FDA Notification to Industry Regarding Potential Adulteration of Pharmaceutical Ingredients used as Emulsifying Agents and Flavorings

FDA's Center for Drug Evaluation and Research (CDER) recently learned that there have been recent instances when clouding and flavoring agents, which have been used outside the U.S. in certain food manufacturing processes, contain undeclared phthalate plasticizers, specifically diethylhexyl-phthalate (DEHP) and diisononyl-phthalate (DINP).

CDER is not aware at this time of any intentional phthalate substitution, in part or whole, in finished pharmaceuticals or pharmaceutical ingredients used in the U.S. market. Nonetheless, significant overlap of global food and pharmaceutical ingredient supply chains raises the potential for adulterated food ingredients to enter the U.S. pharmaceutical supply chain.

CDER advises manufacturers of drug products and suppliers of pharmaceutical ingredients, both in the U.S. and abroad, to be aware of the potential substitution of phthalate plasticizers for vegetable oils in clouding and flavoring agents. Manufacturers using emulsions containing vegetable oils should exercise caution to prevent the use of ingredients that might be intentionally adulterated with phthalates

FDA approves injectable gel to treat fecal incontinence

The U.S. Food and Drug Administration today approved a sterile, injectable gel to treat fecal incontinence in patients for whom other therapies such as diet change, fiber therapy or anti-motility medications failed.

Fecal incontinence is the involuntary loss of bowel control. It can have different causes including nerve damage, weakened anal sphincter associated with aging, or rectum muscle damage. According to the National Institutes of Health, there are more than 5.5 million Americans with fecal incontinence.

The Solesta gel is injected into a layer of tissue beneath the anus lining and may help build tissue in that area. By growing the surrounding tissue, the opening of the anus narrows and the patient may be able to better control those muscles.

“Fecal incontinence is difficult to treat,” said Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. “This approval provides a minimally invasive treatment option for patients with fecal incontinence that does not respond to conservative therapies.”

The FDA based its approval on results from a clinical study of 206 patients. In the primary study, most patients received two treatments, consisting of four injections each, for a total of eight injections. After six months, more than half of the patients injected with Solesta experienced a 50 percent reduction in the number of fecal incontinence episodes. However, one-third of patients who received no Solesta in the study also experienced a similar reduction. Overall, a greater proportion of patients treated with Solesta experienced improvements, indicating the gel provides benefit.

Solesta is approved for use in patients ages 18 and up. It should not be used in patients who have active inflammatory bowel disease, immunodeficiency disorders, previous radiation treatment to the pelvic area, significant rectal prolapse, active infections, bleeding, tumors or malformations in the anorectal area, rectal distended veins, an existing implant in the anorectal region, or allergy to hyaluronic acid based products.

The most common side effects associated with Solesta include injection area pain and bleeding. Infection and inflammation of anal tissue are more serious risks, but are less common. 

 

Birth Control Pills Containing Drospirenone: Possible Increased Risk of Blood Clots

ISSUE: FDA is aware of two newly published studies that evaluated the risk of venous thromboembolism (VTE) in women who use birth control pills that contain drospirenone. The two recently published studies looked at whether there is a higher risk of blood clots in women taking birth control pills containing the progestin drospirenone when compared to similar women taking birth control pills containing a different progestin called levonorgestrel. These two new studies reported that there is a greater risk of VTE associated with birth control pills that contain drospirenone. This risk is reported to be up to 2 to 3 times greater than the risk of VTE associated with using levonorgestrel-containing pills. Other studies have not reported an increase in risk. The FDA is currently evaluating the conflicting results from these studies and will look at all currently available information to fully assess the risks and benefits of drospirenone-containing birth control pills. FDA will continue to communicate any new safety information to the public as it becomes available. Read the drug safety communication for more information on these studies.

 

 

BACKGROUND: Drospirenone is a type of female sex hormone called a progestin. Most birth control pills contain two types of hormones--estrogen and progestin. Birth control pills work by preventing the release of eggs from the ovaries (ovulation) and changing the cervical mucus and the lining of the uterus to prevent pregnancy. Brand names of drospirenone-containing products include Yaz (generics Gianvi and Loryna), Yasmin (generics Ocella, Syeda, and Zarah), Beyaz, and Safyral.

 

 

RECOMMENDATION: If your birth control pill contains drospirenone, do not stop taking it without first talking to your healthcare professional. Contact your healthcare professional immediately if you develop any symptoms of blood clots, including persistent leg pain, severe chest pain, or sudden shortness of breath. If you smoke and are over 35 years of age, you should not take combination oral contraceptives because they increase the risk that you could experience serious cardiovascular events, including blood clots.

 

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: