Depo-Provera is the brand name for a hormonal medication known as depot medroxyprogesterone acetate. This medication is a contraceptive injection containing progestin, a hormone. Depo-Provera injections are given every three months.
Depo-Provera gets injected deep into muscles. There is also a form of the medication known as Depo-SubQ Provera which gets injected just beneath your skin.
Depo-Provera is a very popular birth control method. However, there are now lawsuits pending which allege that this contraceptive technology is associated with an unacceptable health risk: an increased risk of developing a form of brain or spinal tumor known as a meningioma.
Call our lawyers today for a free consultation if you or a loved one has developed a meningioma after taking Depo-Provera. You may qualify for financial compensation in a lawsuit, and we won’t charge any fee to represent you until and unless we recover money on your behalf.
Early Development of Depo-Provera
An Upjohn scientist, in the 1950s, experimented with compounds of progesterone. This experimentation led to the synthesis of depot medroxyprogesterone acetate, which was later given the brand name Depo-Provera.
In 1959, the drug was approved by the FDA for the treatment of habitual and threatened abortion, irregular uterine bleeding and amenorrhea. In 1960, the drug was approved by the FDA for the treatment of endometriosis.
Testing in Brazil led to the discovery of the medication’s effectiveness as a long-term contraceptive. This led Upjohn to initiate the long experimentation and application process the FDA requires for a drug to be approved for use as a contraceptive.
In 1963, Upjohn submitted a Notice of Claimed Investigational Exemption for a New Drug to the FDA so they could conduct clinical trials on humans to determine the efficacy and safety of the drug as a contraceptive. This was after Upjohn had submitted rodent studies as well as plans to conduct further clinical and animal trials. Depo-Provera was given Investigative New Drug status. While this occurred, prescriptions for the drug’s use as a contraceptive were already being handed out in Jamaica as well as Los Angeles, CA. The human clinical trials started in 1965.
In 1965 Upjohn started doing field studies in 70 countries. In 1967, Upjohn contracted with an Atlanta, GA clinic to conduct a clinical trial involving 1,000 women. In 1967, Upjohn also submitted a New Drug Application so Depo-Provera could be approved for use as a contraceptive. However, it wasn’t clear how this application would be considered, since its animal studies results were not yet in.
In 1968, Upjohn initiated two long-term animal studies. One was a seven-year study involving 36 beagle dogs. The other was a 10-year study involving 52 rhesus monkeys. In 1975, the results of the beagle study revealed that two animals developed malignant breast tumors. While the FDA announced in 1974 it intended to approve the drug as a contraceptive, this study result led to the FDA disapproving of Depo-Provera as a contraceptive in 1978.
Additional reasons given for the FDA disapproving the drug’s use as a contraceptive in 1978 included:
- Fetal exposure may lead to a higher risk of birth defects
- Should estrogen supplements be given in order to counter irregularities in menstruation, the drug would no longer have an advantage as a compound composed of only progesterone
- There was no demonstration that the drug was needed by a significant patient population
In 1979, the results of the monkey study revealed that two animals developed endrometrial cancer. This was the first time endrometrial cancer was ever discovered in rhesus monkeys. A second beagle study involving 140 dogs also ended up revealing breast cancer in 24 dogs, casting further doubt on the safety of the drug.
The issue of the drug possibly being carcinogenic was not resolved by these studies. Rather, the studies started a debate over two issues:
- If the animals were adequate models to test the medication’s human carcinogenicity on
- If the large doses given to the animals were appropriate considering the lower doses given to humans when the drug is used as a contraceptive
How Depo-Provera Works
Depo-Provera is part of a class of steroids which employs hormones to prevent pregnancy. There are other steroids in this class, including birth control pills, emergency contraception, the morning-after pill, implantables such as Implanon, Jadelle and Norplant, and some intra-uterine devices.
Depot medroxyprogesterone acetate is a synthetic form of progesterone, a natural hormone, and the active ingredient of Depo-Provera. It was developed originally as a uterine cancer treatment. The drug is injected every three months in a dosage of 150 milligrams.
The drug works in three ways, like other birth control methods containing artificial progesterones:
- It disrupts the menstrual cycle by preventing ovulation
- It alters cervical mucus, inhibiting sperm from entering through the cervix
- It makes it difficult for an egg to implant, should it reach the uterus, by altering the uterus’ lining
Upjohn claims that Depo-Provera inhibits gonadotrophin secretions, claiming that this prevents ovulation and follicular maturation, leading to endometrial thinning.
FDA Approval of Depo-Provera
Upjohn continued to push for Depo-Provera to be approved as a contraceptive after the FDA denied its approval in 1978.
Concerns continued to be raised about the drug. The first recorded human studies found that cervical cancer risks were increased by as much as nine times. However, multiple subsequent larger studies have not found an association between the drug and cervical cancer.
In 1992, the World Health Organization (WHO) presented a review of the drug to the FDA involving its use in four developing countries. Women’s organizations such as the National Women’s Health Network testified against the objectivity of the WHO, noting that the organization had distributed the drug in developing countries.
In 1992, the drug was finally approved by the FDA for use as a contraceptive. The approval was based on the WHO review. The WHO review involved evidence from countries like Thailand. At a prior hearing, the FDA had deemed this evidence insufficient and poorly designed.
Controversies of Depo-Provera
Depo-Provera has been the subject of many controversies.
1967 saw the beginning of an 11-year trial which tested the drug on a disproportionate amount of poor women, black women and rural women. The testing was done without informed consent and was done without providing the women information about the serious side effects of the drug.
Upjohn did a sloppy job of conducting the study, ignoring annual reports that the FDA required, losing 93 percent of the patient records making it so follow-up studies couldn’t be done, and neglecting to report serious side effects and deaths.
Investigators noted that questionable data collection occurred, protocol and consent forms were absent, and that women who did give consent weren’t told about all of the possible side effects. The shot was given t women with known medical conditions indicating that use of the drug could endanger their health. Over half of the study’s 13,000 women got lost to followup because of sloppy record keeping.
As a result, the study’s data was unusable and meaningless. Approval of the drug for use of a contraceptive was withheld by the FDA at the start and end of this study. This was not only due to the way the study was done, but also due to a higher risk of breast cancer in the drug’s users.
In addition, the drug was prescribed and administered to women as a contraceptive long before the drug was approved as a contraceptive by the FDA. Judges even ordered sex offenders to take the drug as a condition of parole and probation. This was prior to the FDA approving the drug’s use as an alternative to criminal sentencing. During a 1984 sexual assault trial, a judge ordered a convicted male sex offender to take Depo-Provera for five years as “castration by chemical means.” The convict refused and appealed, eventually having his probation conditions overturned.
Prior to the drug’s approval as a contraceptive in 1992, its testing and use focused almost entirely on poor Americans and women located in developing countries. This raised questions about lack of consent and coercion, especially illiterate people and the mentally disabled, who were reported to have been given the drug for “menstrual hygiene” reasons even though they weren’t sexually active.
Adverse Side Effects
The most concerning side effect of Depo-Provera is an increased risk of developing meningiomas, which can manifest as brain tumors or spinal tumors. A 2024 study found that women who use the medication for over one year see their risk of developing meningiomas increased by 5.6 times.
The most common side effects of the drug are:
- Acne
- Drowsiness
- Menstrual flow changes
- Birth defects, when pregnant women take the drug
Other side effects which are common include:
- Increased facial hair
- Breast tenderness
- Sleep problems
- Decreased scalp hair
- Weight gain or loss
- Stomach pain
Some women have reported lower libido. The drug may affect menstrual bleeding. Over half of women experience missed periods after using the drug for one year.
The drug can cause a delayed return of fertility when used as a contraceptive. It usually takes 9 or 10 months after the final injection for fertility to return – this is extended in obese or overweight women.
A 2002 study found that the drug, when used with conjugated estrogens, was associated with a higher risk of:
- Pulmonary embolism
- Stroke
- Breast cancer
- Coronary heart disease
When used with conjugated estrogens, the drug is also associated with eye thrombus and dementia, and may be associated with cardiovascular disease.
Multiple studies have found an association between the drug and venous thromboembolism, or blood clots.
The drug may lead to reduced bone mineral density. This can be very concerning regarding teenagers who have not yet reached peak bone mass. A black box warning was added to the drug’s label in 2004, warning about bone mineral density loss. Most women, however, fully regain bone density following discontinuation of the drug.
Usage of Depo-Provera Today
Despite the drug’s history, Depo-Provera is still used a lot today. The drug is still prescribed, despite its dangerous side effects such as meningiomas.
Based on data found in the National Survey of Family Growth, about three percent of women using contraception from 2017 through 2019 reported using Depo-Provera in the last month. Overall use of the drug has declined over the past 20 years as more women have started using long-acting reversible contraceptive methods like implants and IUDS.
According to a 2021 study, around 42 million women use injectable contraceptive worldwide.
Pending Lawsuits Against Depo-Provera
Several lawsuits have been filed alleging that women have developed meningioma tumors because they used Depo-Provera. The lawsuits note that while the drug’s warning label has warned about the risk of meningioma tumors in Canada since 2015, drug manufacturers have chosen not to warn about this risk in the United States.
- A California woman, on October 1, 2024, filed a lawsuit in California alleging that drug manufacturers failed to warn about the risk of meningioma tumors associated with Depo-Provera. The lawsuit named Pharmacia & Upjohn, Greenstone Prasco Labs, Viatris and Pfizer Inc as defendants over their roles in the sale and development of brand name as well as generic versions of the shot. The lawsuit claims the woman receive injections of the drug from 2005 to 2021 and eventually started developing side effects such as vertigo, severe headaches and dizziness. The woman was diagnosed with a Sylvian fissure meningioma at age 37 in June of 2022. The woman needed an invasive brain surgery to remove the tumor. The surgery involved a deep scalp incision and the skull being cut open. Surgeons discovered abnormal tissue surrounding the brain and needed to remove a lot of it, replacing damaged tissue with tissue from a cow’s heart.
- An Indiana woman, on October 15, 2024, filed a lawsuit in Indiana which indicated that drug manufacturers were aware or should have been aware that Depo-Provera can cause users to develop meningioma tumors, yet failed to warn about this risk. The woman allegedly received injections of the drug from 1995 through 2018. The woman allegedly became dizzy in 2008, falling and fracturing a vertebra. By 2015, the woman allegedly suffered from depression, confusion, frustration, irritability and incontinence, as well as light sensitivity and dizziness. By 2017, the woman allegedly was sleeping from 18-20 hours per day. Testing revealed she had a large meningioma, and it was surgically removed in 2017. The woman allegedly kept receiving shots of Depo-Provera even after this surgery since the defendants allegedly failed to warn about the drug’s risks, and her tumor allegedly began to regrow aggressively around six months after the surgery. The woman allegedly went through 36 rounds of radiation treatment in order to stop the tumor’s growth.
- A California woman, on October 18, 2024, filed a lawsuit in California indicating she ended up with a meningioma after receiving injections of Depo-Provera from 2001 to 2024. She allegedly developed health problems such as blurred vision and persistent headaches in recent years, and in 2023, an MRI revealed a meningioma, which caused fluid and pressure to build up in her brain, leading to compression of blood vessels and brain tissue, increased intracranial pressure, and impaired nerve functions. The woman had the tumor removed via surgery in July 2023, involving a section of her skull being removed. 15 bone screws and two titanium plates were required to surgically close her skull, and during recovery, the woman allegedly suffered complications including leakage of cerebrospinal fluid. The woman allegedly continues to suffer from gait instability, vision problems, persistent headaches, cognitive difficulties and hypersensitivity of the skull. In addition, a 2024 MRI allegedly found a residual part of the tumor which the first surgery missed. As a result, she has required stereotactic radiosurgery sessions, leading to vomiting and severe nausea after each session.
- A California woman, on October 24, 2024, filed a lawsuit in California alleging she developed a meningioma brain tumor after taking shots of Depo-Provera from 2000 to 2024. She allegedly developed symptoms including ear itching, lightheadedness, vertigo, blurred vision and headaches over time, and was diagnosed with a meningioma in 2020. Doctors have allegedly told her the tumor is too dangerous to remove, so the woman continues to suffer from painful headaches.
- A California woman, on October 28, 2024, filed a lawsuit in California alleging she ended up with a meningioma because she took shots of Depo-Provera regularly for a period of 19 years, beginning in 1999. The woman allegedly started developing symptoms such as memory issues, persistent headaches, lethargy and disorientation. The woman was allegedly diagnosed with a meningioma after going to the ER following becoming disoriented while she was driving. She had the tumor removed in January 2018 via a surgery which involved removing a portion of her skull then securing the part of her skull back in place with a plate. The woman allegedly suffered from obstructed blood flow to sections of her brain after the operation, leading to double vision and blurred vision.
Contact an Experienced Depo-Provera Lawsuit Attorney
Call us today for a free consultation if you or a loved one has been diagnosed with a meningioma after using Depo-Provera. We can file a lawsuit on your behalf seeking financial compensation for medical bills, lost wages, loss of earning capacity, pain, suffering, wrongful death and more.
We have been representing victims of dangerous drugs since 1990, having recovered in excess of $750 million for our clients. We have extensive experience handling cases like yours and this experience will allow us to recover the most compensation possible on your behalf.
The only fee we will charge to handle your Depo-Provera case is a percentage of any money we recover on your behalf. We won’t charge any upfront or out-of-pocket fee, and won’t charge any fee until and unless we recover money for you.
Call us today for a free consultation.
