Tag Archives: fda recalls

FDA approves first drug treatment for sexual desire disorder

FDA approves first drug treatment for sexual desire disorder

The U.S. Food and Drug Administration has approved Addyi (flibanserin) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Prior to Addyi’s approval, there were no FDA-approved treatments for sexual desire disorders in men or women.

HSDD is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance. HSDD is acquired when it develops in a patient who previously had no problems with sexual desire. HSDD is generalized when it occurs regardless of the type of sexual activity, the situation or the sexual partner.

Addyi can cause severe low blood pressure (hypotension) and loss of consciousness (syncope). These risks are increased and more severe when patients drink alcohol or take Addyi with certain medicines (known as moderate or strong CYP3A4 inhibitors) that interfere with the breakdown of Addyi in the body. Because of the alcohol interaction, the use of alcohol is contraindicated while taking Addyi. Health care professionals must assess the likelihood of the patient reliably abstaining from alcohol before prescribing Addyi.

Addyi is being approved with a risk evaluation and mitigation strategy (REMS), which includes elements to assure safe use (ETASU). The FDA is requiring this REMS because of the increased risk of severe hypotension and syncope due to the interaction between Addyi and alcohol. The REMS requires that prescribers be certified with the REMS program by enrolling and completing training. Certified prescribers must counsel patients using a Patient-Provider Agreement Form about the increased risk of hypotension and syncope and about the importance of not drinking alcohol during treatment with Addyi. Additionally, pharmacies must be certified with the REMS program by enrolling and completing training. Certified pharmacies must only dispense Addyi to patients with a prescription from a certified prescriber. Additionally, pharmacists must counsel patients prior to dispensing not to drink alcohol during treatment with Addyi.

Addyi is also being approved with a Boxed Warning to highlight the risks of hypotension and syncope in patients who drink alcohol during treatment with Addyi, in those who also use moderate or strong CYP3A4 inhibitors, and in those who have liver impairment. Addyi is contraindicated in these patients.

The most common adverse reactions associated with the use of Addyi are dizziness, somnolence (sleepiness), nausea, fatigue, insomnia and dry mouth.

For more information:

FDA Press Release: FDA approves first drug treatment for sexual desire disorder

FDA’s Patient-Focused Drug Development Public Meeting and Scientific workshop on Female Sexual Dysfunction: http://www.fda.gov/Drugs/NewsEvents/ucm401167.htm

Source: FDA.gov

Medical Device Safety and Recalls: Serious Adverse Events with Implantable Left Ventricular Assist Devices (LVADs

Today the FDA issued a safety communication regarding serious adverse events with Implantable Left Ventricular Assist Devices (LVADs). To date, there are two implantable LVADs approved by the FDA: The HeartMate II Left Ventricular Assist System manufactured by Thoratec Corporation, and the HeartWare Ventricular Assist System HVAD manufactured by HeartWare, Inc.

The FDA is aware of serious adverse events associated with both devices, and is alerting health care providers, patients, and caregivers about serious adverse events associated with LVADs. These adverse events include an increased rate of pump thrombosis (blood clots inside the pump) with Thoratec’s HeartMate II and a high rate of stroke with the HeartWare HVAD since approval of the devices. We are also aware of bleeding complications associated with both devices.

For more information, please see: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm457327.htm

Disclaimer: The EDC Developer blog is “one man’s opinion”. Anything that is said on the report is either opinion, criticism, information or commentary, If making any type of investment or legal decision it would be wise to contact or consult a professional before making that decision

New FDA Drug Safety Communication on Gilenya (fingolimod)

The U.S. Food and Drug Administration is warning that a case of definite progressive multifocal leukoencephalopathy (PML) and a case of probable PML have been reported in patients taking Gilenya (fingolimod) for multiple sclerosis (MS). These are the first cases of PML reported in patients taking Gilenya who had not been previously treated with an immunosuppressant drug for MS or any other medical condition. As a result, information about these recent cases is being added to the drug label.

Patients taking Gilenya should contact their health care professionals right away if they experience symptoms such as new or worsening weakness; increased trouble using their arms or legs; or changes in thinking, eyesight, strength, or balance. Patients should not stop taking Gilenya without first discussing it with their health care professionals. Health care professionals should stop Gilenya and perform a diagnostic evaluation if PML is suspected.

Gilenya is an immunomodulator shown to benefit patients with relapsing forms of MS. This type of MS causes attacks or relapses, which are periods of time when symptoms get worse. Immunomodulators alter the immune system to reduce inflammation.

To learn more, please visit: Gilenya.

Source: Division of Drug Information (DDI)

Unichem Pharmaceuticals (USA), Inc. Issues a Voluntary Nationwide Recall of Hydrochlorothiazide Tablets Due to the Potential Presence of Foreign Tablets

Unichem Pharmaceuticals (USA), Inc. Issues a Voluntary Nationwide Recall of Hydrochlorothiazide Tablets Due to the Potential Presence of Foreign Tablets

Unichem Pharmaceuticals (USA), Inc. (Unichem) is voluntarily recalling one lot of Hydrochlorothiazide Tablets 25 mg 1000-count bottle to the consumer level. This recall has been initiated as a precautionary measure due to the identification of a Clopidogrel tablet found in a bottle of the product.

For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.

Recalls, Market Withdrawals and Safety Alerts for U.S. Food & Drug Administration (FDA).

Baxter Initiates Voluntary Recall Of Two Lots Of IV Solutions Due To The Potential Presence Of Particulate Matter

Baxter Initiates Voluntary Recall Of Two Lots Of IV Solutions Due To The Potential Presence Of Particulate Matter

Baxter International Inc. announced today it is voluntarily recalling two lots of intravenous (IV) solutions to the hospital/user level due to the potential presence of particulate matter. The particulate matter in each case was determined to be an insect and was identified as a result of a customer complaint.

. For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.

Medical Device Safety and Recalls: MicroPort Orthopedics Inc., PROFEMUR Neck Varus/Valgus CoCr 8 Degree, Part number PHAC 1254

Medical Device Safety and Recalls: MicroPort Orthopedics Inc., PROFEMUR Neck Varus/Valgus CoCr 8 Degree, Part number PHAC 1254

A recall has been issued for MicroPort Orthopedics Inc., PROFEMUR Neck Varus/Valgus CoCr 8 Degree, Part number PHAC 1254
. MicroPort Orthopedics Inc. has received reports of an unexpected rate of fractures after surgery related to this specific modular neck. If the modular neck fractures, the patient may experience sudden pain, instability and difficulty walking and performing common task. An acute fracture will require revision surgery to remove and replace the neck and stem components. Acute fracture and emergency revision surgery is a serious adverse health consequence and could lead to neurovascular damage, hematoma, hemorrhage, and even death.