February 2025 Drug Safety Part 2: FDA REMS news; Abilify; Isoniazid; Ongentys for Parkinson's; Osphena for menopause
Dear Readers: We normally publish this newsletter every two weeks, but because of a two-week pause in FDA Safety Labeling Change posting activity, followed by a release of the backlogged updates, we are "catching up" by sending this extra edition with summaries of four notable safety-related disclosures. Check the end of this newsletter for an important update on the availability of REMS (Risk Evaluation and Mitigation Strategy) information from the FDA.
Abilify, Abilify Asimtufii, Abilify Maintena, Abilify Mycite (aripiprazole ); Aristada (aripiprazole lauroxil) tablets
Aripiprazole is a second-generation antipsychotic drug used to treat various mental illnesses, including schizophrenia, bipolar disorder, irritability associated with autistic disorder and depression. It is also approved to treat Tourette's disorder, a nervous system condition.
The Abilify label removed clinical trials results relating to Abilify orally disintegrating tablet, oral solution, and intramuscular injection formulations, which have been discontinued. Those formulations are still available as generic versions.
Aripiprazole is detected in human breast milk. Lactation-related clinical trials results were added to the aripiprazole label indicating that exposure during pregnancy and/or the postpartum period can lead to decreases in milk supply or no milk supply in the post-partum period. The breastfed infant should be monitored for dehydration and lack of appropriate weight gain. There is a patient exposure registry that monitors pregnancy outcomes in women exposed to ABILIFY during pregnancy. More pregnancy risks are listed on the drug label.
Cases of fecal incontinence have been reported for this drug and that risk was added to the list of postmarketing experiences on the drug label. FDA recently required that this new adverse effect be added to many antipsychotic drugs. Abilify (aripiprazole) was approved in 2002.
Abilify FDA Safety Label Change
Learn about the different types of antipsychotics and associated side effects:
"Doctors Discuss Antipsychotic Side Effects" at MedShadow.org
Check out all of the aripiprazole-containing drugs at the Ask a Patient site
and an FDA adverse events summary for more than 1,000 reports received by the FDA in one quarter, including top 20 reasons taken and top 20 adverse effects.
Isoniazid and Rifater (Isoniazid, Pyrazinamide, Rifampin) tablets; Nydrazid (Isoniazid) injection
Isoniazid is a drug used along with other medications to treat active cases of tuberculosis (TB). It is also used alone to prevent tuberculosis. The label was updated to include the risk of potentially life-threatening hypersensitivity reactions called Severe cutaneous adverse reactions (SCARs). These include toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Fever, rash, and blisters, with or without peeling skin, are symptoms.
Also, cases of Cerebellar syndrome have been reported and the risk was added to the postmarketing experiences section. Although most cases of cerebellar syndrome involved patients with chronic kidney disease (CKD), cerebellar syndrome was also reported in patients without CKD. Cerebellar syndrome symptoms may include abnormal gait or muscle movements in trunk and limbs, tremor, speech disorder, involuntary eye movements. Isoniazid was originally approved in 1952. Rifater combination drug was approved in 1994 and is still an approved drug but currently not on the market.
Isoniazid FDA Safety Label Change
Rifater FDA Safety Label Change
Nydrazid FDA Safety Label Change
Ongentys (opicapone) tablets
Parkinson's treatment Ongentys had its label changed to warn that patients have been injured falling while using the drug. The adverse event of "falls" was added in the postmarketing experience section. Ongentys was approved in 2020.
Ongentys FDA Safety Label Change
Osphena (ospemifene) tablets
Osphena is used to treat vaginal atrophy and dryness due to menopause. Its label was changed to add results from the Women’s Health Initiative (WHI) clinical trials, which show an increased risk of breast cancer for estrogen plus progestin therapy and a smaller increased risk for estrogen-alone therapy after several years of use. A warning was added that women with a history of breast cancer or have suspected breast cancer should not use ospemifene. This drug has an association with endometrial cancer, and has a boxed warning about this risk.
Osphena is different than hormones or estrogen replacement therapy (like estradiol pills or cream) because it works by acting like estrogen in some parts of the body. It belongs to a class of drugs called selective estrogen receptor modulators (SERM). Osphena was approved in 2013.
Osphena FDA Safety Label Update
Patient ratings and reviews of Osphena
Read more about how Osphena works at MedLine Plus.
FDA REMS Lists and Documents Availability
While drug safety updates, recalls and new drug approvals are posting on the FDA website as usual, the FDA's REMS@FDA database that lists all of the FDA-authorized REMS is "temporarily unavailable" (as of February 16, 2025). The message says "Approved REMS remain in effect, even while the website is unavailable. Thank you for your patience."
REMS (Risk Evaluation and Mitigation Strategy) is a drug safety program that the US Food and Drug Administration (FDA) can require for certain medicines with serious safety concerns, such as drugs that may cause birth defects or pose extreme risk to a patient if not taken strictly according to instructions. There are about 75 drugs with REMS requirements. Some of the drugs, such as certain opioids, have "shared REMS" while others have a program specific to one drug.
Hopefully, the REMS information will be back online at the FDA soon. We will keep you posted. In the meantime, you can find most REMS by running a search on your favorite search engine with the word "REMS" and the drug name to get a link to the REMs program description page. The specific REMS page or site may be managed by the drug company or maintained at the FDA site. For your convenience, we have posted links to about 65 drugs with REMS programs on the AskaPatient website:
List and Links to REMS programs
Here is an example REMs for Clozapine, is a safety program required by the Food and Drug Administration (FDA) to manage the risk of severe neutropenia associated with clozapine treatment.
https://www.newclozapinerems.com/home#
Did you miss Part 1 of February’s Drug Safety Updates? Check it out here:
Thank you for reading this edition of AskaPatient Health News: Drugs & Treatments. Please share it with someone you know who may also be interested in drug safety information. Visit our website at www.askapatient.com.