Archive for August, 2008

Four more Byetta® patients die

Thursday, August 28th, 2008

According to a Bloomberg.com report this week, Byetta® has more problems. The Food and Drug Administration has confirmed four more patients taking the type 2 diabetes drug Byetta® have died from pancreatitis.

That brings the drug-related fatalities to six in the last few months, though the FDA said no definite link between the additional deaths and Byetta® has been proven.

Federal regulators are working with Amylin Pharmaceuticals and Eli Lilly & Co. to develop a stronger warning label for the widely used drug. Regulators stress that patients who exhibit symptoms of pancreatitis should stop taking Byetta right away. Those symptoms include nausea, vomiting and abdominal pain. Regulators warn that it can be very difficult to tell the difference between acute and less dangerous forms of pancreatitis.

Already, a Virginia man has filed a defective drug lawsuit in a California court alleging Byetta’s manufacturers failed to adequately test and monitor the side effects, and didn’t warn doctors or patients of the risk of developing pancreatitis.

Vivitrol Warnings

Thursday, August 28th, 2008

The Food and Drug Administration has released a warning about injection site reactions from Alkermes, Inc.’s drug Vivitrol, known generically as naltrexone. Vivitrol has been approved by the FDA since 2006 for the treatment of serious alcohol addiction. It is administered as an injection into a buttock monthly.

Serious injection site reactions associated with Vivitrol include abscesses, cellulitis, indurations, hemotomas, and necrosis. Sixteen of the nearly 200 reported injection site reactions required surgery to fix.

If you or loved one are receiving Vivitrol injections, you should consider the following:

• Though pain, swelling, bruising, pruritus and redness at the injection site are not uncommon, anyone who experiences these symptoms for more than two weeks after the medication is administered should be referred to a surgeon.
• Vivitrol should be administered into the gluteus muscle, alternating buttocks. Risks increase when Vivitrol is injected into fatty tissue.
• Vivitrol uses a special 1-1/2 inch long needle. No other needle should be used.
• Because of the limited needle length and the necessity to inject Vivitrol into muscular tissue, patients who have thicker gluteal fat (such as women) may be physiologically at risk of developing injection site reactions.

If you have any adverse symptoms to a Vivitrol injection that last more than a couple of weeks, contact your doctor.

Beware False Cancer Cures

Thursday, August 28th, 2008

Products marketed as cancer cures are scams. The Food and Drug Administration has identified 23 companies inside the United States and two foreign that have been marketing so-called cancer prevention and cancer curing tablets, extracts, teas, tonics, salves and creams over the internet.

These products contain such homeopathic substances as bloodroot, shark cartilage, coral calcium, cesium, ellagic acid, Cat’s Claw, an herbal tea called Essiac, and various kinds of mushrooms.

Some common marketing pitches include:
• “Treats all forms of cancer.”
• “80% more effective than the world’s number one cancer drug.”
• “Skin cancers disappear.”
• “Target cancer cells while leaving healthy cells alone.”
• “Shrinks malignant tumors.”
• “Avoid painful surgery, radiotherapy, chemotherapy, or other conventional treatments.”

None of these products are approved to treat, cure, or prevent cancer. They are simply hoaxes, and dangerous ones at that, since taking off-label medication may interfere with a patient’s legitimate cancer treatment through drug-drug and drug-supplement interactions. Homeopathic products such as those listed above are not regulated like FDA-approved medications are, and may differ dramatically from lot to lot.

If you are self-medicating with any one of these products, consult your doctor immediately.

You can view the complete list of fake cancer cures here:
http://www.fda.gov/cder/news/fakecancercures.htm