Agency working with trade associations to increase company vigilance and protect public

In a letter sent to dietary supplement manufacturers, the U.S. Food and Drug Administration expressed concern about undeclared or deceptively labeled ingredients in products marketed as dietary supplements. These substances include the active ingredients in FDA-approved drugs or their analogs (closely-related drugs), or other compounds, such as novel synthetic steroids, that do not qualify as dietary ingredients.

In recent years, FDA has alerted consumers to nearly 300 tainted products marketed as dietary supplements and received numerous complaints of injury associated with these products.

The FDA’s letter emphasizes that manufacturers and distributors are responsible for ensuring that their products comply with the law. Five major trade associations – Council for Responsible Nutrition, Natural Products Association, United Natural Products Alliance, Consumer Healthcare Products Association and American Herbal Products Association– are joining FDA on a call for media and have agreed to share the letter widely within the industry.

The FDA has noted the three most common categories of these illegal products:

* Weight loss products containing active ingredients such as sibutramine: Sibutramine is the active ingredient in the drug Merida, which was recently withdrawn from the market due to increased risk of heart attack and stroke. The FDA has discovered dozens of products, such as Slimming Beauty, Solo Slim, Slim-30, and others, which contain sibutramine or closely related drugs (analogs).
* Body-building products containing anabolic steroids or steroid analogs: These products can cause acute liver injury and increase the risk for heart attack, stroke and death. Products like Tren Xtreme, ArimaDex, and Clomed have been labeled to contain either anabolic steroids or aromatase inhibitors, which prevent anabolic steroids from being converted to estrogen.
* Sexual enhancement products that contain the same active ingredient or an analog of the active ingredient in the approved drugs Viagra, Cialis, and Levitra. The approved products are available only by prescription, and they should not be used by people who have certain medical conditions, such as cardiovascular disease. Products determined to be in violation of federal law by the FDA include Vigor-25, Duro Extend Capsules for Men, Magic Power Coffee, and others.

“The labeling of these tainted products may claim that they are ‘alternatives’ to FDA-approved drugs, or ‘legal’ alternatives to anabolic steroids,” said Michael Levy, director of the Division of New Drugs and Labeling Compliance at the FDA’s Center for Drug Evaluation and Research. “Consumers should avoid products marketed as supplements that claim to have effects similar to prescription drugs. Consumers should also be wary of products with labeling only in a foreign language or that are marketed through mass e-mails.”

Source: U.S. Food and Drug Administration

The U.S. Food and Drug Administration in September announced that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications.

These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.
 
Rosiglitazone also is available in combination with other diabetes medications, metformin under the brand name Avandamet or glimepiride under the brand name Avandaryl.

Avandia, manufactured by GlaxoSmithKline (GSK), is in a class of drugs known as thiazolidinediones, or TZDs. It is intended to be used in conjunction with diet and exercise to improve glucose (blood sugar) control in patients with Type 2 diabetes mellitus.
 
Doctors will have to attest to and document their patients’ eligibility; patients will have to review statements describing the cardiovascular safety concerns associated with this drug and acknowledge they understand the risks. The agency anticipates that the REMS will limit use of Avandia significantly. 
 
“Allowing Avandia to remain on the market, but under restrictions, is an appropriate response, given the significant safety concerns and the scientific uncertainty still remaining about this drug,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

If you or a loved one has been injured as the result of taking a dangerous drug, seek out an experienced defective drug attorney for professional insight.
 
Source: U.S. Food & Drug Administration

An article in the January 2011 issue of “Vanity Fair” details the globalization of our nation’s pharmaceutical trials.

As recently as 1990, the vast majority of drug trials were conducted in the U.S. or Europe. Today, pharmaceutical companies conduct most of their human testing in India, Africa and China.

It’s a lot cheaper and there are fewer regulations these companies much follow — in fact, in many of these countries, nothing regulates drug experiments on humans.

Further, there is absolutely nothing that demands transparency for these trials which lets drug makers pick and choose which trials they use to apply to the U.S. Food and Drug Administration for permission to market drugs in this country.

The FDA depends heavily on these trials. Because our enforcement mechanisms are so dangerously thing — as demonstrated in the heparin scandal — the FDA has precious little ability to oversee drug trials in this country, much less the more than 6,485 trials conducted overseas (in 2008).

Many of the drugs that are currently facing harsh criticism are the very drugs that relied heavily on these overseas trials. Studies for drugs like Celebrex, Ketek, Seroquel, Avandia and Paxil were conducted overseas, and the results of those trials — usually only the trials that showed the drug in the most positive light — used to gain FDA approval.

Often, these drug companies test drugs on children, even when their own researchers insist that the drug will have a limited benefit. Western countries have rigid regulations about testing on children but these regulations do not exists in most third world countries. Parents of these children — who are often illiterate and quite poor — are paid $350 per child enrolled in these studies but seldom told that they were taking part in an experiment.

The article makes the point that drug makers really do put profit first, and have only passing regard for the lives affected by the dangerous and defective drugs they make.

The article cites on study which revealed that, in 2009, 19,551 people died as a direct result of the prescription drugs they took, and that is just the reported number; only about 10 percent of such deaths are reported.

This puts the number of deaths due to FDA-approved drugs near 200,000 — dwarfing the number of people who die every year in car wrecks.

If you or someone you love has been harmed from using a dangerous or defective drug, please contact an experienced defective drug attorney for professional insight.

In August, Johnson & Johnson issued a voluntary recall for up to 93,000 artificial hips that had been surgically implanted since 2005.

The popular hip implant, the DePuy ASR XL Acetabular hip socket implant system, has an unacceptably high rate of failure. In fact, according to one study, one in eight of the implants have failed.

“That’s really a terrible track record,” said Richard Dodd, a senior partner with the Cappolino Dodd Krebs law firm in Cameron. The firm has extensive experience helping patients recover from the fallout of defective medical devices. “Most hip implants are given to older people for whom second surgeries can be life-threatening.

According to Dodd, symptoms of an implant failure include infection, bone fracture, dislocation and pain. In some cases, the implant can became loose in the socket which creates even more problems. Other complications of a failure of the DePuy Hip Implant include bone staining, necrosis, swelling, nerve damage, tissue damage and/or muscle damage. Increased metal toxicity from chromium and cobalt debris entering the blood stream of an unsuspecting patient can also lead to problems, even patients who have experienced no other symptoms.

Dodd said that many patients have received a recall notice, typically from the patient’s treating orthopedic surgeon, and urges patients to discuss any problems or symptoms with a doctor.  Of note, the letter indicates that DePuy will pay for the medical examination and any medical follow up listed in an “Information for Patients” sheet which should accompany the letter.

The letter also includes a medical release form. Dodd cautioned patients against signing the release form without consulting an attorney about it.

“We’re finding that DePuy is using this private medical information to twist the claim back on the patient,” he said. “I know it sounds strange but DePuy’s attorneys can and will use this information to build the case that the patient abused the implant.”

Even if DePuy does cover the costs of a revision surgery, Dodd warned that a second hip surgeries are technically more difficult, take longer to perform, place the patient at risk of higher complications and take longer to recover from.

“That’s in addition to the pain and suffering, invasive surgery, risk for infection, general complications and even risk of death,” he said.

Dodd urged patients who have had implant surgery since 2005 and know that it was a DePuy implant, to call your doctor right away. “Don’t sign anything that would let anyone other than your doctor have access to your medical records without first talking to an attorney.”

An advisory panel to the Food and Drug Administration narrowly voted to recommend a ban of two of the most popular prescription painkillers—Percocet and Vicodin—because of harm they can cause to the liver.

Percocet and Vicodin both combine a narcotic (oxycodone in Percocet, hydrocodone in Vicodin) with acetaminophen, a pain reliever commonly found in over-the-counter medications like Tylenol and Excedrin. Acetaminophen is used to relieve headaches and fevers, but is also known to cause liver damage. High doses of acetaminophen are the leading cause of liver damage around the country.

The FDA is not forced to act on the recommendations of the panel, but they usually do. If the FDA does decide to ban Percocet and Vicodin, doctors will still be able to prescribe their contents (the narcotic and acetaminophen) separately. Though doctors have this option now, many opt for the combination drugs because it makes the process of treating pain easier on patients, doctors, and pharmacists.

Is the Food and Drug Administration properly overseeing the approval and manufacturing of medical devices? This is the question brought by a House Energy and Commerce subcommittee who is seeking legislation to increase oversight of the FDA.

The Congressional subcommittee claims that the FDA has serious deficiencies in their reviewing processes, substandard postmarket surveillance, and that they irregularly inspected manufacturing facilities.

Their basic solution is this—allow consumers to file lawsuits against manufacturers of defective medical devices directly instead of just filing incidences with the FDA. This would prevent companies from being able to hide behind inadequate FDA standards for the products, thus ensuring safer devices.

The Food and Drug Administration has released warnings about the possibility of serious injuries and even death caused by the cancer-treatment drug Tarceva. Generically known as erlotinib, Tarceva is administered as a once-daily pill taken by the patient on an empty stomach. It is intended to block tumor growth in lung and pancreatic cancer patients.

Serious injuries now associated with Tarceva are fatal holes in the gastrointestinal tract, toxic epidermal necrolysis (blistering and separation of the top layer of skin), corneal perforations, and eye ulcerations.

Tarceva is manufactured by Genentech Inc. and OSI Pharmaceutical Inc. The FDA approved Tarceva in 2004 to treat locally advanced lung cancer and metastatic non-small cell lung cancer.  In 2005, Tarceva was approved to treat locally advanced pancreatic cancer when used in combination with gemcitabine.

The drug used for cosmetic purposes and some muscle spasms known as Botox has received criticism for inadequate warnings about off-label uses.

The FDA-approved drug uses a toxin known as botulinium toxin type-A to remove facial wrinkles, relief of excessive sweating, and treatment for cervical dystonia and other facial muscle spasms. The toxin paralyzes the targeted muscles or nerves for an average three to four months.

If improperly used, the toxin (which is essentially the same bacterium that causes botulism) can spread throughout the body, causing muscle weakness, difficulty breathing, blurry vision, bladder control, and even death.

Another concern is the use of Botox to control muscle spasticity in children, including those with cerebral palsy. The FDA has not approved the use of Botox for that purpose; several injuries have been reported as a result of this off-label use.

Botox and two other injections have been linked to rare botulism symptoms according to the Food and Drug Administration (FDA).  Botox and other drugs have been approved to treat certain types of muscle spasms, but health officials have warned doctors and patients about potentially deadly risks of using Botox and other drugs.

Although Botox is usually known for clearing the body of wrinkles by paralyzing facial muscles, it is also widely used for muscle-spasm conditions.  But in some cases, the drug can spread to areas outside of the target site and paralyze or weaken the muscles used for breathing and swallowing thus causing death.

Signs of botulism can appear just several hours after injection and include difficulty swallowing or breathing, slurred speech, and muscle weakness.

The FDA stated that it received reports of children being hospitalized and even dying after they were injected with the drugs to treat cerebral palsy.  Most adult cases came when they were treated for muscle spasms and neck contractions.  Some were hospitalized and had to be put on mechanical ventilation to breathe.

The FDA is now requiring manufacturers such as Allergan, Solstice Neurosciences, and Medicis to put additional warnings on their products and conduct safety studies.  The warnings urge physicians to tell their patients about the risks of the drugs and to seek medical help if they show any signs of botulism.  They also have to create pamphlets that tell the risks to patients.

Allergan said that they would cooperate but also stated that the cases of botulism are very rare.  “Botox has been marketed in the United States for nearly 20 years, its safety and efficacy profile are well understood, and reports of suspected distant spread have been rare,” the company said.

Botox and Botox Cosmetics have been given a new warning label in Canada that indicates that the anti-wrinkle drug can spread to other parts of the body. This potential side effect can be fatal. The new label also states that the drug can cause muscle weakness, difficulties in swallowing, pneumonia, and speech disorders.

The muscle relaxant has been licensed in Canada to treat facial nerve disorders and cerebral palsy, but it is much more commonly used to eliminate wrinkles and other facial age lines. Last February, the FDA linked the spread of Botox in the body to both FDA-approved and non-approved applications of the drug.

The new label stems from an investigation performed by Health Canada last October. Five patients died following Botox injections, and more than eight patients experienced severe side effects. The condition was deemed “distant toxin spread” by Health Canada.

The investigation also determined that doctors downplay the risks involved with Botox injections.