News

The New York Times (3/4, Belluck) reports, “The first nonprescription birth control pill in the United States will be available in stores and online in the coming weeks at a price of $19.99 a month, the manufacturer, Perrigo Company, announced on Monday.” The drug, Opill, “which was approved for over-the-counter sale by the Food and Drug Administration last year, will be the most effective birth control method available without a prescription, research shows – more effective than condoms, spermicides and other nonprescription methods.”

The AP (3/4, Perrone) reports Perrigo “said Monday it has begun shipping the medication...to major retailers and pharmacies.” Opill “will also be sold online.” The medication’s “approval came despite some concerns by FDA scientists about the company’s results, including whether women with certain medical conditions would understand that they shouldn’t take the drug.” American College of Obstetricians and Gynecologists President Verda Hicks, MD, FACOG, in a statement “said studies have shown that patients, including adolescents, can effectively screen themselves to use the pills.”

Patients should not take Opill in conjunction with any other hormonal contraceptive and should be sure they tell their physician that they are taking it.

The Washington Post (9/22, Malhi) reported, “Federal regulators recommended on Friday that expectant mothers get an RSV vaccine to protect their newborns from the potentially deadly respiratory disease.” A CDC advisory panel has recommended the vaccine “for people who are between 32 and 36 weeks pregnant and who will give birth during the fall and winter, when RSV cases usually spike.”

Our office will provide more information about the RSV vaccine once we are able to stock and administer it. 

The AP (9/22, Stobbe) reported the Pfizer vaccine (Abrysvo) “prompts the moms-to-be to develop virus-fighting antibodies that pass through the placenta to the fetus.” That protection “likely drops after 6 months of age, so the shot is for use between September and January in most of the U.S., to coincide with the time of year when RSV infections tend to be most common.”

Reuters (9/22, Roy, Erman) reported, “The CDC recommendation comes after a panel of advisers voted 11 to 1” to recommend the shot.

ABC News (9/22, Cobern) reported American College of Obstetricians and Gynecologists Immunization, Infectious Disease, and Public Health Preparedness Expert Work Group Chair Laura Riley, MD, “told ABC News, ‘as an obstetrician, I am very excited that there’s finally a maternal vaccine. I think that we’ve had the experience with other vaccines that suggest maternally derived antibodies cross the placenta fairly rapidly and can protect the baby from vaccine preventable diseases.’” Also, ACOG “released a statement in support of the vaccine with” Interim CEO Christopher Zahn, MD, FACOG, “saying, ‘The national and global burden of RSV disease demonstrates how critical it is to prevent this virus in infants. ACOG believes the maternal RSV vaccine is efficacious and it is necessary that parents have this option to protect their newborns from RSV after birth. ACOG is currently making updates to its clinical guidance that will be released in the coming days.’”

The Hill (9/22, Choi) and NBC News (9/22, Bendix) also reported.

The American Journal of Managed Care (8/18, Munz) reported, “According to a recent study published in Vaccine, getting the COVID-19 booster shot on top of the initial mRNA vaccine leads to a dramatic increase in antibodies – for mothers and infants – at the time of delivery.” According to the article, “at delivery, the post-vaccine antibody levels were significantly higher in booster recipients compared with pregnant individuals who only went through the primary 2-dose vaccine series.”

The New York Times (8/4, A1, Belluck) reported the FDA has approved Zurzuvae (zuranolone), “the first pill for postpartum depression, a milestone considered likely to increase recognition and treatment of” the condition. According to the Times, “Clinical trial data show the pill works quickly, beginning to ease depression in as little as three days, significantly faster than general antidepressants, which can take two weeks or longer to have an effect.”

NBC News (8/4, Bendix, Kopf) reported, “The medication...is taken daily for two weeks.” Researchers found, “in a pair of clinical trials involving women who experienced severe depression after having a baby, the drug improved symptoms – such as anxiety, difficulty sleeping, loss of pleasure, low energy, guilt or social withdrawal – as early as three days after taking the first pill.”

CNN (8/4, Howard) said the agency “added a boxed warning to the drug’s labeling, noting it can impact a person’s ability to drive and perform other potentially hazardous activities.”

Reuters (8/5) reported that in a statement, the drug’s makers “said the FDA issued a Complete Response Letter for the New Drug Application for Zurzuvae in the treatment of adults with” major depressive disorder. That “letter said the application did not provide substantial evidence of the effectiveness of Zurzuvae for” the treatment of patients with major depressive disorder “and that additional studies would be needed to support the approval.”

Also covering the story were The Hill (8/4, Robertson), the AP (8/4, Perrone), HealthDay (8/5, Mann), MedPage Today (8/4, Monaco), and Medscape (8/4, Marcus, Subscription Publication).

Note: This medication is not quite available yet. The Drug Enforcement Administration must first complete a 90-day review, which is required for all drugs affecting the central nervous system. Our office will have more information once the medication is ready to prescribe.

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Washington, D.C. — The following is a statement from Verda J. Hicks, MD, FACOG, president of the American College of Obstetricians and Gynecologists (ACOG), and Christopher M. Zahn, MD, FACOG, interim chief executive officer of ACOG:

“Today’s announcement of FDA approval of the OTC sale of progestin-only birth control is a critically important advancement in the accessibility of reproductive health care. ACOG has long supported OTC access to hormonal contraception, and we are glad that more patients will now be empowered to choose when and where they obtain a safe method of contraception without having to wait for a medical appointment or for a prescription to be filled.

Read the full statement on the ACOG website.

More Information:
Read the full statement on the ACOG website.