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 What is Cenestin?

Cenestin is the commercial brand for a form of synthetic estrogen used for estrogen replacement therapy. More specifically, Cenestine contains nine different forms of estrogen. Cenestin was prescribed to women to treat the effects of menopause, primarily vaginal irritation, osteoporosis, and other conditions.

Cenestin was first approved in 1999 for treating moderate to severe conditions related to menopause. Teva Pharmaceuticals marketed it. In 2016 Teva notified the federal Food and Drug Administration (FDA) that it was taking Cenestin off the market, but not because it was ineffective or unsafe. The FDA added the medication to its “Discontinued Drug Product List.” Reportedly, the Cenestin brand was then discontinued in the U.S. Other equivalent medications have been approved by the FDA and are available only by prescription.

However, in 2020 two U.S.-based pharmaceutical companies, Aspen Pharma USA and Aspen Global, subsidiaries of Aspen Pharmacare, announced a license and commercialization agreement with Avion Pharmaceuticals, a specialty pharmaceutical company, for the exclusive rights to begin marketing Cenestin again in the U.S. The companies said that the estrogens used in the manufacture of Cenestin would be produced in the Netherlands.

At the time of the announcement, the relaunch of Cenestin was planned for 2021, but it is not clear at this time whether Cenestin is currently available in the U.S.

Other reasons for which estrogens are prescribed are as follows:

  • To provide additional hormones when the body does not produce enough, such as during menopause or when female puberty does not occur on time. Other conditions include a genital skin condition, inflammation of the vagina, or problems of the ovaries, such as female hypogonadism or failure or removal of both ovaries;
  • To help prevent osteoporosis in women past menopause;
  • In the treatment of selected cases of breast cancer in men and women;
  • To treat men with prostate cancer.

It is administered as a transdermal skin patch, skin lotion or cream, or transdermal spray.

Have There Been Lawsuits Filed by People Who Have Taken Cenestin?

In 2008, some 25 women filed separate lawsuits in federal court in St. Louis, Missouri. All the women claim they developed breast cancer from taking various hormone replacement drugs, including Cenestin.

The medications they took were as follows:

  • Climara;
  • Estraderm;
  • Estrace;
  • Estradiol;
  • CombiPatch;
  • Cenestin;
  • Ogen;
  • Ortho-Prefest;
  • “Generic MPA.”

Two of the 25 women claimed they got cancer after taking CombiPatch or Cenestin, made by Aventis and Duramed. The results of these lawsuits have not been reported.

Women filed many other lawsuits claiming that hormone-replacement medications caused their breast cancer. Some were successful in recovering damages from their injuries. However, the drugs in these cases contained progesterone or progesterone and estrogen. Cenestin does not contain progesterone.

The dangerous side effects of these medications became known to the public in 2002. This is the year the Women’s Health Initiative announced that it was stopping a large research study on hormone replacement therapies due to the results they produced. The results showed that the medications increased the risk of breast cancer, blood clots, and stroke.

What Are the Side Effects of Cenestin?

The most significant side effects of Cenestin are that people have experienced coronary problems such as heart attacks and strokes with the use of Cenestin. Another significant side effect is cancer of the lining of the uterus, endometrial cancer. Breast cancer is also a severe side effect associated with synthetic estrogen replacement.

Some other side effects that appear to be common with the use of Censtin are as follows:

  • Nausea;
  • Vomiting;
  • Bloating;
  • Stomach cramps;
  • Breast tenderness, pain, or swelling;
  • Headache;
  • Weight changes or changes in appetite;
  • Freckling or darkening of facial skin
  • Increased hair growth;
  • Loss of hair on the scalp;
  • Problems with contact lenses;
  • Vaginal itching;
  • Changes in a person’s menstrual periods;
  • Lessened sex drive;
  • Nervousness;
  • Dizziness;
  • Feeling of fatigue.

Also, many women taking estrogens with progestin, another female hormone, sometimes start having monthly vaginal bleeding, similar to periods, again. This would go on for as long as the person takes medicine. Of course, women who have had a total hysterectomy would not experience this effect.

Who Should Not Use Cenestin?

A long list of conditions indicates that a person should not use Cenestine. Some of the conditions that would prevent a person from taking the medication are as follows:

  • Uterine fibroids;
  • Breast cancer;
  • Family history of breast cancer;
  • Ovarian cancer;
  • Cancer in the lining of the uterus
  • A condition with low thyroid hormone levels
  • High blood triglyceride levels;
  • High blood calcium levels;
  • Inherited disorder of episodes of swelling;
  • A deficiency in anti-clotting agents;
  • Dementia;
  • A history of migraines;
  • A clot in the small veins that carry blood to or from the retina of the eye;
  • A history of heart attack;
  • Coronary artery disease
  • A blood clot in the lung
  • A history of stroke;
  • Blood clots in the deep vein of the extremities (DVT);
  • A high risk for the development of blood clots;
  • Asthma;
  • Severe liver disease;
  • Disease of the gallbladder;
  • Systemic lupus;
  • Seizures;
  • A person who is bedridden or otherwise unable to move around freely;
  • Tobacco smoking.

What Drugs, Substances, or Supplements Interact with Cenestin?

Cenestin may interact with blood thinners, thyroid medications, insulin or oral diabetes medications, rifampin, ketoconazole or itraconazole, seizure medicines, barbiturates, or antidepressants.

Cenestin should not be used during pregnancy. If a person becomes pregnant or thinks they may be pregnant, they should tell their doctor immediately. This medication passes into breast milk. A person should talk to their doctor before using Cenestin if breastfeeding.

What Remedies Are Available If I Have Been Injured by Cenestin?

A person who believes that Cenestin has injured them may be able to seek a remedy in a court of law. They would want to consult a personal injury lawyer. The lawyer would enlist a medical expert to determine why a person has been injured and whether it is related to treatment with Cenestin. For example, a doctor may have prescribed the drug in error because the person has a condition that indicates that they should not take Cenestin. This could be the basis for a claim of medical malpractice.

A pharmacist may have had information that should have alerted them to the fact that a person should not take Cenestin. Perhaps they were taking other drugs that interact negatively with Cenestin. This could serve as the basis for a claim of pharmacist malpractice.

Another option would be a lawsuit for strict product liability based on the claim that the medication is defective because it has a design defect, a manufacturing defect, or a failure to provide adequate warnings of its negative side effects and other issues.

Success with any of these claims will result in an award of compensatory damages, which would reimburse an injured person for the cost of their medical treatment, lost wages, loss of earning capacity, and pain and suffering.

If a person’s injury from Cenestin should prove fatal, their loved ones would file a lawsuit for wrongful death.

What Is the Current Status of Cenestin?

As noted above, it is not clear whether Cenestin is currently available in the U.S. The FDA has warned about the increased risk of coronary diseases that comes with taking Cenestin. The warning label has been changed, including heart attack and stroke warnings.

Do I Need the Help of a Lawyer for My Cenestin Issue?

If you believe you have suffered an injury because of taking Cenestin, you should consider contacting an experienced class action attorney. A lawyer can help you recover damages for your injuries and represent you in courft as needed.

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