Valisure Finds Another Carcinogen in Blood Pressure Medicine Valsartan, dimethylformamide (DMF)

The most used blood pressure medicine Valsartan, seem to attract troubles like a magnet does iron particles. The newest trouble is a solvent called dimethylformamide or commonly known as DMF, is classified by the World Health Organization as a probable carcinogen. The FDA allows drugs to contain the equivalent of about 8.8 million nanograms of daily exposure to DMF. The agency last revised its allowable solvent levels in 2017; the WHO classified DMF as a probable carcinogen in 2018.

A solvent called dimethylformamide was discovered in the drug valsartan made by several companies, including Swiss pharmaceutical giant Novartis AG, and some companies that were deemed safe by FDA after the recent recalls of valsartan, according to a filing last week to the Food and Drug Administration by New Haven, Connecticut-based Valisure.
Valisure runs an FDA registered facility and its results were verified by Emery Pharma, an FDA-registered research lab in Alameda, California.

“Medicines are kind of like used cars: By the time you get it it’s already five or six years old, it’s touched hundreds of hands and it’s got 100,000 miles on it,” Valisure Chief Executive Officer David Light said in an interview.

Once facts were revealed, none denied the possibility of contamination. Some drugmakers whose pills tested positive for DMF said that neither they nor the outside companies that produce active ingredients for their drugs use the solvent, though some indicated they don’t have complete visibility into their supply chain. Some of the valsartan that was positive for DMF was on a list of medicines the FDA had earlier deemed safe to use amid the recalls, including drugs manufactured by Alembic Pharmaceuticals Ltd. and Macleods Pharmaceuticals Ltd., both based in India.

Alembic doesn’t use DMF in its manufacturing process, according to spokesman Ajay Desai, who said the contamination likely occurred during analysis. A representative for Macleods couldn’t be reached for comment.

“Novartis cannot currently fully exclude the possibility that traces of DMF (within acceptable limits) may have been present in materials” provided to their suppliers, said Novartis spokesman Eric Althoff in an email.

FDA is investigating the Valisure report at the moment. In the meantime these Valsartan had the highest levels of DMF;







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Federal Court Sides With Novartis And Protects Gilenya Patent From Obviousness-Type Double Patenting

This decision arose from ANDA litigation relating to Novartis’s Gilenya® product for treating multiple sclerosis.
In Novartis AG v. Ezra Ventures LLC, the Federal Circuit addressed “the interplay between a patent term extension (PTE) granted pursuant to 35 U.S.C. § 156 and the obviousness-type double patenting doctrine.” In upholding the Novartis Gilenya patent, the court confirmed that the statute permits an extended product patent to “effectively” block the practice of an earlier-expiring method patent, and refused to elevate the judicially-created doctrine of obviousness-type double patenting over the statutory grant of PTE. Pharmaceutical patent owners will welcome this decision as reinforcing the validity of patents during their PTE term, and may consider how it might apply to similar circumstances raised by a patent term adjustment (PTA) award.

Full length document from pharmapatentsblog....

NOVARTIS' Gilenya (fingolimod) Could Induce Severe Worsening of Multiple Sclerosis After Stopping the Medicine

FDA Drug Safety Announcement 

Severe Worsening of Multiple Sclerosis After Stopping the Medicine, NOVARTIS' Gilenya (fingolimod)

If you are a patient and has been instructed to stop Gilenya, should contact your health professional immediately if you experience new or worsened symptoms such as:

• weakness
• trouble using arms or legs
• changes in thinking, eyesight or balance.

Patients should not stop taking the medicine on their own and should speak to their health professional first, as stopping treatment can lead to worsening MS symptoms.

Drug Label : One of many

AUDIENCE: Patient, Health Professional, Neurology, Pharmacy

ISSUE: FDA is warning that when the multiple sclerosis (MS) medicine Gilenya (fingolimod) is stopped, the disease can become much worse than before the medicine was started or while it was being taken. This MS worsening is rare but can result in permanent disability.

BACKGROUND: Gilenya is one of several medicines approved to treat a form of MS called relapsing MS, which are periods of time when MS symptoms get worse. The medicine was approved in the United States in 2010.

RECOMMENDATION:

Healthcare professionals should:

• Inform patients before starting treatment about the potential risk of severe increase in disability after stopping Gilenya.
• Patients should be carefully observed for evidence of an exacerbation of their MS and treated appropriately when Gilenya is stopped.
• Patients should be advised to seek immediate medical attention if they experience new or worsened symptoms of MS after Gilenya is stopped.
• Test for new or enhancing lesions by magnetic resonance imaging (MRI) if an increase in disability occurs and begin appropriate treatment as needed.
• Encourage patients to read the patient Medication Guide they receive with their Gilenya prescriptions, which explains the benefits and risks of the medicine.

Patients who have been instructed to stop Gilenya, should contact your health professional immediately if you experience new or worsened symptoms such as:

• weakness
• trouble using arms or legs
• changes in thinking, eyesight or balance.

Patients should not stop taking the medicine on their own and should speak to their health professional first, as stopping treatment can lead to worsening MS symptoms.