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Pentasa

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Pentasa

Pentasa (mesalamine / 5-ASA) from Shire Development Incorporated is a controlled release oral formulation of mesalazine which is designed to treat Inflammatory Bowel Diseases (IBD), mild to moderate Ulcerative Colitis (UC)[7] and mild cases of Crohn's disease. Pentasa is an anti-inflammatory drug that is thought to act topically in the colonic mucosa by inhibiting Cyclooxygenase (COX) and Prostaglandins (PG). The mesalazine is coated coated with granules that release 5-ASA in the Duodenum, Jejunum, Ileum and Colon.[1]

Pentasa Dosage

It is available in various forms, including granules, tablets and capsules. Suggested dosage for adults is 2 - 4 grams per day.

It is important that you follow the instructions carefully, in particular the tablet form should not be crushed or chewed as this affects the way the drug is released.

If you find the tablet or capsule forms hard to swallow, the tablet may be dispersed in water, and the capsule may be opened and mixed in water. The medicine should then be taken immediately, taking care not to crush or chew the individual granules.

Pentasa, as a controlled-release drug, is only 20% - 30% absorbed, as opposed to 80% absorbance in unformulated versions [7]. The advantage of this lower absorbance of drug systemically (throughout the body) allows more of the drug to continue through the digestive tract where it exerts its anti-inflammatory effects topically.

Potential Side Effects

Acute Intolerance Syndrome - 3%
Diarrhea - 3.4%
Headache - 2%
Nausea - 1.8%
Vomiting - 1.5%
Abdominal Pain - 1.7%
Melena (Bloody Diarrhea)
Rash - 1%
Indigestion - 1.6%
Anorexia
Fever
Rectal Urgency
Worsening of Ulcerative Colitis
Acne

Pentasa is a Pregnancy Category B Drug.

Mesalamine-Induced Acute Intolerance Syndrome

Mesalamine can cause acute intolerance syndrome and the symptoms can be hard to differentiate from the IBD. About 3% of patients are thought to get acute intolerance syndrome. The symptoms may include bloody diarrhea, abdominal pain, cramping, fever, rash, and/or headache. As such, anyone taking Lialda should be closely observed for worsening of these symptoms if they are already present from IBD.

Effectiveness of Pentasa in Ulcerative Colitis

Physician Global Assessment (PGA) - Complete or Marked Improvement[7]
Clinical Trial 1:
Placebo - 36%
Pentasa 4 grams/day Dosage - 59%
Pentasa 2 grams/day Dosage - 57%

Clinical Trial 2:
Placebo - 31%
Pentasa 4 grams/day Dosage - 55%
Pentasa 2 grams/day Dosage - 41%

Treatment Failure - Lack of Significant Improvement or Worsening of UC Requiring Steroid Therapy[7]
Clinical Trial 1:
Placebo - 22%
Pentasa 4 grams/day Dosage - 9%
Pentasa 2 grams/day Dosage - 18%

Clinical Trial 2:
Placebo - 31%
Pentasa 4 grams/day Dosage - 9%
Pentasa 2 grams/day Dosage - 18%

Sigmoidoscopic Index (SI) - Disease Activity Rated on a 15 Point Scale[7]
Clinical Trial 1:
Placebo - -2.5%
Pentasa 4 grams/day Dosage - -5%
Pentasa 2 grams/day Dosage - -4.3%

Clinical Trial 2:
Placebo - -1.6%
Pentasa 4 grams/day Dosage - -3.8%
Pentasa 2 grams/day Dosage - -2.6%

Remission[7]
Clinical Trial 1:
Placebo - 12%
Pentasa 4 grams/day Dosage - 26%
Pentasa 2 grams/day Dosage - 24%

Clinical Trial 2:
Placebo - 12%
Pentasa 4 grams/day Dosage - 27%
Pentasa 2 grams/day Dosage - 12%

Shire Cares. Patient Assistance Program

Shire offers Patient Assistance Programs for patients who may not be able to afford their medication. For more information see Shire Cares Patient Assistance Programs or call 1-888-CARES-55 (1‐888‐227-3755) M-F 8am-8pm US Eastern Standard Time (EST) [6].

FDA Warning Letter to Shire Regarding Pentasa Misleading Claims

In April, 2010 the Division of Drug Marketing, Advertising, and Communications (DDMAC) of the Food and Drug Administration (FDA) issued a letter to Shire Development Incorporated regarding Misleading and Unsubstantiated Claims about their Pentasa product. During the 2009 Annual Meeting of the American College of Gastroenterology Pentasa informational sheets were distributed that were in violation of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 352(a) & 321(n). Cf. 21 CFR 202.1(e)(6)(i), (ii) & (e)(7)(i).

These promotional materials indicated that Pentasa was superior to other drugs in this treatment category, overstated Pentasa's effectiveness, and was useful for a broader range of treatments than had been demonstrated clinically.[3]

(n) If an article is alleged to be misbranded because the labeling or advertising is misleading, then in determining whether the labeling or advertising is misleading there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, or any combination thereof, but also the extent to which the labeling or advertising fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the article to which the labeling or advertising relates under the conditions of use prescribed in the labeling or advertising thereof or under such conditions of use as are customary or usual. - from the Federal Food, Drug and Cosmetic Act 21 USC 321(n) http://www.fda.gov/RegulatoryInforma.../ucm086297.htm[4]
(a) False or misleading label
If its labeling is false or misleading in any particular. Health care economic information provided to a formulary committee, or other similar entity, in the course of the committee or the entity carrying out its responsibilities for the selection of drugs for managed care or other similar organizations, shall not be considered to be false or misleading under this paragraph if the health care economic information directly relates to an indication approved under section 355 of this title or under section 262(a) of title 42 for such drug and is based on competent and reliable scientific evidence. The requirements set forth in section 355(a) of this title or in section 262(a) of title 42 shall not apply to health care economic information provided to such a committee or entity in accordance with this paragraph. Information that is relevant to the substantiation of the health care economic information presented pursuant to this paragraph shall be made available to the Secretary upon request. In this paragraph, the term “health care economic information” means any analysis that identifies, measures, or compares the economic consequences, including the costs of the represented health outcomes, of the use of a drug to the use of another drug, to another health care intervention, or to no intervention. - from the Federal Food, Drug and Cosmetic Act 21 USC 352(a) [url]http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21-chap9-subchapV-partA-sec352.htm[/url[5]]

References

[pos]1a[/pos][1] http://www.hopkins-gi.org/GDL_Diseas...4-11EC9BF3100E

2. http://www.drugs.com/sfx/pentasa-side-effects.html

3. FDA Warning Letter. Food and Drug Administration (FDA). http://www.fda.gov/downloads/Drugs/G.../UCM210909.pdf

4. Federal Food, Drug and Cosmetic Act 21 USC 321(n) http://www.fda.gov/RegulatoryInforma.../ucm086297.htm

5. Federal Food, Drug and Cosmetic Act 21 USC 352(a) Accessed May 2012.http://www.gpo.gov/fdsys/pkg/USCODE-...rtA-sec352.htm

6. Shire Cares. Patient Assistance Programs. Shire Development Inc. Accessed May 2012. http://www.shire.com/shireplc/en/con...ientassistance

7. "Pentasa (mesalamine) Prescribing Infomation" Shire Development Inc. Accessed May 2012. http://pi.shirecontent.com/PI/PDFs/Pentasa_USA_ENG.pdf

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