The FDA and Hi-Tech Pharmaceuticals have notified patients and healthcare professionals of a nationwide recall of all products sold under the name Stamina-Rx. A lab analysis by the FDA found that the product contained the undeclared ingredient − benzamidenafil − a drug in the same therapeutic class of active pharmaceutical ingredients that include the PDE5 inhibitors sildenafil, tadalafil, and vardenafil, that are FDA-approved for the treatment of erectile dysfunction. Benzamidenafil is not FDA-approved, and poses a threat to consumers because benzamidenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and may be most susceptible to adverse effects from this product. Stamina-Rx is sold predominantly in health food and drug stores nationwide. Consumers who have this product in their possession should stop using it immediately.
Acetaminophen Drops recall
Brookstone Pharmaceuticals, LLC, Alpharetta, GA has initiated a nationwide voluntary recall of all lots of Concentrated Acetaminophen Drops (NDC #42192-504-16) in 16 ounce (473 ml) bulk containers. This 16oz container is comparable to the size generally used to package regular strength acetaminophen liquid preparations.
Studies: Lantus diabetes drug may increase risk for cancer
The Food and Drug Administration has notified the public of four recent studies that looked at the use of Lantus (insulin glargine) and possible risk for cancer in patients with diabetes.
Three of the four studies suggest an increased risk for cancer associated with use of Lantus. Based on the currently available data, the FDA recommends that patients should not stop taking their insulin therapy without consulting a physician, since uncontrolled blood sugar levels can have both immediate and long-term serious adverse effects.
FDA is currently reviewing many sources of safety data for Lantus, including these newly published observational studies, data from all completed controlled clinical trials, and information about ongoing controlled clinical trials, to better understand the risk, if any, for cancer associated with use of Lantus.
Discussions are also ongoing between FDA and the manufacturer of Lantus as to whether any additional studies evaluating the safety and efficacy of this drug will need to be performed. FDA will communicate the results on its ongoing review to the public, as appropriate, as its review continues.
July 7, 2009–The U.S. Food and Drug Administration is taking several actions to reduce the risk of overdose in patients using pain medications such as Darvon and Darvocet that contain propoxyphene.
The actions were taken because of data linking propoxyphene and fatal overdoses. The agency is requiring manufacturers of propoxyphene-containing products to strengthen the label, including the boxed warning, emphasizing the potential for overdose when using these products. These manufacturers will also be required to provide a medication guide to patients stressing the importance of using the drugs as directed. In addition, the FDA is requiring a new safety study assessing unanswered questions about the effects of propoxyphene on the heart at higher than recommended doses.
Acetaminophen (Tylenol) tops the list of medicines implicated in liver damage requiring transplantation, according to a new study, as reported in MedPage Today on July 5, 2009.
Researchers analyzed records from a transplant database and found that patients with acetaminophen-induced injury were also more likely to be on life support than patients with liver failure caused by the next most common culprits, antituberculosis drugs, antiepileptics, and antibiotics, according to Ayse L. Mindikoglu, MD, of the University of Maryland in Baltimore and colleagues.
Patients whose liver failure was caused by acetaminophen also had a higher mean serum creatinine, and a greater requirement for dialysis prior to transplantation, the investigators reported in the July issue of Liver Transplantation.
The report comes on the heels of a Food and Drug Administration (FDA) advisory panel recommending a “black box” warning for prescription combination drugs that contain acetaminophen.
The FDA panel also recommended that the maximum single adult dose of Tylenol be reduced from 1,000 mg to 650 mg, and that the maximum daily dose be reduced from its current level of 4,000 mg.