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Review Follistim Safety Reports submitted to FDA

Total Follistim reports: 6.
Follistim FDA safety alerts: No.
Reported deaths: 1    Reported hospitalizations: 3.
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FDA Reported Follistim Side Effects: contusion, coagulopathy, punctate keratitis.
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Follistim Side Effects Report #5591300-0
Consumer or non-health professional from UNITED STATES reported FOLLISTIM problem on Jan 10, 2008. Female patient, 41 years of age, weighting 150.0 lb, was diagnosed with infertility and was treated with FOLLISTIM. After drug was administered, patient experienced the following problems/side effects: abdominal distension, anxiety, dyspnoea, emotional distress, fear, sinus congestion. FOLLISTIM dosage: unknown. During the same period patient was treated with MENOPUR. Patient recovered.

Follistim Side Effects Report #5614424-8
FOLLISTIM problem was reported by a Consumer or non-health professional from DENMARK on Jan 18, 2008. Female patient, 36 years of age, was diagnosed with ovarian disorder and was treated with FOLLISTIM. After drug was administered, patient experienced the following problems/side effects: colitis ulcerative, ovarian hyperstimulation syndrome. FOLLISTIM dosage: unknown. During the same period patient was treated with GANIRELIX ACETATEECTION, CHORIONIC GONADTROPIN, MARVELON, PROGESTERONE, GANIRELIX ACETATEECTION, CHORIONIC GONADTROPIN. Patient was hospitalized. Patient recovered.

Follistim Side Effects Report #5565908-2
Health Professional from DENMARK reported FOLLISTIM problem on Nov 30, 2007. Female patient, 36 years of age, was diagnosed with ovarian hyperstimulation syndrome and was treated with FOLLISTIM. After drug was administered, patient experienced the following problems/side effects: colitis ulcerative, rectal tenesmus. FOLLISTIM dosage: unknown. During the same period patient was treated with MARVELON, GANIRELIX ACETATEECTION, CHORIONIC GONADOTROPHIN, PROGESTERONE. Patient was hospitalized. Patient recovered.

Follistim Side Effects Report #5577817-3
FOLLISTIM problem was reported by a Consumer or non-health professional from DENMARK on Dec 12, 2007. Female patient, 36 years of age, was diagnosed with superovulation and was treated with FOLLISTIM. After drug was administered, patient experienced the following problems/side effects: colitis ulcerative, ovarian hyperstimulation syndrome. FOLLISTIM dosage: unknown. During the same period patient was treated with MARVELON, GANIRELIX ACETATEECTION, CHORIONIC GONADTROPIN, PROGESTERONE. Patient was hospitalized. Patient recovered.


Follistim Side Effects Report #5355795-X
Pharmacist from UNITED STATES reported FOLLISTIM problem on June 11, 2007. Female patient, 27 years of age, weighting 130.0 lb, was diagnosed with infertility and was treated with FOLLISTIM. After drug was administered, patient experienced the following problems/side effects: coagulopathy, contusion. FOLLISTIM dosage: unknown. Patient recovered.

Follistim Side Effects Report #5279926-5
FOLLISTIM problem was reported by a Physician from UNITED STATES on Mar 27, 2007. Female patient, 41 years of age, weighting 160.0 lb, was diagnosed with infertility female, pregnancy and was treated with FOLLISTIM. After drug was administered, patient experienced the following problems/side effects: punctate keratitis. FOLLISTIM dosage: unknown. During the same period patient was treated with GANARELIX. Patient recovered.


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