Med Check
FDA to Change Pregnancy and Lactation Labeling Info For Prescription Drugs
Just before the new year, the FDA published a final rule to set new standards for the presentation of information concerning pregnancy and breastfeeding on labels of prescription drugs and biological products. The rule goes into effect June 15.
“The [current] letter category system [A, B, D, and X] was overly simplistic and was misinterpreted as a grading system, which gave an oversimplified view of the product risk,” said Sandra Kweder, M.D., deputy director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, in a press statement. “The new labeling rule provides for explanations, based on available information, about the potential benefits and risks for the mother, the fetus, and the breastfeeding child.” The information provided under the new labeling requirements will be divided into the following categories:
Pregnancy: Information such as dosing and potential risks to the developing fetus and information about whether there is a registry that collects and maintains data on how pregnant women are affected when they use the drug.
Lactation: Information about using the drug while breastfeeding, such as the amount of drug in breast milk and potential effects on the breastfed child.
Females and males of reproductive potential: Information about pregnancy testing, contraception, and infertility as they relate to the drug.
“The new system is potentially more informative and more useful than the old grading system, ... [but] a great deal will depend on the content of the information that is provided under the new requirements, particularly for psychotropic medicines,” said Nada Stotland, M.D., a professor of psychiatry at Rush University and an expert in OB-GYN psychiatry, in an interview with Psychiatric News. “If the information provided is reasonable, … it should help decrease the anxiety both psychiatrists and patients may feel regarding these medication decisions.”
Stotland, a former APA president, emphasized that psychiatrists must continue to inform the public about multiple treatment options—including psychotherapies and social-support therapies—that can safely aid in reducing symptoms of mental illness during pregnancy. “If left untreated—or unsuccessfully treated—mental illness can have adverse consequences for both mother and child,” she emphasized.
Hydrocodone Product With Abuse Deterrents Gets FDA Approval
As abuse of prescribed opioids continues to rise in the United States, so do the options for abuse-deterrent opioids intended for people with severe pain.
Near the end of 2014, the Food and Drug Administration (FDA) approved Hysingla ER (hydrocodone bitartrate), a once-a-day extended release (ER) analgesic that contains properties that are expected to reduce—but not totally prevent—abuse of the drug when chewed or crushed, snorted, or injected.
According to the FDA, the new tablet is difficult to crush, break, or dissolve. It forms a thick gel-like substance when submerged in water that cannot be easily prepared for injection. However, the FDA emphasized, abuse of Hysingla ER is still possible, as are adverse consequences associated with abuse or unintentional overdose of the drug that could result in death.
The safety and effectiveness of Hysingla ER were evaluated in a clinical trial of 905 people with chronic low back pain. Additional studies assessed abuse-deterrent properties. The most common side effects included constipation, fatigue, upper respiratory tract infection, and drowsiness.
Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research at the FDA, said, “Preventing prescription opioid abuse is a top public health priority for the FDA, and encouraging the development of opioids with abuse-deterrent properties is just one component of a broader approach to reducing abuse and misuse and will better enable the agency to balance addressing this problem with ensuring that patients have access to appropriate treatments for pain.”
Hysingla ER is manufactured by Purdue Pharma L.P.
FDA Flags Generic Versions Of ADHD Medication
The FDA released a statement concerning the therapeutic benefits of two generic versions of Concerta tablets (methylphenidate hydrochloride extended-release tablets) intended to treat attention-deficit/hyperactivity disorder (ADHD) in adults and children. The agency is asking whether the generic products are bioequivalent to the brand-name drug.
The FDA’s inquiry was prompted by an internal reexamination of previously submitted data for the three approved generic versions of Concerta, which included non-brand-name methylphenidate hydrochloride extended-release tablets manufactured by Mallinckrodt Pharmaceuticals, Kudco Ireland Ltd., and Concerta manufacturer Janssen Pharmaceuticals. The results showed that while Janssen’s generic version was therapeutically equivalent to brand-name Concerta—releasing medicine in the body over a period of 10 to 12 hours—the generic versions manufactured by Mallinckrodt and Kudco were more likely to deliver the medicines at a slower rate during the designated time range, which may lessen the drug’s desired effect in some patients.
As a result, the FDA changed the therapeutic equivalence (TE) rating for the Mallinckrodt and Kudco products from AB to BX—meaning that the products are still approved and can be prescribed, but are no longer recommended as automatic substitutes for Concerta at pharmacies. The FDA has asked Mallinckrodt and Kudco to confirm the bioequivalence of their products within six months or to voluntarily withdraw them from the market.
In a statement, the FDA said, “If you or your health care professional are concerned the drug product is not providing the desired effect and you do not know the manufacturer, contact the pharmacy where the prescription was filled to verify the product’s manufacturer. ... [Also] contact the prescribing health care provider to discuss whether or not a different drug product would be more appropriate.” The FDA has not identified any serious safety concerns with the two generic products.
U.K. Approves Medication to Reduce Alcohol Consumption
Lundbeck sealed the deal for approval from the United Kingdom’s National Institute for Health Care and Excellence (NICE) for its once-a-day tablet Selincro (nalmefene), intended to treat alcohol use disorder (AUD).
The newly approved opioid antagonist—similar to naltrexone in the United States—demonstrated effectiveness in clinical trials showing that alcohol consumption was reduced by an average of 61 percent in patients who were administered the drug over six months.
The NICE approval included a license for Selincro to be used alongside psychosocial support for AUD. ■
