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FDA warns of increased risk of hip, wrist and spine fractures from high doses or prolonged use of prescription ulcer medication.

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Bisphosphonates (osteoporosis drugs) include Fosamax label change warning regarding atypical fractures


The U.S. Food and Drug Administration today warned patients and health care providers about the possible risk of atypical thigh bone (femoral) fracture in patients who take bisphosphonates, a class of drugs used to prevent and treat osteoporosis. A labeling change and Medication Guide will reflect this risk.
Bisphosphonates inhibit the loss of bone mass in people with osteoporosis. Bisphosphonates have been shown to reduce the rate of osteoporotic fractures -- fractures that can result in pain, hospitalization, and surgery-- in people with osteoporosis. While it is not clear whether bisphosphonates are the cause, atypical femur fractures, a rare but serious type of thigh bone fracture, have been predominantly reported in patients taking bisphosphonates. The optimal duration of bisphosphonate use for osteoporosis is unknown, and the FDA is highlighting this uncertainty because these fractures may be related to use of bisphosphonates for longer than five years.

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Vita Breath dietary supplement

FDA notified healthcare professionals, their patients, and consumers not to consume Vita Breath, a dietary supplement manufactured by American Herbal Lab and marketed at health fairs and on the Internet, because the product may contain hazardous levels of lead. The New York City Department of Health and Mental Hygiene analyzed a sample of Vita Breath and reported it contained 1,100 parts per million of lead. This level is more than 10,000 times higher than FDA’s maximum recommended level for lead in candy.

People with high blood levels of lead may show no symptoms, but the condition may cause damage to the nervous system and internal organs. Acute lead poisoning may cause a wide range of symptoms, including abdominal pain, muscle weakness, nausea, vomiting, diarrhea, weight loss, and bloody or decreased urinary output. Children are particularly vulnerable to lead poisoning.

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MasXtreme warning

MasXtreme, a product sold as a dietary supplement contains aildenafil close in structure to sildenafil and is expected to possess a similar pharmacological and adverse event profile as well as the drug phentolamine which is an alpha-adrenergic blocker. This may pose a threat to consumers because aildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Common side effects of phentolamine include arrhythmia (abnormal heart rhythm) and tachycardia (rapid heart beat).

The product is distributed nationwide by Natural Wellness Inc. Consumers who have purchased MasXtreme capsules are urged to immediately discontinue their use.

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Plavix get new FDA warning

The FDA has issued a new warning for the aniti-clotting drug Plavix. The new box warning contains language to warn about the reduced effectiveness in patients who are poor metabolizers of Plavix. The drug sold by Bristol-Myers Squibb earns $8 billion dollars a year for the drug company and is the second best selling drug in the world. It is estimated by the FDA that 2 to 14% of the population are poor metabolizers of Plavix. The drug company says people should continue to take Plavix unless told otherwise by their doctor.

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Avandia warning


Two FDA officials have recommended that diabetes drug Avandia be pulled from the market due to potential heart problems. Studies dating back to 2007 have showed a link between the drug and heart attacks. Roughly 304 heart attacks were reported last quarter and it is estimated that removing the drug could prevent another 500 attacks from happening.

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Zicam Cold Remedy Nasal Products (Cold Remedy Nasal Gel, Cold Remedy Nasal Swabs, and Cold Remedy Swabs, Kids Size)

FDA notified consumers and healthcare professionals to discontinue use of three Zicam Nasal Gel/Nasal Swab products sold over-the-counter as cold remedies because they are associated with the loss of sense of smell that may be long-lasting or permanent. The FDA has received more than 130 reports of loss of sense of smell associated with the use of the three Zicam products.  In these reports, many people who experienced a loss of smell said the condition occurred with the first dose; others reported a loss of the sense of smell after multiple uses of the products.

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FDA Warns Consumers About Tainted Weight Loss Pills

Agency seeks recall of products that pose serious health risks

The U.S. Food and Drug Administration is alerting consumers nationwide not to purchase or consume more than 25 different products marketed for weight loss because they contain undeclared, active pharmaceutical ingredients that may put consumers’ health at risk.

The tainted weight loss products are:

Fatloss Slimming

2 Day Diet     

3x Slimming Power

Japan Lingzhi  24 Hours Diet

5x Imelda Perfect Slimming

3 Day Diet

7 Day Herbal Slim

8 Factor Diet

7 Diet Day/Night Formula

999 Fitness Essence

Extrim Plus

GMP

Imelda Perfect Slim

Lida DaiDaihua

Miaozi Slim Capsules

Perfect Slim

Perfect Slim 5x

Phyto Shape

ProSlim Plus

Royal Slimming Formula

Slim 3 in 1

Slim Express 360

Slimtech

Somotrim

Superslim

TripleSlim

Zhen de Shou

Venom Hyperdrive 3.0

 

 

An FDA analysis found that the undeclared active pharmaceutical ingredients in some of these products include sibutramine (a controlled substance), rimonabant (a drug not approved for marketing in the United States), phenytoin (an anti-seizure medication), and phenolphthalein (a solution used in chemical experiments and a suspected cancer causing agent). Some of the amounts of active pharmaceutical ingredients far exceeded the FDA-recommended levels, putting consumers' health at risk.

These weight loss products, some of which are marketed as “dietary supplements,” are promoted and sold on various Web sites and in some retail stores. Some of the products claim to be “natural” or to contain only “herbal” ingredients, but actually contain potentially harmful ingredients not listed on the product labels or in promotional advertisements. These products have not been approved by the FDA, are illegal and may be potentially harmful to unsuspecting consumers. 

The FDA advises consumers who have used any of these products to stop taking them and consult their healthcare professional immediately.

“These tainted weight loss products pose a great risk to public health because they contain undeclared ingredients and, in some cases, contain prescription drugs in amounts that greatly exceed their maximum recommended dosages,” said Janet Woodcock, M.D., director, Center for Drug Evaluation and Research, FDA. “Consumers have no way of knowing that these products contain powerful drugs that could cause serious health consequences. Therefore FDA is taking this action to protect the health of the American public.”

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FDA adds suicide warning to epilepsy drugs

The FDA announced it was adding new warnings to the labels of antiepileptic drugs regarding a heightened risk of suicide among users.  This action stops short of the strongest warning a drug can have which is the "black box" warning.  Patients taking these antiepileptic drugs should be monitored for any signs of the emergence of or worsening of depression, suicidal thoughts, behavior or unusual mood changes.  Again the warning issued includes a heightened risk to users of suicidal thoughts and behaviors.

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FDA investigating Vytorin cancer link

Based on recently released studies showing Vytorin increasing the risk of cancer, the FDA announced that the Agency is investigating a report from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial of a possible association between the use of Vytorin and a potentially increased incidence of cancer.

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FDA Seeks stronger warnings for Byetta

The U.S. Food and Drug administration is seeking stronger warnings for people taking the diabetes drug Byetta due to the risk of pancreatitis after the deaths of two patients.  The FDA announced it had received six reports of hemorrhagic or necrotizing pancreatitis requiring hospitalization.  In October, the FDA said it had reviewed 30 reports of pancreatitis in patients being treated with Byetta.

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Vytorin news: clinical trials of Vytorin did not help people avoid heart related problems but did show an increase risk of cancer.  A clinical study known as "Seas" showed an increase risk of cancer for those patients taken Vytorin. These results heighten the concern over the drugs safety and effectiveness.

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 The FDA said today that Bayer Pharmaceuticals Corp. has agreed to an agency request to suspend marketing of the company's Trasylol blood-clotting drug because of an increased risk of death.

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Avandia Warning

FDA informed healthcare professionals of new information added to the existing boxed warning in Avandia's prescribing information about potential increased risk for heart attacks. The new information refers to a meta-analysis of 42 clinical studies, most of which compared Avandia to placebo, that showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. At this time, FDA has concluded that there isn't enough evidence to indicate that the risks of heart attacks or death are different between Avandia and some other oral type 2 diabetes treatments. People with type 2 diabetes who have underlying heart disease or who are at high risk of heart attack should talk to their healthcare professional about the revised warning as they evaluate treatment options. Healthcare professionals are advised to closely monitor patients who take Avandia for cardiovascular risks.

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Cefepime warning

FDA issued an early communication about the ongoing review of new safety data and the request for additional data to further evaluate the risk of death in patients treated with cefepime. An article in the May 2007 issue of The Lancet Infectious Diseases (Efficacy and safety of cefepime: a systematic review and meta-analysis) raised the question about increased mortality with the use of cefepime, a broad spectrum B-lactam antibiotic currently approved for the treatment of a variety of infections due to susceptible strains of microorganisms. The article describes a higher all-cause mortality in patients treated with cefepime compared to other B-lactam antibiotics. Until FDA's evaluation is completed, healthcare professionals who are considering the use of cefepime should be aware of the risks and benefits described in the prescribing information and the new information from this meta-analysis.






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