Potentially harmful pain relief supplement is being sold under new name
The US Food and Drug Administration (FDA) has issued a safety warning that a potentially harmful dietary supplement, Reumofan Plus, is being relabeled and sold under the name “Wow.” The supplement is marketed for the treatment of arthritis, muscle pain, osteoporosis, bone cancer, and other conditions.
 
According to an FDA laboratory analysis, Wow contains the same undeclared prescription drug ingredients found in Reumofan Plus: dexamethasone, diclofenac sodium, and methocarbamol. These ingredients may interact with other medications and cause serious adverse events.
 
In June and August 2012, the FDA warned the public about potential harm from using Reumofan Plus after receiving dozens of adverse event reports from consumers. The reports included liver injury, severe bleeding, corticosteroid withdrawal syndrome, adrenal suppression, stroke, and death.
 
Since the FDA’s warning, some distributors have relabeled Reumofan Plus as Wow to sell remaining supplies to online retailers, other distributors, and directly to consumers. Manufactured by Riger Naturals S.A., Reumofan Plus and Wow products are sold on various Web sites.
 
Health care providers should ask patients whether they use Reumofan Plus, Wow, or similar dietary supplements if they present with unexplained symptoms that suggest:

• nonsteroidal anti-inflammatory drug (NSAID) toxicity
• psychiatric changes
• use or abrupt discontinuation of corticosteroids.

 The FDA is asking health care professionals to report any adverse events related to the use of these products to the MedWatch Safety Information and Adverse Event Reporting Program.


Crush-resistant Opana ER is available in 2 new strengths
Last month, Endo Health Solutions introduced a 7.5- and 15-mg strength tablet to its line of crush-resistant Opana ER (oxymorphone HCl extended-release) tablets. The 2 new strengths join existing crush-resistant offerings that include 5-, 10-, 20-, 30-, and 40-mg tablets.
 
An opioid agonist, Opana ER is indicated for the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period. Endo reports that surveillance data suggest that the introduction of the crush-resistant formulation of Opana ER beginning in February 2012 has led to reduced abuse rates of the drug when compared to the non-crush resistant version the company discontinued in May.  
 
For the prescribing information, including important safety information, go to: www.opana.com.
 
For information on the Food and Drug Administration’s new draft guidance on abuse deterrent opioid formulations, see “FDA proposal encourages development of abuse deterrent opioids.” 


FDA approves Zecuity, a sumatriptan patch for migraine treatment
NuPathe Inc announced on January 17, 2013, that the Food and Drug Adminstration (FDA) has approved Zecuity (sumatriptan iontophoretic transdermal system), a battery-powered skin patch, for the acute treatment of migraine with or without aura in adults. The single-use patch is the first migraine patch approved by the FDA.
 
The device uses a low electrical current to deliver 6.5 mg of sumatriptan over 4 hours through the skin; patients apply the patch to their upper arm or thigh. If headache relief is incomplete, a second patch can be applied to a different site. No more than 2 patches, however, should be used in a 24-hour period.
 
In phase 3 trials, Zecuity was proven safe and effective in treating migraine and relieving such symptoms as headache pain, migraine-related nausea, and sensitivity to light and sound 2 hours after patch activation. The most common adverse reactions reported by study patients included application site pain, paresthesia, itching, warmth, and discomfort.
 
Individuals who have cardiac disease, stroke, peripheral vascular disease, severe liver disease, and other serious conditions should not use the sumatriptan patch.
 
Physicians should review the drug’s full prescribing information for contraindications and warnings and precautions before prescribing Zecuity. Note that the patches contain metal parts and must be removed before patients undergo magnetic resonance imaging procedures to avoid risk of injury.
 
The manufacturer anticipates that the migraine patch will be available for clinical use in the fourth quarter of 2013.