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Recent Blog Posts in April 2011 |
| April 28, 2011 |
| FDA Proposes Studies on How Drug Maker Websites Influence Consumers |
| Posted By DeCarli Law |
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The FDA has proposed three studies to test how consumers react to promotional websites for prescription drugs based on the content and format of the website. The FDA published its proposal on April 28, 2011, and is seeking public comment.
The proposal explains that FDA regulations require that advertisements for prescription drugs “include a ‘fair balance’ of information about the benefits and risks of advertised products, both in terms of the content and presentation of the information.” The concern is that the old rules governing drug advertisements for print media are not adequately crafted to insure that online advertising discloses the potential risks from the drugs promoted online.
As an initial step toward creating new rules, the proposed studies seek to determine how website content and organization impact consumers’ understanding of the risks associated with prescription drugs. For example, one study will test consumers’ comprehension of drug risks based on how many clicks away from the home page risk information is located. It also will compare consumer comprehension of bulleted lists vs. paragraph text. Another study will scrutinize the use of personal testimonial videos.
The FDA will be accepting public comment on the proposed studies for the next 60 days. A complete copy of the FDA proposal may be found HERE. |
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| Continue reading "FDA Proposes Studies on How Drug Maker Websites Influence Consumers" » |
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| April 18, 2011 |
| FDA Orders Clinical Trials for Asthma Drugs |
| Posted By DeCarli Law |
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The FDA has ordered clinical trials to test the safety of Long-Acting Beta-Agonists (LABAs) when used in combination with inhaled corticosteroids. The clinical trials will involve 53,000 patients. The specific drugs to be studied are Symbicort (budesonide and formoterol), Advair Diskus (fluticasone and salmeterol), Dulera (mometasone and formoterol), and Foradil (formoterol).
LABAs are used to treat asthma by relaxing the muscles of the airways. However, they can increase the risk of severely worsening asthma symptoms that can lead to hospitalizations and death.
The FDA previously issued a safety announcement on LABAs on June 2, 2010 regarding their use in asthma treatment. The FDA ordered that the LABA labels be changed to state the following:
- Use of a LABA alone without use of a long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated (absolutely advised against) in the treatment of asthma.
- LABAs should not be used in patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.
- LABAs should only be used as additional therapy for patients with asthma who are currently taking but are not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid.
- Once asthma control is achieved and maintained, patients should be assessed at regular intervals and step down therapy should begin (e.g., discontinue LABA), if possible without loss of asthma control, and the patient should continue to be treated with a long-term asthma control medication, such as an inhaled corticosteroid.
- Pediatric and adolescent patients who require the addition of a LABA to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a LABA, to ensure adherence with both medications.
Last year's label change came after hospitalizations and deaths from the use of LABAs in asthma treatments. The complete announcement from the FDA may be found
HERE.
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| April 15, 2011 |
| Benzocaine Topical Products Can Cause Rare and Potentially Fatal Blood Disease Warns FDA |
| Posted By DeCarli Law |
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The FDA is warning the public about a potentially fatal side effect associated with Benzocaine, the main ingredient in over-the-counter gels and liquids applied to the gums or mouth to reduce pain. The over-the-counter products containing Benzocaine include Anbesol, Hurricaine, Orajel, Baby Orajel, Orabase, and store brand equivalents. These products are marketed to be used for pain relief from teething, canker sores, and irritation of the mouth and gums.
These and other Benzocaine products have caused a drug side effect called Methemoglobinemia.
Methemoglobinemia results in the amount of oxygen carried through the blood stream being greatly reduced. In the most severe cases,
Methemoglobinemia can result in death.
Signs and symptoms of Methemoglobinemia can appear within minutes to one or two hours after using Benzocaine. They include pale, gray or blue colored skin, lips, and nail beds; headache; lightheadedness; shortness of breath; fatigue; and tachycardia. Symptoms can appear after just one use of a Benzocaine product, or after multiple previous uses where there was no side effect before. You may read more about
Methemoglobinemia
HERE.
Even though Benzocaine products are sold over-the-counter, they should not be used on children under two years of age, except on advice and direct supervision of a physician. Instead of Benzocaine, the American Academy of Pediatrics recommends more natural remedies for teething pain. For example, give the child a teething ring chilled in the refrigerator, or gently rub or massage the child's gums with your fingers to relieve the symptoms of teething pain.
If a Benzocaine product has caused you, your child, or your family member to develop Methemoglobinemia, PLEASE report this to the FDA so the agency knows the extent of the problem. You may do so online
HERE, at
the FDA's website. Also, please save the product package, any unused portion of the product, and your purchase receipt if you still have it. Keeping these items will strengthen your ability to assert a legal claim if you choose to do so.
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| April 14, 2011 |
| Topamax Recall for Contamination From TBA, By-Product of Wood Treating Chemical |
| Posted By DeCarli Law |
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Drugmaker Johnson & Johnson today recalled 57,000 bottles of its Topamax epilepsy and migraine drug due to complaints of an “uncharacteristic odor” associated with the tablets. A spokesman stated that the odor is caused by trace amounts of a compound called TBA, a by-product of a chemical used to treat wood in some countries. The wood is used to construct pallets on which products are transported and stored.
The two lots involved in the recall were shipped between Oct. 19, 2010, and Dec. 28, 2010, and distributed in the U.S. and Puerto Rico. The recall includes Topamax with NDC code 50458-641-65 and lot numbers OKG110 with an expiration date of 06-2012 and OLG222 with an expiration date of 09-2012. Although Johnson & Johnson claims TBA is not considered toxic, some patients taking the contaminated drug have reported gastrointestinal symptoms.
This recall follows shortly after the FDA safety announcement we previously reported that
Topamax can cause birth defects such as cleft lips and cleft palates in the children of women who took
Topamax while pregnant. To learn more about the potential dangers of
Topamax, go
HERE.
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| April 11, 2011 |
| Migraine/Epilepsy Drug Topamax Causes Cleft Lip and Cleft Palate Birth Defects |
| Posted By DeCarli Law |
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The FDA has announced that when pregnant women take Topamax (generic name Topiramate), there is an increased risk their babies will have cleft lips and cleft palates (oral clefts).
Topamax is approved for treating epilepsy and migraines.
The FDA’s safety announcement cautions that “[t]he benefits and risks of topiramate should be carefully weighed when prescribing this drug to women of childbearing age, particularly for conditions not usually associated with permanent injury or death. Alternative medications that have a lower risk of oral clefts and other adverse birth outcomes should be considered for these patients.” The FDA further warned that women should use effective birth control if they do take Topamax/Topiramate. This is particularly important because oral clefts occur in the first trimester of pregnancy, before many women know they are pregnant.
Although the FDA has only approved Topamax/Topiramate for use in treating epilepsy and migraines, unapproved or “off label” uses include bipolar disorder, cluster heahaches, weight loss, PTSD, and alcoholism. In April 2010, Topamax manufacturer Ortho-McNeil agreed to pay $6.14 million in criminal fines, and $75.37 million in civil penalties for illegally promoting
Topamax for treatment of psychiatric conditions.
Women of childbearing age who are currently taking Topamax or a generic equivalent should immediately consult their physicians. If women who gave birth to children with cleft lips or cleft palates were taking
Topamax while pregnant, these birth defects may have been caused by
Topamax.
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