PharmaLink gets orphan drug designation for Nefecon
STOCKHOLM The Food and Drug Administration has given orphan drug designation to a treatment for a rare kidney disease under mid-stage clinical development by privately owned Swedish drug maker PharmaLink, the company said.
The FDA granted the designation to Nefecon (PL-56), a treatment for IgA nephropathy, also known as Berger’s disease, a disorder that leads to end-stage kidney disease. The FDA gives orphan drug designation to incentivize development of treatments for rare and serious disorders.
“Today’s news marks a significant milestone for PharmaLink and increases the commercial value of Nefecon as it moves toward the marketplace,” PharmaLink managing director Johan Haggblad said. “We believe this product candidate has great potential in treating IgA nephropathy.”
FDA issues warning over unapproved OTC chelation products
SILVER SPRING, Md. The Food and Drug Administration on Thursday warned eight companies that their over-the-counter chelation products are unapproved drugs and devices and that it is a violation of federal law to make unproven claims about these products. There are no FDA-approved OTC chelation products, the FDA confirmed.
The companies that received the warning letters claim that their products treat a range of diseases by removing toxic metals from the body. Some also claim to treat autism spectrum disorder, cardiovascular diseases, Parkinson’s disease, Alzheimer’s disease, macular degeneration, and other serious conditions. Some companies that received the warning letters also claim their products will detect the presence of heavy metals to justify the need for chelation therapy.
The drug products involved have not been evaluated by the FDA for treatment of these diseases, and violate the Federal Food, Drug and Cosmetic Act. Despite the claims of the companies that received warning letters, the effectiveness in treating any of the diseases listed is unsubstantiated. Depending on the condition, when relying on unproven OTC chelation products to treat serious conditions, patients may delay seeking effective medical care.
In addition, there are serious safety issues associated with chelation products, which can alter the levels of certain substances in the blood. Even when used under medical supervision, these products can cause serious harm, including dehydration, kidney failure and death.
“These products are dangerously misleading because they are targeted to patients with serious conditions and limited treatment options,” stated Deborah Autor, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The FDA must take a firm stand against companies who prey on the vulnerability of patients seeking hope and relief.”
The agency advises consumers to avoid non-prescription products offered for chelation or detoxification. The only FDA-approved chelating agents are only available by prescription and are approved for use in specific indications such as lead poisoning and iron overload. Procedures involving these agents carry significant risks and should be performed only under medical supervision.
The FDA has noted an increase in “chelation therapy” products marketed on the Internet that claim to cleanse the body of toxic chemicals and heavy metals. Although some of the products are marketed as dietary supplements, they are unapproved drugs because they claim to treat, mitigate, prevent, or diagnose disease. The products come in various dosage forms, including transmucosal sprays, suppositories, capsules, liquid drops, and clay baths.
Some of the companies also sell unapproved screening tests that claim to detect the presence of heavy metals in urine to justify the need for chelation therapy.
“FDA will seek enforcement action against companies that promote therapeutic benefits of products not yet evaluated by the agency for safety and effectiveness,” noted Dara Corrigan, associate commissioner for Regulatory Affairs.
The companies must take prompt action to correct the legal violations cited in the warnings letters or face possible legal action, including seizure and injunction.
The FDA issued warning letters to the following companies:
- World Health Products: Detoxamin oral, Detoxamin suppositories, and the metal detector test kit;
- Hormonal Health and World Health Products: Kelatox suppositories, and the MetalDetector instant toxic metals test;
- Evenbetternow: Kids Chelat Heavy Metal Chelator, Bio-Chelat heavy metal chelator, Behavior Balance DMG liquid, AlkaLife alkaline drops, NutriBiotic grapefruit seed extract, Natur-Leaf, Kids Clear detoxifying clay baths, EBN detoxifying bentonite clay, and the heavy metal screen test;
- Maxam Nutraceutics/Maxam Labs: PCA-Rx, PC3x, AFX, AD-Rx, AN-Rx, Anavone, AV-Rx, BioGuard, BSAID, CF-Rx, CreOcell, Dermatotropin, Endotropin, GTF-Rx, IM-Rx, Keto-Plex, Natural Passion, NG-Rx, NX-Rx, OR-Rx, Oxy-Charge, PN-Rx, Ultra-AV, Ultra Pure Yohimbe, and the heavy metal screening test;
- Cardio Renew: CardioRenew and CardioRestore;
- Artery Health Institute: Advanced Formula EDTA oral chelation;
- Longevity Plus: Beyond chelation improved, EndoKinase, Viral Defense, Wobenzym-N; and
- Dr. Rhonda Henry: Cardio Chelate (H-870)
Enactment of new drug-disposal law a victory for pharmacy, NACDS says
WASHINGTON Enactment by the White House of a landmark, pharmacy-friendly drug-disposal bill won quick praise from chain pharmacy leaders Thursday.
President Obama signed the Secure and Responsible Drug Disposal Act into law Wednesday, changing the way the Drug Enforcement Administration regulates the return and destruction of unused and unwanted higher-risk medications. The new law establishes a legal process by which consumers can return their lawfully obtained controlled substance medications to DEA-authorized entities for disposal.
The National Association of Chain Drug Stores dubbed the bill’s enactment “a victory for pro-patient, pro-community and pro-pharmacy policy.”
“Importantly, and consistent with NACDS’ urging, the bill prevents the mandating of drug take-back programs in pharmacies,” the group noted.
NACDS president and CEO Steve Anderson today thanked the President and the bill’s chief supporters in Congress, including Sen. Amy Klobuchar, D-Minn.; Reps. Jay Inslee, D-Wash., and Bart Stupak, D-Mich.; and Texas Republicans Joe Barton and Lamar Smith. Those lawmakers, he said, “demonstrated a commitment to addressing the issue of drug disposal in a way that will not create new problems for public health and safety.
“The fact that this new law does not create a drug take-back program mandate for pharmacies means that these members of Congress listened and kept an open mind, and that deserves a great deal of recognition,” Anderson added. “NACDS remains committed to being part of the solution when it comes to advancing the safe use and safe handling of medications.”