foods are less risky than drugs.

The report asks Congress to expand the FDA’s authority to police unwarranted and untested claims made by food and supplement makers. But it’s not at all clear that Congress is eager to “put the food and supplement industries on a shorter leash,” as our colleague Andrew Zajac writes on our sister blog, The Swamp:

Fresh restrictions on what food growers or producers can say about the health benefits of their tofu or Brussels sprouts likely won't go down well. Supplements manufacturers have even less incentive to welcome invitations to prove their health claims.

You can read a summary of the committee’s report on the Institute of Medicine website. If you’re interested in the full 267 pages, it’s available online as well. And here's the link to the IOM press release.

-- Karen Kaplan

Photo: The regulators in this building should test foods and drugs with equal rigor, according to an expert panel. Credit: Dennis Drenner/For the Times

The FDA warns against ... giving your dog a bone

April 21, 2010 | 10:28 am

The Food and Drug Administration, which protects the public against faulty and contaminated drugs, fake medical products and a host of other medically oriented products, has a new target in its sights -- bones for dogs.

"Some people think it's safe to give dogs large bones like those from a ham or a roast," said Dr. Carmela Stamper, a veterinarian in the FDA's Center for Veterinary Medicine. "Bones are unsafe, no matter what their size. Giving your dog a bone may make your pet a candidate for a trip to your veterinarian's office later, possible emergency surgery or even death."

Potential problems with bones, the FDA says, include:

-- Broken teeth, which may require veterinary dentistry.

-- Mouth or tongue injuries, which can be very bloody and messy.

-- The bone gets looped around the dog's lower jaw, which can be painful and frightening to the animal.

-- Bone can get stuck in the esophagus, necessitating surgery.

-- Bone can get stuck in the windpipe, necessitating surgery

-- Bone may be too big to pass out of the stomach, necessitating surgery

-- Bone may get stuck in the intestines, necessitating surgery.

-- Bone fragments may cause constipation.

-- Bone fragments can cause bleeding from the rectum, which is very messy.

-- Bone fragments can poke a hole in the stomach or intestines, causing peritonitis.

The bottom line, Stamper said, is stick with chew toys and artificial bones. "And if your dog 'just isn't acting right," call your veterinarian right away."

-- Thomas H. Maugh II


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