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Breaking News Topics:

Defective Drug News, Recall Information, and FDA Warnings

 

9/02/2009 Yasmin Ocella Lawsuit May begin:
Yasmin, also known as Ocella, has been causing severe side effects in woman that have prompted many to contact lawyers seeking compensation for their suffering. Is Yasmin safe for woman? What are the known side effects and what are the steps to a Yasmin lawsuit? Find out more on the potential Yasmin Lawsuit

 

FDA's View on antiepileptic drugs:
FDA Analysis shows patients receiving antiepileptic drugs have twice the risk of suicidal behavior.
The FDA announced today that is has completed review of reports of suicidal behavior from its clinical studies of 11 drugs used to treat epilepsy, psychiatric disorders and other conditions.

LIST OF DRUGS MENTIONED BY THE FDA:

Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
Felbamate (marketed as Felbatol)
Gabapentin (marketed as Neurontin)
Lamotrigine (marketed as Lamictal)
Levetiracetam (marketed as Keppra)
Oxcarbazepine (marketed as Trileptal)
Pregabalin (marketed as Lyrica)
Tiagabine (marketed as Gabitril)
Topiramate (marketed as Topamax)
Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
Zonisamide (marketed as Zonegran)

http://www.fda.gov/medWatch/safety/2008/safety08.htm#Antiepileptic

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1/25/08 Class I recall of All Fire Star and Dura Star balloon catheters
Cordis Corporation and FDA informed healthcare professionals of a Class I recall of All Fire Star and Dura Star balloon catheters, lots 13173912 through 13315455, plus 52 additional lots above 13315455. Balloon catheters are used in a medical procedure (known as percutaneous transluminal coronary angioplasty or PTCA) to open narrowed or blocked blood vessels or arteries of the heart. The product has a potential for slow deflation or no deflation of the angioplasty balloon when inserted into the artery or other blood vessels. This may potentially result in a total blockage of the artery or blood vessels, resulting in a change in the heart rate or heart rhythm, injury to the heart artery, a heart attack, need for a surgical procedure, or death.

Read the complete MedWatch 2008 safety summary, including a link to the recall notice, at http://www.fda.gov/medwatch/safety/2008/safety08.htm#DuraStar

11/19/07 Age Intervention Eyelash
FDA informed healthcare professionals and consumers of the seizure of 12,682 applicator tubes of Age Intervention Eyelash, sold and distributed by Jan Marini Skin Research, Inc. of San Jose, California. The product was seized because it may lead to decreased vision in some users. The eyelash product is an unapproved and misbranded drug because it is promoted to increase eyelash growth. Before a new drug product may legally be marketed, it must be shown to be safe and effective, and approved by FDA. FDA considers the product to be an adulterated cosmetic because it contains bimatoprost, an active ingredient in an FDA-approved drug to treat elevated intraocular pressure (elevated pressure inside the eye). Use of the prescription drug in addition to the eyelash product containing the drug, may increase the risk of optic nerve damage because the extra dose of bimatoprost may decrease the prescription drug's effectiveness. Damage to the optic nerve may lead to deceased vision and possibly blindness. Other possible adverse events may include macular edema (swelling of the retina) and uveitis (inflammation in the eye) which may lead to decreased vision.

Dermatologists, estheticians, and consumers who may still have Age Intervention Eyelash should discontinue use and discard any remaining product. Consumers should also consult their healthcare professional if they have experienced any adverse events that they suspect are related to use of the product. Click for MedWatch Alert.

10/29/07 CellCept (mycophenolate mofetil)
Roche and FDA notified healthcare providers that use of CellCept (mycophenolate mofetil) is associated with increased risk of first trimester pregnancy loss and increased risk of congenital malformations, especially external ear and facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, and kidney. Based on postmarketing data from the United States National Transplantation Pregnancy Registry and additional postmarketing data collected in women exposed to systemic mycophenolate mofetil during pregnancy, the pregnancy category for CellCept has been changed from Category C (risk of fetal harm cannot be ruled out) to Category D (positive evidence of fetal risk). Labeling changes include the following sections: BOXED WARNING, WARNINGS/Pregnancy and Pregnancy Exposure Prevention, PRECAUTIONS/Information for Patients, and ADVERSE REACTIONS/Postmarketing Experience.

Within one week of beginning CellCept therapy, women of childbearing potential should have a negative serum or urine pregnancy test. In addition, women of childbearing potential (including pubertal girls and peri-menopausal woman) taking CellCept must receive contraceptive counseling and use effective contraception. Healthcare professionals and patients should be aware that CellCept reduces blood levels of the hormones in the oral contraceptive pill and could theoretically reduce its effectiveness. See the Dear Healthcare Professional Letter for additional recommendations for women of childbearing potential. Click for MedWatch Alert.

10/11/2007 - Recall issued for children's cough and cold medicine.
The various makers of different brands of cough and cold over the counter medicine are issuing a recall because of the chance of young children having an overdose. Warning labels so far are not clear enough to highlight the dangers.

Cough and Cold Medicine brands listed for the recall include:

• Concentrated Infants' TYLENOL Drops Plus Cold;
  
• Concentrated Infants' TYLENOL Drops Plus Cold & Cough;
  
• PEDIACARE Infant Drops Decongestant (PSE);
  
• PEDIACARE Infant Drops Decongestant & Cough (PSE);
  
• PEDIACARE Infant Dropper Decongestant (PE);
  
• PEDIACARE Infant Dropper Long-Acting Cough;
  
• PEDIACARE Infant Dropper Decongestant & Cough (PE) products;
  
• Dimetapp Decongestant Plus Cough Infant Drops;
  
• Demetapp Decongestant Infant Drops;
  
• Little Colds Decongestant Plus Cough;
  
• Little Colds Multi-Symptom Cold Formula;
  
• Robitussin Infant Cough DM Drops;
  
• Triaminic Infant & Toddler Thin Strips Decongestant and Triaminic Infant & Toddler Thin Strips Decongestant Plus Cough.

Please contact us today if your child was harmed by taking any of the above listed medications. Lawyers and Attorneys can help in these situations. To read more on this please visit this page; Children's cough and cold medicine recall information and recall list.

9/21/07 - Axcil and Desirin (marketed as dietary supplements
TWC Global LLC, Inc., issued a nationwide recall of Axcil and Desirin, both marketed as dietary supplements, because they contain potentially harmful, undeclared ingredients. FDA laboratory analysis of Axcil and Desirin found that the lot of 02B07 contained 3mg/g of sildenafil, the active ingredient of a FDA approved drug used for Erectile Dysfunction (ED). The products also contained sulfosildenafil and sulfohomosildenafil, which are analogs of sildenafil. All of these undeclared chemicals pose a threat to consumers because they may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
(see FDA Medwatch alert)

9/21/07 - Baby's Bliss Gripe Water, Apple flavor
MOM Enterprises Inc., and FDA informed consumers and healthcare providers that Baby's Bliss Gripe Water, apple flavor, with a code of 26952V and expiration date of October 2008 (10/08) is being recalled due to the presence of Cryptosporidium infection. The product is labeled Baby's Bliss. Pediatrician Recommended Gripe Water. Apple Flavor. An herbal supplement used to ease the gas and stomach discomfort often associated with colic, hiccups, and teething in infants and children.
(see FDA Medwatch alert)

9/14/2007 - B. Braun Medical Inc. Normal Saline Flush Syringes
B. Braun Medical Inc., issued a recall of Normal Saline Flush Syringes with lot numbers ending in "SFR" due to an increase in customer complaints of particulate matter in the saline. The introduction of particular matter into the blood stream may result in phlebitis and/or damage to vital organs such as the brain, kidneys, heart and lungs. To a less likely extent, there is also a potential for the development of pulmonary embolism or silicone embolism syndrome, which could cause sever injury and/or death. To date, B. Braun has received no reports of any patient injury associated with this issue.

Customers that have the recalled product in their possession should discontinue use immediately and contact their physician if they have experienced any problems that may be related to the usage of this product.
(see FDA Medwatch alert)

9/7/2007 - Zencore Tabs- Product Marketed As A Dietary Supplement Recalled Because It Was Found To Contain Potentially Harmful Ingredients
Bodee LLC, Inc., issued a nationwide recall of Zencore Tabs, a product marketed as a dietary supplement, because it contains undeclared ingredients. FDA laboratory analysis of Zencore Tabs found that the product contains aminotadalafil, an analog of tadalafil, and sildenafil, both of which are active ingredients of FDA-approved drugs used for Erectile Dysfunction. The product also contained sulfosildenafil and sulfohomosildenafil which are analogs of sildenafil. All of these undeclared chemicals pose a threat to consumers because they may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
Consumers who have this product should stop using it immediately and consult their healthcare professional if they experience any problems that may be due to this product. (see FDA Medwatch alert)

8/21/2007- Confidence Inc., Voluntarily Recalls One Lot of METABOLISM Apple Cider – These dietary supplement capsules are being recalled after they were found to contain Sibutramine, an FDA approved ingredient that is often used as an appetite suppressant. However, METABOLISM Apple Cider has not been approved by the FDA, classifying it as as undeclared drug ingredient, and therefore cannot be distributed containing an FDA approved drug. Use of Sibutramine is cautioned due to its ability to raise blood pressure and heart rate. Unused products can be returned directly to the manufacturer.

8/15/2007 Children's Cough Medicine - Public Health Advisory – The FDA has announced that the Nonprescription Drug Advisory Committee will meet in October to review and confer regarding children's cough and cold medicine, its labeling, active ingredients, dosage guidelines, and effectiveness. Concerns have been raised that consumers are not following dosing requirements and usage allowances as directed, as well as administering the nonprescription drugs to children under the age of 2. The FDA stresses that no medication can cure the common cold, they are to be used to ease symptoms and the sickness will subside with time. If your child's symptoms do not improve you should immediately take him/her to see your health care provider.

8/14/2007 Kaletra Oral Solution Dear Healthcare Provider Letter - Abbott Laboratories disseminated a Dear Healthcare Provider Letter throughout the world to physicians and pharmacists that prescribe/distribute Kaletra Oral Solution. The letter informed healthcare professionals of an accidental overdose that occurred with a pediatric patient taking Kaletra Oral Solution. The infant received a significantly large dose of Kaletra and subsequently died. Healthcare professionals should pay special attention to accurate calculation of the dose of Kaletra, transcription of the medication order, dispensing information and dosing instructions to minimize the risk for medication errors. (see FDA Medwatch alert)

8/9/2007 Prilosec & Nexium – FDA Issues Safety Statement : After the release of results following a 14 year study surrounding Prilosec and Nexium, the FDA has yet to formulate its own conclusive stand on the issue. The FDA has stated they will research the information that has been presented to them and consider the conclusions of the research conducted prior to taking any action against two of the most commonly prescribed medications in the United States. Prilosec and Nexium, both manufactured by AstraZeneca Pharmaceuticals, have primarily been used to to treat gastroesophageal reflux disease (GERD), as well as gastric ulcers. Both medications promote the healing process of erosion on the esophagus and stomach lining due to excessive amounts of acids. The study claims to have found a link between long-term use of Prilosec or Nexium and severe cardiovascular complications such as heart attacks and heart failure which can lead to sudden death.

5/23/2007 Gadolinium The U.S. Food and Drug Administration (FDA) has asked manufacturers to include a new boxed warning on the product labeling of all gadolinium-based contrast agents which are used to enhance the quality of magnetic resonance imaging (MRI). Gadolinium has been found to cause a severe condition in those with renal failure called Nephrogenic Systemic Fibrosis (NSF), also known as Nephrogenic Fibrosing Dermotherapy (NFD). Though it is still considered a rare disease, NSF cases are becoming more prevalent among those patients who have kidney malfunctions.

5/21/2007 Avandia/Avandamet/Avandaryl FDA is aware of a potential safety issue related to rosiglitazone maleate, sold as Avandia, Avandamet, and Avandaryl. Safety data from a pooled analysis of controlled clinical trials has shown a significant increase in the risk of heart attack and heart-related deaths in patients taking this medication. The FDA is not advising healthcare providers to stop prescribing the medication, but rather states it will continue investigating its preliminary findings and results will be made available for public awareness and safety following their conclusions and a professional review.

3/30/2007 Zelnorm FDA Issues Public Health Advisory- FDA is announcing that Novartis Pharmaceuticals has agreed to FDA’s request that they voluntarily discontinue marketing and sales of Zelnorm (tegaserod maleate). The request was based on newly available information that showed increased risk of serious cardiovascular events including myocardial infarction (heart attack), unstable angina (chest pain), and stroke, associated with use of the drug.

4/24/2007 Diacetyl  The U.S. Labor Department's Occupational Safety and Health Administration (OSHA) has begun a National Emphasis Program (NEP) initiative to further research the detrimental side effects that are becoming prevalent in an occupational capacity.  Diacetyl is a chemical that is contained in the butter flavoring of microwave popcorn and has been linked to bronchiolitis obliterans, a potentially life-threatening obstructive lung disease, usually contracted by workers in the factories that manufacture the butter flavoring.

12/11/2006 Quinine - FDA Warns About Off-Label Use - Quinine is often prescribed to patients who suffer from chronic leg cramps. However, recent statistics have revealed several potentially serious problems with the off-label use of this drug. Off-label use is defined as using a medication for a purpose other than what it is intended to be prescribed for. Quinine is approved for use as treatment for Malaria and the FDA is urging healthcare providers to adhere to the approved label use. If you are suffering from ongoing medical problems as a result of a careless doctor's off-label prescription please contact our firm today in regard to your case.