Macugen Lawsuit

Macugen Lawsuit Macugen Side Effects

Macugen Lawsuit

Macugen Side Effects


              Mecugen® is a pegaptanib sodium injection used to treat

neovascular (wet) macular degeneration related to age. It is a sterile,

watery solution for intravitreous injection supplied in a pre-filled, single

dose syringe containing monobasic sodium phosphate monohydrate, sodium

chloride, hydrochloric acid, dibasic sodium phosphate heptahydrate, and/ or

sodium hydroxide to regulate the pH and water for injection.

              The active ingredients in Mecugen include:

·       0.3mg- free acid form of oligonucleotide

·       1.6mg of pegaptanib sodium

Pegaptanib sodium is a covalent conjunctive of an

oligonucleotide consisting

of 28 necleotides in length that destructs in pentylamino linker. Two 20-

kilodalton monomethoxy polyethylene glycol (PEG) units are covalently using

the two amino groups on a lysine residue in the pentylamino linker.

Macugen Lawsuit

Macugen Side Effects

Indicated for the treatment of neovascular (wet) macular degeneration related

to age, Macugen is to be administered by intravitreous injection into the eye

once every six weeks. It is critical that Macugen be inspected visually,

prior to admisistration, for particulate matter and discoloration.

The injection procedure of Macugen should be initiated under controlled

aseptic conditions including the use of sterile gloves, a sterile drape, and

sterile eyelid speculum. The pouches should be carefully opened when ready to

assemble syringe and administer injection. The contents should be removed and

placed on a sterile field. If the plastic clip is missing or not attached to

the syringe upon opening the pouch, it should not be used. If there are

bubbles in the syringe contents, the syringe should be held with the needle

pointing up and gently tapped with finger until the bubbles rise to the top

and then the plunger should be slowly depressed to remove the bubbles and

also to expel the excess Macugen.

Prior to administering this drug, the patients’ medical history should be

evaluated for hypersensitive reactions and if present, the proper amount of

anesthesia and broad-spectrum microbicide should be given prior to

application. Patients should be monitored for endorphthalmitis and

intraocular pressure after the injection is given. Any such symptoms should

be reported immediately.

Macugen is should be stored in the refrigerator at 2 ° to 8°C and is supplied

in a sterile foil pouch. The syringe should not be frozen or shook

vigorously.

Less than 1% of the intraviteous injections result in the following adverse

events:

·      endophthalmitis

·      retinal detachment

·      iatrogenic traumatic cataract

The following adverse events are the most frequently reported in patients

treated with Macugen 0.3mg for up to two years:

·       anterior chamber inflammation

·       blurred vision

·       conjunctival hemorrhage

·       eye pain

·       corneal edema

·       eye discharge

·       Cataract

·       eye irritation

·       hypertension

·       increased intraocular pressure (IOP)

·       ocular discomfort

·       punctate keratitis

·       reduced visual acuity

·       visual disturbance

·       vitreous floaters

·       vitreous opacities

The following are some side-effects reported in ocular patients:

·       blepharitis

·       conjunctive

·       photopsia

·       vitreous disorder

·       allergic conjunctivitis

·       conjunctival edema

·       corneal abrasion

·       corneal deposits

·       corneal epithelium disorder

·       endophthalmitis

·       eye inflammation

·       eye swelling

·       eyelid irritation

·       meibomianitis

·       mydriasis

·       periorbital hematoma

·       retinal edema

·       vitreous hemorrhage

The following are some side-effects reported in non-ocular patients:

·       bronchitis

·       diarrhea

·       Dizziness

·       Headache

·       Nausea

·       urinary tract infection

·       arthritis

·       bone spur

·       carotid artery occlusion

·       cerebrovascular accident

·       chest pain

·       contact dermatitis

·       contusion

·       diabetes mellitus

·       dyspepsia

·       hearing loss

·       pleural effusion

·       transient ischemic attack

·       urinary retention

·       vertigo

·       vomiting

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