Tysabri (natalizumab) Drug Safety Communication

Posted on January 23, 2012 by Ws Revelations

Tysabri (natalizumab): Drug Safety Communication – New Risk Factor for Progressive Multifocal Leukoencephalopathy (PML)

AUDIENCE: Neurology, Gastroenterology

ISSUE: FDA notified healthcare profesisonals that testing positive for anti-JC virus (JCV) antibodies has been identified as a risk factor for progressive multifocal leukoencephalopathy (PML). PML is a rare but serious brain infection associated with use of Tysabri (natalizumab) for the treatment of multiple sclerosis (MS) or Crohn’s disease.

A patient’s anti-JCV antibody status may be determined using an anti-JCV antibody detection test that has been analytically and clinically validated, and has been ordered by a healthcare professional. The Stratify JCV Antibody ELISA test2 was cleared by FDA on January 20, 2012. Testing positive for anti-JCV antibodies means that a person has been exposed to JCV in the past.

BACKGROUND: Tysabri (natalizumab) is in a class of medications called immunomodulators. It works by stopping certain cells of the immune system from causing damage to the body. Tysabri is approved for the treatment of relapsing forms of multiple sclerosis since November 2004 and for the treatment of moderately to severely active Crohn’s disease since January 2008.

RECOMMENDATION: The risks and benefits of continuing treatment with Tysabri should be carefully considered in patients who are found to be anti-JCV antibody positive and have one or more of the other known risk factors for PML. Patients with all three known risk factors have an estimated risk of PML of 11/1,000 users. See the Drug Safety Communication Data Summary section for additional information.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including links to tht eFDA Drug Safety Communication and News Release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm288602.htm

Posted in FDA 2012, FDA Notice, Gastroenterology, Neurology | Tagged , , , , , , , , | Comments Off

Perfect Image Solutions Topical Hair Regrowth Products Recall

Posted on January 23, 2012 by Ws Revelations

Perfect Image Solutions Topical Hair Regrowth Products: Recall – Unapproved Drugs, Risk of Health Hazards

  • Men’s Minoxidil 15% Azelaic 5% Hair regrowth topical, 60ml
  • Men’s Minoxidil 10% Azelaic 5% Hair regrowth topical, 60mL
  • Men’s Minoxidil 5% Azelaic 5% Hair regrowth topical, 60mL
  • Women’s Minoxidil 3% Azelaic 5% Hair regrowth topical, 60mL
  • Hair regrowth shampoo enhanced with Ketoconazole and salicylic acid, 180mL

AUDIENCE: Consumer

ISSUE: Perfect Image Solutions recalled all lots of these topical hair regrowth products because they are deemed “unapproved new drugs” under FDA regulations, and may present potential health hazards.

Use of these topical products containing 15% and 10% Minoxidil have not been shown to be safe, and could pose a risk to the general public due to the possibility of systemic absorption. Skin abrasions or irritations, such as psoriasis or sunburn, could increase the systemic absorption of topically administered Minoxidil. Minoxidil 15% and 10% could cause low blood pressure, heart palpitations and associated cardiac symptoms. Azelaic acid contained in the topical products could make the skin where it is applied more sensitive to sunburn. Ketoconazole contained in the shampoo product could cause hair discoloration and abnormal hair texture, removal of the curl from permanently waved hair, itching, rash, skin irritation and dry skin. Salicylic acid contained in the shampoo could cause mild, temporary burning, itching, irritation, or stinging.

BACKGROUND: These products are used to slow or stop hair loss and promote hair regrowth and are packaged in glass-dropper containers or plastic shampoo bottles, and are sold in single units. They are used by men and women generally in middle to late adulthood. The product can be identified by the name Perfect Image Solutions on the container. Product was distributed nationwide or worldwide via the internet.

RECOMMENDATION: Consumers that have product which is being recalled should discard it.

Read the MedWatch safety alert, including a link to the Press Release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm288562.htm

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Vagifresh Ball Vagifresh Gel Female One Recall

Posted on January 23, 2012 by Ws Revelations

Vagifresh Ball, Vagifresh Gel, Female One: Recall – Undeclared Drug Ingredient, Bacterial Contamination

AUDIENCE: Consumer, OB/GYN

ISSUE: USA Far Ocean Group Inc. notified the public of a recall of Vagifresh Ball and Vagifresh Gel, sold as cosmetics. Vagifresh Gel was found by FDA analysis to contain benzocaine, an active ingredient for many anesthetic drug products. FDA analysis of Vagifresh Ball found the product contains bacteria. The FDA has also determined that marketing material for these products contained unsubstantiated therapeutic claims related to various gynecologic conditions that could have caused women taking these products from seeking appropriate medical care for potentially serious medical conditions.

BACKGROUND: Vagifresh Ball and Vagifresh Gel products are marketed as cosmetics, and applied by inserting deeply into the vagina for a prolonged period of time. These products were sold via herbal stores, beauty shops, drug stores, internet and mail order. These two products were also sold under the mixed package named Female One, which contained Vagifresh Ball, Vagifresh Gel and Vagifresh Liquid (this recall does not involve Vagifresh Liquid). FDA analysis of Vagifresh Ball found the product contains bacteria including Staphylococcus lentus, S. sciuri, Bacillus Lantus, Alloiococcus otitis, Aerococcus viridans, Aeromonas salmonicid, Gemella spp, and Leuconostoc spp.

RECOMMENDATION: Consumers in possession of these products should stop using it immediately and contact their physician if they experienced any problem that may be related to using any of these products.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Press Release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm288432.htm

Posted in Consumer Products, FDA 2012, FDA Recall, FDA Warning, OBGYN | Tagged , , , , , , , , , , , , , , | Comments Off

The Biggest Drug Recalls of 2011

Posted on January 14, 2012 by Ws Revelations

The Biggest Drug Recalls of 2011

Always be careful when you take your medications. Make sure you talk about it with your doctor or make some research because some of them may worsen the condition or risk your health instead of improving it.

Fortunately, FDA drug recalls exist to keep you safe. In partnership with Department of Health and Human Services, the Food and Drug Association makes sure that pharmaceutical companies abide by its safety standards.

Some of the biggest FDA drug recalls of 2011 are:

Gotu Kola and Bladderwrack freeze dried capsules: Eclectic Institute voluntarily recalled this in December because of possible Salmonella contamination.

Oral contraceptives: Qualitest Pharmaceuticals recalled their birth controls in September because of packaging error. The error in the label may cause product misuse leading to unwanted pregnancy.

Vasopressin Injection: American Regent Incorporated voluntarily recalled this in August because of its reduced effectiveness through time. Vasopressin Injection treats and prevents post-operative abdominal distention.

Tylenol Extra Strength Caplets: McNeil Consumer Healthcare recalled this in July because of its moldy odor. The odor indicates the presence of 2, 4, 6-tribromoanisole chemical. It may cause temporary and non-serious gastrointestinal problems.

Endocet tablets (10 mg, 325 mg): FDA and Endo Pharmaceuticals recalled this in July because a bottle may have tablets of different strengths. This may lead to overdose and liver ailments.

Butalbital, Acetaminophen and Caffeine tablets (50 mg, 325 mg, and 40 mg), and Hydrocodone Bitatrate and Acetaminophen tablets: FDA and Qualitest recalled them in July because a bottle may have the wrong tablets. This may cause patients taking wrong medications.

Risperdal risperidone tablets (3 mg and 2 mg): Ortho-McNeil-Janssen Pharmaceuticals recalled this in June because of its musty odor indicating a trace of 2, 4, and 6 tribromoanisole. Risperdal treats schizophrenia, bipolar disorder and irritability related to autism.

Pentrexyl Forte Natural: FDA and Phoenix Import Distribution recalled this in May because of misleading packaging. Patients may confuse it as an antibiotic causing delayed treatment to serious illness.

Irinotecan Hydrochloride Injection: APP Pharmaceuticals voluntarily recalled this in May because of possible fungal contamination.

Metronidazole tablets (250 mg): FDA and Teva Pharmaceuticals recalled this in May because its tablets are underweight. Patients may not be getting the prescribed dose with underweight tablets.

Jantoven Warfarin Sodium tablets (3 mg): FDA and Upsher-Smith Laboratories recalled this in May because its actual dosage is higher than what the label says. This may cause drug overdose.

Stop taking any FDA drug recalls mentioned above. If you have one, you may return it to its manufacturer and ask for a refund. You are also encouraged to report any adverse effect related to its consumption to the FDA.

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Adcetris (brentuximab vedotin) Drug Safety Communication

Posted on January 13, 2012 by Ws Revelations

Adcetris (brentuximab vedotin): Drug Safety Communication – Progressive Multifocal Leukoencephalopathy and Pulmonary Toxicity

AUDIENCE: Oncology, Hematology, Neurology

ISSUE: FDA notified healthcare professionals that two additional cases of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection that can result in death, have been reported with the lymphoma drug Adcetris (brentuximab vedotin). Due to the serious nature of PML, a new Boxed Warning highlighting this risk has been added to the drug label.

In addition, a new Contraindication warning was added against use of Adcetris with the cancer drug bleomycin due to increased risk of pulmonary (lung) toxicity.

The signs and symptoms of PML may develop over the course of several weeks or months. They may include changes in mood or usual behavior, confusion, thinking problems, loss of memory, changes in vision, speech, or walking, and decreased strength or weakness on one side of the body.

BACKGROUND: Adcetris (brentuximab vedotin) is used to treat Hodgkin lymphoma and a rare lymphoma known as systemic anaplastic large cell lymphoma. At the time of Adcetris’ approval in August 2011, one case of PML was described in the Warnings and Precautions section of the label.

RECOMMENDATION: Patients who develop any signs and symptoms of PML should notify their healthcare professional immediately. Healthcare professionals should hold Adcetris dosing if PML is suspected and discontinue Adcetris if a diagnosis of PML is confirmed. See the Data Summary in the Drug Safety Communication for additional information.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm287710.htm

Posted in FDA 2011, FDA Label Change, FDA Notice, FDA Warning, Hematology, Neurology, Oncology | Tagged , , , , , , , , , | Comments Off